ASPR’s Strategic Approach to Ebola Medical Countermeasure Development and Utilization in the 2018 Ebola Outbreak

Blog Series:  Battling the Ebola Epidemic

Ebola reemerged as a health threat in 2018, in the Democratic Republic of the Congo (DRC), where two outbreaks of Ebola virus disease have occurred since May 2018. The first of these two outbreaks, in western DRC, was quickly contained. However, the second outbreak, in eastern DRC, has yet to be contained due in large part to the volatile security situation in that region. This second outbreak has now become the second largest Ebola outbreak since the virus was discovered in 1976, surpassed only by the 2014-2016 outbreak in West Africa. It is unlikely to be the world’s last.

Ebola and other highly infectious diseases can cross borders.  In order to protect the American people from this deadly disease, we must fight the outbreak at its source.  As a critical part of the global response, the U.S. Department of Health and Human Services (HHS) is developing and deploying medical countermeasures, which may help save lives by protecting individuals in DRC from infection and may reduce the severity of disease.  Within HHS, the Office of the Assistant Secretary for Preparedness and Response (ASPR) plays a critical role in medical countermeasure development and use.

Developing New Medical Countermeasures

During the 2014 Ebola outbreak in West Africa, HHS/ASPR’s Biomedical Advanced Research and Development Authority (BARDA) started working closely with partners in industry and throughout government to accelerate the development of potential vaccines, therapeutics, and diagnostics. 

Today, BARDA is supporting the late-stage development of two vaccine candidates one by Merck (V920) and one by Janssen and  Bavarian Nordic (Ad26.ZEBOV/MVA-BN®-Filo). BARDA is working with these vaccine developers to support potential licensure of the vaccines.

In addition, BARDA is using Project BioShield funds to support the advanced development of two therapeutic candidates, by Regeneron (REGN3470-3471-3479) and by Mapp Bio (ZMapp).  These products are being made available in the DRC in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), within the National Institutes of Health, as part of the NIAID-sponsored randomized clinical trial to evaluate the safety and efficacy of these products.  The randomized clinical trial also includes mAb114, which is being supported by NIAID Vaccine Research Center, and Remdesivir by Gilead.  BARDA continues to support pre-clinical testing of Remdesivir.

Voluntary Ring Vaccination

Although a licensed vaccine is not yet available, more than 86,000 people have been given the single-dose investigational recombinant rVSV-ZEBOV vaccine developed by Merck under a Compassionate Use protocol to prevent the spread of Ebola in DRC.  

This vaccination campaign uses a voluntary “ring vaccination” strategy, which focuses on individuals at an increased risk of infection because of their contact with a patient who has a confirmed case of Ebola virus disease. The strategy seeks to vaccinate contacts and contacts-of-contacts — the network of people who may have been exposed to the patient while he or she was symptomatic, and who may be protected by the vaccine.  In some cases, people in targeted geographic zones near the Ebola patient are getting vaccinated. As of February 4, 2019, 695 rings and two geographic zones were targeted for vaccination. In addition, healthcare workers and frontline workers are being vaccinated. 

Neighboring countries have started vaccinating healthcare workers and front line workers as well. Uganda has vaccinated healthcare workers and front line workers in 101 health facilities.  Vaccination started in South Sudan on January 28, 2019 and plans for vaccination of healthcare workers and front line workers are advanced in Rwanda and Burundi.

In addition, Janssen and Bavarian Nordic have developed a two-dose vaccine and are working with the WHO and other organizations to potentially evaluate the vaccine in the region.

Using Point-of-care Diagnostics to Help Contain the Disease

When investigating a recent death in an area where the Ebola virus may be circulating, it is essential to determine quickly if the person died from Ebola. After a person has died from Ebola, their body can continue to transmit the virus to anyone who is exposed to the body without wearing appropriate personal protective equipment, so appropriate steps, such as a safe and dignified burial, must be taken to keep the disease from spreading.

To protect the community, bodies of people who have died in areas where the Ebola virus may be circulating are being checked for Ebola virus using a rapid point-of-care test developed by OraSure with support from BARDA, and authorized for emergency use by the U.S. Food and Drug Administration (FDA). These rapid diagnostic tests provide results in minutes, giving responders the information they need to make more effective decisions.

Emerging disease outbreaks, particularly those with the potential to become epidemics, are but an international flight away and are significant global health threats.  ASPR will continue to support the medical countermeasures needed to protect health and save lives in the face of Ebola and other 21st century health threats.

This is the first blog in a two-part series on battling the Ebola epidemic.  This series is designed to highlight the actions that ASPR is taking to protect health and save lives during current Ebola outbreak.  The next post in this series will detail the ways that we are working with partners to enhance U.S. healthcare capabilities and enhance domestic response capacity. To stay up to date as new blog posts are published, follow us on  Twitter ,  Facebook  or  LinkedIn.