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​Advancing Biodefense Enterprise Response: Goal 4 Biodefense Highlights

 

Goal 4: Rapidly Respond to Limit the Impacts of Bioincidents — Developing, Testing, and Deploying MCMs against Ebola in the DRC

An infectious disease threat somewhere could be an infectious disease threat anywhere. The USG continually works to develop new and improved measures to protect the public from serious infectious diseases, to accelerate the end of outbreaks at home or abroad, and to reduce deaths and suffering among those infected. The Ebola virus has been a particular concern due to two large, recent outbreaks that threatened to spread well beyond the initially affected areas. 
 
 

Figure 9: Clinical research team at theEbola treatment center in Katwa, DRC Photo Credit: NIAID/WHO​

The mortality rate during the 2014-2016 outbreak in the West African countries of Liberia, Guinea, and Sierra Leone was 40 percent, and the second outbreak, which began in August 2018 in northeastern DRC, currently has a 66 percent mortality rate.11 To reduce morbidity and mortality rates and stop the spread of Ebola, the USG has funded and led vital clinical research. Such research has advanced the development of diagnostics, vaccines, and therapeutics to identify, prevent, and treat the disease. 12, 13, 14

​During the cur​rent outbreak, NIH and the DRC National Institute of Biomedical Research led a consortium coordinated by the World Health Organization (WHO) to conduct an Ebola therapeutics trial comparing a previously tested therapeutics candidate, ZMapp, to three other candidates. Through this clinical research response, two experimental treatment products known as monoclonal antibody 114 (mAb114) and Regeneron Ebola therapeutic​ (REGN-EB3), were found to reduce the risk of death from Ebola. 15

Healthcare-associat​ed transmission of Ebola and healthcare worker infection is also a significant factor in the DRC outbreak. In 2019, CDC collaborated with the WHO and the DRC Ministry of Health to develop and initiate a new infection prevention and control (IPC) training program for a cadre of “IPC supervisors” responsible for training healthcare workers to recognize and prioritize risk at a healthcare facility and determining how to effectively address the IPC gaps that they identify. CDC’s IPC protocols and trainings have reached 1,300 healthcare facilities in the DRC. After the identification of a cluster of Ebola cases in Uganda in 2019, CDC successfully instituted further training to cover 117 additional healthcare facilities in Uganda. No additional cases were reported in Uganda beyond the initial cluster of cases, preventing further spread of the outbreak.

​To safeguard people in America and around the globe from Ebola,HHS agencies have made significant progress in diagnostics,treatment, and prevention of Ebola:12, 13, 14, 15

      • ​​The FDA licensed an Ebola vaccine (the Merck ERVEBO vaccine), which has been widely used to vaccinate individuals in the DRC
      • NIAID scientists and scientists in the DRC, with support from BARDA, developed the Ebola therapy known as mAb114.
      • BARDA has also supported the development of REGN-EB3, as well as ZMapp that was also supported by DOD and NIH; NIH, and partners, also evaluated ZMapp through clinical trials.
      • The Pamoja Tulinde Maisha (PALM) study revealed the importance of timely Ebola treatment. Therapies are most effective if received within a day after the first signs of illness, resulting in an 81 percent survival rate, compared to a 53 percent survival rate among those who started therapy five days after onset of their first symptoms.
      • NIAID and BARDA are supporting the ongoing production ofthe two leading therapeutics, mAb114 and REGN-EB3, for continued use in the DRC outbreak and to ensure there will be adequate reserve supply for the United States if needed.
      • NIH has started a combination therapy study in non-human primates of two experimental Ebola therapies.
      • NIAID’s Integrated Research Facility facilitated the development of rapid diagnostics to enable people with Ebola virus disease to be identified and treated early in the course of their disease.
      • FDA allowed marketing of the first rapid diagnostic test fordetecting Ebola virus antigens in 2019 and has authorized a number of other diagnostic tests for emergency use.
      • CDC and ASPR provide technical expertise and resources tothe National Ebola Training and Education Center and other Special Pathogen Treatment Centers to increase the capability of U.S. public health and healthcare systems to safely and effectively manage suspected and confirmed patients with emerging infectious disea​ses.

Goal 4: Plum Pox Eradication

Since 2000, several USDA components, including APHIS and the Agricultural Research Service, working with SLTT partners, and representatives from industry, academia, and communities, have eradicated plum pox from our country. Over the past several decades, plum pox virus—known around the world by its Slavic name, sharka—had spread through several U.S. states and threatened all species of stone fruits.

 ​This figure is a photo of a peach with the plum pox virus. 

Figure 10: Peach with
plum pox virus

Plant diseases, such as plum pox virus, while not a direct risk to human or animal health, pose significant risk to U.S. agricultural interests and the economy at large. The impacts of a quickly spreading plant disease can have devastating and wide-reaching effects, threatening livelihoods and trade, and creating product shortages for U.S. consumers.

​Eradication of plum pox required collecting and testing plant samples, removing diseased and suspect trees, using plum pox virus-tolerant plants, and temporarily banning the planting of susceptible stone fruit varieties. By the end of 2018, APHIS and its collaborators had completed three consecutive years of stone fruit field surveys in eastern New York—the last remaining quarantined area in the United States.

After two decades of work, APHIS announced in October 2019 that plum pox had officially been eradicated from our nation. To ensure that we remain free of the disease, APHIS has put in place safeguards, including ongoing monitoring for the disease in stone fruit-producing states, science-based import regulations to prevent the disease’s reentry via nursery stock and propagative material, and continued cooperation with Canada to help prevent plum pox virus incursions from that country. APHIS’s past and continued work to identify and quickly respond to any incursion of disease helps to safeguard a $6 billion industry.

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