By Lillian Parr
As the COVID-19 pandemic has highlighted, rapid detection and swift information sharing are key to stemming the spread of emergent infectious diseases and their variants. To gain insight into a novel pathogen or variant, it must be quickly sequenced and analyzed to determine what threat it poses and what interventions are most likely to be effective.
The recent monkeypox outbreak shows the importance of a rapid response: sequencing has found two strains of the virus circulating in the United States, raising concerns that it has been circulating undetected for a significant period of time.
Currently, regions that lack the technical capacity to sequence and analyze potentially-novel pathogens detected through their biosurveillance systems need to send their samples abroad for further processing. At this time, the process of sending and sharing pathogens is mostly guided by bilateral agreements between countries and done on an ad hoc basis. This can be inefficient, as there is not always a clear and pre-established procedure that can immediately begin when needed.
Another issue in this space is that when countries share pathogen samples with other countries, they have historically not always reaped the benefits of research conducted using their samples. In some cases, for example, low-income countries send pathogen samples to high-income countries but do not receive ready access to the medical countermeasures developed in high-income countries. Though there are now mechanisms in place to address this, the protocols are bureaucratically cumbersome, which slows response activities in a public health emergency. Additionally, these protocols only mandate the bilateral sharing of information and materials, meaning that research results are not necessarily shared broadly, and countries that may benefit will not necessarily have access.
The World Health Organization (WHO) aims to address these issues with a new initiative called BioHub, which will designate a network of specific laboratories to serve as distribution and research hubs for pathogen samples. Countries that encounter a potentially novel pathogen or a variant will be able to safely and securely send their sample to one of these designated facilities, which will then conduct deep sequencing, analysis, and risk assessment that could not be done in the country where the sample originated. Sequences and research will then be quickly shared with all WHO Member States, providing useful information for the development of vaccines and diagnostics and helping to inform intervention tactics.
State and non-state entities may request samples from one of the designated laboratories in order to conduct their own biodefense research, particularly toward the development of medical countermeasures. These requests must be approved by the WHO through an agreement designed to minimize information and biosecurity risks. The agreement also ensures that research publications are widely accessible and appropriately credit the researchers who contributed samples. Through this process, the BioHub will allow for clearer understanding of where dangerous pathogen samples are stored and when they are transported, an improvement upon the decentralized and opaque status quo. This degree of transparency and oversight may help prevent pathogens from being used in unsafe research or for nefarious purposes. As such, the BioHub will not only improve pandemic response, but may be a valuable biosecurity tool.
The BioHub began a pilot phase in May 2021 by establishing a designated distribution and research facility at the Spiez Laboratory in Spiez, Switzerland. The Spiez Laboratory is a world-renowned facility with the resources necessary to safely store pathogens, conduct research and risk assessments, and transport pathogen samples securely to other labs. Currently, the pilot phase is focusing solely on SARS-CoV-2 variants to test the feasibility of the system. If the pilot phase is successful, the BioHub will expand to form an international network of trusted facilities that will assist in sharing samples for all emerging pathogens and variants.
The pilot program has also worked on promoting the sharing of biological materials with manufacturers in an effort to create a system that develops medical products in a more distributed and equitable fashion to all countries. During the pilot phase, material products are not expected to be developed, but public health information and tools that are generated will be shared with all WHO Member States.
If material benefits are produced, the WHO will work to ensure that they are equitably distributed to Member States. CSR’s recent research has indicated that getting this right will be a potent driver of whether countries are more trusting and cooperative—or uncooperative and nationalistic—in biological threat reduction in the future.
Based on the results of the pilot phase, the WHO will determine the best methods for equitable distribution. This will be a critical measure to improve the access of lower income countries to medical countermeasures, and to improve international trust. Ensuring that populations across the world have access to vaccines will help lower disease circulation rates, saving lives and lessening the chances of new variants emerging.
The BioHub is still in its early stages, and a great deal of work must be done before the system is fully operational. However, it holds significant promise for improving states’ abilities to quickly and effectively respond to health emergencies in an equitable manner, and will be a valuable tool in a robust early warning system in a time of heightened biological risks.