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Recap of SBSTTA 26 - what happened to gene drives?
At the 26th meeting of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA 26) to the Convention of Biological Diversity (CBD) Gene Drives received significant attention in the context of the CBD’s horizon scanning of new challenges arising from synthetic biology as well as the Biosafety Protocol’s guidelines for risk assessment and risk management. Stop Gene Drives followed closely the preparation of texts to be adopted at the upcoming Conference of the Parties (COP16) in Cali, Colombia, this October.
At the last COP15 in 2022, adopting the "Kunming-Montreal Global Biodiversity Framework 2020", two pivotal decisions concerning Synthetic Biology and the risk assessment of Gene Drives had been adopted and two ad hoc technical expert groups (AHTEG) were established. A multidisciplinary one (mAHTEG) was charged with designing a horizon scanning, technology assessment, and monitoring methodology to evaluate impacts of future technologies on biodiversity. It’s 'multidisciplinary' was hard-won and is still a contentious issue. Barbara Pilz of Stop Gene Drives was amongst the members of this group. The second AHTEG with no m focused on developing voluntary guidelines for the risk assessment of mosquitoes containing genetically engineered Gene Drives.
The groups produced reports on synthetic biology and on case-by-case risk assessment of living modified organisms containing engineered gene drives. From these reports national representatives gathered in Nairobi were expected to draft recommendations for COP16.
The first day of SBSTTA 26 saw both topics discussed in the plenary, allowing the Chair to gauge whether these issues were contentious enough to warrant further group discussions (called “contact groups” in UNish) or if they could be addressed in the plenary itself. The risk assessment guidelines for engineered Gene Drives, developed by the AHTEG, identified major risks and uncertainties, such as gene flow to non-target species, potential transboundary movements, and significant public health risks. While these guidelines provided a foundation, they were criticized for using methodologies for GMO assessment and not a Gene Drive specific assessment. Questions about potential conflicts of interest within this AHTEG were raised.
The discussions on the AHTEG were less controversial compared to those on synthetic biology. However, significant portions of the text were put in brackets, indicating that no consensus was reached at the SBBSTA and further discussions will be needed at COP16. The majority in the plenary welcomed the work of AHTEG. However, while some argued that there was no need for further AHTEG meetings, many countries, particularly African nations where Gene Drives might first be tested, called for more refined guidelines that could truly aid practitioners in assessing gene drive risks. COP16 will now have to decide whether the Cartagena Protocol maintains its expert group and continues providing oversight and resources to the parties, or closes this chapter. As usual, there was a general agreement on the need for increased capacity building. NGO as well as Youth observer groups emphasized the precautionary principle, criticized the overreliance on computer modeling in the guidance materials. They called for further AHTEG sessions and refined methodologies.
In the synthetic biology discussions, the report from the multidisciplinary ad hoc technical expert group (mAHTEG) was insightful, despite the limited time available to assess technologies after extensive methodology development. The experts recognized that some assessed technologies warranted precautionary measures and broader evaluations including socio-economic, cultural, and ethical considerations. The report specifically recommended to conduct such in-depth assessments for Gene Drives. During the debates, there was a clear division between those favoring continued horizon scanning and others advocating for a shift towards capacity building. The African group generally saw the value in an expert group that could assess emerging technologies and inform state decisions, also calling for capacity building, technology transfer, and cooperation in the field of synthetic biology. However, differences emerged on what this would entail, with asking when discussions would shift from risks to benefits, hinting at an interest in developing Gene Drives. Meanwhile, other African states sought "appropriate" technology transfers to avoid becoming dumping grounds for untested and unsafe Western technologies.
A faction within the room, particularly Argentina, Brazil, Japan, and New Zealand, strongly supported the call for recognizing benefits. During the plenary, Argentina proposed an action plan on synthetic biology that would promote such technologies globally.
The two options at hand during the contact group were quite opposing:
- continuation of the mAHTEG with proper horizon scanning and capacity building also for risk assessment and monitoring
- promotion of synthetic biology worldwide with a new action plan, and reducing the mAHTEG to conduct a literature review
Brazil criticized the mAHTEG members as lacking expertise and other states supported this reasoning. The mAHTEG’s assessments that these technologies posed risks not only to biodiversity but also to society and livelihoods were obviously not well received by states promoting synthetic biology. There were further attempts to obstruct the process, in line with an incident at COP15 where a delegate boasted about "killing the process" before COP16.
The recommendations SBSTTA delegates finally agreed to send to COP16 fails to reflect the mAHTEG's clear formulations and recommendations, particularly on Gene Drives. It is crucial that the mAHTEG continues in its current or an enhanced form, and not be diminished to only review predominantly English literature from mostly Western institutions and patent holders. Also, capacity building and technology transfer must reduce disparities between more or less industrialised countries, rather than serving as avenues for testing potentially harmful technologies.
The document prepared for COP16 suggests that the current methodologies are sufficient for assessing environmental and socio-economic impacts of Gene Drives, which is misleading. These methodologies were originally designed to assess the risks of GMOs cultivated and traded in restricted agricultural environments. These are fundamentally different from Gene Drives, designed to spread in the environment and alter entire species in their wild habitats. This inadequacy extends to monitoring capabilities, making it challenging to manage GDOs effectively if issues arise.
Significant efforts are required both before and during COP16 to ensure that parties advocate for the continuation of the mAHTEG on horizon scanning for synthetic biology and the AHTEG on risk assessment. These efforts are crucial for developing a truly robust methodology for assessing the risks associated with Gene Drives.
Seminar and Press Conference on Gene Drives in Nairobi
This morning, Friday 17th of May, Save Our Seeds with Pollinis hosted a hybrid seminar on GMOs and gene drives. This event offered an exceptional opportunity to gain insights into the political landscape surrounding GMOs and the increasingly contentious topic of gene drives currently under consideration at the United Nations Convention on Biological Diversity. Our expert speakers, fresh from the recent SBSTTA discussions, shed light on what transpired during those crucial debates and what it means for local contexts.
Following the seminar we hosted a press conference attended by journalists from several African countries.
Press Release
UN Body Considers Risky New Genetic Technologies: Civil Society Urges Precaution
Nairobi, Kenya, May 17 2024: Parties to the United Nations Convention on Biological Diversity (CBD) are currently discussing controversial technologies in Nairobi. One such technology is engineered gene drives. It is a form of extreme genetic engineering which is designed to spread its modification throughout an entire species and persist in the environment. In Africa, gene drive projects, largely funded by the Bill and Melinda Gates Foundation, are already underway in several countries including Burkina Faso, Ghana, Uganda and most recently in Tanzania, aiming to eradicate malaria. However, these techno-fixes do not address the root causes of health challenges on the continent and pose novel risks. Furthermore, these projects are proceeding despite the absence of adequate local capacity to assess and regulate them effectively.
While gene drive lobbyists, at the 26th meeting of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) to the CBD in Nairobi, use the possibility of malaria eradication to promote the technology, civil society organizations have found that most patents are being filed for agricultural use. Patents reference hundreds of agricultural uses, such as for herbicides, pesticides and so called “pests”. Researchers found that agribusiness firms such as Monsanto-Bayer and Cibus Bioscience were also engaging with gene drive development.
At this year’s SBSTTA meeting, member states are examining reports from expert groups, highlighting numerous risks and unanswered questions about gene drives. Discussions are particularly focused on the contrasting potential benefits and risks these technologies might pose. Sub-Saharan countries are advocating for enhanced capacity building, technology transfer, and some seem to be willing to adopt gene drives. African civil society organizations (CSOs) are calling for ongoing evaluations and a robust, updated regulatory framework to manage these technologies. They endorse a precautionary approach and support the establishment of an international expert group to review new technologies before they are introduced to the environment.
Decisions made at SBSTTA will be taken to the Conference of the Parties to the CBD in October 2024 to be further discussed, where heads of states will decide on how to proceed with these technologies.
Contacts:
Sabrina Masinjila
African Centre for Biodiversity
+255 767 089 834
Barbara Ntambirweki
ETC Group Uganda
bntamby@gmail.com
References:
Gene Drive Brochure
Forcing the Farm:
https://www.etcgroup.org/content/forcing-farm
SBSTTA 26: Robust risk assessment needed for LMOs containing engineered gene drives
As participants in the 26th Subsidiary Body on Scientific, Technical, and Technological Advice (SBSTTA 26) of the UN Convention on Biological Diversity (CBD), we will be sharing insights through articles authored by members of the CBD-Alliance's Working Group on Synthetic Biology, to which we belong.
Key topics of discussion at the Nairobi conference include synthetic biology and the risk assessment of gene drives. For more detailed information on the issues at play, we invite you to consult the briefings (short/long) we have developed in preparation for this conference.
Please find below an article by our partner Dr Eva Sirinathsinghji from Third World Network:
Robust risk assessment needed for LMOs containing engineered gene drives
The development of living-modified organisms containing engineered gene drives (EGD-LMOs) has raised significant controversy due to their explicit design intention of spread and persistence within wild populations.
The novelties of EGD-LMOs raise fundamental challenges to (i) the ability to assess risk; (ii) the capacity to mitigate or recall them; (iii) the ability to prevent transboundary movement; (iv) assessment of socio-economic impacts; (v) operationalizing mechanisms of obtaining free, prior and informed consent; and (vi) liability and redress.
In decision 14/19, Parties recognized that specific guidance may be useful for the risk assessment of EGD-LMOs and set out precautionary conditions that should be met before any consideration of environmental release. The AHTEG on Risk Assessment has now developed guidance materials, for discussion at SBSTTA-26.
The guidance identifies major risks and uncertainties of EGD-LMOs, including the potential for gene flow to non-target species, the likely inability to isolate or prevent transboundary movement for some EGD-LMOs, and potential serious risks to human health for public health applications.
However, while the guidance provides a starting point, it lacks methodological guidance on how to address the identified risks and uncertainties. There is an overemphasis on describing a new methodology, but not how it can be applied specifically to EGD-LMOs.
Moreover, concerns were raised over a potential conflict of interest involving a member of the AHTEG, and an associated failure by this individual to disclose the relevant situation in accordance with decision 14/33.
We therefore call on Parties to:
- Improve the draft guidance materials and define appropriate modalities to do so
- Ensure the proper application of the procedure for avoiding or managing conflicts of interest, including adopting the amendments set out in CBD/SBI/4/11
- Ensure a wider assessment of the socioeconomic, cultural, and ethical impacts of EGD-LMOs
- Reaffirm the precautionary approach and ensure no release of high-risk and unassessed EGD-LMOs.
SBSTTA 26: Ensuring good governance of synthetic biology
As participants in the 26th Subsidiary Body on Scientific, Technical, and Technological Advice (SBSTTA 26) of the UN Convention on Biological Diversity (CBD), we will be sharing insights through articles authored by members of the CBD-Alliance's Working Group on Synthetic Biology, to which we belong.
Key topics of discussion at the Nairobi conference include synthetic biology and the risk assessment of gene drives. For more detailed information on the issues at play, we invite you to consult the briefings (short/long) we have developed in preparation for this conference.
Please find below an introductory article from the Working Group on Synthetic Biology:
Ensuring good governance of synthetic biology
At the Conference of Parties (COP) 15 of the Convention of Biodiversity, Parties established, in Decision 15/31, a “broad and regular” process of multidisciplinary horizon scanning, assessment and monitoring of new developments in Synthetic Biology. The need for this process was already identified by Parties in Decision 14/19, and provides a means for governments to collaboratively track and provide timely responses to biodiversity threats and opportunities emerging from modern biotechnology developments.
In the past two years, the multidisciplinary Ad Hoc Technical Expert Group (mATHEG) on Synthetic Biology undertook extensive work to design, review and test a working methodology for the broad and regular process. This was reported as Annex IV of CBD/ SBSTTA/26/4. It involves an expert-driven process with multiple steps of information gathering, synthesis, screening, selection, filtration, and analysis.
The mAHTEG identified 5 priority topics for assessment: self-spreading vaccines for wildlife, self- limiting insect systems, development of engineered gene drives to control vector-borne diseases and invasive species, integration of artificial Intelligence and machine learning, and inequity in the participation of developing countries in the context of synthetic biology.
The group undertook a first round of multidisciplinary horizon scanning, monitoring, and assessment for these 5 topics, reported their findings, and articulated proposals for further policy work.
They identified key areas of developments for policy attention, and issued a set of recommendations to the SBSTTA. Read the CBDA Working group on synthetic biology brief on this topic here- https://cbd-alliance.org/en/2024/factsheet-synthetic-biology
Drawing on the work of the mAHTEG, we believe the Parties at SBSTTA 26 should:
- Agree the methodology of the broad and regular process, as outlined and road-tested by the mAHTEG, and confirm that the process should occur at least each biennium (ie; between every COP).
- Re-emphasize the importance of multidisciplinarity and precaution to the functioning of the broad and regular process.
- Initiate timely policy formulation processes on priority topics identified by the mAHTEG, including 1. The Integration of Artificial Intelligence (AI) with synthetic biology and 2. Self- spreading vaccines for wildlife.
- Request that assessment guidelines on gene drives also incorporate socioeconomic, cultural, and ethical impacts.
- Address other topics raised by the mAHTEG: including issues of North-South equity, self- limiting insects, technology facilitation, and capacity-building for horizon scanning, assessment and monitoring activities.
- Ensure no release of high risk and unassessed synthetic biology organisms, components, or products takes place.
World Malaria Day 2023 and the gene drives deception
World Malaria Day 2023 and the gene drives deception
At the occasion of World Malaria Day (25 April), the Stop Gene Drives Campaign encourages you to take a closer look at the insights and perspectives shared by prominent actors and other organisations closely monitoring the subject on this significant day.
By 2030, the World Health Organization (WHO) hopes to reduce the global malaria burden by ninety percent (in comparison to a 2015 baseline). Running against the clock, facing unforeseen obstacles, and with multiple interests on the table, recent years have seen setbacks in the progress of malaria control.
Particularly during the Covid-19 pandemic, health service disruptions, diverted resources, and reduced access to affected communities posed concrete obstacles towards the 2030 target.
Aiming at overcoming such obstacles and accelerating the process, the 2023 World Malaria Day was marked by the theme “Time to deliver zero malaria: invest, innovate, implement”. On social media and online, this slogan was well exploited to reinforce a narrative in which biotechnology (particularly gene drives) is the pinnacle of innovation in malaria control.
We invite you to look at a few examples and join us in uncovering the stories behind them.
A new type of celebrity
Target Malaria, a controversial research consortium backed by US military funding from DARPA, took the opportunity to reinforce its narrative of innovation equals solution.
In their story, scientists are the equivalent of rockstars, who will use their latest creations to save the world from malaria. They insist that urgent innovation (i.e. new genetic technologies, particularly gene drives to eradicate mosquitos) is the only viable remedy in the face of the critical situation. This scenario, in their view, seems to exist is a vacuum where risks are minimal and negative consequences are not taken into account. Other organisations followed a similar recipe of presenting ‘science and innovation’ as the (only) tools that can put malaria control back on track. (See examples here, here and here)
This tunnel-vision narrative is dangerous and deceptive. In addition to spreading misinformation, efforts that are led by pressure to produce immediate results and return on investment, can easily overlook risks, produce flawed results, and only address issues at surface level. In addition to that, it creates momentum towards a false idea that a final solution to the malaria burden has been found – which is unfortunately still not a reality.
A deep wound cannot be treated with a bandage
Fighting malaria is a complex issue that requires structural and long-term solutions. The push for the deployment of technologies (such as gene drives) ignores both ecological risks and context-related challenges.
At the occasion of World Malaria Day 2023, several organisations and actors raised concerns about why it is crucial to go beyond the superficial, quick-fix/technical aspect of fighting malaria.
The most recurrent concerns highlighted the need to also fight socio-economic and infrastructural factors that enable the prevalence of malaria. These include poverty, gender and other inequalities, inadequate water, sanitation, and hygiene infrastructure, and lack of access to education and healthcare.
Some argue that every malaria case is preventable and avoidable, urging global leaders to increase funding and action. They promote different tools such as enhanced bed nets, vaccines, monoclonal antibodies, and mosquito sugar baits. Advocating for a holistic approach that provides communities with necessary tools and addresses underlying causes. (See examples here, here, and here)
What else is there to uncover?
There seems to be a consensus among those engaged in eradicating malaria that progress towards a dramatic reduction by 2030 is delayed. In this context, narratives that advocate for rushed ‘innovation’ and new technologies as the solution tend to overlook risks and potential irreversible ripple effects.
The emergency of new challenges, such as the detection of a new malaria vector in Sub-Saharan Africa, highlights the importance of carefully considering whether technofixes can soon become obsolete. This is in addition to being sensitive to the myriad of cascading effects that the deployment of an unpredictable and irreversible technology could have in ecosystems and human health.
Research aimed at malaria eradication should be conducted with caution and responsibility as well as be based on serious and accurate scientific methods and findings. Furthermore, it should explore multiple solutions and alternatives (e.g., nets, antimalarial drugs, vaccine, etc.) and not exist in isolation from its context. All efforts to reduce the malaria burden need to consider and address the underlying socio-economic and infrastructural factors that contribute to its prevalence.
Finally, breaking down the narratives and stories being communicated on the topic can be helpful to uncover hidden agendas and identify oversights in the evaluation of tools and methods to eradicate malaria. Hopefully, contributing to a more adequate and informed evaluation of options and balanced and responsible decision-making in fighting malaria.
Further resources:
Learn more here about the applications and risks of gene drives in the context of malaria eradication.
Access here the African Center for Biodiversity’s analysis on the linkages between capitalism and malaria.
Watch here an interview with Burkinabé activists Ali Tapsoba and Guy Yameogo assessing community engagement for gene drive release in their country.
Access here some insights from front line workers on the issue of gene drives and malaria.
What happened to Gene Drives at COP15 of the UN Convention on Biodiversity?
What happened to Gene Drives at COP15 of the UN Convention on Biodiversity?
In December 2022, States from all around the world gathered in snowy Montreal to discuss the future of biodiversity protection and conservation until 2030. What did they have to say about new technologies such as gene drives?
The Post-2020 Biodiversity Framework (GBF) has been often referred as a ‘breakthrough’ to halt biodiversity loss. However, the discussions and decisions made in Montreal left synthetic biology watchdogs, like the Stop Gene Drives Campaign, with a bitter aftertaste of corporate influence.
Biotechnology giants such as Brazil and Argentina strongly negotiated to remove any mentions to the precautionary principle and risk assessment from all texts. There was also persistence in inserting the dogma of ‘innovation’ wherever possible. After five Open Ended Working Groups over the course of three years and two weeks of COP15 discussions, the world is left with a Target 17 on Biotechnology that does not do anything beyond reiterating the CBD Convention of 1992. One clear sign that the world of biotechnology has evolved since 1992 is that some of the negotiators sitting at the table today were born in that year. Unfortunately, the new Post-2020 Biodiversity Framework does not seem to keep up with it.
In good time, not all was gloom in Montreal. In addition to adopting the GBF, COP15 managed to set up a new multidisciplinary Ad-Hoc Technical Expert Group for horizon scanning, monitoring and technology assessment of synthetic biology. “Expertise from a broad range of scientific disciplines, as well as interdisciplinary and intercultural expertise, indigenous peoples and local communities” will be included in the process.
Another constructive aspect of the decision is that the conflict of interest resolution from the COP14 will apply, aiming to ensure the scientific integrity and independence of the work of expert groups. It builds on harmful past experiences revealed in the Gene Drives Files (= documents obtained under the US freedom of information provisions showing that the Bill and Melinda Gates Foundation financed an agribusiness public affairs firm to covertly skew an expert process under the CBD in order to lobby against the regulation of GDOs). This is an attempt to confine so called ‘independent’ scientist acting on behalf of philanthropists and billionaires in CBD expert groups.
When it comes to the particular issue of gene drives, the most relevant decision was taken at the meeting of the Parties to the Cartagena Protocol (CP-MOP 10). This Protocol manages biosafety matters. Gene Drives present new uncharted challenges in comparison to ‘classic’ Genetically Modified Organisms covered by the Protocol. Accordingly, an Ad-Hoc Technical Expert Group was established in Montreal to develop additional guidance materials on risk assessment and management of gene drive organisms. Important to note: without the ‘m’ of multidisciplinary.
The focus area of this group will be gene drive mosquitoes, as for them gene drives have been furthest developed to date. These guidance materials will be of voluntary nature, but will help to inform risk assessment globally and, hopefully, unveil open questions, concerns and challenges regarding impacts of gene drives on the environment.
What lies ahead?
The next one to two years are decisive for the (multidisciplinary) technical expert groups scanning biotechnologies like gene drives and working on guidance materials. In the meantime, governments and their institutions, Indigenous Peoples and Local communities, and civil society organizations can submit information to be considered by the expert groups. These actors can also directly participate in online forums to raise their concerns and open questions on synthetic biology and gene drives.
At the next COP (16) in Turkey, States will discuss whether the process of horizon scanning and technology assessment should be continued. They will as well present the indicators that will help to measure the progress of reaching Target 17. We are curious to see how the ‘successful’ attainment of that Target will be measured and for what sorts of projects governments will be eligible for funding.
In short, this means two broad possibilities. On the one hand, the UN CBD could continue requesting risk assessment of new technologies such as gene drives in order to be able to measure all their impacts on biodiversity. On the other hand, the process can be cut short and no risk assessment would be guaranteed.
Finally, when it comes to gene drives under the Cartagena Protocol we hope that the process will genuinely work towards better equipping national governments for risk assessment of gene drives.
At the Stop Gene Drives campaign, we believe that a thorough and holistic risk assessment of gene drives will further expose that current levels of scientific understanding are not sufficient to predict their (irreversible) potential impacts. This would bring yet more clarity on why the release of gene drives into the environment is incompatible with the objectives of the Convention and its Protocols.
Further COP related posts/articles by the Stop Gene Drive Campaign:
ECO articles during the COP15:
01.12.2022 Gene drives are the opposite of nature conservation
05.12.2022 Ecuador’s Galápagos Islands are not a laboratory for testing risky gene drive organisms
07.12.2022 All CBD watchdogs should guard against synthetic biology threats to biodiversity
10.12.2022 Brazilian intransigence on biotech is a violation of human rights
18.12.2022 Snowman to snow-mess: negotiations at COP15 are opening doors to risky technologies
Blogpost leading up to the Conference:
Gene drives are the opposite of nature conservation
Gene drives are the opposite of nature conservation
Civil society organisations around the globe demand a moratorium on genetically engineered gene drives at UN Biodiversity Conference
Berlin, 1 December 2022 – Ahead of the UN Biodiversity Conference COP 15 and its Cartagena Protocol on Biosafety in Montreal over 140 civil society organisations from Africa, Asia, Europe, Australia and the Americas have issued a joint manifesto exposing alarming risks of environmental releases of genetically engineered gene drive organisms which could lead to irreversible ecological consequences and drive entire species into extinction.
Gene drives use new genetic engineering techniques such as CRISPR-Cas to forcibly spread new genetic information within the genome of populations and entire species of organisms in nature, including traits that can cause their extinction. The signatories of the manifesto are urging national governments at COP15 to resolve critical legal, environmental, biosafety and governance issues as well as fundamental ethical and cultural questions before considering any environmental release of gene drive organisms.
The call for a global moratorium is consistent with demands at previous occasions including at COP13 in Cancun and COP14 in Sharm El-Sheikh. “This controversy will not go away”, said Barbara Pilz, who coordinates the international Stop Gene Drives campaign. “We will continue to fight for a global moratorium on this pretentious concept of reprogramming and extincting entire species in nature.”
The manifesto highlights the need for thorough and genuine risk assessment and uncovers the lack of participatory decision-making processes on this topic to date. It proposes the inclusion of multi-disciplinary expertise and respect for diverse knowledge systems in any processes of technology assessment involving gene drives. This should include indigenous peoples and local communities whose territories are among those being proposed for the first releases of gene drive organisms.
Recalling the goals of the UN Convention on Biological Diversity, Pilz added:
“We urge decision makers at COP15 to approach the issue of gene drives with utmost caution. Once released, they cannot be controlled, reversed or recalled and will respect no borders. This technology adds immense risks to the conservation of biological diversity and is at odds with the concept of nature protection. Let us not create another destructive legacy to future generations. ”
Representatives of the Stop Gene Drives campaign and of other signatories of the manifesto will attend the events of the Convention on Biological Diversity in person in Montreal this December and can be reached for comment. They will join other strong civil society voices striving for inclusive and participatory processes of precautionary technology assessment and equitable decision making on the subject of synthetic biology and gene drives.
The full text of the manifesto is available here and it is still open for signature.
Contact details in Montreal:
Naomi Kosmehl (Public Relations Lead) – kosmehl@saveourseeds.org
Barbara Pilz (Campaign Manager) – pilz@saveourseeds.org
Phone number: +49 152 23 678426
Further links:
Brochure – Gene Drive Organisms. A New Dimension Of Genetic Engineering: Applications, Risks and Regulation.
Video interview series – Worldwide: Experts on Gene Drives.
Are gene drives natural phenomena?
One of the most commonly recycled arguments in the world of gene drive research is that gene drives are natural. More specifically, there has been an attempt in the public discussion to make it seem like there is no material difference between an engineered gene drive using CRISPR-Cas technology and a naturally occurring selfish genetic element (which are indeed found occasionally in nature).
Convincing the non-scientific public that there is little difference between a novel, laboratory-based genetic modification, altered to have a genetic trait based on purely human design or intention and an age-old, naturally evolved, evolutionarily beneficial phenomenon is perhaps one of the most useful tricks in the attempt to make gene drive technology more accepted by the public and policy makers. This attempt to change the definition of a gene drive to make it more publically palatable, extending the definition of gene drive to include both natural and synthetic phenomena, was made explicit with the publication of an opinion piece in 2020, penned by gene drive researchers Luke Alphey, Andrea Crisanti, Filippo Randazzo and Omar Akbari, titled ‘Standardising the definition of gene drive’.
A recent scientific letter written by Mark Wells and Ricarda Steinbrecher of Econexus, published in August 2022 in PNAS cell biology, explores these definitions and explains why this shift in definitions is important and cannot go unchallenged. They emphasises why it is particularly important to pay attention to the differences between natural selfish genetic elements and synthetic gene drives, especially in the context of the fraught and high-stakes political and regulatory debate around gene drives currently taking place. They argue that a narrower definition of gene drives is crucial in order to highlight the novelty of the technology- for example the unprecedented, permanent incorporation of homing genes into animals and irreversible genetic chain reaction that is started.
Read the letter from Mark Wells and Ricarda Steinbrecher in PNAS Cell biology here
A new vaccine against malaria
A new vaccine against Malaria
This month saw another breakthrough in the treatment and prevention of malaria, this time with the publication of the phase 2 clinical trial results of the new University of Oxford R21 vaccine against malaria. This vaccine demonstrated an 80% efficacy against malaria, the highest efficacy ever seen in a malaria vaccine. Professor Adrian Hill, co-creator of the Astra Zeneca vaccine, describes it as “the best malaria vaccine yet” and has stated that it could help to reduce deaths from Malaria by 70% by 2030 and could eradicate it by 2040¹. This is a stunning milestone in the campaign to eradicate malaria, an extremely promising therapeutic which could help us end malaria for good. This new vaccine could be viewed as an intervention with minimal risk, and maximal gain- with this development, the case against using the extremely risky, untried and poorly tested gene drive mosquito as a tool to end malaria comes further into question.
Malaria vaccine development has been historically plagued with difficulties, with over 100 potential candidates and so far only one approved vaccine, Mosquirix, approved in 2021². This difficulty stems from the fact that the Plasmodium parasite has many developmental stages, meaning there are thousands of potential targets³. The Mosquirix vaccine has had a difficult start, with a lower efficacy of around 30% for 4 years and is limited in the number of doses that can be produced. That said, there is still good data available for its effectiveness when used in combination with preventative chemotherapy, with one recent study from the London School of Hygiene and Tropical medicine showing a 70% reduction in the chance of hospitalisation and severe illness or death from malaria⁴. However, the new R21 vaccine, developed at the Jenner Institute at Oxford University, shows the highest efficacy yet seen in a malaria vaccine, the first of its kind to surpass the minimum 75% efficacy goal set by the World Health Organisation.
The R21 vaccine trial took place in Burkina Faso, and was carried out in 450 infants between 5-17 months old, the demographic most in need of treatments and prevention of malaria, with 16 percent of deaths in children in Africa caused by malaria. The cohort was split into two groups receiving the new vaccine and one control group: Two groups received a dose of the vaccine with either a higher or lower amount of immune-stimulating adjuvant respectively and the other group received a rabies vaccine as the control group. All of the children received three doses four weeks apart followed by a 4th dose one year later, and were followed for the full two years to see how the vaccine (or control treatment) affected the cases of malaria observed within the cohort.
The higher adjuvant dose performed best, with an 80% relative risk reduction of contracting malaria in the high-adjuvant group compared with the control group, with no serious side-effects reported. The R21 vaccine targets the Plasmodium parasite before it develops in the blood shortly after someone is bitten and is based a small protein from the immature malaria parasite combined with the Matrix-M adjuvant to help increase the immune response⁵. Despite the success, before approval the R21 vaccine must still be tested in larger groups during the ongoing phase 3 trials, involving 4,800 children in Burkina Faso, Mali, Kenya and Tanzania. Professor Halidou Tinto, the trials principal investigator, is confident that the efficacy will be replicated in these phase 3 trials.
R21 marks a real revolution and beacon for hope in the treatment and prevention of malaria. The path towards a vaccine for malaria has been far from smooth, but the potential for bringing us closer to the eradication of malaria in Africa is huge. The vaccine is both very effective, easy to produce and, very importantly, possible to produce for a few dollars- it is possible to produce 200 million doses per year reasonably through the Serum Institute of India and could therefore be rolled out quickly and widely. Professor Tinto hopes that the vaccine will be used from 2023 in around 250,000 children in Burkina Faso, thus maximising the beneficial effects of the vaccine to those who need it most on a short timeline⁶. With innovative new treatments and preventatives emerging such as the R21 vaccine, the chances of drastically reducing the malaria burden and even achieving eradication are looking ever more likely.
References
¹’⁶Anon, 2022. New malaria vaccine comes a step closer as experts say it’s ‘the best yet’. The Guardian. Available at: https://www.theguardian.com/global-development/2022/sep/07/malaria-vaccine-truss-cut-funding [Accessed September 26, 2022].
² Laurens MB. RTS,S/AS01 vaccine (Mosquirix™): an overview. Hum Vaccin Immunother. 2020 Mar 3;16(3):480-489. doi: 10.1080/21645515.2019.1669415. Epub 2019 Oct 22. PMID: 31545128; PMCID: PMC7227679.
³ Mahmoudi S, Keshavarz H. Malaria Vaccine Development: The Need for Novel Approaches: A Review Article. Iran J Parasitol. 2018 Jan-Mar;13(1):1-10. PMID: 29963080; PMCID: PMC6019592.
⁴ Chandramohan, D. et al., 2021. Seasonal malaria vaccination with or without seasonal malaria chemoprevention. New England Journal of Medicine, 385(11), pp.1005–1017.
⁵ Datoo, Mehreen & Magloire, Natama & Somé, Athanase & Bellamy, Duncan & Traore, Ousmane & Rouamba, Toussaint & Tahita, Marc & Ido, N & Yameogo, Prisca & Valia, Daniel & Millogo, Aida & Ouedraogo, Florence & Soma, Rachidatou & Sawadogo, Seydou & Sorgho, Faizatou & Derra, Karim & Rouamba, Eli & Ramos-Lopez, Fernando & Cairns, Matthew & Tinto, Halidou. (2022). Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after 2 years’ follow-up in children in Burkina Faso: a phase 1/2b randomised controlled trial. The Lancet Infectious Diseases. 10.1016/S1473-3099(22)00442-X.
Can gene drives spread between mosquito species?
Can gene drives spread between mosquito species?
The issue of Malaria in Africa has for a long time been at the forefront of the discussion about gene drive technology. Leading the research is Target Malaria, a non-profit aimed at using genetic means to eliminate malaria. However, despite the initial success in their laboratory studies, there are glaring open questions and unknowns around releasing gene drive Anopheles gambiae sensu strictu mosquitoes into the environment.
High on the list of concerns are the ecological effects. The risk to an ecological system is considerable when we are talking of eliminating just one species. However Anopheles gambiae sensu strictu is just one member of at least nine mosquito species in the ‘Anopheles gambiae complex’ (known as A. gambiae sensu lato, i.e ‘in the wider sense’), a family of mosquito species that look identical and are well-known to interbreed and produce young hybrids that are capable of breeding1. This has already been troublesome for the fight against malaria as it has been shown to lead to the exchange of mutations that help the survival of species within the complex. For example, Anopheles arabiensis acquired genes that make it resistant to dry and arid conditions through A. gambiae s.s and A. coluzzi, and A. coluzzi acquired a gene for insecticide resistance through A. gambiae s.s2,3,4. In the context of a gene drive, which actively forces inheritance of a chosen gene upon all its offspring, the consequences of the exchange of genes between species is even more concerning.
The real risk comes when the target of the gene drive is taken into account. The doublesex gene is an essential gene for sexual development, and thus the disruption of it means females develop into intersex, infertile adults that cannot reproduce5. Breeding rates drop drastically, and the population crashes. Because of its vital importance to mosquito survival, the gene is called ‘highly conserved’- this means natural selection puts a strong pressure on it remaining unchanged. This is useful to the development of a gene drive as it means that less genetic ‘resistance’ develops and the gene drive is more likely to spread without problems. However, it turns out that this gene is so vital to insect development that it remains almost identical in sequence across the whole Anopheles complex (and even across all insects ever investigated for the gene, making interspecies spread through horizontal gene transfer a further risk)6. This identical genetic target, together with the fact of interbreeding, means there is no barrier remaining preventing the gene drive potentially spreading and crashing all 9 species of the A. gambiae complex in Africa. Six of the species under threat play either no or only minor roles in malaria transmission- just the three species A. gambiae sensu strictu, A. coluzzi and A. arabiensis are considered to be major vectors of malaria7,8.
From the linear, simple perspective of malaria control, it could be argued that this is beneficial- why risk it and leave any possibility that other A. gambiae complex species could take over the role of A. gambiae s.s in transmitting malaria? This concern is justified as the replacement of one vector with another has occurred at least once, with Anopheles funestus being replaced with Anopheles rivolurum after the habitat was sprayed with insecticide in rural Tanzania9. However, from an ecological perspective, the elimination of the whole A. gambiae species complex could imply ecological catastrophe. A recent landmark study demonstrated that the alteration of even one gene in a plant that insects rely on can significantly increase the likelihood of insect extinction10. If the alteration of even one gene can have a detrimental impact on biodiversity, it leads naturally to the question of what happens when 9 species are eliminated.
There is an incredible lack of research on the ecological role of A. gambiae, and the little there is seems to be mostly from Target Malaria themselves. To carry out a risk assessment that is in any way close to satisfactory for a gene drive, this ought to be the first priority. However the few studies there are demonstrate an important ecological role of mosquitoes; one study Target Malaria published showed that around 95% of the larvae of the A. gambiae complex are eaten before they develop11. Furthermore, a recent study showed that the number and diversity of birds and dragonflies were reduced following the use of a biological insecticide12. Pollination, vital for the ecosystem, is also at risk; as well as being prey for other insects and birds that are pollinators, Anopheles mosquitoes also need sugar to survive. Mosquitoes actually need to feed on sugar through feeding on nectar more frequently than they do on blood. This behaviour may also play a direct role in pollinating13.
Target Malaria recently made the step of acknowledging the spread of their gene drive to other mosquito species14. However, the central concern of the blog and paper seems to be little more than a game of wordplay and regulatory chess regarding how to define the ‘target organism’ for the purposes of making the risk assessment less complicated. Almost unmentioned in this was the ecological risk; the potential ecological destruction that might ensue as a result of the release of a gene drive being let loose into a ‘leaky’ mosquito species complex.
This question must be taken seriously by developers and regulators. Malaria is indeed a serious issue, but risking the effects of environmental collapse on local populations with a direct reliance on a healthy, resilient ecosystem, could be equally or more deadly. However, due to the impossibility of trialling gene drive organisms in the wild before their official release, the extent of this risk could be overlooked until it is too late. The very nature of their design dictates that any release could result in their unfettered spread, due to the ‘genetic chain-reaction’ that ensues. The current methods suggested to reverse gene drives are entirely theoretical, untested and therefore insufficient to use to remedy the situation should the need arise.
This acknowledgement of the likely spread of the gene drive and subsequent crash of the A. gambiae complex should lead to serious questions around whether this is a safe, reasonable avenue to pursue in the fight against malaria. This risk is just one of many in the story of gene drives and is a neglected area of research. These unanswered questions have led us and many others to call for a global moratorium on the release of gene drives until these risks have been satisfactorily ruled out. To read more on our policy recommendations, click here.
1,6,14John B. Connolly, Jörg Romeis, Yann Devos, Debora C.M. Glandorf, Geoff Turner, Mamadou B. Coulibaly, Gene drive in species complexes: defining target organisms, Trends in Biotechnology, 2022
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7Anopheles gambiae (African malaria mosquito, Mosquito, Malaria mosquito, ANOGA) | BCH-ORGA-SCBD-260392 | Organism | Biosafety Clearing-House (Correct as of September, 2022)
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