Update on Ebola Preparedness in the U.S.

Watch the Video: Ebola Preparedness in the U.S. — One Year Later

Overview

Since the recognition of the Ebola epidemic in West Africa in 2014, HHS has worked with its Federal, state, local government and private sector partners to build up the nation’s capabilities to prevent and respond to cases of Ebola in the U.S. and abroad.

We learned important lessons during the effort to respond to several cases imported or transmitted in the U.S. Safety of health care workers must be foremost in health care system preparedness and response activities; the care of Ebola patients is clinically complex and demanding; and early case recognition is critical for preventing spread and improving patient outcomes. Assuring that Ebola patients are safely and well cared for in the U.S. health care system and that frontline providers are trained to recognize and isolate a person with suspected Ebola are the cornerstones that underpinned the HHS Hospital Preparedness Program and related Ebola funding opportunities.

The Department’s work in supporting the outbreak response in West Africa along with the experience of Ebola cases in the U.S have galvanized our efforts to strengthen systems for monitoring and screening travelers; to implement a robust regional network of hospitals and health care worker training programs for treating patients suspected of infection with Ebola in the U.S.; and to accelerate development of diagnostics, vaccines, and therapeutics to identify, prevent and treat the disease.

Protecting Against Cases at Home

Just as we mounted an aggressive whole-of-government response to bring the epidemic under control in West Africa, we took prudent measures to respond to the threat of Ebola cases in the United States. Since October 2014, the Centers for Disease Control and Prevention (CDC) and Department of Homeland Security (DHS) personnel have conducted entry screening to detect signs of illness or potential exposure to Ebola among all passengers arriving in the United States who recently traveled to, from, or through Guinea, Liberia, or Sierra Leone. Entry screening was expanded to include Mali while cases were being reported there. Beginning in September 2015, in response to the WHO declaration of Liberia being free of Ebola transmission, travelers arriving in the U.S. from that country no longer will be subject to enhanced visa and port-of-entry screening. Travelers departing Liberia will remain subject to outbound screening measures, and the U.S. will continue to support Liberia’s Ebola prevention and detection measures, including at its primary international airport.

Screening and monitoring measures remain in place for travelers entering the U.S. from Guinea and Sierra Leone. This includes travelers from Liberia who have also traveled to either Guinea or Sierra Leone within the previous 21 days.

• Since October 2014, more than 30,000 travelers from West Africa have been screened and monitored in the United States.
• CDC and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) developed national guidance on Ebola exposure risk levels and relevant public health and medical actions. This guidance included recommendations for public health officials to actively monitor the health of recently-arrived travelers who have some degree of identifiable risk each day for 21 days from the date of their last possible exposure, as well as creating a national Ebola treatment network of hospitals that are ready and able at a moment’s notice to safely assess and treat patients with suspected or confirmed Ebola. Each traveler being monitored receives a Check and Report Ebola (CARE) Kit, a 21-day pre-paid cell phone, and a digital thermometer, and meets with a trained educator to learn about daily symptom monitoring and reporting.

Enhancing Domestic Preparedness

In addition to entry screening measures, we undertook a concerted effort to ensure that, if we needed to treat an Ebola patient in the U.S., our national health system would be prepared to spot, diagnose, transport, and treat the patient effectively without infecting others. CDC and ASPR led efforts to enhance domestic preparedness. CDC implemented a series of tools to assess and improve facility readiness, allowing us to have confidence in our nationwide ability to respond to any additional cases at home.

CDC released interim guidance to prepare U.S. health care facilities for Ebola through a 3-tiered approach: Ebola treatment centers, assessment hospitals, and frontline health care facilities. Building on the interim guidance, ASPR established a nationwide, regional treatment network for Ebola and other infectious diseases, which balances geographic need, differences in institutional capabilities, and accounts for the potential risk of needing to care for an Ebola patient. Because of this approach, more than 80 percent of travelers returning from West Africa are now within 200 miles of a hospital ready and able to safely assess and treat a patient with Ebola.

Building on the interim guidance, ASPR established a nationwide, regional treatment network for Ebola and other infectious diseases, which balances geographic need, and differences in institutional capabilities, and accounts for the potential risk of needing to care for an Ebola patient. Because of this approach, more than 80 percent of travelers returning from West Africa are now within 200 miles of a hospital ready and able to safely assess and treat a patient with Ebola.

Regional Ebola and Other Special Pathogen Treatment Centers. To further strengthen the nation’s infectious disease response capability, HHS selected nine health departments and associated partner hospitals to become regional Ebola and other special pathogen treatment centers to provide treatment for patients with Ebola or other severe, highly infectious diseases. These are geographically dispersed to ensure nationwide coverage. The facilities selected to serve as regional Ebola and other special pathogen treatment centers are required to:

• Accept patients within eight hours of being notified,
• Have the capacity to treat at least two Ebola patients at the same time,
• Have respiratory infectious disease isolation capacity or negative pressure rooms for at least 10 patients,
• Conduct quarterly trainings and exercises,
• Receive an annual readiness assessment from the National Ebola Training and Education Center, composed of experts from health care facilities that have safely and successfully cared for patients with Ebola in the U.S. to ensure clinical staff is adequately prepared and trained to safely treat patients with Ebola and other infectious diseases,
• Be able to treat pediatric patients with Ebola or other infectious diseases or partner with a neighboring facility to do so, and,
• Be able to safely handle Ebola-contaminated or other highly contaminated infectious waste.

Ebola Treatment Centers. State and local public health officials, with technical assistance from CDC and ASPR, have collaborated with hospital officials to increase domestic capacity to treat Ebola patients. Prior to October 2014, there were three facilities in the United States recognized for their biocontainment capability for treating Ebola and other infectious diseases: Emory University Hospital, University of Nebraska Medical Center, and the National Institutes of Health (NIH) Clinical Center. Today, we have a network of 55 state- or jurisdiction-based Ebola treatment centers (ETCs) in 18 states and the District of Columbia.

• Hospitals with treatment centers have been designated by state health officials, based on a collaborative decision with local health authorities and the hospital administration, to serve as treatment facilities for Ebola patients from their states or jurisdictions. ETCs are staffed and equipped, and have been assessed to have the capability, training, and resources to provide the treatment necessary to care for an Ebola patient.
• ETCs have been assessed by a CDC-led Rapid Ebola Preparedness (REP) team, a concept that brings together experts in all aspects of Ebola care, including staff training, infection control, and PPE use. In total, CDC-led REP teams visited 80 facilities in 20 states and the District of Columbia.

Assessment Hospitals. CDC and ASPR have also made progress working with state and local public health officials in identifying Ebola assessment hospitals. Assessment hospitals have been identified by state health officials as the point of referral for individuals who have a travel history and symptoms compatible with Ebola.

• These hospitals have the capability to evaluate and care for individuals who have a travel history and symptoms compatible with Ebola for up to 96 hours and initiate or coordinate Ebola testing and testing for alternative diagnoses. These hospitals can either rule out Ebola or transfer the individual to a regional Ebola and other special pathogen treatment center or state- or jurisdiction-based ETC, as needed.
• States with the majority of travelers from the affected countries have developed strategies to evaluate persons under investigation and to provide care for up to 96 hours at an assessment hospital while Ebola testing can be arranged.

Frontline Health Care Facilities. Acute care hospitals and other emergency care settings can also serve as frontline health care facilities. Frontline health care facilities are prepared to identify a person with a travel history, potential exposure, and symptoms suggestive of Ebola.

• These facilities have the ability to identify and isolate patients with a relevant exposure history and signs or symptoms compatible with Ebola.
• Frontline health care facilities have enough PPE to last for 12 to 24 hours of care and can prepare a patient for transfer to an assessment hospital or treatment center, if needed.
• Regardless of a facility’s pre-designated role, CDC is ready to support any U.S. hospital or medical clinic that identifies a probable Ebola patient by sending a CDC Ebola Response Team (CERT) within a few hours of a highly suspected or confirmed diagnosis. The CERT Teams will help clinicians and state and local public health practitioners to consistently follow strict protocols that protect the patient and health care workers. These teams are operational and have already been called on for assistance. CDC has also provided additional resources and guidance to assist with hospital readiness.

National Ebola Training and Education Center. To ensure that U.S. health care providers and facilities are prepared to safely identify, isolate, transport, and treat patients with Ebola and other emerging threats, HHS launched a National Ebola Training and Education Center (NETEC).

Through this effort, ASPR and CDC will provide funding over the next five years to Emory University in Atlanta, Georgia; University of Nebraska Medical Center/Nebraska Medicine in Omaha, Nebraska; and Bellevue Hospital Center in New York City, New York, which together co-lead the NETEC.

Through this collaborative among ASPR, CDC, and three academic institutions, the NETEC will support further training of health care providers and facilities on strategies to manage Ebola and other emerging infectious diseases.

Ebola Testing Laboratories. Just as we have expanded the network of hospitals capable of responding to an Ebola patient, CDC’s Laboratory Response Network (LRN) has grown the network of public health laboratories able to test a potential Ebola specimen. In order to qualify as an LRN Ebola testing lab, a laboratory must have an appropriate and functioning biosafety level 3 laboratory, the necessary test reagents, appropriate staff training, and the proper PPE to perform the assay safely. A testing lab demonstrates competency by successful completion of a quality assurance panel. Upon completion and evaluation of the panel, the laboratory is considered approved to test for Ebola.

• Prior to the current outbreak in West Africa, Ebola could be confirmed only at the CDC laboratory in Atlanta, Georgia. As of January 31, 2015, there are 55 LRN laboratories in 43 states that are approved to test for Ebola using a DoD test authorized for emergency use by the U.S. Food and Drug Administration (FDA). Since we have more than quadrupled our capacity to test for Ebola, turnaround time for Ebola results dramatically decreased in the United States.
• With the expansion of testing services, a test result is typically available 4 to 6 hours after receipt of a specimen in the lab. This allows clinicians to make patient-care decisions in a shorter timeframe and protects the American public from unnecessary exposures. By comparison, the first Ebola specimen domestically tested at Mt. Sinai in August 2014 took close to 24 hours to complete.
• Since the authorization of the first test for the detection of Ebola in August 2104, there are now a total of 10 diagnostic tests that have been authorized for emergency use by FDA. While there are commercial Ebola tests available for qualified hospital laboratories, their test results must be confirmed at CDC.

Health Care Worker Outreach and Training. We have conducted extensive outreach to the health care community, including hospitals, clinicians, health care worker unions, and professional associations. Our outreach has focused on training and on preparing facilities to identify, isolate, diagnose, and care for patients under investigation for or confirmed with Ebola. At the height of the Ebola outbreak CDC and ASPR conducted daily and weekly calls and webinars to provide a forum for partners to have questions answered directly by CDC and ASPR staff.

• Since the start of the outbreak, CDC and ASPR have educated more than 150,000 health care workers and hospital executives via more than 150 webinars and conference calls with professional organization members.
• CDC has also conducted numerous live, onsite training events for healthcare professionals. These events have reached more than 6,500 people in-person and over 20,000 people from 10 countries via live webcast. CDC partnered with Partnership for Quality Care, hospital associations, and healthcare unions on three live events.

Developing Countermeasures to Prevent and Treat Ebola

Over the longer-term, vaccines and therapeutics will be a key tool in our arsenal to address future epidemics, and we have significantly ramped up development and clinical trials of vaccine and drug candidates. HHS — led by efforts at the National Institutes of Health (NIH), CDC, the Biomedical Advanced Research and Development Authority (BARDA) within ASPR, and the FDA — has made tremendous progress in development, manufacturing, and conducting human clinical trials of several Ebola vaccine and therapeutic candidates. Many of these trials have been conducted in partnership with Guinea, Sierra Leone and Liberia, as well as international research institutions.

Ebola Vaccine Development. The U.S. government is supporting the development and manufacturing of multiple Ebola vaccine candidates in various stages of development. In September and October 2014, two vaccine candidates — cAd3-EBOZ and rVSV-ZEBOV — began Phase 1 clinical trials in the United States. The cAd3-EBOZ Ebola vaccine candidate was developed by the NIH and GlaxoSmithKline. The rVSV-ZEBOV investigational vaccine was developed by the Public Health Agency of Canada and licensed to the NewLink Genetics Corp., with Merck & Co., Inc. responsible for advancing the vaccine toward regulatory approval. Interim results from the Phase 1 trials showed no significant safety concerns and demonstrated immune responses consistent with the immune responses generated in vaccinated non-human primates that are protected from disease. Other vaccine candidates are either in Phase 1 testing or are expected to begin Phase 1 testing during the year. BARDA is now supporting the advanced development of four (4) Ebola vaccine candidates to ensure robust and controlled commercial scale production of thermostable vaccines for clinical studies.

The FDA convened the Vaccines and Related Biological Products Advisory Committee in May to discuss potential paths to licensure for Ebola vaccine candidates. In addition, the FDA has held meetings with the sponsors of several other vaccine candidates to help guide their development plans.

Both the cAd3-EBOZ and rVSV-ZEBOV investigational vaccines began Phase 2 testing in February 2015 through the launch of the Partnership for Research on Ebola Virus in Liberia (PREVAIL), a clinical research partnership between HHS and the Liberian Ministry of Health. The PREVAIL I trial, a Phase 2 randomized, placebo-controlled clinical trial led by the Liberian Ministry of Health and NIH, is assessing the safety and immunogenicity of both investigational vaccines. The trial has successfully enrolled 1,500 planned participants with follow up expected to conclude in spring 2016.

In April 2015 CDC and ASPR/BARDA, in partnership with the Sierra Leone College of Medicine and Allied Health Sciences (COMAHS) and the Sierra Leone Ministry of Health and Sanitation (MoHS), launched the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). This study is assessing the safety and immunogenicity of the rVSV-ZEBOV candidate Ebola vaccine among health and other frontline workers. To date, over 8,700 individuals have been enrolled with over 4,100 individuals vaccinated in the first cohort with the second cohort to initiate vaccination in September.

Ebola Therapeutics Development. Additionally, the U.S. government is supporting the development of investigational therapeutics to treat patients infected with Ebola.

• ZMapp: BARDA transitioned Mapp Biopharmaceutical’s monoclonal antibody candidate produced in tobacco plants from early development with DoD’s Defense Threat Reduction Agency (DTRA) into advanced development. In February 2015, the PREVAIL II clinical trial to test ZMapp began in Liberia and the United States. This adaptive, randomized controlled clinical trial was designed to obtain safety and efficacy data on ZMapp compared to optimized standard of care and to establish a framework for potentially evaluating multiple Ebola therapeutic candidates if warranted in the future. With the agreement of the governments of Sierra Leone and Guinea, sites in those two countries joined the ZMapp trial in the spring and summer of 2015, respectively. To date, more than 60 patients have been enrolled in the clinical trial.
• Mammalian cell monoclonal antibody therapeutic: BARDA is supporting the development of several mammalian cell-derived Ebola monoclonal antibody candidates from Regeneron and Genentech. These antibody candidates have shown promising results in nonhuman primate Ebola challenge studies. Phase 1 clinical studies for the Regeneron antibody candidate are expected to start in 2016 in the U.S.; Phase 2–3 in West Africa will follow later. BARDA’s Centers for Innovation in Advanced Development and Manufacturing (CIADM) at Emergent BioSolutions will be scaling up production of Genentech’s antibody candidate for more animal and human clinical studies in the future.
• BCX4430: BCX4430 is a small molecule drug developed by BioCryst Pharmaceuticals with support from NIH and currently is undergoing advanced development with support from BARDA. NIH-sponsored Phase 1 clinical studies in healthy volunteers began in December 2014 to determine safety and a treatment dosage. In July, BARDA began supporting advanced development of the drug, including improving manufacturing processes and scale up production of the drug in U.S. facilities to increase product yield, reduce process steps, and increase scalability of manufacturing so that thousands of doses can be made with consistent product quality.

FDA continues to work with product sponsors, U.S. government funding agencies, and international partners, to clarify data, clinical studies, and regulatory requirements necessary to facilitate the development and expedite the availability of the most promising vaccines and therapeutics that could potentially mitigate the current Ebola outbreak, as well as potential future outbreaks.

Unfortunately, during outbreak situations, fraudulent products that claim to prevent, treat or cure a disease appear on the market. The FDA monitors for these fraudulent products and false claims and takes appropriate action to protect consumers.

Ebola Natural History Study. In June 2015, the PREVAIL III study was launched to evaluate people in Liberia who have survived Ebola within the past two years. The study investigators hope to better understand the long-term health consequences of Ebola infection, determine if survivors develop immunity that will protect them from future Ebola infections, and assess whether previously Ebola-infected individuals can transmit the virus to close contacts and sexual partners. The five-year study is expected to enroll approximately 7,500 people — 1,500 people of any age who survived Ebola virus disease and 6,000 of their close contacts.