ASPR’s Response to the Bundibugyo Ebolavirus Outbreak
HHS is coordinating with federal and international partners in responding to the ongoing Ebola Bundibugyo outbreak in the Democratic Republic of the Congo (DRC) and Uganda. As part of that response, ASPR is coordinating preparedness and medical response activities. This is a coordinated, whole-of-government effort and we are working to ensure the safety of Americans at home and abroad.
ASPR is supporting access to an investigational medical countermeasure for potential use in high-risk exposed individuals. In addition, ASPR is supporting efforts to [BM1.1]maintain readiness across the National Special Pathogen System, including the National Emerging Special Pathogens Training and Education Center (NETEC) and Regional Emerging Special Pathogen Treatment Centers (RESPTCs).
Medical Countermeasures
The Biomedical Advanced Research and Development Authority (BARDA) within ASPR has played a major role in advancing Ebola Zaire medical countermeasures over the past decade through public-private partnerships, supporting diagnostics, vaccines, therapeutics, and manufacturing capacity. These efforts have led to the first FDA approvals for a vaccine (ERVEBO), two Zaire therapeutics (Inmazeb and Ebanga), and a rapid antigen diagnostic (OraQuick).
BARDA continues to invest in additional vaccines and therapeutics for Sudan and Marburg viruses to increase national preparedness. BARDA is currently evaluating candidates for Bundibugyo. These efforts are part of ASPR’s broader mission to strengthen national preparedness for high-consequence infectious diseases.
There are currently no FDA-approved treatments or vaccines specifically for Bundibugyo ebolavirus. MappBio’s MBP134 is an investigational monoclonal antibody treatment that is being evaluated with BARDA support to address Sudan virus, which is closely related to other ebolaviruses. Laboratory data suggest that MBP134 may be effective against Bundibugyo ebolavirus. The product has also completed a phase I study for safety.
BARDA is supporting access to MBP134 for potential use in high-risk exposed individuals. Any potential use of the product is being coordinated through a whole-of-government approach that includes ASPR, FDA, and the Department of State.
An investigational medical countermeasure is a product that is still being evaluated and has not yet received FDA approval for general use. In certain public health or emergency situations, the FDA can authorize access to investigational products through established regulatory pathways when no approved alternatives are available and the potential benefits may outweigh the risks.
The National Special Pathogen System
ASPR’s Center for Preparedness supports and coordinates with the NSPS, which helps the country prepare the health care system, protect the health care workforce, and respond to special pathogen events by coordinating special pathogen care across the United States. The NSPS is a tiered system of care with four facility levels that have increasing capabilities to care for suspected or confirmed patients with high consequence infectious diseases (HCIDs).
Within the NSPS, the 13 RESPTCs provide the highest level of care. The RESPTCs are regional resource hubs which provide highly specialized care, designed to treat and care for patients for their duration of illness.
As part of routine preparedness planning for high-consequence infectious diseases, ASPR maintains visibility of the readiness status of each RESPTC, including reviewing bed capacity, staffing, diagnostic testing, transport, and waste management capabilities to ensure the U.S. health care system is prepared to safely evaluate and care for patients infected with Bundibugyo ebolavirus if needed.