By Tom Kariuki, Denis Chopera, May 29, 2024
A volunteer takes part in an Ebola vaccine trial in LIberia. Credit: NIAID. CC BY-SA 2.0.
Editor’s note: This article is part of a collection of expert commentaries. You can read the rest of the series here.
The world is seeing an increase in disease outbreaks that underscore the critical importance of robust biosafety and biosecurity measures in pathogen research. We are emerging from a COVID-19 pandemic that has left a trail of economic devastation throughout the world, and more similar crises are almost guaranteed. These will inevitably affect Africa perhaps more than any other region. After all, the continent grapples with around 80 disease outbreaks a year. Moreover, these are coupled with a perpetual risk that novel diseases will emerge—which is increasingly likely as Africa’s population and global interconnectedness grow and the environment continues to degrade.
These outbreaks, are always swiftly followed by research to understand disease pathogens and to protect humanity, therefore making the responsible conduct of enhanced potential pandemic pathogen (ePPP) research a paramount concern. This research involves experimentally altering potential pandemic pathogens in ways that can alter attributes such as transmissibility and virulence, it’s sometimes called “gain of function” research. Yet gaps still exist in human resources (a particularly acute problem for African institutions); financing; procurement of laboratory supplies and parts; and scheduled audits to sustain biosafety levels.
A lack of national regulations for the design and construction of biosafety level (BSL) laboratories in Africa, has left this expertise elsewhere. Only one country out of the 11 African countries in the Emerging and Dangerous Pathogen Laboratory Network surveyed by the World Health Organization in 2016, for example, had national regulations for the design and construction of BSL-3 laboratories. This is not ideal.
Why are these labs necessary? Pathogen research enables in-depth understanding of the characteristics of different disease agents, such as viruses, bacteria, and fungi and is essential for informing public health efforts such as the development of diagnostic, prevention, and treatment strategies. However, in research, sometimes scientists need to study viruses that are hard to grow in labs or animals. To do this, they might use parts from a different virus that’s easier to grow to create a new virus. This method of studying viruses is deemed safe because the new virus can’t spread further as it lacks the necessary genetic instructions to reproduce itself inside a host cell. There is, however, a risk that the new virus could become highly contagious and more harmful if its genes change and it becomes able to spread beyond one cycle of growth. Typically, research on enhanced potential pandemic pathogens is conducted in high biosafety laboratories, such as BSL-3 labs.
BSL-3 labs are specifically designed to handle dangerous pathogens, including those that can cause serious or deadly diseases through inhalation such as SARS-CoV-2. These laboratories play a crucial role in public health and scientific research. Increasing the number of BSL-3 laboratories in Africa would enhance the region’s capacity to detect, respond to, and prevent infectious diseases, ultimately contributing to global health security. Disease outbreaks are very difficult to contain in settings where appropriate research infrastructure such as BSL-3 facilities does not exist. An example of the problem: During the recent mpox outbreak in the Democratic Republic of Congo (DRC), in which more than 19,000 people were suspected to have been infected, very few cases were confirmed through laboratory testing.
It is imperative to ensure that research adheres to strict biosafety regulations and that there is stringent oversight at both institutional and national levels. The European Union and the United States have robust regulations for conducting enhanced potential pandemic pathogen research. However, this is not the case in Africa, which calls for the need for relevant regional and governmental bodies to put in place laws, rules, regulations, and codes of conduct that address inherent biosafety and biosecurity risks and ensure responsible conduct of such research.
These regulations need to include risk-benefit assessment of enhanced potential pandemic pathogen research and clearly outline the criteria for such an assessment. In addition to having regional and national regulations in place, institutions conducting such research also need to have specific biorisk management and research review processes that are aligned to regional and national regulations. Oversight in the form of laboratory audits and other mechanisms should be enforced to safeguard communities from potential risks associated with enhanced potential pandemic pathogens research. The onus is not only on regulators and institutions, but on funders that can ensure those awarded grants are encouraged to promote biosafety.
At the Science for Africa Foundation, we are funding huge networks that handle pathogens. To further biosafety and biosecurity in Africa, we’re sharing the Bulletin’s A Framework For Tomorrow’s Pathogen Research report, which contains considerations for research with dangerous pathogens. One of us (Tom Kariuki) worked on it as part of the organization’s Pathogen Project Task Force. Independent reviewers of our grants will keep in mind the recommendations of the task force, as public safety is paramount to us.
Responsible conduct of enhanced potential pandemic pathogen research in Africa demands concerted efforts to harmonize regulations at both regional and national levels, bolstered by stringent oversight mechanisms. By prioritizing biosafety and biosecurity measures and ensuring adherence to regulations, we can safeguard public health and mitigate the risks associated with pathogen research on the continent.
This article was produced with the support of Deborah-Fay Ndlovu, Acting Head of Corporate and Science Communication at the SFA Foundation.
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The call for additional P3 labs in Africa seem to pose a series of questions and make variety of assumptions that require a more thorough examination.
The statement that the EU and US have robust regulations for conducting ePPP research and that there are none in Africa is true. But this speaks more to the need for new regulatory and enforcement capabilities than it does to the need for new labs.
Labs should be limited in number and located in politically stable countries where they can be subjected to oversight, and where the infrastructure exists to monitor and control them.
The need for Africa to prefect the use and understanding of this technology is as great and possibly greater than any place on the globe. This must be done in a manner that protects the people and does not make unwarranted assumptions about this technology or the benevolence of those who will control it.
Effectiveness of the Proposed Biosecurity Oversight Framework for the Future of Science, that was published in March of last year in the US, is yet to be proven, and clearly the predecessor framework was not effective. With just CDC and USDA monitoring thousands of government, industrial, academic and private labs, what could go wrong?
The regulations in place within the US and EU are helpful and useful but they alone will do little to prevent dangerous pathogens from being created. Accidents by law abiding well intentioned scientists are not the only ones the world and Africa needs protection from.
In the US today we see a raging debate over what constitutes gain of function research with definitions and interpretation shaped for the convenience of the person speaking at the time. After all, these are words on paper and mean little without struct enforcement.
We see that in the US, an advanced country, regulations which were weak and unenforced, did nothing to detect or prevent COVID-19 from reaching pandemic proportions killing over 1 million people.
An article in this same issue of The Bulletin, is about a team at MIT who were able to order from synthetic DNA providers everything they needed to reproduce the 1918 pandemic influenza virus and the toxin ricin. They concluded that current oversight methods are insufficient to detect even slightly disguised orders of materials that could be used to make select agents.
The international global surveillance network for pathogens should be enhanced so detecting and reporting new pathogens for analysis in the environment can be done in near real-time. Techniques for environmental surveillance such as wastewater analysis should be widely deployed so new pathogens are rapidly identified and contained.
Instead of constructing a system that brings pathogens from the wild back to urban labs where over time they will leak (all labs leak) and impact millions, it is safer to focus on detecting these pathogens as they occur in the wild before they become widespread. Experiments involving ePPPs should be conducted in silico where computer simulations and AI will provide the knowledge and understanding without the global danger.