From 2014 to 2016, the world witnessed one of the worst naturally-emerged infectious disease outbreaks in Western Africa. The Ebola Zaire (EBOV) outbreak started in Guinea and quickly spread to neighboring countries of Liberia and Sierra Leone and threatened the entire globe with a potential pandemic. This outbreak resulted in 28,616 cases and 11,310 deaths (case fatality ratio of ~39.5%). During that outbreak, Defense Biological Products Assurance Office (DBPAO), at that time known as Critical Reagents Program (CRP), supported the relief efforts on several fronts through its Targeted Acquisition of Reference Materials Augmenting Capabilities (TARMAC) initiative in what was viewed as an unprecedented rapid response by DOD.
CRP worked in close collaboration with other U.S. Government (USG) partners and sister organizations, such as U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Naval Medical Research Center (NMRC), Joint Project Manager Medical Countermeasure System (JPM MCS), Defense Threat Reduction Agency Cooperative Biological Engagement Program (DTRA CBEP), and JPM MCSDiagnostics. CRP provided support to two reference labs (one in Kenema, Sierra Leone and the Liberian Institute of Biomedical Research (LIBR) lab, Liberia) including detection assays to test patient samples for EBOV infection, and provided logistical support through its online ordering system, Ordering System for Assays and Reagents (OSCAR). The prepositioning of infrastructure, materials and personnel resources in these countries enabled an effective USG response to a rapidly evolving and quickly spreading outbreak. In addition, CRP was able to track the rapidly evolving (in the literal sense) EBOV genome for signature erosion in order to continuously monitor the effectiveness of DBPAO assays. During the outbreak, several thousand DBPAO/pre- Emergency Use Authorization (EUA) assays were used in the field attesting to the huge impact CRP/TARMAC was able to make. Since then, DBPAO has invested heavily on building expansive capacities in various parts of Africa and other strategic locations of the globe in an effort to shrink the response time and get actionable information. One pathway DBPAO employed to accomplish this goal was through a funded partnership with National Strategic Research Institute (NSRI)/ Institut National de Recherche Biomédicale (INRB). The effectiveness of this approach became apparent at the INRB lab in deciphering the etiological agents and their whole genome architecture within a short period of time in two separate instances, caused by Crimean-Congo hemorrhagic fever (CCHF) and Monkeypox virus. The partnership with NSRI was also responsible for generating whole genome sequences for a number of Lassa virus isolates from this endemic region for signature erosion analyses.
Recently, two independent Ebola outbreaks occurred from May to July 2018, one in Bikoro, Equateur Province, Democratic Republic of Congo (DRC) and the other in North Kivu province near the Ugandan border of the DRC. In both instances, DBPAO-funded NSRI researchers were able to generate whole genome sequence data which enabled in silico evaluation of effectiveness of DBPAO assays, all within a couple of weeks after sample receipt. In addition, DBPAO EBOV assays have been deployed to INRB for the testing of suspected patient samples. Thus, DBPAO has changed the response approach in an outbreak event by placing resources in the field rather than the traditional way of trying to bring samples to the U.S. for testing and countermeasure development, which may take months if not years. This paradigm shift has resulted in a ~25x reduction in time from sample collection to an actionable response.