[Senate Hearing 116-]
[From the U.S. Government Publishing Office]




 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2020

                              ----------                              


                        THURSDAY, MARCH 14, 2019

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:07 a.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Roy Blunt (chairman) presiding.
    Present: Senators Blunt, Hyde-Smith, Murray, Durbin, 
Shaheen, and Schatz.

Testimony on the Ebola Outbreak in the Democratic Republic of the Congo 
                   and Other Emerging Health Threats


                 opening statement of senator roy blunt


    Senator Blunt. Well, by Senate time standards we are not in 
too bad a shape, but let me apologize for keeping you waiting 
for a few minutes and apologize to Senator Murray and Senator 
Schatz for keeping them as well.
    I think we will have other members attend but they are just 
now beginning to think about the time to leave their office and 
come to the hearing, as maybe I was.
    The Appropriations Subcommittee on Labor, Health and Human 
Services, Education and Related Agencies will come to order.
    We are certainly glad to have our witnesses here today. We 
are really trying to hold this hearing in a way that highlights 
the importance of emerging health threats to our country's 
security, and our economic and physical well-being. The second 
largest Ebola outbreak is currently occurring in the Democratic 
Republic of the Congo. We have concerns about antibiotic 
resistance as a global danger. And there is always an impending 
flu outbreak that we worry about every year.
    We do know for sure that disease has no boundaries, that 
infectious diseases not only spread from country-to-country, 
but also affect whether people are willing to go from country-
to-country, they affect trade, they affect travel. Every year 
since the 2014 Ebola outbreak in West Africa, the World Health 
Organization has released a list of infectious diseases that 
experts believe are especially high risk.
    These are diseases for which there are no treatments, no 
cures, no vaccines, and I know all of you think about that. 
That list of diseases is really, all too familiar, things like 
Ebola and Zika and the Middle East Respiratory Syndrome, or 
MERS. Many have not heard of the Crimean-Congo or the Nipah 
virus, and we hope we do not hear a lot about either of those 
things.
    What we learned with the Ebola outbreak in West Africa was 
that any patient, patient zero, can board a flight and be in 
the United States in less than 24 hours and suddenly that 
problem that seemed to be isolated somewhere else is a problem 
that we are very aware of, and that is why many of you spend a 
lot of your time thinking about how we impact these challenges 
right there.
    The last 4 years the Labor/HHS Subcommittee has focused 
substantial resources on trying to do a better job of being 
where the disease is, rather than letting the disease come here 
and not only to help ourselves, of course, but to help those 
who are immediately impacted by it.
    The National Institute of Allergy and Infectious Diseases 
has a budget of over $5.5 billion to lead research to 
understand, to treat, and to prevent infectious diseases. In a 
recent bill, we focused increased investment toward antibiotic 
resistance research and an universal flu vaccine. Dr. Fauci, 
the NIAID (National Institute of Allergy and Infectious 
Diseases), all a vital part of how we respond to these 
challenges.
    As our Nation's health protection agency, the Centers for 
Disease Control and Prevention saves lives and protects people 
from health threats. We strengthen that nation-wide system, 
invested almost $500 million, and an additional $480 million in 
a biosecurity lab that is in process. We provided nearly $700 
million every year for Public Health Emergency Preparedness 
grants which are distributed to every State.
    These are all investments here that are complemented by our 
investments abroad. The $700 million we provided in the last 4 
years to CDC (Centers for Disease Control and Prevention) for 
Global Health Security Agenda. The Office of the Assistant 
Secretary of Preparedness is the lead response agency to 
protect Americans from these health security risks.
    I have a few more things that I want to put in the record, 
but I think it is clear the impact you do have all over the 
world and the preventive impact. We are hopeful that it always 
has, for many communities in many societies that could 
otherwise be devastated by antibiotic resistance or other 
things that they have no way to anticipate and no way to 
respond to.
    [The statement follows:]
                Prepared Statement of Senator Roy Blunt
    Good morning. Thank you to our witnesses for being here.
    I called today's hearing to highlight the importance of emerging 
health threats to America's security and economic wellbeing. With the 
second largest Ebola outbreak currently occurring in the Democratic 
Republic of the Congo, antibiotic resistance a global danger, and an 
impending flu outbreak every year, we need to remain focused on these 
threats. Disease knows no boundaries. Outbreaks of infectious diseases 
not only spread from country-to-country and impact Americans' health, 
but also affect trade and travel. It is clear that our investments to 
improve global health have a direct impact on the wellbeing of every 
American.
    Every year since the 2014 Ebola outbreak in West Africa, the World 
Health Organization has released a list of infectious diseases that its 
experts believe are especially high-risk. These global health risks 
could turn into epidemics or are diseases for which there are no 
treatments, cures, or vaccines. This list includes diseases we are all 
too familiar with, like Ebola, Zika, and the Middle East Respiratory 
Syndrome (MERS). It also includes those that many may not have heard of 
like Crimean-Congo hemorrhagic fever and the Nipah virus.
    As we learned with the Ebola outbreak in West Africa, patient zero 
can board a flight from the far reaches of the globe and be in the 
United States within less than 24 hours. We live in a global society, 
where travel is a vital part of economic opportunity. We no longer live 
in a world where global health is separated from America's health. That 
is why it is critical to ensure that we are in a position to protect 
Americans from threats--both at home and abroad.
    Over the past 4 years, the Labor/HHS Subcommittee has focused 
substantial resources in doing just that--ensuring our Nation's public 
health system can respond to a threat in the United States as well as 
responding overseas before it reaches our shoreline.
    The National Institute of Allergy and Infectious Diseases has a 
budget of over $5.5 billion to lead research to understand, treat, and 
prevent infectious disease. In recent Labor/HHS bills, we have focused 
increased investment toward antibiotic resistance research and 
developing a universal flu vaccine. NIAID is also a vital part of our 
ongoing response to the current outbreak of Ebola in the Democratic 
Republic of the Congo.
    As the Nation's health protection agency, the Centers for Disease 
Control and Prevention saves lives and protects people from health and 
security threats. We have strengthened CDC's Nation-wide system of 
laboratories and invested in a new $480 million biosecurity laboratory. 
We also provide nearly $700 million every year for the Public Health 
Emergency Preparedness grants, which are distributed to every State to 
strengthen their capabilities to respond to public health threats.
    These U.S. based investments are complemented by investments made 
abroad, including the nearly $700 million we provided in the past 4 
years to CDC for the Global Health Security Agenda (GHSA). GHSA is 
designed to help build developing countries' capacities to predict, 
prevent, and respond to infectious disease outbreaks before they reach 
the United States.
    The Office of the Assistant Secretary for Preparedness and Response 
is the lead response agency to protect Americans from health security 
threats. Now the lead agency supporting the Strategic National 
Stockpile, the Committee provides $610 million annually to maintain a 
repository of antibiotics, vaccines, and other critical medical 
supplies. Further, the Biomedical Advanced Research and Development 
Authority supports the transition of vaccines, treatments, and 
diagnostic tests from research and development to deployment.
    These three agencies of the Department of Health and Human Services 
work in concert with USAID, our lead international agency focused on 
improving global health, to ensure our Nation can prepare and respond 
to emerging and existing health threats. Together, they create the 
backbone of our Nation's health security strategy.
    As we continue to prioritize strengthening our public health system 
while preventing diseases from becoming threats, it is important to 
point out a recent addition to the WHO infectious disease threat list: 
Disease X. Disease X is not the name of a newly discovered disease, but 
a reminder that we need to be ready for the unknown, an infectious 
disease we have never thought of. What happens when a disease mutates 
like we saw with the Zika virus? How do we understand, but more 
importantly try to predict, the risk a new disease may bring? What do 
we do during outbreaks of rare infectious diseases like the polio-like 
disease, AFM? How do we respond when there is no diagnostic test, 
treatment, or cure for a disease?
    Adding Disease X to the threat list was a warning by the WHO to 
stay vigilant. As outbreaks like Zika illustrate, we need to monitor 
where emerging infections are, where they go, how they develop, and who 
may be most at risk. It is critical to invest not only in robust 
surveillance efforts at home, but also abroad. Research should focus on 
the diseases that are threats today and the ones that may be threats 
tomorrow. We should prioritize infectious disease outbreak response and 
control efforts. And we must work with both State and global partners 
to ensure that we can detect infectious disease outbreaks and 
adequately respond before they turn into a national or global epidemic.
    I look forward to today's hearing and the testimonies of our 
experts to help us better understand and assess the U.S. health 
security strategy. Thank you.

    Senator Blunt. So, we are glad you are here. We hope we do 
not discover Disease X, but I know you are always concerned 
about what Disease X might be. We are glad you are concerned 
about that and we hope to hear more about all of these issues, 
but first let us go to Senator Murray for her opening 
statement.

                   STATEMENT OF SENATOR PATTY MURRAY

    Senator Murray. Well, thank you very much Senator Blunt and 
welcome to all of our distinguished witnesses. I am really 
looking forward to your testimony today about the emerging 
disease threats and how we can better protect the health of 
families across the country, and really across the world.
    Today the Democratic Republic of Congo is facing the second 
largest Ebola outbreak in history. Since the outbreak began in 
the DRC last year, the response has been complicated by 
internal conflict and violence, making it much more difficult 
to respond, including to conduct contact tracing and get 
treatments into the area and more dangerous for our healthcare 
workers who are facing hostility. Almost 600 people have died, 
and public health experts predict the situation could get much 
worse.
    This outbreak is a tragedy for families who are grappling 
with the loss of loved ones, and communities, who are now 
struggling with the challenges of getting this outbreak under 
control and rebuilding in the aftermath. And it is also a 
threat for neighboring countries as confirmed cases have 
continued to shift closer to the DRC's borders.
    We all saw the heartbreaking images of loss during the 2014 
Ebola outbreak. We also saw how much fear that outbreak caused 
here in the United States, even leading to ill-advised 
proposals to implement a travel ban on impacted countries.
    During the current outbreak, it is important we remember 
that in a world as connected as ours, one of the best ways to 
keep our country safe is to continue U.S. leadership on global 
health security and that means investing in public health and 
preparedness systems both here and abroad. This is especially 
important as we face greater threats from viruses, which spread 
from animals to people, such as Ebola, as well as dangerous, 
less exotic but no less dire threats, such as anti-microbial 
resistance.
    In response to these threats, we have to make sure our 
partners around the world can identify emerging diseases early 
and respond appropriately. They need strong public health 
systems that can respond quickly to threats in their countries 
before they fester and expand beyond control, threatening both 
their citizens and people across the globe.
    For many years, the U.S. Government has provided funding to 
our partners abroad to address specific diseases such as HIV-
AIDS, malaria, polio and those investments have been crucial to 
saving lives and stopping the spread of diseases and in 
building the capacity of public health systems in other 
countries.
    These investments are not just the right thing to do for 
their own sake, they are the smart thing to do to keep families 
in our country safe as well, and we have realized these 
investments must be broader than specific diseases. We need to 
make sure that other countries have trained public health 
staff, rapid emergency response systems, and improved 
communications to respond to all types of emerging diseases.
    In response to the 2014 Ebola outbreak, this committee 
provided over $2.7 billion to build more prepared health 
systems both here and abroad that included funding for the 
development of new and improved vaccines, and medical 
countermeasures against emerging pathogens, funding to equip 
U.S. hospital systems for dealing with the most deadly 
pathogens, and almost a $600 million to the Centers for Disease 
Control and Prevention as part of President Obama's Global 
Health Security Agenda.
    These investments have made a clear difference. Thanks to 
this work, Nigeria was able to stop the 2014 Ebola outbreak 
from ballooning when the virus reached the largest city in 
Africa. And more recently an Ebola vaccine is being used 
successfully on a limited basis in the current outbreak. Its 
development was supported with funding from the National 
Institutes of Health and BARDA.
    U.S. investment in the Global Health Security Agenda has 
led to countless other public health advances in other 
countries as well and I look forward to hearing more examples 
from all of you here today, but continued U.S. leadership is 
critical, so, as we work to address this current crisis we have 
to remember the dangers of falling back on America First 
rhetoric. We cannot do this on the cheek, and we cannot pretend 
diseases are stopped by borders, or walls, or bans.
    So, while I am glad this administration has said it 
supports this critical work, I want to hear about its plans to 
continue the progress of the Global Health Security Agenda. And 
as the current Ebola outbreak continues to pose a very serious 
public health threat, I want to hear more about the specific 
actions all of your agency's plan to take moving forward.
    This dangerous outbreak demands global attention and I am 
eager to understand how decisions are being made to navigate 
this complex crisis and what the U.S. Government and Congress 
can do to bolster critical public health efforts.
    I hope today will provide an opportunity for all of you to 
share your insights on this and tell us what else is needed on 
the ground in the DRC.
    Thank you all for being here.
    Senator Blunt. Well, thank you Senator.
    We are pleased with our panel today, in two cases their 
first time to testify, but both people have spent a lot of time 
individually with members of the committee and with the 
Congress over the last few years.
    Dr. Robert Kadlec is the Assistant Secretary of 
Preparedness and Emergency at the Department of Health and 
Human Services. It is his first time to testify here, but 
again, someone who we have had a long working relationship 
with.
    Dr. Robert Redfield is the Director of the Centers of 
Disease Control and Preparedness, his first time to testify but 
I know he has been actively trying to keep our committee 
updated on his first year in this job.
    Dr. Tony Fauci, the Director of the National Institute of 
Allergy and Infectious Diseases at the National Institutes of 
Health has testified before our committee often and we are 
pleased to have his expertise with us again today.
    And then Admiral Tim Ziemer is the Acting Assistant 
Administrator at USAID. I appreciate his willingness to be here 
today to reinforce, really, the collaborative nature between 
what happens at HHS and CDC and USAID (U.S. Agency for 
International Development).
    Dr. Kadlec, if you would like to start, and then we will 
just go across the panel here with any opening remarks you 
might have.
STATEMENT OF DR. ROBERT KADLEC, M.D., ASSISTANT 
            SECRETARY FOR PREPAREDNESS AND RESPONSE, 
            U.S. DEPARTMENT OF HEALTH AND HUMAN 
            SERVICES, WASHINGTON, D.C.
    Dr. Kadlec. Thank you, Mr. Chairman, and thank you Chairman 
Blunt and Ranking Member Murray and other distinguished members 
of the committee. I am Dr. Bob Kadlec, the Assistant Secretary 
for Preparedness and Response at the Department of Health and 
Human Services and today I will discuss how ASPR is supporting 
the Ebola response in the Democratic Republic of Congo and how 
we are advancing domestic preparedness in response for future 
infectious disease events.
    ASPR is currently developing a variety of medical 
countermeasures to save lives in the DRC that will also help 
preparedness for future domestic infectious disease outbreaks. 
First, we are supporting two vaccine candidates by Merck and 
Janssen, and Bavarian Nordic; three therapeutic candidates by 
Regeneron, Mapp Bio and Gilead that are being used currently 
and also being evaluated in the ongoing outbreak.
    The effectiveness of these medical countermeasures will 
inform our plans for manufacturing, procurement, for the 
Strategic National Stockpile for the future.
    We have also exercised a movement of infectious disease 
patients from overseas locations to receiving hospitals in the 
United States. ASPR has participated in four full-scale 
exercises that reviewed notification processes, coordinated 
decisions, and identified resources needed to move highly 
infectious disease patients.
    Related to preparedness efforts across our healthcare 
system, the Hospital Preparedness Program received 
approximately $225 million from the Ebola Emergency 
Supplemental in 2014 to establish a nationwide regional Ebola 
treatment network.
    The network enables healthcare system partners to come 
together to identify, isolate, assess, transport, and treat 
patients with, or suspected of having, Ebola. Using these same 
supplemental funds, we worked with grantees to establish the 
NETEC, the National Ebola Training and Education Center. The 
NETEC provides training--technical training, expert assistance 
and peer assessments to stakeholders.
    Lastly, the Ebola Supplemental funding supported enhanced 
training for-a-National Disaster Medical System, NDMS 
personnel. This training ensures our first responders for 
disasters, or NDMS personnel, have the skills to treat highly 
infectious patients without becoming infected themselves or 
spreading the infections to others.
    But, please note all the funding for these activities will 
cease at the end of fiscal year 2019.
    I would like to spend the remainder of my time discussing 
how ASPR is protecting the Nation from all hazards.
    First, I would like to acknowledge and thank the 
subcommittee for appropriating $2.6 billion to ASPR in fiscal 
year 2019. Your increased funding and timely enactment of 
appropriations reaffirmed many things to our stakeholders and 
to the industry that supports U.S. Government efforts to be 
prepared. $1.3 billion was appropriated for BARDA, or 
Biomedical Advanced Research Development Authority, and Project 
BioShield, which sustain investments in countermeasure 
development.
    Remember Project BioShield's authority speeds up the 
availability and use of countermeasures in emergencies and 
BARDA's strong public/private partnership with industry, by 
using flexible authority's multi-year advance funding, and 
cutting-edge expertise, has resulted in 43 products licensed by 
the FDA (Food and Drug Administration).
    The $256 million for pandemic influenza permits ASPR to 
continue supportive of domestic vaccine manufacturing, as well 
as stockpiling of that vaccine, as well as international 
activities. To date, BARDA has supported development of 23 
influenza-related products and this appropriation ensures our 
work will continue.
    $57 million appropriated in fiscal year 2019 supports 
further training for the NDMS personnel. The NDMS workforce was 
at an all-time low in 2017, at-a-roughly 2,500 personnel. Using 
the temporary direct hire authority provided in the 2017 
Hurricane Supplemental, ASPR nearly doubled the overall NDMS 
workforce, yet we still have the gap of the 2,000 vacancies.
    ASPR will continue to hire personnel under traditional 
practices, but encourages Congress to permanently authorize 
direct hiring authority, and enhanced death benefits for NDMS 
personnel.
    You also provided $265 million in fiscal year 2019 for the 
Hospital Preparedness Program that will support annual grants 
to all 62 awardees and continue implementation of a Regional 
Disaster Health Response System. In building a regional network 
of health system partners, two grants were recently awarded for 
pilot projects evaluating how we can build a regional system, 
similar to the regional Ebola treatment network to enhance 
readiness for complex mass casualty events, improve care for 
pediatric populations, and for burns, for example.
    I look forward to discussing modifications to the Hospital 
Preparedness Program and sharing the successes of our regional 
pilot projects in the future. I look forward to working 
collaboratively with you and your staff to protect the Nation 
from 21st century national security and health threats.
    Thank you again for your bipartisan commitment to this 
national security imperative and I look forward to your 
questions. Thank you.
    [The statement follows:]
               Prepared Statement of Robert Kadlec, M.D.
    Good morning Chairman Blunt, Ranking Member Murray, and other 
distinguished Members of the Committee. I am Dr. Bob Kadlec, the 
Assistant Secretary for Preparedness and Response (ASPR) at the 
Department of Health and Human Services (HHS). Thank you for the 
opportunity to testify before you today on our efforts to support a 
coordinated response to the Ebola outbreak in the Democratic Republic 
of the Congo (DRC) as well as general preparedness for other emerging 
infectious diseases.
    This morning, I will share with you how ASPR is supporting the 
response to the Ebola outbreak in the DRC. I will also take a few 
minutes to highlight existing public health and medical preparedness 
and response capabilities and how we monitor, consider, and incorporate 
global health threats into the programs and initiatives of ASPR.
  assistant secretary for preparedness and response: mission & duties
    ASPR's mission is to save lives and protect Americans from 21st 
century health security threats. On behalf of the Secretary of HHS, 
ASPR leads public health and medical preparedness for, response to, and 
recovery from disasters and public health emergencies in support of 
State, local, Tribal, and territorial (SLTT) authorities, in accordance 
with the National Response Framework (NRF) (Emergency Support Function 
(ESF) # 8, Public Health and Medical Services), as well as the National 
Disaster Recovery Framework (Health and Social Services Recovery 
Support Function). ASPR also supports HHS's role in the delivery of 
mass care and human services in emergencies (NRF ESF # 6).
    ASPR coordinates across HHS and the Federal interagency to support 
SLTT health partners in preparing for and responding to emergencies and 
disasters. In partnership with HHS agencies, ASPR works to enhance 
medical surge capacity by organizing, training, equipping, and 
deploying Federal public health and medical personnel, such as National 
Disaster Medical System (NDMS) teams, and providing logistical support 
for Federal responses to public health emergencies. ASPR supports 
readiness at the State and local level for all threats--chemical, 
biological, radiological, and nuclear (CBRN)--by coordinating Federal 
grants such as the Hospital Preparedness Program (HPP), leading 
programs like the Medical Reserve Corps, and carrying out drills and 
operational exercises to test capabilities. ASPR also oversees advanced 
research, development, and procurement of medical countermeasures (MCM) 
(e.g., vaccines, medicines, diagnostics, and other necessary medical 
supplies), and coordinates the stockpiling of such countermeasures. As 
such, ASPR manages the Biomedical Advanced Research and Development 
Authority (BARDA), Project BioShield, the Strategic National Stockpile 
(SNS), and the Public Health Emergency Medical Countermeasures 
Enterprise.
    In addition to these programs, ASPR supports the development and 
implementation of national- level strategies and policies to frame and 
guide Federal preparedness, response, and recovery efforts. In 
September 2018, the White House released the National Biodefense 
Strategy (Strategy). This Strategy focuses on naturally occurring, 
deliberate and accidental biological threats. Importantly, this 
Strategy is the first to identify a lead coordinating official--the HHS 
Secretary--for the biodefense enterprise. In addition, this Strategy 
establishes an organizational structure to assess and improve 
biodefense efforts across the Federal interagency. A second critical 
strategy, the National Health Security Strategy (NHSS), released in 
January 2019, provides a vision for strengthening our Nation's ability 
to prevent, detect, assess, prepare for, mitigate, respond to, and 
recover from 21st century health security threats. Specifically, the 
NHSS is aligned under three objectives that are flexible and adaptable 
to existing or emerging threats and have an operational focus to aid 
implementation. The first objective is to prepare, mobilize, and 
coordinate the whole-of-government to bring the full spectrum of 
Federal medical and public health capabilities to support SLTT 
authorities in the event of a public health emergency, disaster, or 
attack. The second objective is to protect the Nation from the health 
effects of emerging and pandemic infectious diseases and CBRN threats. 
Lastly, the third objective is to leverage the capabilities of the 
private sector. Working within these three objectives, the NHSS creates 
a more resilient medical product supply chain and builds private sector 
healthcare surge capacity. This quadrennial strategy supports the 
National Security Strategy, the National Defense Strategy, and the 
National Biodefense Strategy. Lastly, ASPR leads and participates in a 
number of international initiatives to build partnerships, enhance 
situational awareness, and work toward better collaboration between 
international partners.
aspr's support of the current ebola outbreak in the democratic republic 
                              of the congo
    As you are all aware, 2018 brought about a reemergence of Ebola, 
specifically within the DRC. This highly infectious virus is of global 
concern and international efforts are underway to limit its spread 
within the DRC and surrounding countries. ASPR is working with the 
Centers for Disease Control and Prevention (CDC), United States Agency 
for International Development (USAID), and Department of State (DOS) to 
monitor the events within the DRC and is working to support domestic 
efforts, should a highly infectious disease outbreak occur within our 
borders. For this, as with other health security events, ASPR is the 
designated lead for the HHS and is responsible for bringing together 
officials from across HHS to discuss the domestic preparedness related 
activities relevant to the emerging event. ASPR convened the Disaster 
Leadership Group on January 9, 2019, to discuss the current situation 
in the DRC. Participants included representatives from CDC, the 
National Institutes of Health (NIH), Food and Drug Administration 
(FDA), and BARDA, along with other relevant agencies and offices. Staff 
provided updates on vaccination of persons within the DRC, containment 
efforts, engagement with DOS and other HHS officials, and general 
domestic preparedness efforts.
    To support the development of MCMs, beginning during the 2014-2016 
Ebola outbreak in West Africa, BARDA worked closely with partners in 
industry as well as partners at the National Institute for Allergy and 
Infectious Diseases (NIAID), the FDA, and the Department of Defense 
(DoD) to advance the development of vaccines, therapeutics, and 
diagnostics. Last year, BARDA transitioned two vaccine candidates 
(Merck and Janssen/Bavarian Nordic) and two therapeutic candidates 
(Regeneron and Mapp Bio) to Project BioShield. BARDA continues to 
support late-stage development of these candidates and several are 
currently being evaluated in the ongoing outbreak in the DRC. BARDA is 
working with NIAID to make these therapeutics available for a 
randomized clinical trial and continues to work with vaccine developers 
to support potential licensure of the vaccines. The MCM development was 
supported initially from supplemental funding that has been fully 
obligated. Through Project BioShield funding, BARDA will continue to 
complete activities in support of FDA licensure/approval of these 
products.
    In addition to the development of vaccines, therapeutics, and 
diagnostics to treat a potential outbreak, ASPR is also supporting 
efforts to augment capabilities across the Nation's healthcare 
infrastructure to ensure that healthcare providers have the knowledge 
and capabilities to support a response to Ebola, or other highly 
infectious diseases should one arise in our country. ASPR is doing this 
primarily in two ways. First, ASPR has supported a patient transport 
exercise, to test planning assumptions, supporting infrastructure, and 
general knowledge and guidance about how to handle, transport, and 
treat an infected patient or someone suspected of infection. Second, 
ASPR continues to refine regional treatment centers to handle an influx 
of patients, should an infectious disease outbreak occur within our 
borders.
    Immediately after the Ebola outbreak in 2014, ASPR collaborated 
with DOS and other Federal Departments and agencies to develop 
protocols and capabilities, to include transport systems and a network 
of domestic receiving hospitals that could activate biocontainment 
units on short notice. Since 2014, ASPR has participated in four 
exercises testing the movement of patients from overseas locations to 
these receiving hospitals. Three of the four exercises were led by DOS 
and examined a number of international transport issues. The goal of 
the fourth ASPR-led exercise, Tranquil Terminus, April 9-12, 2018, was 
to focus on domestic cases and care. Tranquil Terminus was a full-scale 
exercise that included officials from DOS, State, local, and healthcare 
officials. The goal of Tranquil Terminus was to review notification 
processes, coordination decisions, and resources needed to move highly 
infectious disease patients utilizing both air and ground 
transportation resources. Within the scenario, seven patients were 
presented to healthcare facilities with Ebola-like symptoms. Each 
patient received a positive laboratory diagnosis for Ebola which 
triggered a series of notification and coordination processes among 
local, State, Federal, private sector, and nongovernmental partners to 
facilitate the movement of these patients to Regional Ebola Treatment 
Centers. The exercises revealed strengths, as well as areas for 
improvement, in current planning and existing capabilities. Specific 
gaps included: planning discrepancies; understanding of DOS vendors' 
roles; and coordination of inter-regional patient movement activities. 
HHS is working to address these gaps and is in the initial planning 
phase of designing a follow-on exercise to test an even larger number 
of patients requiring transport and care.
    To strengthen regional capabilities to support a response to a 
highly infectious disease outbreak, during the 2014-2016 Ebola outbreak 
in West Africa, ASPR, in collaboration with CDC, developed a tiered 
approach to prepare U.S. healthcare facilities to safely and rapidly 
identify, isolate, evaluate, and manage travelers or patients with 
possible or confirmed Ebola, like the Quarantine Unit at the University 
of Nebraska Medical Center. ASPR provided awardees with approximately 
$214 million of Ebola emergency supplemental funding to establish a 
nationwide, regional treatment network for Ebola and other highly 
infectious diseases. The funding provided through HPP Ebola 
Preparedness and Response activities has established the foundation 
required for the Nation's healthcare system to safely and successfully 
identify, isolate, assess, transport, and treat patients with the Ebola 
virus disease or under investigation for Ebola (or other highly 
infectious diseases). To prepare for and provide safe and successful 
care of patients with Ebola, ASPR also awarded $14 million (and CDC 
provided $10 million) from the same supplemental appropriation to 
establish a National Ebola Training and Education Center (NETEC). NETEC 
is a consortium of three non-governmental U.S. health facilities--Emory 
University in Atlanta, Georgia; University of Nebraska Medical Center/
Nebraska Medicine (UNMC) in Omaha, Nebraska; and the New York City 
Health and Hospitals Corporation/HHC Bellevue Hospital Center in New 
York, New York. These are in addition to the clinical facility 
associated with NIH. The NETEC provides expertise, training, technical 
assistance, peer review, and mentoring to State health departments, 
regional Ebola and other special pathogen treatment centers, State- and 
jurisdiction-based Ebola treatment centers, and assessment hospitals. 
HHS funded these activities through the Ebola emergency supplemental 
bill. The period of availability for these funds ceases at the end of 
fiscal year 2019.
    Leveraging the best practices from investments made with the Ebola 
supplemental appropriations, ASPR is piloting innovative, tiered, 
regional demonstration projects that can serve as models to test a 
Regional Disaster Health Response System (RDHRS) that could leverage 
and enhance existing programs such as HPP, NDMS, and CDC's Public 
Health Emergency Preparedness Program. Using HPP funding provided in 
the fiscal year 2018 appropriation, ASPR awarded two $3 million grants 
on September 27, 2018, to the University of Nebraska Medical Center in 
Omaha, Nebraska, and Massachusetts General Hospital in Boston, 
Massachusetts. Using this funding, these centers will conduct pilot 
projects to test the effectiveness and viability of a RDHRS. Such a 
system could help integrate existing specialized capabilities, such as 
the tiered Ebola treatment center network to make specialized care 
easily accessible to all Americans. The proposed RDHRS could help 
expand existing training to address other modern health security 
threats including the medical trauma caused by CBRN weapons. The 
proposed RDHRS model could also expand upon healthcare coalitions (also 
funded by ASPR's HPP), adding trauma centers, burn centers, pediatric 
hospitals, public health laboratories, outpatient services, and Federal 
facilities like Veterans Affairs clinics to better meet the healthcare 
needs in a disaster.
    Lastly, to ensure that our responders are able to support future 
infectious disease outbreaks, ASPR is utilizing Ebola supplemental 
funding to provide enhanced training to NDMS personnel. NDMS has 
partnered with the University of Nebraska Medical Center to support two 
specific trainings for personnel. The first, Isolation, Simulation and 
Quarantine Training, provides situational awareness, preparedness and 
planning, infection prevention and control, and crisis and risk 
communications. The second, Highly Infectious Disease Patient Transport 
Training, trains personnel in transportation of highly infectious 
patients to appropriate facilities, use of personal protective 
equipment, and infection control practices while avoiding excessive 
delays in care. Both of these trainings will ensure that NDMS personnel 
have appropriate skills and general awareness to treat highly 
infectious disease patients without becoming infected or spreading 
infection within the impacted area.
aspr's capabilities to prepare and respond to future public health and 
                            medical threats
    Ebola is a significant threat to public and medical health and ASPR 
is working diligently to respond to this threat. I would also like 
highlight ASPR's efforts to ensure that the Nation is protected against 
all threats. The fiscal year 2019 appropriations bill included $1.9 
billion for ASPR's programs and activities, and I would like to thank 
this Subcommittee for its support of ASPR's programs. With this 
funding, ASPR is able to support innovative and effective programs to 
further the Nation's preparedness against all types of threats.
Building and Supporting International Partnerships
    Recognizing that effective response to 21st century health threats 
requires both domestic and international coordination, ASPR has and 
continues to participate and support a number of global initiatives to 
address health security issues. First, ASPR has developed policy 
frameworks on the distribution of MCMs as well as the sharing of 
biological samples among countries within the activities of the Global 
Health Security Initiative (GHSI). The GHSI, created after September 
11, 2001, is an informal network of G7 countries, Mexico, the European 
Commission, and the World Health Organization (WHO) with the goal of 
addressing CBRN threats to global health security and infectious 
diseases with pandemic potential. ASPR has also supported close 
coordination with Canadian and Mexican officials to prevent and prepare 
regionally for a potential influenza pandemic under the North American 
Plan for Animal and Pandemic Influenza (NAPAPI). Specifically, the 
three nations are working jointly to analyze key challenges, develop 
policy and operational instruments, and test regional capabilities to 
ensure that we are all able to work collaboratively in the event of a 
potential or actual flu influenza pandemic. Third, ASPR serves as the 
U.S. International Health Regulations (IHR) (2005) National Focal 
Point, communicating regularly with WHO and other global partners to 
monitor potential health security threats. Lastly, ASPR serves as the 
lead coordinator of U.S. activities related to the Joint External 
Evaluation (JEE). The JEE was released in 2016 and is an evaluation and 
monitoring mechanism to strengthen basic national health security 
capabilities. Engagement in the JEE process allows ASPR to contribute 
to global health security while ensuring that our national preparedness 
is able to address any health security threats, whether it is domestic 
or originates abroad. In follow-up to the U.S. JEE assessment, ASPR led 
the development, and is leading implementation, of the U.S. Health 
Security National Action Plan, released in October 2018. The Plan 
contains hundreds of cross-sectoral activities that the government will 
carry out to address capacity gaps found by national and international 
subject-matter experts during the JEE. Implementation of the Plan will 
further the multi-sectoral and multi-disciplinary approach promoted by 
the IHR to adequately prevent, detect, and respond to public health 
security threats. Through participation in these various international 
organizations and policy conversations, ASPR is able to maintain 
awareness of emerging threats and has relationships in place to 
communicate evolutions in threats as well as preparedness efforts in 
place to mitigate such threats.
Medical Countermeasures Enterprise
    To ensure that the Nation has MCMs available to meet existing as 
well as emerging CBRN threats, $735 million was included in fiscal year 
2019 for Project BioShield, an increase of $25 million over fiscal year 
2018 funding levels, and $562 million was included for BARDA advanced 
research and development efforts. This funding enables BARDA to 
continue to fill remaining gaps in our Nation's preparedness for CBRN 
threats by transitioning products from advanced development to initial 
procurement and stockpiling. By using flexible, nimble authorities, 
multiyear funding, strong public-private partnerships, and cutting edge 
expertise, BARDA has successfully pushed innovative MCMs, such as 
vaccines, drugs, and diagnostics, through advanced development to 
stockpiling and FDA approval or licensure. In the last decade, BARDA's 
strong partnerships with biotechnology and pharmaceutical companies, 
the National Institutes of Health, and other HHS components have led to 
43 FDA approvals for 38 unique MCMs addressing CBRN threats, pandemic 
influenza, and emerging and re-emerging infectious diseases.
    To support preparedness for pandemic influenza, the fiscal year 
2019 appropriations bill includes $260 million, of which $256 million 
is allocated to ASPR. To date, BARDA has supported the development of 
23 influenza related products: vaccines, antiviral drugs, devices, 
respirators, personal protective equipment, and diagnostics to address 
the risk of pandemic influenza. BARDA has a unique responsibility in 
supporting advanced research, development, and procurement of pandemic 
influenza MCMs. While the promise and advantages of universal influenza 
vaccines may take years to achieve, with early stages led by our 
colleagues at NIH, the near-term threat and risk of influenza demand 
that we work right now to make influenza vaccines better and faster, 
and we must ensure that diagnostic tools and antiviral treatments are 
also available to save lives. Influenza virus is a formidable global 
threat to human and animal health because it evolves quickly and is 
constantly jumping between host species. We must maintain our focus and 
monitor the rapid changes of influenza viruses through effective 
international surveillance and control networks. BARDA co-chairs an 
active interagency group, the ``Flu Risk Management Meeting (FRMM),'' 
that is comprised of partners from HHS agencies, DoD, VA, and United 
States Department of Agriculture, as well as public health leaders and 
influenza technical experts. The FRMM meets monthly and conducts in-
depth reviews of all pandemic risk assessment data, including global 
surveys of emerging influenza viruses. Using this information, FRMM 
participants review existing diagnostics, antivirals, and vaccines to 
frame decisions and make recommendations to senior leaders to support 
strategic preparedness investments. Although transmission of H7N9 to 
humans has been reportedly lower in the 2018 season, history indicates 
that avian influenza eradication is elusive because the virus evolves 
quickly to escape protection by any vaccine. Consequently, it is 
critically important for the US to continue receiving, in a timely 
manner, pre-pandemic viruses from China and other countries where these 
viruses emerge, to evaluate the efficacy of diagnostics, antiviral 
drugs, and vaccines. HHS has made great progress in developing new 
vaccines and drugs to respond rapidly to newly emerging viruses. 
However, there is still work to be done to ensure that we are fully 
prepared for this threat. Going forward, ASPR will support continued 
domestic influenza vaccine manufacturing and stockpiling capacity and 
will maintain hard won gains in vaccine manufacturing capabilities, 
advanced development of novel influenza vaccines and therapeutics, and 
international pandemic preparedness activities.
    As BARDA develops, MCMs and as products are being manufactured, 
long-term procurement and stockpiling needs are regularly considered, 
to ensure that products are available and are on hand to dispense to 
impacted populations. The SNS is the Nation's largest repository of 
life- saving MCM and medical supplies intended to support State and 
local emergency needs. In fiscal year 2019, the oversight and 
operational control of the SNS transferred from CDC to ASPR. This move 
aims to more fully assimilate the SNS with other public health and 
medical preparedness and response capabilities under ASPR, improve the 
efficiency of emergency responses, strengthen and streamline the MCM 
enterprise, and leverage synergies in supply chain logistics. I look 
forward to working closely with this committee as the SNS continues to 
be fully integrated into the ASPR organization.
Domestic Response Capabilities
    The fiscal year 2019 appropriations bill includes $57 million for 
NDMS and $265 million for HPP. This funding will enable ASPR to rebuild 
NDMS teams and train them to respond to 21st century threats and invest 
in innovative approaches to build regional health system readiness for 
complex mass casualty events. In addition, the funding will enhance the 
efforts of HPP to prepare the Nation's healthcare infrastructure.
    The 2018 hurricane season highlighted the importance of regional 
healthcare readiness and medical surge capacity. ASPR led the public 
health and medical responses to Hurricanes Florence, Isaac, and 
Michael; Typhoons Mangkhut and Yutu; and the California wildfires under 
the NRF ESF # 8 mission. The Secretary's Operations Center (SOC) 
provided 24 hour, 7 day a week monitoring of each incident. The SOC 
served as the focal point for synthesis of critical public health and 
medical information. During these events, the SOC maintained real-time 
situational awareness and provided analytical reports on the incidents 
to senior leadership. In addition, ASPR worked to identify, organize, 
and visualize critical information related to the communities and 
people impacted by these events which informed decision makers on what 
and where to provide assets. During these responses, ASPR worked 
closely with such officials to augment care, when needed, utilizing 
NDMS teams, U.S. Public Health Service Commissioned Corps Officers, 
Department of Veterans Affairs personnel and facility support, and DoD 
transportation, facilities, and clinicians. Today, HHS continues to 
support recovery efforts in impacted communities.
    Earlier in my statement, I discussed how ASPR is strengthening NDMS 
to support a future response to a domestic infectious disease outbreak. 
Going forward, ASPR is working to modernize and strengthen NDMS 
capabilities to ensure that NDMS continues to provide critical support 
during and immediately after public health and medical emergencies. 
ASPR has made tremendous progress in hiring NDMS personnel--increasing 
NDMS overall size from 2500 to approximately 4000--utilizing the direct 
hire authority included in the 2017 Hurricane Supplemental 
appropriation. Despite this success, the direct hire authority expired 
in November 2018, and a gap of approximately 2000 personnel remains. 
ASPR will continue to hire personnel under traditional hiring practices 
but encourages Congress to consider reauthorizing the direct hire 
authority for NDMS, if possible. In addition to direct hire authority, 
ASPR continues to seek Public Safety Officer Benefit (PSOB) Act 
coverage for NDMS personnel. The PSOB Act provides death benefits and 
educational assistance to survivors of fallen public safety officers 
killed in the line of duty, as well as disability benefits to officers 
catastrophically injured. This coverage is currently offered to 
emergency response personnel deployed by FEMA; extending coverage to 
NDMS personnel could ensure consistent coverage for all first 
responders. Lastly, ASPR will continue to utilize annual appropriations 
to ensure that NDMS teams are trained and ready to respond to 21st 
century health security threats.
    Understanding that strengthening the Federal response capability is 
critical to augment care within an impacted community, it is also 
critical to provide communities tools and resources so they are able to 
respond immediately and mitigating the overall impact of a public 
health and/or medical incident. HPP was established after the September 
11, 2001, terrorist attacks, with the goal of improving the capacity of 
local hospitals across the country to deal with disasters and a large 
influx of patients in an emergency. Using HPP funding, State grantees 
initially purchased equipment and supplies needed for emergency medical 
surge capacity. Over time, the program successfully evolved to support 
local coordinated healthcare coalitions, including hospitals, public 
health facilities, emergency management agencies, and emergency medical 
services providers. Fifteen years after it was established, HPP can be 
further strengthened to better utilize existing resources and enhance 
healthcare preparedness and response capabilities at the local level.
                               conclusion
    Emerging disease outbreaks, particularly those with pandemic 
potential, are an international flight away, and are significant global 
health threats that require domestic preparedness investments and 
programs. ASPR looks forward to working with this committee in fiscal 
year 2019 and beyond to protect the Nation from 21st century health 
security threats. Thank you, again, for your bipartisan commitment to 
this national security imperative, and I look forward to continuing to 
work together to enhance our Nation's health security. I am happy to 
answer any questions you may have.

    Senator Blunt. Thank you.
    Dr. Redfield.
STATEMENT OF DR. ROBERT R. REDFIELD, M.D., DIRECTOR, 
            CENTERS FOR DISEASE CONTROL AND PREVENTION, 
            ATLANTA, GA
    Dr. Redfield. Good morning Chairman Blunt and Ranking 
Member Murray and members of the subcommittee. I am Dr. 
Redfield, Director of the Centers for Disease Control and 
Prevention.
    Thank you for the opportunity to update you in the Ebola 
outbreak in the DRC and outline what CDC is doing to prevent, 
detect, and respond to this and other emerging global health 
threats. CDC's efforts are grounded in over 40 years of the 
Ebola research, more than 20 outbreak responses and seven 
decades of responding to global health disease threats around 
the world and here at home.
    I want to emphasize our goal is to end this outbreak as 
soon as possible. Last week I traveled to the outbreak zone 
where I met with the responders on the front lines. My goal was 
to assess and recalibrate the response for a long-term 
strategy. When I first went to Beni in August, I saw firsthand 
the complexity of this urban Ebola outbreak. Now, 7 months 
later, the outbreak has spread and grown even more complex. 
This trip further reinforced my understanding of the critical 
role experienced technical leadership plays in the field and 
CDC's role in changing the trajectory of this outbreak.
    This is the 10th Ebola outbreak in the DRC since first, 
Ebola was discovered in 1976 on the Ebola River. However, this 
is the first urban outbreak in the DRC occurring in areas that 
experience decades of conflict and civil unrest. The two 
currently affected provinces have busy borders with Uganda, 
Rwanda and South Sudan. These challenges make this outbreak 
much more complex than previous outbreaks.
    As of yesterday, there were 927 cases, 584 deaths reported 
so far involving 20 health zones. As you can see from the map, 
the outbreak is diffuse, over--of note is a significant 
percentage of the cases were acquired in healthcare settings, 
including 75 healthcare workers. In the past 42 days alone, 
there have been 174 active cases in 16 health zones; less than 
a third were known contacts and monitored, and roughly half 
presented as community deaths.
    An effective response depends on early recognition and 
effective isolation of at least 70 percent of cases and 
sustaining this for several months. We are currently not 
meeting this target. The outbreak is not under control at this 
time. In spite of these challenges, we are leveraging new tools 
and countermeasures to confront the outbreak. CDC is working 
with the World Health Organization and has supported 
vaccination of more than 87,000 people in the DRC and 
surrounding counties. CDC's global rapid response team provides 
critical search capacity for the responses. CDC has deployed 
more than 130 experts to the DRC, neighboring countries, the 
World Health Organization for early case recognition and 
contact tracing, infection control and healthcare settings and 
burials, real-time data analysis to direct the response, 
laboratory testing, border health, risk communication, and 
vaccination.
    While the security situation has limited our direct----
participation at the epicenter, CDC continues to provide direct 
assistance to the DRC Ministry of Health in Kinshasa, the World 
Health Organization in Geneva, and the U.S. Government response 
in the DRC, while enhancing preparedness efforts in the 
neighboring countries.
    While this continues to be an urgent situation in the 
region, the current risk to America is low. America is better 
protected from infectious disease threats when more countries 
have the capacity to prevent, detect, and respond to emerging 
threats.
    Through the support of Congress, CDC receives supplemental 
resources to implement the Global Health Security Agenda in 17 
priority high-risk countries, and through those efforts we have 
made tremendous progress in rapid disease detection response 
and stopping disease at their source.
    CDC's Field Epidemiology Training Program continues to 
improve the public health workforce abroad; having trained over 
11,000 graduates now in 70 countries, including 196 graduates 
in the DRC, many whom were confronting the Ebola outbreak 
today. CDC continues to position our assets globally, to 
quickly respond to new threats in disease hotspots, putting 
science into action to end epidemics and eliminate disease.
    Finally, I would like to thank you for your continued 
commitment and support of CDC in our critical global health 
security mission.
    [The statement follows:]
             Prepared Statement of Robert R. Redfield, M.D.
    Good morning Chairman Blunt, Ranking Member Murray, and members of 
the Subcommittee. I am Dr. Robert R. Redfield, Director of the Centers 
for Disease Control and Prevention (CDC). Thank you for the opportunity 
to testify before you on the Ebola outbreak in the Democratic Republic 
of the Congo (DRC) and our efforts to protect Americans here at home 
and eliminate emerging threats, like Ebola, overseas.
    CDC is working, in collaboration with interagency and international 
partners, to end this outbreak and ensure the health and security of 
our country. We have comprehensive Ebola response capabilities 
developed over 40 years at the forefront of Ebola virus research and 
further refined by more than 20 Ebola outbreak responses. In the wake 
of the worst Ebola outbreak in history, the 2014--2016 West Africa 
outbreak that claimed over 11,000 lives, CDC has made significant 
advancements in Ebola science, surveillance, and response. For example, 
we confirmed that live Ebola virus can persist in specific body fluids, 
such as in seminal fluids, for over a year following infection. In 
response to the epidemic, we also trained epidemiologists and 
laboratory scientists and provided testing materials and support to 
African countries at greatest risk of Ebola outbreaks. In addition, in 
June 2015 we established CDC's Global Rapid Response Team, a cadre of 
over 500 highly-trained responders ready to deploy on short notice 
anywhere in the world to respond to global health emergencies.
    In response to the current outbreak in the eastern DRC, CDC has 
deployed 133 expert disease detectives to the DRC, neighboring 
countries, and the World Health Organization (WHO) headquarters in 
Geneva to coordinate activities and provide expertise in surveillance, 
laboratory testing, vaccine administration, emergency management, 
infection prevention and control, health communications, and border 
health. Our operational expertise allows us to quickly and efficiently 
identify the unique scientific and social variables of outbreaks and 
address them with proven interventions. However, the unique challenges 
of the current outbreak mean this fight is even harder than past 
responses.
    The complex situation in the DRC has limited CDC's direct 
participation at the outbreak's epicenter, which is located far from 
the capital city of Kinshasa in an area threatened by armed conflict, 
crime, and civil unrest, as well as heavy cross-border movement. The 
DRC is also experiencing multiple infectious disease outbreaks such as 
cholera, vaccine-derived poliovirus, malaria, and measles. Disease 
control is challenging because of weak healthcare and hygienic 
infrastructure, including the lack of running water and safe waste 
disposal methods. In addition, the affected population has low levels 
of trust in the government and international responders. All of these 
factors make this an extremely challenging environment for an Ebola 
response. Furthermore, from late December 2018 until the end of January 
2019, the U.S. Embassy in the DRC was in ordered-departure status with 
extremely limited CDC staff presence permitted.
    In August 2018, before the security situation escalated, I was able 
to visit the DRC city of Beni to see first-hand the work being done. I 
heard directly from our international partners on the ground how valued 
and desired CDC's contribution is, with their greatest request being 
expanded CDC technical leadership and expertise in the field. My visit 
reinforced for me the essential role CDC can play in changing the 
trajectory of the Ebola outbreak. The current outbreak is the largest 
and longest single country Ebola outbreak to date, with case counts 
continuing to increase and key response indicators going in the wrong 
direction.
                         status of the epidemic
    On August 1, 2018, the DRC Ministry of Health and Population 
reported an outbreak of Ebola virus disease in North Kivu Province. It 
is now the largest Ebola outbreak in the DRC and the second largest 
ever since the virus was discovered there in a village near the Ebola 
River in 1976. As of March 7, 2019, 907 cases have been reported, 
including 569 deaths (63 percent). This includes 841 laboratory-
confirmed cases and 66 probable cases. Due to challenges in detecting 
and reporting cases posed by the security situation, CDC suspects the 
true number of cases is much larger.
    As of March 7, 2019, cases have been reported in 19 health zones of 
North Kivu and Ituri provinces (Beni, Biena, Butembo, Kalunguta, Katwa, 
Kayina, Kyondo, Mabalako, Mangurujipa, Masereka, Musienene, Mutwanga, 
Oicha, and Vuhovi zones in North Kivu; Komanda, Mandima, Nyakunde, 
Rwampara, and Tchomia zones in Ituri). Past outbreaks of Ebola in the 
DRC typically occurred in sparsely-populated, rural areas. The current 
outbreak--like the prior outbreak in West Africa--includes densely-
populated urban areas, increasing the likelihood of human- to-human 
spread. Since the outbreak began, the greatest number of cases has been 
in Beni town (235 cases), which has a municipal population of 340,000 
and a greater area population of about 1 million. North Kivu health 
zones of Katwa (260 cases) and Butembo (84 cases) are also heavily-
affected, and encompass an urban area with a population of 
approximately 1 million. The affected region is about 780 miles away 
from Equateur province, where a prior Ebola outbreak was reported in 
May 2018 and declared over in late July. Although both outbreaks were 
caused by Zaire ebolavirus, genetic differences between the viruses 
suggest the two outbreaks are not linked.
                       status of response efforts
    The DRC Ministry of Health and Population is leading the response, 
with strong assistance from WHO. CDC is providing technical guidance to 
the DRC government, bordering countries, and partners, bringing to bear 
decades of experience, global health investments, and lessons learned 
in the West Africa Ebola response. For example, CDC has updated ring 
vaccination protocols, which strategically focus vaccination efforts on 
the contacts of cases and people who are in close contact with those 
contacts. CDC has also updated vaccination training materials, trained 
150 and deployed 127 Field Epidemiology Training Program (FETP) 
graduates, and developed two new Ebola databases for surveillance and 
vaccination tracking to replace a manual record- keeping system. All 
partners are working together toward one goal: to end this outbreak as 
soon as possible.
    In August, CDC deployed Ebola experts to Beni, but they were 
removed due to security concerns. In December 2018, the DRC held a 
presidential election. Preceding the election, several areas of the 
country experienced a deterioration in the overall security situation, 
leading the U.S. State Department to reduce the number of U.S. 
Government personnel in Kinshasa by issuing a departure order on 
December 17, 2018. During the ordered departure, CDC developed 
temporary infrastructure and capacity to deliver technical response 
support remotely. But this had its own challenges, as Internet access 
and other communication modalities were disrupted in large areas of the 
DRC for extensive periods, limiting connectivity between CDC, WHO, and 
DRC teams. CDC has also enhanced its work through local partners in the 
DRC and mobilized its locally-employed staff. Congolese graduates of 
the CDC-sponsored FETP have participated in operations in North Kivu, 
and plans are underway to augment and extend this technical support.
    The departure order was lifted on January 31, 2019 following the 
peaceful completion of the electoral process. CDC's Country Director 
for the DRC has returned, and CDC has deployed five staff to Kinshasa. 
CDC is ready to deploy more teams to support the DRC and WHO and the 
integrated U.S. Disaster Assistance Response Team (DART) emergency 
outbreak response, as required. Specifically, CDC would apply its 
technical and scientific expertise to help strengthen contact tracing 
and infection control practices in the field, two critical factors 
affecting ongoing transmission in the area. We are working closely with 
other U.S. government agencies, such as Department of State, the U.S. 
Agency for International Development, Department of Defense, National 
Security Council, and others to consider all potential options for 
support and deployment. CDC is continuing to support contact tracing, 
infection prevention and control in healthcare settings, border health, 
risk communications and health education, and vaccine administration-- 
key pillars of the Ebola outbreak response.
    In addition to CDC's presence in the DRC, CDC also has deployed 
staff to augment our country offices in the neighboring countries of 
Uganda, Rwanda, and South Sudan, which are preparing for the 
possibility of imported cases arriving from the DRC. As of March 6, 
2019, 133 CDC headquarters-based staff have participated in a combined 
188 deployments: 42 to the DRC, 57 to support WHO in Geneva, 37 to 
Uganda, 32 to Rwanda, 19 to South Sudan, and 1 to Washington, D.C.
Contact Tracing
    Contact tracing is finding everyone who comes in contact, either 
directly or through contaminated materials, with a sick Ebola patient. 
Contacts are watched for signs of illness and if ill, taken to a health 
facility before they can infect others. One missed contact can keep the 
outbreak going. When someone is not known to be a contact, they are 
usually only identified in a late stage of illness and have spread the 
infection to others already. As of March 7, 2019, a total of 4,265 out 
of 4,950 (86 percent) known contacts of people with Ebola were 
followed.
    However, of recent cases, only 65 percent were known contacts and 
only 38 percent were known contacts that were being followed at the 
time of symptom onset. The high proportion of cases that are not known 
contacts or lost to follow-up indicates that contact tracing must 
improve if the outbreak is to be contained. CDC designed ``train- the-
trainers'' courses for frontline response workers, focusing on contact 
tracing methods. CDC also created an Ebola ``Exposure Window 
Calculator'' app for case investigators, which can be downloaded for 
free on smartphones.
Infection Prevention and Control in Healthcare Settings
    Healthcare settings have played an important role in amplifying 
transmission in this and many prior outbreaks. Implementing proper 
infection control and prevention practices is critical to stopping the 
spread of the virus within the healthcare delivery system and to the 
community. Prompt identification and isolation of patients arriving at 
healthcare facilities with possible Ebola virus infection is essential 
so they may be safely evaluated and, if necessary, transported to an 
Ebola Treatment Unit for further care. CDC estimates that, as of 
February 27, 2019, approximately 42 percent of cases were still not 
being effectively identified and isolated to prevent transmission to 
others. Infected people who are not initially recognized to have Ebola 
may receive care at multiple facilities before Ebola is suspected, 
exposing numerous patients and healthcare workers to the virus. As of 
February 27, 2019, 73 local healthcare workers have contracted Ebola in 
the DRC.
    CDC is providing assistance to response partners and surrounding 
countries to improve the capacity of healthcare facilities to rapidly 
identify and isolate suspected Ebola cases, train personnel, and 
improve infection prevention and control. At least 150 healthcare 
personnel have been trained by CDC in Uganda and Rwanda since October 
2018. Using information from interviews conducted at border crossings, 
refugee transit centers, and district health offices, CDC identified 
clinics and hospitals in border districts of neighboring countries that 
would be most likely to receive an imported case of Ebola from the 
outbreak area. CDC assessed triage practices at these facilities, 
interviewed and informed staff about risks of imported Ebola, and 
prioritized facilities for additional training and support.
Border Health
    The two DRC provinces affected by this outbreak, North Kivu and 
Ituri, border Uganda. North Kivu also borders Rwanda and Ituri province 
touches South Sudan. There is significant population movement across 
these country borders. The Mpondwe Border Crossing is the busiest 
official ground crossing on the border between Uganda and the DRC, with 
a peak of 19,000 travelers passing through each day. At the Rubavu 
District Point of Entry between Goma, DRC and Gisenyi/Rubavu City, 
Rwanda, 60,000 people cross daily. This high volume of movement, which 
includes pedestrian, commercial car, and truck traffic, poses 
significant concern for potential cross-border transmission of 
infectious diseases. The WHO assessment is that there is a very high 
risk of spread regionally.
    Preparedness activities in bordering countries are ongoing and CDC 
is providing technical assistance on their border health security 
efforts. Building on collaborations from the earlier 2018 outbreak, CDC 
is working with the DRC Ministry of Health and Population and other 
partners to adapt and implement screening protocols at country-
prioritized airports and ground crossings, and to map population 
movement into and out of the outbreak zone to determine where 
surveillance should be enhanced. As of March 3, 2019 about 40.4 million 
travelers have been screened at 80 priority ports and crossing points 
in the DRC since the outbreak began.
                risk communications and health education
    CDC social and behavioral scientists have deployed to WHO 
headquarters and several countries bordering the DRC to guide risk 
communication and community engagement strategies. Risk communication 
leads from CDC, WHO, International Red Cross, and UNICEF have set a 
strategic direction for risk communication activities and produced a 
framework that has been shared widely with response partners. CDC and 
the Red Cross are leveraging the unique strengths of each of their 
organizations to bring the perspectives of DRC residents to the 
attention of Ebola response teams. Red Cross volunteers engage with and 
educate DRC community members about Ebola and document individuals' 
beliefs, observations, questions, and suggestions about combating 
Ebola. Red Cross sends this information to CDC, where scientists 
analyze it and develop reports for all participating partners to inform 
outreach efforts. Data are being collected and analyzed at regular 
intervals to monitor changes in knowledge, attitudes, and perceptions 
as the outbreak evolves and to assess the effectiveness of health 
communication messages.
Vaccine Administration
    CDC conducted a clinical trial in Sierra Leone during the West 
Africa Ebola outbreak, enrolling and vaccinating nearly 8,000 
healthcare and frontline workers. Although this and several other 
studies have shown that the investigational vaccine is safe and 
protective against the Ebola virus, more scientific research is needed 
before the vaccine can be licensed. Therefore, the investigational 
vaccine is being used in the current outbreak on a compassionate basis. 
WHO and the Ministries of Health lead the vaccination program, but CDC 
contributes expert technical support and our experience continues to be 
valued in each new country undertaking the process.
    CDC has played a critical role in identifying and implementing 
preventive vaccination of high-risk healthcare and frontline workers in 
the DRC. In the field, CDC's Ebola vaccination implementation expert 
has provided supervision to national-level teams to ensure high-quality 
vaccination implementation. We have embedded CDC staff in the DRC 
Vaccine Commission within the Emergency Operations Center to assist 
with data analysis of vaccine indicators and improving the quality of 
the ring vaccination efforts.
    As of March 7, 2019, the remaining number of vaccine doses in Beni 
was approximately 11,490. Our projections show that, depending on the 
vaccination strategies used and other contextual factors, demand for 
Ebola vaccine could exceed supply sometime between May and mid-
September of 2019, indicating a need to augment the available vaccine 
supply. However, there are many uncertainties about the current 
outbreak in DRC. WHO and the government of DRC recently issued an 
updated Strategic Response Plan (SRP 3.0) for the next 6 months in the 
Ebola Response activities and plans. The SRP 3.0 includes expanded 
recommendations for vaccination of pregnant women (after their first 
trimester) and vaccination of infants, including newborns. Further, the 
SRP 3.0 includes the possibility of offering vaccination to all people 
at risk who reside in ``satellite belts'' (i.e. all the places that the 
symptomatic person visited before being isolated or dying). Such a 
tactic could notably increase the rate of vaccine use. Actual vaccine 
use will vary depending upon availability, the vaccination strategy 
used, and conditions in the field. As of March 7, 2019, 85,877 
individuals have been vaccinated.
    CDC has also collaborated with WHO colleagues in Uganda, South 
Sudan, and Rwanda to translate ring vaccination concepts for Ebola 
preparedness, and has provided technical assistance to countries as 
they have considered the use of Ebola vaccine. In addition, we have 
applied our expertise to update Ebola vaccination protocols, operating 
procedures, and training and communications materials for use at 
national and local levels, and facilitated trainings for national 
staff. Our work across multiple countries has helped standardize 
procedures and facilitate dissemination of best practices.
                        outlook of the epidemic
    Based on the lessons learned from the West Africa Ebola outbreak, 
transmission can be stopped and the outbreak terminated when at least 
70 percent of cases are effectively isolated after becoming ill, that 
is, moved to an Ebola Treatment Unit before they have infected anyone 
else. This needs to be sustained for at least two to 3 months to end 
the outbreak. Without improving the current effective case isolation 
rate of 58 percent, our models indicate that the cumulative number of 
Ebola cases could reach an estimated 1,184 by late August of 2019, or 
worse with further deterioration of the fragile security situation. 
However, as noted above, there are many uncertainties about the current 
outbreak in the DRC. The WHO and the government of the DRC's SRP 3.0 
includes recommendations to strengthen contact tracing and rapid 
identification and isolation of cases. CDC is committed to leveraging 
its resources and global health security expertise to help end the 
outbreak.
                       risk to the united states
    CDC understands that an international outbreak of Ebola puts the 
United States at risk and we appreciate the trust placed in CDC to keep 
Americans safe from public health threats both domestically and abroad. 
At this time, we believe the direct risk to the United States remains 
extremely low based on the travel volume and patterns from the outbreak 
areas to the United States and the implementation of border screening 
measures at key airports and ports in the DRC and neighboring 
countries. On average, of the approximately half a million air 
travelers arriving in the United States daily, about 43 travelers are 
from the DRC, largely from unaffected regions. CDC is implementing 
routine border health security measures at U.S. Ports of Entry and has 
issued a Level 2 (Practice Enhanced Precautions) travel notice for the 
DRC. Travel notices are designed to inform travelers and clinicians 
about current health issues related to specific international 
destinations, and range from Level 1 (Practice Usual Precautions) to 
Level 3 (Avoid Nonessential Travel). In addition, the U.S. Department 
of State has identified the outbreak area as a ``do not travel'' zone 
because of armed conflict, crime and civil unrest. Current CDC guidance 
for managing Ebola cases in U.S. healthcare settings has been reviewed 
and provided to healthcare facilities as part of domestic preparedness 
efforts. CDC's Laboratory Response Network stands ready to perform 
testing on Ebola specimens should any need arise, with testing kits 
deployed across the United States.
                  big picture: global health security
    The ongoing response to Ebola in the DRC demonstrates CDC's 
commitment to strengthening global health security. CDC has been 
engaged in global health security work for over seven decades and is 
able to leverage the essential public health assets developed by 
notable initiatives like the U.S. President's Emergency Plan for AIDS 
Relief (PEPFAR), the President's Malaria Initiative, and global polio 
eradication to support core global health security programs and ensure 
the safety of Americans. With an understanding of the increasing 
threats posed by infectious disease globally and in the context of the 
West Africa Ebola outbreak, CDC received $582 million in supplemental 
funding for a 5-year effort in support of the Global Health Security 
Agenda (GHSA). GHSA was launched by a growing partnership of nations, 
international organizations, and non-governmental stakeholders in 2014 
with a stated vision of a world safe and secure from global health 
threats posed by infectious diseases. Since GHSA's launch, CDC's global 
health protection work has helped contain meningitis in Liberia, 
Marburg virus in Uganda, multidrug-resistant tuberculosis in India, and 
vaccine-preventable diseases including measles and pertussis in 
Pakistan and diphtheria in Vietnam, among other threats across the 
globe. CDC, in collaboration with our country partners, stopped these 
outbreaks at their source, saving lives and reducing the amount of time 
it takes to effectively respond.
    We appreciate the continued commitment of Congress to global heath 
security, as demonstrated by the funding provided to CDC for global 
health security in fiscal year 2018 and 2019. This support enables CDC 
to continue work that protects Americans by detecting and preventing 
infectious disease threats before they reach our borders. We are seeing 
progress in the 17 priority countries where we have invested our global 
health security resources: all 17 have improved rapid response to 
disease threats through established or expanded public health workforce 
training of field-based epidemiologists, 13 have improved prevention of 
vaccine-preventable diseases through increased community immunization 
coverage, 15 have ensured effective public health emergency operation 
centers through training of emergency management officials, and 9 have 
increased their ability to identify country-prioritized pathogens 
through improved national laboratory testing capacity.
    The DRC serves as an example of a country where CDC investments 
have built capacity since program operations began in 2002, including 
activities specifically to prepare for an Ebola outbreak. These efforts 
have also fostered strong relationships with the DRC and surrounding 
countries' ministries of health that have proved critical in times of 
crisis. In May 2018, an outbreak of Ebola in the Equateur province of 
the DRC raised international concern due to its size, logistical 
challenges caused by the remote area, and early spread to more 
populated cities. That outbreak was limited to 53 cases and 29 deaths. 
The swift response ensured it was quickly controlled, and on July 25, 
2018 WHO and the DRC officially declared that the outbreak was over. 
Without a doubt, our global health security activities in the DRC 
enabled a faster, more effective and successful response to the May 
2018 outbreak, and have made a difference even considering the complex 
security situation of the current outbreak.
    The DRC Field Epidemiology Training Program (FETP), developed with 
assistance from CDC and modeled after CDC's own training programs, has 
trained around 150 disease detectives who are crucial to accurately 
detecting and identifying outbreaks. The DRC graduated its first cohort 
of FETP residents in 2015. These are the disease detectives who are 
supporting the current Ebola outbreak and serve as an example of how 
CDC supports sustainable capacity development of countries to respond 
to outbreaks within their own borders. Training programs like these 
work effectively because they are complemented by decades of field 
experience that CDC experts bring, teaching new detectives how to not 
only respond to issues after they have occurred, but rapidly identify 
diseases and prevent spread. CDC maintains long-standing collaborations 
in the DRC for priority diseases, including monkeypox virus response 
and prevention, building capacity and skills that have been beneficial 
for Ebola response. Sustainable investments, such as resources and 
expertise to train laboratory technicians, renovate and upgrade two 
laboratories, and establish a National Emergency Operations Center in 
the DRC, are all being leveraged in the current Ebola response.
    In addition to faster, more robust responses to Ebola, our global 
health security work is enhancing the world's ability to respond to 
other emerging health threats. More than 70 countries have participated 
in FETP, resulting in more than 11,000 graduates around the world. In 
Liberia, improved laboratories, epidemiology training, surveillance, 
and surge capacity resulted in the identification of an April 2017 
meningitis outbreak within one day of the first discovery of a case. By 
comparison, it took 90 days for the country to respond equally to Ebola 
in 2014. The Uganda Virus Research Institute has emerged as a regional 
reference laboratory for viral hemorrhagic fevers thanks to 
collaboration with CDC and its subject matter expertise. In addition, 
Uganda's Public Health Emergency Operations Center, established with 
CDC support in 2013, is a model for other global health security 
program countries. This center has been activated for over 75 outbreaks 
and public health events. Due to improved capacity, Uganda has detected 
16 viral hemorrhagic fever outbreaks as of July 2018, and responded 
quickly to keep outbreaks small and contained. They also detected a 
yellow fever outbreak in spring of 2016 in only four days, compared to 
over 40 days that it took to identify the yellow fever outbreak of 
2010.
    Another important component of CDC's global health work is the 
agency's ability to monitor threats globally and to provide rapid 
response through deployment of staff from across the agency. CDC's 
Global Emergency Alert and Response Service (GEARS) closely monitors 35 
to 45 outbreaks a day through event-based surveillance and supports 
emergency deployments to respond to selected outbreaks. GEARS brings 
together the Global Disease Detection Operations Center (CDC's 
electronic surveillance and analysis system for global threats) and the 
Global Rapid Response Team (GRRT). Since its inception, the GRRT has 
rostered and trained over 500 CDC deployers that have provided nearly 
17,000 person-days of response support.
    CDC is also promoting a safer world by strengthening interagency 
collaborations. Following the West Africa Ebola Response, CDC and USAID 
signed a memorandum of understanding outlining areas for future 
collaboration. Through one component of this agreement, CDC will 
continue to provide technical assistance to USAID's Office of Foreign 
Disaster Assistance (OFDA) while OFDA supports the placement of a 
Humanitarian Advisor at CDC's Atlanta headquarters.
    As we saw during the West Africa Ebola epidemic, current measles 
outbreak, and the ongoing Middle East Respiratory Syndrome (MERS) 
outbreak, infectious disease threats do not respect borders. An 
outbreak that starts in another country could hit our shores in a 
matter of hours; this is why CDC works globally to stop health threats 
before they do. CDC is unique in our public health approach, working 
side-by-side with partners to secure global health and America's 
preparedness.
                               conclusion
    CDC's number one priority during any public health emergency is to 
save lives. CDC never loses sight of its primary mission to protect the 
health and safety of the American people, and we know that global 
health security is national security. In order to effectively protect 
the American people, CDC works overseas to ensure health threats do not 
reach U.S. borders, most importantly by working to stop these threat 
outbreaks where they start. CDC works to protect the United States from 
direct health threats, protect U.S. interests in global economic 
security, and ensure that lessons learned overseas can be applied here 
to increase the strength of the U.S. public health system. While 
significant progress has been made, we know that we will continue to 
see the emergence of both known and unknown threats that will require 
the laboratory and surveillance infrastructure that CDC continues to 
support. Our long-term investments in public health infrastructure and 
health systems in Africa continue to help us rapidly respond to Ebola 
outbreaks in the region. CDC's global health programs have allowed us 
to build strong relationships with the DRC and surrounding countries' 
ministries of health. This has resulted in ministries being both ready 
to take actions themselves and directly requesting assistance when they 
need it, demonstrating confidence in CDC's ability to provide technical 
and on-the-ground support quickly during an outbreak.
    The ability to rapidly detect and effectively respond to threats to 
the public's health is a top priority for CDC, the Department of Health 
and Human Services, and the Nation. CDC works around the clock to not 
only ensure its readiness but the readiness of those on the front 
lines. CDC remains vigilant, because at any given moment, thousands of 
infectious diseases are circulating in the world. We don't know exactly 
which outbreak is coming next, but we know it is coming. The work we do 
now ensures that, when the next major outbreak does come, we are able 
to protect the health of Americans and save lives.

    Senator Blunt. Thank you, Dr. Redfield.
    Dr. Fauci.
STATEMENT OF DR. ANTHONY S. FAUCI, M.D., DIRECTOR, 
            NATIONAL INSTITUTE OF ALLERGY AND 
            INFECTIOUS DISEASES, NATIONAL INSTITUTES OF 
            HEALTH, BETHESDA, MD
    Dr. Fauci. Thank you very much, Mr. Chairman, Ranking 
Member Murray, members of the committee, for giving me this 
opportunity to speak to you today about the role of the NIH 
(National Institutes of Health) in emerging infectious 
diseases.
    I show this map almost historically. The first time I 
testified before this committee was 34 years ago and I showed 
this map and that was in the very beginning of the HIV-AIDS 
epidemic, and the point I made that was this was truly an 
emerging disease.
    I have now testified before this committee dozens and 
dozens of time and I keep adding different points to that map. 
This is what that map looks like today, namely dozens and 
dozens of emerging infectious diseases. Some of them are 
curiosities that affect few people, but nonetheless are a 
danger to be monitored and yet others have transformed global 
health like we have seen with HIV, like the possibility of a 
pandemic flu, and like we are seeing with Ebola.
    So, what is the role of the NIH in this? As you know, we 
fund biomedical research, and this slide shows the three major 
components that we address: basic research, research capacity, 
and countermeasure development.
    For the purposes of today's hearings, I would like to focus 
on countermeasure development.
    Now, in 2019, we take a bit of a different approach than we 
have over the years, where you find the microbe, isolate it, 
grow it, and either kill it or inactivate it and that is your 
vaccine.
    That is not the way we do it today. Today it is very, very 
heavily steeped in three components that are shown here, on 
this slide. The first is priority pathogen, in other words, to 
try and anticipate what are the likely microbes, viruses, 
bacteria that will conceivably be an outbreak. WHO has their 
blueprint of priority diseases, the CEPI Organization, which is 
an independent organization also does that, and we have our own 
for bio-defense, which we have actually addressed with the help 
of BARDA and ASPR.
    The next is platform approach. Let me explain what this 
means, this means instead of always having to grow the microbe 
in question, you create a platform and a platform is a kind of 
vaccine template. For example, the first platform on the slide 
is DNA and RNA vaccines. Now you can get a very small clip of 
the genetic makeup of a virus and have it code for a very 
specific protein.
    The next is a viral vector platform, which means you get a 
harmless virus and stick the gene in that you want to make a 
protein for this is what we have done with Ebola.
    The other one is a prototype pathogen approach, mainly 
knowing that you have experience with multiple types of 
microbes in the same category. If you look at this slide, we 
have a lot of experience with yellow fever and with tickborne 
encephalitis that helped us with West Nile and with Zika, 
because in fact, these are the kinds of viruses that fall 
within that category.
    You have already alluded to the historic Ebola outbreak in 
West Africa in 2014 and 2015. What have we learned from that? 
We did research during that outbreak, and we were able to prove 
that you can do ethically sound and scientifically sound 
research to get answers within the context of an outbreak, to 
help you for the next time you are challenged with that. These 
are just some of the trials that were done during the West 
Africa outbreak: vaccine trials, therapy trials, and following 
survivors to determine the long-term consequences of disease.
    Now, we have the ongoing Ebola outbreak that we are talking 
about today. You already heard about the statistics of that 
from Dr. Redfield. We have a clinical trial right now that is 
asking the question which of the therapeutic modalities 
actually work? And this randomized controlled trial right now 
is evaluating four drugs: ZMapp, which is three monoclonal 
antibodies; Remdesivir, which is a nuclear-side analog, 
monoclonal antibody 114; and a Regenerome product which is a 
monoclonal antibody. We now have 84 individuals accrued in this 
trial and hopefully by the end of this epidemic, we will know 
which of these therapies work.
    We also have now, and I just want to mention it because you 
mentioned it in your opening statement, that a universal 
influenza vaccine is a major goal and priority for NIAID you 
know we have established a strategic plan and a research 
agenda, and I would be happy to talk to you about that during 
the question period.
    And finally, I want to end with this slide which is a paper 
that I wrote over 10 years ago, and the title is the thing that 
keeps reminding me of what we do here, Emerging Infections of 
Perpetual Challenge. They have been with us forever. I started 
talking about them here to you 34 years ago and I am talking 
about them now. They are not going to go away, and that is the 
reason why we have to be perpetually prepared for them.
    Thank you for giving me the opportunity, happy to answer 
any questions later.
    [The statement follows:]
              Prepared Statement of Anthony S. Fauci, M.D.
    Mr. Chairman, Ranking Member Murray, and members of the 
Subcommittee, thank you for the opportunity to discuss the role of the 
National Institutes of Health (NIH) in the research response to 
emerging and re-emerging infectious diseases. I direct the National 
Institute of Allergy and Infectious Diseases (NIAID), the lead NIH 
institute for conducting and supporting infectious disease research. 
Infectious pathogens are a perpetual challenge to human health because 
of their diversity and inherent capacity to adapt and evolve, allowing 
them to emerge and re-emerge in different populations, different 
circumstances, and new geographic locations. NIAID addresses this 
ongoing challenge with basic research to better understand mechanisms 
of pathogenesis and immunity, as well as applied and clinical research 
to evaluate candidate diagnostics, therapeutics, and prevention 
strategies, including vaccines. NIH funding for emerging infectious 
disease research was approximately $2.8 billion in fiscal year 2018.
             pandemic preparedness: a multifaceted approach
    Preparedness for emerging and re-emerging diseases and the 
potential epidemic and pandemic threats they pose requires a 
multifaceted approach. A critical component of preparedness is 
biomedical research to develop medical countermeasures that could be 
rapidly deployed in response to a naturally occurring or deliberately 
introduced infectious disease outbreak. NIAID-supported biomedical 
research includes several approaches:

  --Targeting specific pathogens that are likely threats that might 
        emerge. Examples are Ebola virus, Lassa virus, Middle East 
        Respiratory Syndrome (MERS) coronavirus, and Nipah virus.
  --Prototype pathogen research, in which basic research on one microbe 
        may inform the development of countermeasures for a closely 
        related pathogen. A typical example is the intensification of 
        research on viruses of the Flavivirus genus. The flaviviruses 
        have been extensively studied by NIAID and effective vaccines 
        for Japanese encephalitis virus, yellow fever virus, and tick-
        borne encephalitis virus have been successfully developed. This 
        experience has positioned us well in attempts to develop 
        vaccines for the related flaviviruses West Nile virus, dengue 
        virus, and Zika virus.
  --Developing flexible platform-based technologies. The field of 
        vaccinology is advancing from the historical requirement of 
        growing a virus and either inactivating it or attenuating it 
        for use as a vaccine, an approach that is cumbersome and often 
        fraught with delays in production. Now, various novel vaccine 
        ``platforms'' that have been intensively studied employ 
        recombinant DNA technology that bypasses the need to grow the 
        virus. Such platforms include recombinant proteins, viral 
        vectors containing genes that express specific viral proteins, 
        virus-like particles that can be manufactured, nanoparticles 
        with high immunogenicity, and genetic approaches such as DNA 
        and RNA that code for viral proteins. These platforms can be 
        rapidly deployed against a variety of pathogens.
    NIAID builds upon more than 60 years of experience and lessons 
learned from prior outbreaks to inform our biomedical research response 
to emerging pandemic threats. In doing so, NIAID coordinates with its 
Federal partners, such as the Centers for Disease Control and 
Prevention (CDC); the Food and Drug Administration (FDA); and the 
Department of Health and Human Services (HHS) Office of the Assistant 
Secretary for Preparedness and Response (ASPR) and its Biomedical 
Advanced Research and Development Authority (BARDA).
             pandemic preparedness: building infrastructure
    NIAID advances its research through a robust research 
infrastructure that includes long- term partnerships with individual 
scientists, scientific organizations, and governments worldwide. NIAID 
has prioritized research on pathogens with known or suspected pandemic 
potential in cooperation with international organizations such as the 
World Health Organization (WHO) and the Coalition for Epidemic 
Preparedness Innovations (CEPI). NIAID is poised to leverage its 
existing research investments to develop and test candidate vaccines 
and therapeutics. Critical to these efforts are longstanding NIAID 
clinical research networks such as the NIAID Vaccine and Treatment 
Evaluation Units (VTEUs), which conduct clinical trials on candidate 
interventions, and the Centers of Excellence for Influenza Research and 
Surveillance (CEIRS), which advance our understanding of influenza 
viruses and support early identification of emerging viruses with 
pandemic potential.
     pandemic preparedness: response to selected emerging diseases
    Ebola. Ebola was first identified in the Democratic Republic of the 
Congo (DRC) in 1976, and 27 additional Ebola outbreaks have 
subsequently occurred. The largest Ebola outbreak occurred in West 
Africa from 2014--2016, with more than 28,600 infections and 11,300 
deaths. NIAID built upon biodefense research investments made after the 
2001 anthrax attacks to rapidly launch a robust research response to 
the West African Ebola outbreak. A critical component of that response 
was the Partnership for Research on Ebola Virus in Liberia (PREVAIL), 
an agreement between HHS and the government of Liberia that enabled the 
evaluation of candidate vaccines and therapeutics during the outbreak. 
These NIAID-supported Ebola studies showed the feasibility of 
conducting scientifically and ethically sound clinical research during 
a major public health emergency.
    NIAID has incorporated the lessons learned in conducting research 
during the West African outbreak into its response to the most recent 
re-emergence of Ebola in the DRC. The current outbreak began in August 
2018 and already is the second largest in history. Many Ebola cases are 
occurring in an area of armed conflict and tenuous security, which is 
hindering response efforts. Data from prior NIAID-supported studies, 
including large-scale vaccine trials conducted by PREVAIL, have 
provided evidence supporting the use of candidate Ebola countermeasures 
during the current outbreak. NIAID has entered a memorandum of 
understanding with the WHO to facilitate a research response to 
emerging infectious diseases; this collaboration underpins the 
Institute's efforts in the DRC.
    Safe and effective Ebola vaccines will be crucial tools in the 
response to future Ebola outbreaks, especially for situations in which 
conflict or other factors limit the healthcare response. The rVSV-EBOZ 
Ebola vaccine candidate evaluated by the PREVAIL 1 study currently is 
being used in a ring vaccination campaign in the DRC to immunize 
frontline workers, people potentially exposed to Ebola virus, and 
individuals who may have been in contact with them. NIAID is supporting 
continued development of additional vaccine candidates through its 
intramural and extramural research programs, including a prime-boost 
strategy combining the Ad26.ZEBOV and MVA-BN-Filo vaccines that is 
being evaluated by the ongoing PREVAIL partnership.
    NIAID also is supporting a randomized controlled trial of candidate 
Ebola therapeutics in the DRC through a partnership between NIAID and 
the DRC's National Institute of Biomedical Research (INRB). The trial 
is comparing three candidate therapeutics with a control treatment, the 
investigational monoclonal antibody cocktail ZMappTM that showed signs 
of efficacy in NIAID-supported testing during the West African 
outbreak. The three additional investigational therapeutics being 
evaluated in the DRC are the broad-spectrum antiviral remdesivir, a 
cocktail of monoclonal antibodies known as REGN-EB3, and mAb114. The 
monoclonal antibody mAb114 was isolated from a survivor of the 1995 
Ebola outbreak in Kikwit, DRC, and further developed by scientists at 
the NIAID Vaccine Research Center (VRC) in partnership with the DRC's 
INRB and the U.S. Department of Defense. The isolation and development 
of mAb114 as an Ebola therapeutic highlights the future promise of 
strategic deployment of monoclonal antibodies to prevent and treat 
emerging infectious diseases and potentially alter the course of 
epidemics. These advances are made possible by investments in pathogen-
specific research that have improved our ability to identify precisely 
tailored monoclonal antibodies to combat infectious diseases.
    Zika. Zika virus was first identified in Uganda in 1947 and was 
considered a relatively minor threat until a major outbreak occurred in 
the Americas. Increased case numbers in the 2015--2016 Zika outbreak 
led to the identification of a previously undetected risk of 
microcephaly and other birth defects in the children of women infected 
with Zika virus during pregnancy. NIAID responded to this outbreak by 
quickly establishing a broad Zika research portfolio using a prototype-
pathogen approach that built upon decades of research on closely 
related viruses of the Flavivirus genus that cause diseases such as 
dengue fever, Japanese encephalitis, and West Nile virus disease. 
Experienced investigators and a wealth of knowledge about flaviviruses 
contributed to robust basic research on Zika virus and the disease it 
causes, as well as efforts to develop diagnostics, therapeutics, and 
vaccines to address the outbreak.
    For example, NIAID has supported several natural history studies to 
better understand the long-term consequences of Zika virus infection. 
This includes the Zika in Infants and Pregnancy (ZIP) study, which has 
enrolled women throughout the Americas to follow the effects of Zika 
virus during pregnancy on the growth and development of affected 
infants. NIAID scientists also used Zika virus genetic information to 
rapidly develop a vaccine candidate using a DNA vaccine platform that 
moved from sequence selection to a first-in-human trial in less than 4 
months. A Phase II/IIb clinical trial of the vaccine candidate has 
completed enrollment in several countries in the Americas, and analysis 
of the vaccine's safety and ability to prompt an immune response is 
ongoing. The NIAID Zika vaccine was developed with a readily deployable 
DNA vaccine platform that was previously used by NIAID to develop a 
candidate vaccine for West Nile virus. Using this broadly applicable 
platform technology, NIAID was able to accelerate its response to a 
previously unrecognized public health threat.
    Influenza. NIAID has a longstanding research program to address the 
constant threat of seasonal and pandemic influenza, including studies 
to understand influenza pathogenesis and develop effective antiviral 
treatments. Influenza poses a challenge to vaccine developers because 
the virus can undergo significant mutational changes to its surface 
proteins (the target of current influenza vaccines). This phenomenon 
was highlighted by recent experience with H7N9 influenza, which was 
identified as a potential pandemic strain when it first emerged in 
China in 2013. HHS preparations to address the possibility of a 
pandemic included the development and stockpiling of an H7N9 vaccine. 
In 2017, a new H7N9 strain was detected and studies showed that the 
stockpiled 2013 H7N9 vaccine did not provide adequate protection 
against the new 2017 strain. NIAID has sought to avoid such challenges 
in the future by developing broadly protective influenza vaccines that 
would be effective against existing strains as well as newly emerging 
strains. Broadly protective, or ``universal,'' influenza vaccines would 
be vital tools to prepare for future pandemics, as well as to improve 
our ability to prevent seasonal influenza.
    NIAID recently published a strategic plan for universal influenza 
vaccine development that focuses on three key areas: improving 
knowledge of the transmission and pathogenesis of influenza infection; 
characterizing influenza immunity and immune factors that correlate 
with protection; and supporting the design of universal influenza 
vaccines. NIAID is actively engaging Federal partners, including HHS 
agencies and other key domestic and international stakeholders involved 
in influenza vaccine research, to coordinate and advance activities 
outlined in the strategic plan. Novel vaccine platforms are 
particularly suited to the development of a universal influenza 
vaccine. Notable accomplishments in this area include the development 
of a ferritin nanoparticle-based vaccine candidate by the NIAID VRC; 
the formulation of a vaccine cocktail of virus-like particles by NIAID 
scientists that protects against diverse influenza strains in animal 
models; and the launch of an NIAID-sponsored Phase II clinical trial to 
evaluate the M-001 vaccine candidate, which contains several influenza 
fragments or peptides common among multiple influenza virus strains.
    The development of a truly universal influenza vaccine may take 
years to achieve, but clear progress is being made. To continue to make 
steady progress toward that goal, NIAID continues to support the 
development of improved vaccines for influenza strains with pandemic 
potential. NIAID is partnering with BARDA to develop multiple candidate 
vaccines through the NIAID VTEUs, including an updated H7N9 vaccine.
    NIAID also is supporting the development of a number of novel 
influenza therapeutics to support pandemic preparedness. An investment 
in NIAID basic research nearly 40 years ago enabled the development of 
XofluzaTM, an important new drug recently licensed for 
influenza treatment. XofluzaTM became the first influenza 
antiviral with a novel mechanism of action to gain FDA approval in 
nearly 20 years.
                               conclusion
    Together with academia, industry, and national and international 
partners, NIAID will continue to meet public health emergency needs by 
advancing high-priority research for infectious disease threats. These 
efforts include pathogen-specific research, the application of a 
prototype-pathogen approach, and the development of platform 
technologies, to enhance pandemic preparedness and response efforts. 
NIAID remains committed to supporting biomedical research to advance 
pandemic preparedness and enhance international research capacity to 
respond to emerging and re-emerging infectious diseases.

    Senator Blunt. Thank you Dr. Fauci.
    Admiral Ziemer.
STATEMENT OF R.T. ZIEMER, REAR ADMIRAL, USN (RET), 
            ACTING ASSISTANT ADMINISTRATOR, BUREAU FOR 
            DEMOCRACY, CONFLICT, AND HUMANITARIAN 
            ASSISTANCE, U.S. AGENCY FOR INTERNATIONAL 
            DEVELOPMENT, WASHINGTON, DC
    Admiral Ziemer. Chairman Blunt, Ranking Member Murray, 
members of the subcommittee, thank you very much for the 
opportunity to present USAID's role in this latest Ebola 
outbreak.
    Before I launch into my testimony though, I just want to 
acknowledge the recent attacks on the Ebola treatment centers 
in Butembo and Katwa and the bravery of the frontline health 
workers that are working day and night to get this under 
control. Just as I walked into the hearing this morning, we 
were informed of another attack in a town just west of Butembo.
    Seven months ago, when the government of DRC reported this 
most recent Ebola outbreak, we have been engaged. Transmission 
has been rapid and has now spread to multiple hotspots through 
both rural and urban areas. Responders face considerable 
challenges and this outbreak is occurring in areas with ongoing 
civil unrest and fighting between armed groups. The long 
history of violence and marginalization of the local 
populations in this area contributes to the deeply--deep-rooted 
distrust of the central government and outsiders.
    This distrust has been a major roadblock and has fueled 
misconceptions about the disease, including beliefs that Ebola 
was created to wipe out populations, extort money from people, 
or is a political tool to prevent participation in elections.
    In September as the lead Federal agency charged with 
responding to complex international disasters and natural 
disasters, USAID deployed a Disaster Assistance Response Team, 
known as the DART, to coordinate the U.S. response to this 
Ebola outbreak. The expert team is comprised of disaster and 
health experts from CDC, as well as USAID, and is working 
tirelessly to coordinate activities with partners on the ground 
and to ensure an effective U.S. Government response.
    Building on the lessons learned from the West Africa 
experience, USAID is closely collaborating with our key and our 
agency partners like CDC, as well as the government of DRC and 
WHO. The DART is supporting a multi-pronged approach to contain 
the disease, stop the spread of infection, provide medical care 
to patients, and training to medical personnel to support 
community engagement and to coordinate all of this with our 
partners.
    As Dr. Redfield has already mentioned, USAID is co-
implementing the Global Health Security Agenda. Senator Murray, 
thank you for bringing that up, it is a priority of USAID and 
the agency. This initiative was launched to prevent and 
mitigate infectious disease threats like this Ebola outbreak, 
and the goal has been to strengthen health systems of targeted 
countries to detect, respond to these infectious disease events 
early with the aim of containing them at their source.
    A critical part of the Global Health Security Agenda is the 
strong collaboration and coordination across the U.S. 
Government agencies, with the ambassador as the overriding 
customer that we have to support the health programs in the 
countries where we are engaged.
    In conclusion, USAID is well-equipped to respond to a Ebola 
and other disease threats due to our long-standing expertise 
and leadership in responding to humanitarian emergencies, 
support for programs that strengthen health and security, and 
prevent the spread of infectious diseases by continuing our 
efforts in Eastern DRC to improve contact tracing, infection 
prevention and control, case management, safe and dignified 
burials, and community engagement, we are adapting to the 
unique challenges that this outbreak presents.
    So, we will continue to work alongside with all of our 
government agencies, the government of DRC, the World Health 
Organization, and our international partners to bring this 
outbreak to an end as soon as possible.
    Thanks very much, I look forward to your questions.
    [The statement follows:]
             Prepared Statement of Rear Admiral Tim Ziemer
    Chairman Blunt, Ranking Member Murray, members of the subcommittee, 
thank you for the opportunity to speak with you today, alongside my 
distinguished colleagues from the Department of Health and Human 
Services.
    Since August 2018, the Democratic Republic of the Congo (DRC) has 
been facing what is now an unprecedented Ebola outbreak in the country. 
As of March 6, health officials have recorded 907 confirmed and 
probable cases, including 569 deaths as a result of the outbreak that 
continues to spread in North Kivu and Ituri provinces in the eastern 
part of the country. It is now the second largest recorded outbreak of 
the disease, eclipsed only by the 2014 West Africa outbreak that 
resulted in nearly 29,000 cases and killed more than 11,000 people. I 
know you are interested in the recent attacks on health facilities in 
areas affected by the outbreak. While I will touch on this later, I 
want to start by saying that our hearts go out to the people affected 
by these tragedies. We are tracking the effects of these incidents.
    Since the outbreak began, the U.S. Government has been working 
closely with the Government of the DRC, the World Health Organization 
(WHO), and other international partners to contain the spread of 
disease. Bringing an end to this devastating outbreak is a priority for 
the U.S. Government, not only because we are committed to supporting 
those affected, but also because effective efforts to contain and end 
the outbreak can prevent it from reaching the broader region, as well 
as our borders. This latest outbreak also highlights the importance of 
the U.S. Government's continued investments in global health security.
    This outbreak is not yet contained. In this testimony, I will 
outline the scale of the DRC Ebola outbreak and some of the challenges 
facing responders, how USAID is responding, and the critical role USAID 
plays in global health security and responding to emerging disease 
threats like Ebola around the world.
                   overview of the drc ebola outbreak
    The Government of the DRC declared the most recent Ebola outbreak 
more than 7 months ago, in North Kivu Province in eastern DRC. Within a 
few days, the virus had begun to spread through communities and the 
first cases were reported in the city of Beni, a hotspot for insecurity 
in the region. Within two weeks, newly confirmed cases were being 
reported in neighboring Ituri Province. By mid-October, increased 
transmission in hospitals and health facilities led to a spike, and 
cases in Beni had multiplied, making it the new epicenter of the 
outbreak. While there has only been one case in Beni since the end of 
January due to the robust response, this outbreak is still uncontained. 
It has continued to be transmitted quickly, and has now spread to 
multiple hotspots throughout both rural and urban parts of North Kivu, 
including Katwa, a particularly difficult environment facing high 
community reticence, including physical attacks on healthcare 
facilities.
    Unlike previous outbreaks in the DRC, this outbreak has spread 
beyond isolated rural areas to urban areas with more dense populations. 
With multiple concurrent outbreak hotspots across the region, a robust 
response is more important than ever, given the high mobility of people 
within the affected region, as well as the risks associated with spread 
in both rural and urban areas. But responders face considerable 
challenges to stopping the disease. First, the virus has spread along a 
fairly busy regional trade route, making the response more difficult to 
control. Second, this outbreak is occurring in areas with ongoing civil 
unrest and fighting between armed groups, leading to access 
constraints. Violence is contributing to the intermittent suspension or 
modification of ongoing activities--including those of USAID partners. 
In late December, at least 36 health facilities were looted or damaged 
in Ebola-affected Beni, as well as others in Butembo, due to civil 
unrest immediately following the postponement of elections there. The 
response has also faced troubling violence with recent attacks on Ebola 
Treatment Units in Katwa and Butembo. Two attacks in late February 
forced partners to pull staff out of the immediate area while the 
incidents were further investigated. Every day health teams are absent 
for an outbreak area is a lost day of critical response activities, 
like isolation at a treatment center or contract tracing and 
surveillance, that can help prevent the disease from spreading further. 
Attacks like this remind us that we must remain vigilant. Not only do 
they threaten the response and the brave people working to save lives, 
they also put the very patients we're trying to help in danger.
    Third, the long history of violence and marginalization of the 
local populations in this area contributes to the deeply rooted 
distrust of the central government and associated efforts to respond to 
the outbreak, including of Ebola responders themselves. This widespread 
distrust has fueled misconceptions about the disease, including beliefs 
that Ebola was created to wipe out populations, extort money from 
people, or is a political tool to prevent participation in elections. 
Aid and medical workers on the frontlines of fighting this outbreak 
feel the brunt of this distrust. Not only do they face the constant 
threat of contracting this disease, they face resistance in helping 
those most at risk.
    Separately, the DRC has long faced an ongoing humanitarian crisis, 
with 4.5 million people displaced. Ongoing violence, restricted 
humanitarian access, poor infrastructure and a weak healthcare system, 
forced recruitment into armed groups, and reduced access to 
agricultural land and traditional markets have contributed to the 
deterioration of humanitarian conditions in the DRC and triggered mass 
internal displacement and refugee outflows.
    To date, the global response to this Ebola outbreak has been 
relatively well-funded through the generous contributions of the United 
States Government and other donors. In February, WHO and the Government 
of DRC issued an updated 6-month Strategic Response Plan which outlines 
resource needs and response strategy. We are working with WHO and 
partner to implement and secure resources for the strategy.
                    u.s. government's ebola response
    In September, USAID deployed a Disaster Assistance Response Team, 
or DART, to coordinate the U.S. response to the Ebola outbreak in the 
DRC. This expert team--comprising disaster and health experts from 
USAID and the U.S. Centers for Disease Control and Prevention (CDC)--is 
working tirelessly to identify needs and coordinate activities with 
partners on the ground. By augmenting ongoing efforts to prevent the 
spread of disease and by providing aid to help affected communities, 
this work ensures an efficient and effective U.S. Government response.
    The DART, as the lead coordinator of the U.S. Government response 
in the DRC, knows what to do because we've done this before. From 2014 
to 2016, USAID deployed its expert DART to lead the U.S. response to 
the unprecedented Ebola epidemic in West Africa that killed more than 
11,000 people. Our flexible strategy during that response allowed us to 
respond effectively to the changing conditions, as we learned more 
about the social aspects of the crisis. For example, when we learned 
that safe burials were likely to have an important effect in reducing 
the transmission rate of the virus, we quickly worked with partners to 
establish and support safe burial teams in every county in Liberia. For 
the DRC Ebola response, as in our West Africa response, USAID is 
closely collaborating with our interagency partners like CDC, the 
Government of the DRC, other donors, the U.N. and international 
partners, and affected communities to battle this disease.
    The DART is working with partners, not only to provide vital 
assistance, but also overcome some of the key challenges that have made 
this outbreak difficult to contain. As such, the DART is supporting a 
multi-pronged approach to: (1) contain the disease and stop the spread 
of infection; (2) provide medical care to patients and training to 
medical personnel; (3) support community outreach and behavior change 
activities that dispel misconceptions about Ebola and inform 
communities how to prevent and detect the disease; (4) increase the 
pipeline of supplies to the region for use by front-line responders; 
and (5) coordinate with international partners.
    First, contact tracing activities and case investigations have been 
hampered because of the security situation and lack of community trust, 
yet they are critical to contain the disease and stop its spread, so we 
are helping to train 1,330 community healthcare workers to conduct 
surveillance including contract tracing. We're also supporting efforts 
to ensure safe and dignified burials for people who have died from 
Ebola. Infected bodies are highly contagious, but burials are deeply 
emotional experiences, often rooted in cultural patterns not easily 
changed just because the death was from Ebola. This has proven 
challenging during the response, and some burial teams have even been 
physically attacked, hindering their ability to help families safely 
bury their dead. Our partners are working with community leaders and 
within the communities themselves to help encourage safe practices and 
save lives. One partner has even directly engaged with Butembo town's 
Catholic bishop, who worked with local priests to promote safe 
funerals, including advocating testing bodies for Ebola before burial.
    Next, we're prioritizing treatment to patients and training of 
medical personnel. Transmission in healthcare facilities has continued 
to be a challenge in this response, so we're working aggressively with 
CDC and other partners to address it effectively. Specifically, USAID 
is currently providing vital support to more than 220 health facilities 
across at least 18 health zones by strengthening infection prevention 
and control measures, and working to train more than 1,800 community 
healthcare workers on best practices in case detection, triage, patient 
screening, and waste management. Additionally, USAID provides resources 
to improve disease screening, isolation, and triage; and additional 
supplies such as durable vinyl mattresses to replace foam mattresses 
that can potentially spread infection. Among the supplies we've 
transported to support the response are nearly 53 metric tons of life-
saving personal protective equipment from our warehouse in Dubai for 
use by frontline health workers at more than 100 health facilities who 
are at greatest risk of contracting the disease. We're also providing 
enough food to meet the needs of 20,000 survivors, contacts, family 
members, frontline responders, and individuals in treatment and 
isolation each month, over the course of 6 months. This assistance 
helps people grow or stay healthy, as well as prevents potential 
contacts or cases from traveling throughout the community to get food.
    While all of these efforts are important, it's just as critical 
that the people in affected communities understand the risks of disease 
so they, too, can be invested in efforts to prevent it. USAID is 
helping aid groups gain the trust of affected communities and dispel 
rumors about the disease by supporting community outreach efforts that 
improve communication within communities and by working with trusted 
community leaders. Our partners are working to reach more than 93,300 
households--or 560,000 people, including more than 270 community 
leaders, with key health messages that help raise awareness about Ebola 
transmission.
    None of this is possible without resources on the ground to 
implement these programs. USAID has an unparalleled capacity to provide 
the response equipment when it's needed, which is why we are increasing 
the pipeline of people and supplies to the region. USAID's vital 
support for logistics operations ensures Ebola responders safely get to 
the affected region and have the equipment and supplies needed to keep 
the response moving. USAID worked hand-in-hand with the Department of 
State to provide critically needed specialized medical equipment to 
safely isolate and transport patients affected by the deadly disease at 
the request of the World Health Organization. After State shipped the 
critical equipment to the DRC, our team in Kinshasa made sure it made 
it to WHO quickly.
    However, it's not just these activities that make our role in this 
response unique. USAID works with HHS--specifically CDC--to align and 
strengthen U.S. Government engagement with key multilateral 
institutions, such as WHO, in this particular response. We also work 
alongside other donors to influence the response's overall strategic 
management, while also encouraging additional donors to step up and 
contribute to this critical effort. We're applying our longstanding 
knowledge of the humanitarian system and the operational context to 
guide international efforts and provide vital support to partners that 
can implement public health programs to a scale that will help contain 
this outbreak.
    Our DART is charged with coordinating all of these interventions, 
and with such a critical situation, USAID has deployed some of our most 
seasoned staff with extensive experience battling Ebola in Africa, as 
well as working in the DRC. One of our team members is a health expert 
and an infectious disease physician. A few years ago, she treated 
patients in West Africa, helping to save lives during the worst Ebola 
outbreak in history. After watching a mother lose her only child to 
Ebola in Liberia, she has dedicated her career to ensuring no other 
parent has to lose their child to such a devastating illness. She was 
also on the ground for several months during this response to help stop 
the spread of this same virus in the DRC--this time in the country 
where she grew up. This is the kind of passion and drive that's fueling 
our disaster team on the ground.
    There are signs that these interventions, and the hard work of 
Ebola responders, are paying off: 304 people have recovered from the 
disease during this outbreak, as of March 6. However, the disease 
continues to spread, meaning that we still have much more work to do 
and must continue to adapt to the myriad challenges facing this 
response.
                       past experience with ebola
    USAID is no stranger to battling the Ebola virus in Africa. For the 
2014-2016 West Africa response, our DART, together with our interagency 
and international partners --and affected countries--helped bend the 
epidemiological curve in Liberia, Guinea, and Sierra Leone, and avert 
the worst-case scenarios initially predicted. This experience, along 
with our long history of being fast, scalable, operational, and 
flexible during humanitarian disasters, makes USAID uniquely equipped 
to respond to this outbreak. We've proven our ability to respond to 
humanitarian emergencies around the world, and we're applying that 
leadership here. We have also been providing humanitarian assistance in 
the DRC since 1984, so we know how to operate in this environment 
because we have long-standing experience coordinating with the DRC 
government, other donors, and partners during high-profile emergencies. 
However, we fully acknowledge that despite the global lessons learned 
during the West Africa outbreak, we are faced with a unique and 
difficult challenge in trying to operate in a highly insecure area.
    We are also taking the lessons learned from the West Africa 
outbreak and applying them to this response. For example, there are 
improved methods for patient isolation and triage while minimizing the 
risk to healthcare workers. Also, many of the people responding to this 
outbreak also responded in 2014 and have been able to leverage their 
expertise in this response. And while we are applying these lessons 
learned wherever possible, we recognize that this context is highly 
unique and includes an active conflict zone, and are making adjustments 
to respond to the challenges.
         addressing emerging threats and global health security
    This outbreak, as well as other recent disease outbreaks like SARS, 
the 2009 H1N1 influenza pandemic, Middle East Respiratory Syndrome 
(MERS-CoV), and the West Africa Ebola epidemic are reminders of the 
global vulnerability to infectious diseases, which have the ability to 
rapidly spread across the globe and threaten the United States within 
hours. In addition to the high morbidity and mortality often associated 
with pandemic and epidemic events, there can be devastating 
consequences that can adversely impact global trade, travel and 
commerce around the world. It is critical that the United States 
continue to use its expertise to respond to these threats to prevent 
global spread of deadly diseases.
    Perhaps the greatest infectious disease threat is the emergence of 
a novel influenza virus resulting in a severe flu pandemic. The 1918 
influenza pandemic, which resulted in more than 50 million deaths 
worldwide, is an example of this worst-case scenario. While medicine 
and public health have made great progress since this time, the 
potential pace and rapid spread of a novel virus in humans with little 
to no immunity would likely surpass response capacity and existing 
resources, especially in areas with weak health systems.
    This past year, the world continued to experience multiple health 
emergencies and infectious disease outbreaks. As the DRC was responding 
to its ninth recorded Ebola outbreak in the summer of 2018, India was 
responding to a Nipah outbreak in the state of Kerala. Thankfully, both 
of these outbreaks were contained relatively quickly as a result of 
concerted efforts, but it was a reminder to the global health community 
of how two serious diseases with the ability to infect many people and 
result in a high number of deaths, could have simultaneously spread 
rapidly in two different regions of the world.
    All of these events demonstrate the need for enhanced multi-
sectoral coordination and collaboration, before, during, and after 
outbreaks. Pandemic and large-scale epidemics should not be solely 
considered the responsibility of the health sector. Recognizing this 
fact, pandemic preparedness and response requires a whole-of-society 
approach to help mitigate these possible consequences and bring 
together multiple sectors to better prevent, detect, and respond to 
infectious disease threats.
    Under the leadership of the National Security Council (NSC), and in 
collaboration with CDC and other interagency colleagues, USAID has 
worked to implement the Global Health Security Agenda (GHSA), which was 
launched in 2014, to prevent and mitigate disease emergence and spread. 
The goal of GHSA is to build the capacities and strengthen the health 
systems of targeted countries to detect infectious disease events 
early, respond rapidly and effectively to new outbreaks, and to prevent 
avoidable outbreaks. When things happen--like the current Ebola 
outbreak--we also work to ensure response agencies have the tools and 
operational structures necessary to respond quickly and effectively. 
This is why we invested $35 million into WHO's Health Emergencies 
Program and constantly work with other partners to encourage adequate 
operational readiness.
    USAID's GHSA program builds upon our development work across 
sectors such as global health, food security, economic growth, and 
environmental portfolios; our longstanding work at the community level 
with local organizations; and our foreign disaster assistance and 
global resilience programs.
    With our in-country Missions, USAID forges strong relationships 
with host country Ministries, including health, agriculture, finance, 
and forestry, as well as international organizations--such as the Food 
and Agriculture Organization and WHO--to help achieve our objectives.
    One of our key focus areas is addressing zoonotic diseases and 
animal health services. This is critical since about 70 percent of new 
outbreaks come from animals. USAID is doing this by preparing the next 
generation of local health, agricultural, and environmental 
professionals to deal with zoonotic diseases. USAID has helped nearly 
80 African and Asian universities train more than ten thousand 
students, faculty, and professionals in zoonotic diseases, 
antimicrobial resistance, risk communication, and other disciplines. 
For example, as part of this training, students in Uganda helped 
respond to the 2017 Marburg, Anthrax, and Avian Influenza outbreaks 
through community mobilization, contact tracing, and community 
messaging.
    USAID is also helping countries detect viruses in wildlife that 
have the potential to cause the next epidemic or pandemic. The point is 
to stop these threats at their source by designing interventions early 
on to reduce the risk to humans. Since the GHSA launch, USAID has 
helped detect almost 300 new viruses that could pose threats to human 
populations, including a new Ebola virus strain (Bombali virus) that 
was discovered in Sierra Leone in 2018 through the USAID-funded PREDICT 
Ebola Host Project. In addition, very recently the USAID PREDICT 
project also identified the Zaire Ebola virus strain in a bat in Nimba 
County, Liberia. These discoveries help target disease surveillance 
activities as well as information for communities.
    In addition, we are strengthening more than 40 animal health and 
other national labs in GHSA countries, including reestablishing central 
veterinary laboratories in Guinea, Liberia, and Sierra Leone after the 
Ebola outbreak. For example, in Guinea, USAID helped refurbish the 
chief veterinary lab, provided diagnostic equipment and access to 
water, and trained staff on diagnostic procedures and biosafety. These 
efforts were effective; shortly after opening, Guinean technicians 
detected an outbreak of anthrax, conducted a livestock vaccination 
campaign, and rapidly controlled the outbreak without any human cases.
    USAID is also working to promote health security at the local level 
by helping at-risk communities develop preparedness plans and train 
community volunteers to detect and respond to infectious disease 
threats in their own neighborhoods. We are developing an emergency 
supply chain program specially designed to distribute commodities, like 
personal protective equipment, that are critically needed during 
outbreaks. We are helping countries establish risk communication 
programs that provides individuals and communities with the information 
needed to reduce the spread of diseases and outbreaks. Finally, we are 
building upon our more than two decades of work addressing 
antimicrobial resistance by helping to prevent healthcare associated 
infections. For example, USAID has helped improve infection prevention 
and control, and waste management in more than 400 health facilities 
across six countries.
    USAID will continue to respond to international outbreaks in ways 
that build long-term capacity. This includes two stockpiles of 
emergency non-medical commodities, on-the-ground activities that can be 
quickly reprogrammed, and the availability of technical experts in 
water, sanitation, and hygiene; communication; and other areas.
    A critical part of the GHSA is the strong collaboration and 
coordination with the CDC, the Department of Defense, the Department of 
State, and across U.S. Government agencies both state-side, and in 
partner countries under the aegis of the U.S. Ambassador, and we're 
proud of the targeted activities being implemented by U.S. partners on 
the ground.
                               conclusion
    In conclusion, USAID is well equipped to respond to Ebola and other 
disease threats due to our longstanding expertise and leadership in 
responding to humanitarian emergencies, as well as our commitment and 
support for implementing programs that strengthen global health 
security and prevent the spread of infectious diseases. We are able to 
draw upon decades of experience in this area--from training community 
health workers to health systems strengthening to supply chain 
development. By continuing our efforts to improve contact tracing, 
infection prevention and control, case management, safe and dignified 
burials, and community engagement, we're adapting to the unique 
challenges this outbreak presents, to bring it under control as soon as 
possible.
    Moving forward in this outbreak, we will continue to work alongside 
the Government of the DRC, WHO, other U.S. Government agencies, and our 
international partners to provide technical assistance and ensure U.S. 
support is best accounting for needs and response priorities. While 
responding to this outbreak is challenging and complex, it is a whole-
of-government response, and we are working alongside our partners in 
the U.S. Government and our partners on the ground to ensure a well-
coordinated response that makes the most of each agency's expertise.
    Thank you for your time, and I look forward to answering your 
questions.

           EBOLA OUTBREAK IN DEMOCRATIC REPUBLIC OF THE CONGO

    Senator Blunt. Well thank you Admiral. Let us just start 
with you. I was going to ask about if things are getting better 
or worse in the Eastern Congo. I think you answered that, they 
are not getting better.
    To both you and Dr. Redfield, how do you make a decision in 
an environment like that where the government cannot provide 
the security that we would want to have for people there trying 
to help? How do you balance that decision knowing how quickly 
this can spread and the danger of this now second biggest 
outbreak of Ebola ever?
    Admiral Ziemer. Senator, the security and the community 
distrust are the two major vectors that seem to be going in the 
wrong direction. We understand the virus that is also 
spreading, so as you mentioned, the disease is not contained. 
But, if we just step back a couple of years, DRC has been 
successful in responding to Ebola outbreaks. What was different 
is the community engagement, as well as the security platform, 
or this environment.
    So, this one is much different, and we are having to make 
adjustments with the reality on the ground. We defer to the 
chief of mission to determine where our teams are able to go. 
That is being reassessed on a daily basis. The ambassador has 
traveled to the epicenter a couple of times. I believe he was 
with Dr. Redfield, surely, so he is very much aware of the need 
and the contributions that the U.S. Government team makes.
    So, I would--to answer your question, the way we make these 
decisions are a--is a moving target, it is not a one-time 
decision. It is made at the interagency level, it is made in 
collaboration through the DART team, but we focus in on the 
expert counsel and advice given to us by the Embassy. It is a 
moving target and we continue to work on that.
    Senator Blunt. Anything to add to that Dr. Redfield?
    Dr. Redfield. I would just like to emphasize, as you know, 
I was just in Butembo on Saturday with the U.S. ambassador to 
the DRC. I just want to emphasize what the Admiral said. I 
think we need to disassociate the rebels from a criminal 
element that is there trying to extort money from people who 
are trying to work in the treatment centers. The day that we 
were there, there was actually an attack in the morning before 
we got there, but it was actually by a criminal element that 
was trying to extort money from the people that were trying to 
serve the people, and from the community.
    And as the Admiral said, I think the thing that was clear 
that in this area, Butembo and Katwa, which is now the 
epicenter of the third wave of this outbreak, the community 
does not trust. It does not trust its own government, it has 
been in conflict for over 20, 25 years, and it sure does not 
trust outsiders, and that lack of community trust is just 
underscored by the comment I made to you earlier that almost 
half of the cases present to the health system now, dead, 
because they do not trust the system to come and present 
themselves while they are sick. Which again is a disastrous 
indicator for an Ebola response, because as people get 
symptomatic, they get infectious and if they do not present 
themselves, then that is why we have an ongoing epidemic.
    So, I do think this community engagement, trying to build 
community trust--and it is more difficult in this environment 
than any one I have seen before, because we are trying to do it 
in an environment where the people do not trust their own 
government.
    Senator Blunt. So, is this an environment where people are 
more likely to stay in place because of the chaos going on, or 
more likely to be moving around, which obviously, is even more 
challenging in terms of spread of the disease?
    Dr. Redfield. Since this outbreak has started, and this is 
really a big number, over 20 million people have crossed 
borders in and out of the outbreak, almost on a daily basis it 
is over 100,000. This is a highly mobile population.
    Truthfully, it is nearly miraculous that we have not seen 
cross-border spread yet, but I will say since August when the 
outbreak started, that CDC augmented our in-country teams in 
South Sudan, Uganda, and Rwanda with the local ministries of 
health to build preparedness, so that they are prepared to 
recognize a case when it occurs and in a sense, bring to a 
halt, as Senator Murray talked about in Nigeria, bring out to a 
halt as soon as they see in-country transfer case, to be able 
to stop that right there.
    So, very mobile. It is--the amount of border screening that 
is going on, on a daily basis, is really measured in the 
80,000, 90,000, 100,000 people going in and out of the 
outbreak.
    Senator Blunt. There will be time for a second round of 
questions, so I would like everybody to do their best, 
including me, to keep their question time to 5 minutes and then 
we will come back and do it again.
    Senator Murray.
    Senator Murray. Well, thank you, Mr. Chairman.

  CENTERS FOR DISEASE CONTROL AND PREVENTION PERSONNEL IN DEMOCRATIC 
                         REPUBLIC OF THE CONGO

    The trends surrounding this Ebola outbreak really are 
incredibly alarming and we--you are talking about the security 
concerns and I am concerned that CDC's best experts are not on 
the ground working in the affected areas and there is a real 
risk that this outbreak could reach major urban areas or 
crossover into neighboring countries.
    Dr. Redfield, you were just there in the DRC last week, how 
important is it for CDC to get staff on the ground closer to 
the outbreak's hotspots?
    Dr. Redfield. Echoing Admiral Ziemer's comment that from a 
public health point of view we believe it is very important. We 
have 700 WHO employees right now responding to this outbreak. 
When I was first there in August, it was 200 employees, and 
then they went to 300, then 500. When I was there this weekend, 
they have 700 people, courageous people, on the ground, fairly 
competent people on the ground. Where there is a huge gap, is 
the gap in leadership of highly experienced technical people 
that have been in multiple Ebola outbreaks to be able to help 
lead the teams to an effective response.
    That said, I am a public health leader, I am not a security 
expert and I defer to the security experts. I can tell you CDC 
is prepared to be in the outbreak as soon as our security 
people tell us that we have permission to go there. But I do 
think this lack of leadership to complement the WHO leadership, 
is critical.
    The last thing I would say is there is fatigue setting in. 
You saw it with the original Doctors without Border recently in 
the attacks. WHO has been there for almost 8 months now; they 
need some leadership reinforcements.

                         EBOLA RESPONSE EFFORTS

    Senator Murray. Well, the head of Doctors without Borders 
criticized the response efforts current approach as ``Unlikely 
to end this outbreak'', and she expressed concern that the use 
of security forces is actually provoking community hostility 
and making communities view health workers as the enemy.
    Do you agree with that assessment?
    Dr. Redfield. This is a very complex area between--and when 
I was there on Saturday, right, literally two hours after an 
attack on the health center that was burned several days 
earlier by the rebel attack, this time it was attacked by a 
community that wanted to extort money, I can tell you there was 
only two people that complained to the minister that they were 
worried about their paycheck. But all of them complained that 
they did not feel safe at the health center.
    So, it is a balance and part of the additional challenge of 
security is you are trying to provide security by a force that 
is either the Congolese military, which is not trusted by the 
community, or MUNESCO, which is not trusted by the community, 
but it has to be a balance.
    Senator Murray. Would more CDC personnel themselves have 
better community trust?
    Dr. Redfield. Well, I think historically, those of us that 
have worked in the field providing healthcare have been able to 
gain trust. The question is how we do be able to do that in a 
way that protects the safety of the individuals. Again, I defer 
to Admiral Ziemer on that because we defer to, really, the 
Department of State and Mission to make those assessments to 
allow us to deploy.

           CENTERS FOR DISEASE CONTROL AND PREVENTION BUDGET

    Senator Murray. Well, let me--just, let me talk about the 
budget, which is what our committee's responsibility is. The 
administration budget does continue to invest in the Global 
Health Security Agenda, which started in the Obama 
administration, but I am alarmed that it does not call for 
enough funding to prevent a damaging scale-back of that 
important work, and I see the budget proposes some dramatic 
cuts to CDC's global HIV-Aids work. My understanding is CDC's 
global HIV-AIDS investments have not only been incredibly 
successful across the globe, but in the DRC have boosted that 
country's public health infrastructure, which is such a 
critical part of this.
    It is--aren't the proposed cuts counterproductive Dr. 
Redfield?
    Dr. Redfield. Thank you Senator. You know, I think we all 
know this is a very complex budget environment that we are in 
right now, and priorities have to be made.
    I was excited about new funding for the HIV, new funding 
for the opioid infectious disease interface, as you are 
experiencing in the State of Washington now, and one of the 
outbreaks from HIV is linked to IV drug use, and our new 
funding for global health security, our new funding for flu and 
new funding for AFM.
    So, again, complicated environment, priorities have to be 
made, we are going to continue to do the best that we can with 
the resources that we have.
    I would like to make one point that I did not emphasize in 
my previous comment, that to date CDC has deployed 130 people 
to the DRC and Geneva for this response. So, while we have not 
been in the epicenter, we have deployed a number of people to 
the DRC, to Uganda, South Sudan, Rwanda and Geneva. So, I want 
to leave you with the impression we are well engaged, we are 
just not engaged where I think we could also be of critical 
help to begin a path to bringing this to an end.
    Senator Murray. Okay, and I am just focused on how we can 
build that community trust with the right people there.
    Dr. Redfield. I agree, Senator.
    Senator Murray. Okay. Thank you.
    Senator Blunt. Thank you, Senator.
    Senator Schatz.

                       EFFECTS OF SEVERE WEATHER

    Senator Schatz. Thank you Mr. Chairman, thank you ranking 
member, thanks to all the testifiers for being here, but 
especially for what you do for public health for the United 
States and across the planet
    According to the World Health Organization, one of the 
biggest health threats for 2019 is air pollution and climate 
change. I know that the phrase climate change can be 
polarizing, so I do not want you to opine on that, but I do 
need to know that we are preparing for the types of pandemic 
threats that a warming planet could bring.
    So, my question for the panel is, how do droughts, heat 
waves, hurricanes, poor air quality, extreme weather, increase 
our risks, and I will start with Dr. Kadlec.
    Dr. Kadlec. Well, thank you Sir for the question and I 
think from--and again, I think each of the panelists will have 
their own perspectives, but I will give you just some ASPR 
relevant ones, which is, in terms of our ability to prepare for 
a pandemic we are far more well prepared than then we were 10 
years ago, thanks to Congress and again, the appropriations 
that Congress gave back in 2005 and 2006 about $7 billion to 
really focus our efforts about pandemic influenza, which is the 
principal pandemic risk, probably, we face.
    The second issue is on global, and so with that we have 
been focusing on domestic manufacturing, development----
    Senator Schatz. Sir, let's, because I have four to answer, 
the question is how severe weather, especially droughts----
    Dr. Kadlec. Hurricanes----
    Senator Schatz. Hurricanes--increase our risk.
    Dr. Kadlec. They do increase our risk and we have been 
actively preparing for that. We have actually pre-positioned 
equipment and supplies in Hawaii so that we can respond in the 
Pacific Basin to all the territories out there as we had to, 
with hurricanes Utip and Yutu and Lane and Hector, so, we see 
this is an active issue and that we have already been 
responding to it to prepare in a way that would position 
ourselves for that.
    Senator Schatz. Dr. Redfield.
    Dr. Redfield. I think, you are looking at the health 
consequences independent of cause, the health consequences of 
weather and extreme weather, or the ones that I think would 
jump out that we are very focused on, obviously, is changing in 
vectors. So, obviously, with hurricanes, floods, mosquito 
vectors, it can cause disease. Obviously, with changes in 
temperature cycle we are seeing an increase in the tick 
population and seeing more tick-borne disease and being able to 
be able to respond and try to develop strategies to confront 
that. In extreme weather, fires, obviously with the chronic 
health there are consequences by that. And finally, I would 
argue another example would be changes in, say, water 
temperature in the Gulf for example, and you are seeing die-
offs from algae blooms and fish.
    So, there are definitely health consequences of weather and 
we continue to----
    Senator Schatz. And climate.
    Dr. Redfield. And climate, okay, and we try to develop 
strategies to do them. I think the one that I am most focused 
on right now is vector borne disease.
    Senator Schatz. Thank you.
    Dr. Fauci.
    Dr. Fauci. Let me just underscore what Dr. Redfield said 
about vector, particularly the range of vectors and how long 
vectors stay around. We live in a temperate climate where you 
have cold that essentially puts at least underground, if not 
gets rid of, certain vectors, be they ticks or mosquitoes. If 
you have climate modification where you might have warmer 
weather you could see the range increase, not only the 
duration, but even the geographic distribution of vectors. So, 
I totally underscore what Bob said.
    But there are also other things, for example, you mentioned 
droughts and things like that. Then you have situations that 
have an impact on animals, like mice in areas where you could 
wind up having Hantavirus virus outbreaks, when you have 
certain changes in weather in the Southwest part of the 
country. Dust storms lead to increases in coccidioidomycosis in 
certain areas such as in Southern California and Arizona. So 
those are three or four, right away.
    Senator Schatz. You are also going to have people moving as 
a result of severe weather and maybe, they can be a vector 
themselves, correct?
    Dr. Fauci. Right.
    Senator Schatz. Mr. Ziemer.
    Admiral Ziemer. Thanks, there are many factors that affect 
the work that we are engaged in and the trends in whether 
affect migration, water sanitation, and clearly, the vectors as 
has already been mentioned.
    We spent a lot of time looking at our famine prediction 
model based on a number of factors, which weather comes into 
and climate change, which helps us anticipate pre-position 
funding and commodities in order to meet the effects of those 
changes.
    Senator Schatz. Thank you.
    Senator Blunt. Thank you, Senator Schatz.
    Senator Durbin.
    Senator Durbin. Thanks a lot, Mr. Chairman, and thank you 
to the witnesses. I would go out on a limb and say that if you 
wanted to look at the most important room in Washington, D.C. 
when it comes to medical research over the last few years, it 
would be this room year, this subcommittee. Under the 
leadership of Chairman Blunt and Senator Murray, we have seen 
for four straight years a 5 percent increase in real growth at 
the NIH. I think an overall 30 percent over that period of 
time, but 5 percent real growth each year.
    Increase at CDC, I wish were equal, but they have been 
good, and we hope they will get better in the future. I reject 
the President's budget out of hand. This notion of 12 percent 
cuts at NIH is just unacceptable, and I think most Democrats 
and Republicans would agree on that score. So, I hope in the 
course of the budget we can continue this run of good luck and 
good effort by the Chairman and Senator Murray. It makes a 
difference. I believe it and I know you do too.

                              TUBERCULOSIS

    Dr. Fauci, you reflected on your service over a number of 
decades, and I would like to ask you a question about something 
that has not come up yet this morning. I have always said that 
the education of a Senator is a daunting task, and someone came 
in my office this week and tried to educate me on tuberculosis. 
What I was surprised to learn is that the year that Alaska 
became a State, the number one cause of death in Alaska was 
tuberculosis and it was at a horrible incidence rate, which had 
been the case for decades. Good things started happening at the 
end of the 50s and the 60s with medicines and approaches, but 
today, the rate of death from tuberculosis in Alaska is still 
three times the National average. So, it is a battle; it is not 
easily won.
    Internationally, argument could be made we are not getting 
close to winning. A 2 percent decline in tuberculosis infection 
rates per year presage a long, long period where tuberculosis 
will still be the number one cause of death of children in the 
world and will continue to haunt us all over the world.
    And, so my question to you is this, we have spoken of 
Ebola, and not to take anything away from its seriousness, when 
you look at disease, an epidemic like the tuberculosis 
epidemic, why have we failed when we put so much into it to 
really make a dramatic impact in the world?
    Dr. Fauci. It is a very good question; the numbers are 
stunning. When you tell people that they do not believe it. 
Tuberculosis is the leading cause of infectious disease death 
in the world. It is the leading cause of death among HIV-
infected individuals. There is one third of the entire world's 
population, between 20 percent and 30 percent of the world's 
population, infected with tuberculosis, latent tuberculosis. 
There are 10 million new cases each year and 1.8 million deaths 
per year.
    So, your question is obvious, What the heck is going on? 
Why in 2019 do we still have that? And it is a complicated 
issue, because first of all, we have not addressed tuberculosis 
as a global problem with the 21st century technology of drug 
development and vaccine development, because we had initial 
success when early-on in the developed world, at least, we 
developed good drugs for tuberculosis. So, it became a 
treatable disease.
    Then we wound up getting multiple and extensively drug-
resistant tuberculosis. Then what we had was a large gap of 
about 40 years where we did not have one new class of drugs for 
tuberculosis. Only recently in the last couple of years, have 
we developed a couple of new drugs that are now quite 
successful.
    The other issue with tuberculosis: it is one of those 
diseases that is a disease of poor people of the world and if 
you look at people that do not have healthcare, if you look at 
the countries in which tuberculosis ravages people, it is in 
those areas where they do not have access to healthcare.
    I must say on an uplifting note, that in the last year and 
a half there has been a major global surge in enthusiasm about 
addressing tuberculosis. It started off with a ministerial 
meeting that I attended in Moscow in November 2017. Then we had 
the UN Special Session on Tuberculosis, just this past year, 
and very soon, in the next couple of days, a Lancet Commission 
report is coming out looking at all of the things that we need 
to do.
    We, at NIAID, have put out a strategic plan and research 
agenda for tuberculosis, for the reasons that you are saying; 
it is neglected.

                             ETHYLENE OXIDE

    Senator Durbin. I want to stay to Chairman Blunt's deadline 
here and I have 13 seconds to say to Dr. Redfield, CDC I hope, 
will join us in taking a look at a challenge we have in 
Illinois with ethylene oxide used as a sterilizing agent for 
medical equipment. We are now--determined it is a severely--a 
seriously carcinogenic gas and we are getting readings in some 
of our suburban towns 350 times the accepted level. I am hoping 
we can work with the CDC to take a look at this company, 
Sterigenics, and the situation we are facing in Willowbrook.
    Dr. Redfield. Thank you, Senator. I appreciate your concern 
and I have been briefed on the situation. We are engaged and we 
are working with your staff and the local health departments 
and we will keep you informed. We think it is an important 
issue, the area of environmental health threats is truly just 
as important as our infectious disease health threats.
    Senator Durbin. Thank you.
    Senator Blunt. Thank you Senator Durbin.
    Senator Shaheen.

                    SPREAD OF EBOLA TO UNITED STATES

    Senator Shaheen. Thank you Mr. Chairman, and thank you all 
very much for being here.
    I know that we all remember the public fear in the United 
States after they Ebola outbreak in, I guess it was 2013 and 
2014, and I just--given the number of people who are going in 
and out of the disease zone, how concerned should we be about 
the potential for Ebola to get spread outside of Africa and to 
the United States? I do not know who wants to answer that.
    Dr. Fauci. Well, I guess each of us can answer it, but I, 
having been very deeply involved in the scares of the 2014/2015 
outbreak, I think it is important to point out that there may 
be an individual case that could come to a country that is a 
developed country, including our own; we have had that 
experience. Given the U.S. healthcare system and our ability to 
respond, it is extremely unlikely that we would ever have an 
outbreak of Ebola here because of how Ebola is spread. It is 
not like influenza, it is spread, as you well know Senator, by 
direct contact with patients who have infected body fluid that 
you have contact with, be that blood, or urine, or feces, or 
what have you.
    We did that here in the United States at several centers 
where we took care of individual people. Under those 
circumstances, you do not have an outbreak, but----
    Senator Shaheen. Right. I think--excuse me for 
interrupting, I think I misspoke. I did not mean an outbreak of 
Ebola, I meant more an outbreak of fear and----
    Dr. Fauci. Well, the fear for sure, it will happen, as soon 
as you get a patient. We had patients that we took care of 
under the best of circumstances. I took care of two of them 
myself at the NIH. The fear that was associated with just 
having an Ebola patient in the country, as you might remember, 
created a firestorm of publicity that was just very, very 
disturbing, because it was really completely unrealistic. And 
what we did, you might recall, is we took our attention away 
from West Africa, which really needed the attention and we were 
focusing on an unrealistic fear here in the United States.

                       EBOLA VACCINE DEVELOPMENT

    Senator Shaheen. So, I am sorry that I missed the testimony 
in the earlier questioning, but can you talk about the vaccine 
and the response to Ebola that is being developed. I know that 
during the outbreak in 2014 that people were feeling very good 
about the potential to get a vaccine that might be able to help 
us, and to get more treatment options that I think would help 
address the fear that people have about this disease.
    Can you talk about that I guess, Dr. Fauci? And also, I 
understand that you are studying three therapeutics designed to 
help treat Ebola. Four, okay.
    Dr. Fauci. Starting with the vaccine, back in 2014/2015/
2016 with West Africa, we did a Phase 1 and then a Phase 2 
trial of a vaccine candidate called VSV which was initially 
developed in Canada (Merck has it right now). That VSV vaccine 
was shown in a trial that did not definitively show that it was 
effective, but strongly suggested that it was effective. That 
was back then.
    That same vaccine right now is being deployed in an 
experimental way, because it is still not approved, and there 
are over 80,000 people in the DRC who have been vaccinated, 
usually contacts of Ebola patients and contacts of contacts, 
but even some geographic distribution. Simultaneously with 
that, in West Africa, Liberia, Sierra Leone, Guinea and Mali, 
there is a vaccine trial that is going on that is taking the 
VSV vaccine with another vaccine strategy from Janssen and 
Jansson, which includes a vectored vaccine called Ad26 vaccine, 
against a control.
    So, on the one hand we are deploying it in response, and on 
the other hand we are testing it. That is the vaccine update.
    With regard to therapy, one of the therapies used in the 
West Africa outbreak was called ZMapp, which is a triple 
combination antibody. It tested in a randomized controlled 
trial that strongly suggested but did not definitively 
statistically prove it was effective. Today that intervention 
is now being tested in a randomized trial along with monoclonal 
antibody 114, which was developed by the NIH from a person who 
actually recovered from a former DRC outbreak; a monoclonal 
antibody from the company Regeneron; and a drug called 
Remdesivir from Gilead. There are four therapies now in trial, 
it is ongoing and as we heard from our colleagues here, not 
only is it difficult to take care of patients when you have 
security issues, it is difficult to do a clinical trial. But 
the clinical trial is ongoing.
    Senator Shaheen. Thank you. Thank you all.
    Senator Blunt. Thank you. Thank you, Senator. Let me ask a 
couple of questions here, before I go to Senator Hyde-Smith.

                 NATIONAL STRATEGIC STOCKPILE TRANSFER

    Dr. Kadlec, my understanding is that the responsibility for 
maintaining the National Strategic Stockpile has now largely 
shifted to you, I believe you are working in cooperation with 
Dr. Redfield and others, but things like the Ebola outbreak and 
our country's new concerns about measles. Do you want to talk 
just a little bit about any concerns you have about the new 
reality of managing that stockpile and whether we are providing 
the resources you need to do that kind of management?
    Dr. Kadlec. Well thank you Senator for the question and I 
think one of the issues here is prioritizing what the threats 
are and what we need in the stockpile. Historically, a lot of 
what is been in the stockpile has been subject to 
determinations made by the Department of Homeland Security 
through a material threat determination, which is derived from 
Intelligence. Much of that was derived from terrorism.
    I think the critical consideration is today is, how do you 
take real-world events and current intelligence and kind of 
modify your approach.
    And I think your point about the Ebola circumstance is one 
that is, I think, very appropriate because quite frankly, we 
have a limited Ebola supply of vaccine that we are prepared to 
mobilize to support the efforts USAID and CDC in West Africa, 
and so we are going to have to make some critical decisions 
about replenishment of what that supply looks like and further 
production.
    Subject to the measles issue, which is one that maybe does 
not touch on the Strategic National Stockpile because we do not 
have the measles vaccine for that, but a lot of the networks 
and capabilities have been worked on together with CDC and 
ASPR, in terms of preparedness in the State and local levels, 
have been very significantly beneficial for the response to 
measles; I will just say that.
    The last point though is, is that the challenge we have now 
is how do we go to the future. And one of the areas that we are 
really focusing in is a strategic plan, How can we base it to 
be more nimble, responsive to the effects of maybe a new 
outbreak, and how can we work with NIH and with CDC and with 
our DOD colleagues to quickly mobilize what may be a nascent 
capability, or a vaccine or a diagnostic, and quickly run it 
through the paces so that we can deploy it in real time. And 
so, those are some of the challenges that we have, and we are 
working actively, and I would love to brief your staff on some 
of our planning efforts on that.
    And as far as the resourcing is concerned, we have a 
significant shortfall that we anticipate in 2020 and 2021 with 
the stockpile with the replenishment of--vaccines in products 
that were actually products of the Project BioShield Program. 
Right now, about $900 million shortfall in 2020 and going 
forward to 2021, about 800.
    Senator Blunt. And that is because some of that what you 
have is no longer going to be viable.
    Dr. Kadlec. It is basically going to expire, Sir.
    Senator Blunt. Anyone else want to comment on how they 
would work with the two or the three of you. I think you 
mentioned CDC and NIH both, in anticipating where that future 
risk might be, or how to quickly respond to a current 
challenge.
    Dr. Redfield. The only comment I would make, Mr. Chairman, 
because it is cross-cutting, one of the things that is critical 
when your countermeasures is vaccine is to have an attitude in 
this Nation that people want to accept vaccine. So, I do think 
that the current vaccine hesitancy that we have in our Nation 
is something that we plan to continue to try to address.
    You have mentioned the measles outbreak. The reason we are 
having seven measles outbreaks already this year, 17 last year 
in this country, is all driven by vaccine hesitancy. 
Vaccination is our most powerful tool we have to prevent 
disease. It is going to be one of our most powerful tools in 
our stockpile to confront threats, and so bringing the American 
public to a point of being more aggressive in accepting 
vaccines for themselves, their family, their schools, their 
churches, their workplaces. I think many of you know, last year 
we lost 80,000 people from flu and less than 50 percent of 
people chose to get vaccinated from flu, and while the flu 
vaccine may not totally protect you from flu, it does have a 
very strong predictive value to protect you from death.
    I do think from our point of view, continuing to get the 
American public affirmative towards the important scientific 
advancements that we have in vaccinology is going to be 
critical, because when a pandemic comes the countermeasure is 
likely going to be a vaccine.

                     INFLUENZA VACCINE DEVELOPMENT

    Senator Blunt. Well, we were going to talk about flu later, 
so let us just do that right now. How is your work there going? 
How close are we to being better, either better to anticipate 
this year's flu, or better yet, a universal flu vaccine?
    Dr. Fauci. Well, as we discussed many times in the past, 
Mr. Chairman, with influenza, getting a better seasonal flu 
vaccine is the pathway to getting a universal flu vaccine. So, 
we are simultaneously doing two things. We are trying to 
develop a better vaccine that has greater protection and 
greater durability for a season, but for a universal flu 
vaccine, a lot of things have happened since we last testified 
before you.
    As you know, as I mentioned in my opening statement, we 
have a Universal Influenza Vaccine Strategic Plan and Research 
Agenda. Over the past year, several candidates, which have 
first in preclinical, mainly in animal models have now 
graduated into Phase 1, some Phase 2, and there is even one 
Phase 3 clinical trial. The fundamental principle of a 
universal flu vaccine is to induce in the body a response to 
that part of influenza in general, that does not drift or 
change from season to season, and that does not even change 
greatly when you get a pandemic. And over the last 5 to 10 
years, through structural biological approaches, we have been 
able to identify that very part of the virus that is constant 
from virus to virus.
    The task now is to try and get the body to respond to that 
particular constant part of the influenza virus. The body, 
interestingly, has a tendency to respond to an important part 
of the virus, and that can protect you for this season because 
it changes a lot and may change next season. When you get it 
right for this season, the vaccine is a good match. We call 
that tendency immunodominance. We want to have the body make a 
response against that part of the virus that it tends not to 
make a ready response to, but if it does, it can be really 
quite protective.
    I might say there are some preliminary data coming out that 
is showing that type of protective response. We were not sure 
whether we could actually induce that, but using some of the 
platform technology that I showed on one of my slides, there 
are early studies to show that this not only is quite possible, 
but actually the results are really quite encouraging. So, I 
think we are making considerable progress and I am cautiously 
optimistic that we are going in the right direction.
    Senator Blunt. I am sure that, particularly this time of 
the year that people we all work for would be most encouraged 
of the things that we hope won't happen to deal with the things 
we know will happen, in this one area, and that is a good 
report and I am glad to hear it.
    Senator Hyde-Smith.
    Senator Hyde-Smith. Thank you, Mr. Chairman.

                       INFLUENZA VACCINE SUPPLIES

    Following up on that, you know, we as you well know just 
had the 100th anniversary of the Spanish flu of 1918, which 
claimed an estimated 100 million lives globally. Coming through 
Katrina, living through that in Mississippi, it taught me that 
being prepared before disaster is so vital.
    So, following up with that and the vaccines as you 
discussed--this may go to you, Dr. Kadlec, what are the 
challenges of having enough flu vaccines and the stockpile is 
current and not expired?
    Dr. Kadlec. Well, thank you Ma'am. I just want to 
capitalize on a comment that Dr. Fauci made which is talking 
about platform technologies in which we can basically make 
vaccines potentially faster. One of the challenges we have now, 
quite frankly, with our flu vaccine supply, is the predominance 
of that is from eggs, which are, again, you have to have 
chickens to have eggs, obviously, but I think the key thing 
there is that is a challenge in terms of the long duration it 
takes to make vaccine. Some of the technologies that Dr. Fauci 
has identified were common in technologies, vaccines are made 
from cell culture that we have invested in already, they will 
have a limited domestic supply of, or capacity for, is a 
critical adjunct to what Dr. Fauci is talking about in terms of 
developing the types of vaccines, not only that are better, but 
that can be produced faster, so we can respond faster.
    I think if you ever have a chance to look at the curves of, 
not necessarily what happened in 1918, but if we projected what 
would happen today in terms of the speed of the transmission of 
a flulike illness in a population that is vulnerable it would 
be explosive, and in some ways, the faster you can get 
vaccines, literally saves thousands of lives, and again the 
economic benefits are also derived from that. It is a--it is 
really kind of like complementary effort that we have to pursue 
with Dr. Fauci, with Dr. Redfield, to basically make sure they 
have all the pieces of this in place, at the ready, should it 
happen. And it has happened, and it is historically we know, 
and it is likely to happen again.

                     INFLUENZA ANTIVIRAL TREATMENTS

    Senator Hyde-Smith. Wow. Turning to treatments, I know 
there is a worry that some future pandemic flu strains might 
develop the resistance to the antiviral treatments. Of course, 
we are all concerned about that. How would adding new antiviral 
treatments to the stockpile that work differently, help address 
that?
    Dr. Kadlec. That would be the hedge against that kind of 
uncertainty and quite frankly, reality. There have been reports 
coming from Asia, even though it is not getting a lot of public 
exposure, that there are cases of eight, seven, and nine 
influenza strains that are more, or tend to be more resistant 
to Tamiflu, our existing stockpile drug.
    So, diversification of our stockpile with different 
antivirals that work by different mechanisms would be the hedge 
against that. And again, to underscore what was mentioned 
earlier by Dr. Redfield, our vaccine is our first line of 
defense, but the antivirals are significant adjuncts, important 
adjuncts, to not only buy time but save lives.

                             ASIAN BIRD FLU

    Senator Hyde-Smith. And referring to Asia, the Asian 
influenza bird flu and this you said, comes from eggs--vaccine 
that you have. Is there a correlation study that if we have 
both those epidemics at the same time?
    Dr. Fauci. I am sorry, what was the question?
    Senator Hyde-Smith. Asian influenza, bird flu.
    Dr. Fauci. Right. If we had a bird flu epidemic at the same 
time----
    Senator Hyde-Smith. When we are trying to use the eggs--
that it affects the poultry.
    Dr. Fauci. Yes, that is a theoretical issue, I do not think 
it is going to be a practical issue. We always say that 
theoretically if you have bird flu that you might kill the eggs 
that you are trying to produce it in, but that has not been a 
problem. We have been able to grow the vaccine from a bird flu 
in eggs, and we have successfully done that.
    Senator Hyde-Smith. Being a former Commissioner of 
Agriculture we were always under the threat of that and 
watching out for that. And I am thinking if we are making the 
vaccine from the eggs, you know, we have the problem with the 
poultry industry having to exterminate so many, if that would 
create the problem there. I am glad that that is not a 
legitimate concern, at least not at this point.
    Dr. Fauci. Well, we think about it and that is one of the 
things that prompts us to go full speed ahead on the platform 
technologies that I mentioned that would not rely on eggs.
    I just want to make a comment, because you asked Dr. Kadlec 
about influenza and stockpile. The ultimate, I would say dream 
or Holy Grail that we would have, the day that you could 
actually stockpile influenza vaccines. We cannot do that now 
because it changes from season to season. If we get a really 
good universal flu vaccine, you might actually be able to 
stockpile it, which we have not been able to do, because it 
changes from season to season.
    Senator Hyde-Smith. Have a broader spectrum, I guess. Okay, 
well I had some follow-up. I think I am out of time.
    Dr. Kadlec. Ma'am can I just offer one thing about the 
chicken and egg issue, is, one thing that Dr. Fauci mentioned 
is, it does take a little longer, a lot longer to basically 
cultivate the vaccine in eggs. Whereas some of the technologies 
that he is developing, particularly with recombinant, gives you 
a speed that probably is unequaled by any other technology. 
There is lots of reasons to do that and I think the key thing 
here is not only do we hope that he is successful in the 
universal flu vaccine, but we also develop those technologies 
that allow us to produce these vaccines faster and with more--
with greater focus on being effective.
    Senator Hyde-Smith. Having the resource. Thank you.
    Senator Blunt. Senator, if you have a follow-up this would 
be a good time to take that time if you want to.

                      STRATEGIC NATIONAL STOCKPILE

    Senator Hyde-Smith. Okay, just on general supplies in the 
stockpile adequately funded for just the foundational products, 
such as saline and other medical supplies, to meet the needs of 
the pandemic.
    Dr. Kadlec. Well Ma'am, I think the key thing is if you do 
have a pandemic there will be an incredible burden on the 
healthcare industry, and particularly the supply chain that 
goes with that. A couple of issues there is, there is not 
enough materials in our stockpile, nor could we afford 
everything we would need. I mean fundamentally, we do not even 
still have enough needles and syringes that we would need to 
use.
    There are a couple of ways of doing that, we are looking at 
supply chains. We realize that the majority of supply chains 
supporting the healthcare industry are from overseas, 40 
percent of the medications, 80 percent of the active 
pharmaceutical ingredients needed to make medicines come from 
overseas, particularly China. So, if there were to be a 
pandemic, we could expect those supply chains to be 
compromised. We have a--we have put a premium not only on 
looking at our stockpile, but also on innovation, things that 
we could do to change our dependencies either on raw materials 
or pharmaceutical ingredients, but also to focus on domestic 
production, which is not only good for pandemics, but also good 
for the economy.
    So, we have some very novel, innovative ideas that I would 
suggest that your staff would love to hear about. How we 
believe that we can basically reduce our dependencies not only 
for saline, but for other products that we call Pharmaceuticals 
On-Demand, that I think would go a long way to help make sure 
that we are ready for a pandemic, but quite frankly, ready for 
any kind of emergency going forward.
    Senator Hyde-Smith. Thank you, reassuring.
    Senator Blunt. Thank you Senator Hyde-Smith.

                     GLOBAL HEALTH SECURITY AGENDA

    The last question I want to ask today is on the whole 
concept of Global Health Security Agenda, starting really with 
the fiscal year 2015 bill which would have been response to the 
Ebola crisis at the time. We provided, I think, a total of a $1 
billion and requested a report. The National Security Council 
is probably the lead agency in that report, but certainly, CDC 
and AID would be critical agencies. We had asked for a report 
in September, 5 months ago. Where are we and how close to 
coming up with a plan? I know there was phase one and phase two 
countries that perhaps have been named already, but when should 
we expect to see that report?
    And I would like for both of you to comment on where you 
think that current discussion is, more than the timeframe of 
the report, where you think that current discussion is. And if 
you have a timeframe of the report that is fine, but I want to 
hear your view of what that billion dollars is producing.
    Admiral Ziemer. Thanks for your question Senator and your 
continued focus on the Global Health Security Agenda. It is 
significant. I think a couple of lessons that we have seen is 
that with a modest amount of money that has been invested in 
the first tranche of 17 countries we have seen significant 
improvements and we discussed some of those earlier in our 
responses. The response to Marburg three previous Ebola 
outbreaks in DRC and then the monkeypox response in Cameroon.
    There are a number of positive results that have been 
documented that will be brought--will be on record through the 
report. I do not know the exact status of the report, but I 
will be happy to give you that. I know it is in work and it 
should be out shortly.
    Senator Blunt. Dr. Redfield.
    Dr. Redfield. Mr. Chairman, we are working in close 
collaboration with the NSC, particularly as relates to also the 
sort of phase 2 country selection. It is clear that the 
initial, I mean--global health security and domestic 
preparedness is core to CDC's mission. The 17 priority 
countries that we are involved in, we have really made 
significant progress. I had a second slide I was going to show 
showing the impact in Uganda, for example in yellow fever, it 
went from taking 42 days to recognize we had yellow fever very 
significant pathogen, the second outbreak it was 10 days, the 
third outbreak it was two days, because we really have spent an 
enormous effort equipping these priority countries to be able 
to detect, respond and prevent by building surveillance, 
laboratory diagnostic capacity, a workforce, emergency 
operation center and then showing them how to put that all 
together. So, I think it has been an extremely important 
investment.
    The phase two countries are being developed in coordination 
with the National Security Council, and again, we will continue 
to try to build within each of these countries the ability--the 
priority countries, the ability to have those core pillars of 
surveillance, diagnostics, workforce, emergency operation 
center, to be able to respond to outbreaks when they occur.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Blunt. Well thank you. Thanks all of you for being 
here. Thanks for your testimony today. The record will stay 
open for one week for additional comments.
    I am sure there will be some written questions and 
appreciate all of you being here today.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
               Questions Submitted to Robert Kadlec, M.D.
                Questions Submitted by Senator Roy Blunt
    Question. Dr. Kadlec, how do prioritize the renewal of Strategic 
National Stockpile products currently stockpiled and the purchase of 
new products while working with limited resources?
    Answer. To determine the appropriate prioritization and stockpiling 
goal, the HHS medical countermeasures (MCM) requirements process 
leverages public health consequence modeling, subject matter expert 
evaluations, and estimates of current national response capabilities. 
Public health response and medical consequence modeling conducted by 
HHS calculates the rate of morbidity and mortality because of such 
exposures. Groups of HHS subject matter experts assess the mitigated 
consequence modeling and identified the number of casualties that could 
benefit from intervention with pharmaceutical and non-pharmaceutical 
MCMs (i.e., the need-based quantity). The capabilities of the medical 
and public health systems to effectively utilize broad categories of 
MCMs (e.g., oral or parenteral) are then assessed for acquisition 
prioritization and quantity needed. Stockpiling goals may include both 
centrally stockpiled and alternatively stockpiled MCMs. The MCM 
requirement prioritization process and subsequent stockpiling goals are 
based upon sound scientific, medical, and epidemiological principles.
    Question. Without additional resources, what specific products 
would go unpurchased and how might that create vulnerabilities to 
preparedness?
    Answer. At the fiscal year 2020 President's Budget level of $620 
million, the Strategic National Stockpile (SNS) will replace the 
highest priority expiring countermeasures identified through an HHS 
requirements setting process. This includes $61.4 million for two 
products that transitioning to the SNS from Project BioShield funded 
contracts (a thermal burn bandage and smallpox antiviral drug).
    SNS currently relies on the Biomedical Advanced Research and 
Development Authority (BARDA) to make initial procurements of most 
products developed through Project BioShield investment. At the fiscal 
year 2020 Budget level for SNS, several products will continue to be 
funded under Project BioShield, specifically, two anthrax therapeutic 
drugs (obiltoxaximab and raxibacumab), a smallpox vaccine that may be 
used by immunocompromised patients, and botulism antitoxin.
    Question. Dr. Kadlec, since responsibility for managing the 
Stockpile shifted from CDC to ASPR, what processes are in place to 
ensure that ASPR continues working with CDC to make sure the speed in 
which products are deployed and delivered is not disrupted?
    Answer. The transfer of the SNS from the Centers for Disease 
Control and Prevention (CDC) to the Office of the Assistant Secretary 
for Preparedness and Response (ASPR) has not impacted or resulted in 
any modifications to MCM development, procurement, or delivery 
planning. The transfer has resulted in closer integration of ASPR's 
existing countermeasure procurement program with the SNS procurement 
program, leading to improved product development and utilization. In 
addition, the transfer resulted in a consolidation of response 
capabilities and assets, ultimately streamlining deployment of 
personnel and resources for future emergency response efforts. Lastly, 
ASPR is currently engaging with partners at the CDC on medical 
countermeasure distribution planning. These efforts bring subject 
matter experts together to identify ways to ensure medical 
countermeasures can be quickly and effectively distributed if and when 
needed. Leveraging the State and local connections of the CDC, ASPR and 
CDC are jointly engaging local planners in this effort to ensure 
assumptions factor in existing needs and requirements and as well as 
bridge gaps.
    Generally, please be aware that ASPR and CDC staff communicate and 
engage on various aspects of MCM development, procurement, and 
distribution activities on a daily basis. Communication is both formal 
(interagency working groups and the PHEMCE) and informal (liaisons, 
email, phone calls, etc.). CDC's scientific expertise will continue to 
be critical in examining procurement options as well as for planning 
for the transition of new countermeasures.
    Question. Dr. Kadlec, the Ebola supplemental provided funds to 
establish a 5-year regional treatment network and Ebola treatment 
centers for patient care. How have these networks improved our public 
health preparedness?
    Answer. The National Ebola Training and Education Center (NETEC) 
and regional Ebola treatment network (RETN) were established using 
Ebola supplemental funding following the Ebola outbreak in West Africa. 
The RETN is a tiered approach for Ebola and other special pathogens 
that balances geographic need, differences in institutional 
capabilities, and accounts for the potential risk of needing to care 
for a patient with Ebola. The HHS regional framework for the tiered 
approach designates four roles for healthcare facilities: regional 
Ebola and other special pathogen treatment centers; Ebola assessment 
hospitals, Ebola treatment centers, and frontline healthcare 
facilities.
    Ten Regional Ebola and other special pathogen treatment centers can 
accept two patients and stand up a biocontainment unit within 8 hours 
of notification.Facilities within this Network possess respiratory 
isolation capacity and negative pressure rooms to treat at least 10 
patients. They conduct annual staff trainings and exercises, are 
assessed on overall readiness by the NETEC, and possess the capability 
to handle Ebola-contaminated or other highly-contaminated infectious 
waste. In addition to these ten Treatment Centers, the Network also 
includes 60 designated State or jurisdiction Ebola treatment centers, 
which can accept one patient and stand up a biocontainment unit within 
72 hours of notification. Like the regional Ebola and special pathogen 
treatment centers, they conduct annual staff trainings and exercises 
and have the ability to handle Ebola-contaminated infectious waste. The 
network includes 178 Ebola assessment hospitals with the ability to 
identify, isolate, assess, and care for patients for assessment up to 
96 hours until lab tests are confirmed and patients can be transferred 
to a regional or State Ebola treatment center. Finally, frontline 
healthcare facilities are prepared to rapidly identify and isolate 
patients who may have Ebola These facilities must be able to promptly 
inform the hospital/facility infection control program and State and 
local public health agency and assessment hospitals or Ebola treatment 
centers (as necessary) to arrange patient transfer.
    Frontline healthcare facilities are also responsible to provide 
stabilizing treatment, Supplemental funding also created the NETEC, 
which is comprised of staff from Emory University, the University of 
Nebraska Medical Center/Nebraska Medicine, and New York City Health + 
Hospitals/Bellevue, who have successfully treated patients with or 
suspected of having Ebola. The NETEC conducts on-site training, peer 
review, and assessments of treatment centers and assessment hospitals 
in the network to ensure preparedness. The NETEC conducted 57 facility 
readiness consultations in 2018, trained 8,286 healthcare workers on 
clinical guidelines for providing safe care to patients with Ebola and 
other special pathogens, and created 44 exercise templates for 
facilities. The NETEC developed and maintains the Special Pathogens 
Research Network, which includes all 10 regional Ebola treatment 
centers and ensures the ability of the facilities to rapidly administer 
experimental therapeutics for Ebola and other special pathogens. 
Finally, the NETEC established a 24/7, 365 phone line for emergency 
consultation with Federal partners and healthcare facilities requiring 
assistance with patients suspected of or proven to have infections with 
special pathogens.
    The establishment of the NETEC and the RETN have greatly bolstered 
the Nation's public health security and readiness to respond to Ebola 
and other emerging infectious diseases. Clinical capabilities now exist 
across the entirety of the Nation to treat patients with or suspected 
of having Ebola or other highly infectious diseases.
    Question. The budget does not appear to request additional 
resources to continue these efforts. Why not and what are the 
consequences to preparedness efforts if we do not include funding for 
these activities?
    Answer. Grants from the Hospital Preparedness Program (HPP) and 
CDC's Public Health and Emergency Preparedness Cooperative Agreement 
program will continue to be awarded annually to support coalition 
building and general public health efforts at the local and State 
levels.
                                 ______
                                 
             Questions Submitted by Senator Lamar Alexander
    Question. Does the Strategic National Stockpile (SNS) have the 
resources it needs to increase our domestic stockpile of the Ebola 
vaccine to protect national security?
    Answer. Currently, BARDA is supporting the development of Ebola 
MCMs. To date, investments have supported four Ebola vaccine 
candidates, four therapeutic candidates, and a point-of-care Ebola 
diagnostic. Two of the vaccine candidates are in late-stage development 
and potential procurement under Project BioShield (Merck and Janssen). 
BARDA is responsible for procuring MCMs prior to licensure.
    Question. Do we have enough resources to procure the vaccine to 
help our international partners?
    Answer. Currently, BARDA is supporting the development of Ebola 
MCMs. To date, investments have supported four Ebola vaccine 
candidates, four therapeutic candidates, and a point-of-care Ebola 
diagnostic. Two of the vaccine candidates are in late-stage development 
and potential procurement under Project BioShield (Merck and Janssen). 
BARDA is working with Merck to make vaccine available for use to 
address the outbreak. The current vaccine being deployed was 
manufactured under an agreement between Merck and Gavi. BARDA is 
supporting licensure of the Ebola vaccine manufacturing facility. Two 
therapeutics are also supported under Project BioShield (Mapp Bio and 
Regeneron). A third candidate is supported under advanced research and 
development (Gilead). All three products are being made available in 
support of the randomized clinical trial being conducted by NIAID in 
the DRC. Ebola is considered both a public health threat and a national 
security threat. Continued support for late-stage development of all 
Ebola products under Project BioShield and any potential procurement of 
products will occur in the coming years based on availability of funds 
under Project BioShield.
    Ensuring access to vaccine by affected countries requires a global 
effort and commitment and ASPR is working closely with the World Health 
Organization and our other international partners, including through 
the Global Health Security Initiative, to ensure that there is 
sustainable infrastructure for Ebola vaccine manufacturing that can 
support global needs.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
    Question. Dr. Kadlec, at the recent hearing on Ebola and emerging 
threats, we heard testimony from Dr. Fauci that suggested there is no 
pandemic influenza stockpile. However, in the President's Budget 
Request for fiscal year 2020, the Administration requests funding for a 
Pandemic Influenza Stockpile within HHS. Additionally, the recent 
Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) 
budget also articulated the resources required to maintain a pandemic 
influenza stockpile and for life cycle management. For the record, 
could you clarify the Administration's position regarding the 
stockpiling of vaccines and vaccine components, such as adjuvants, as 
well as the resources to prepare for and against pandemic influenza? 
Additionally, as I noted during the hearing, it is my understanding 
that the U.S. Government's stockpile of adjuvant was procured in 2009 
during the H1N1 pandemic. Is the adjuvant expired? Do the methods BARDA 
uses to determine whether a product in the stockpile is safe and 
effective match that of the requirements the FDA uses for commercially 
available influenza vaccines and component parts?
    Answer. ASPR maintains a stockpile of bulk vaccine antigen and 
adjuvants for influenza viruses with pandemic potential in the National 
Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). The aim of the NPIVS 
is to maintain security, protect workers essential to maintain 
community and healthcare services, as well as young children, pregnant 
women, and other vulnerable populations. HHS colleagues from ASPR, 
BARDA, CDC, FDA, NIH and others across the USG review the threat 
assessment on emerging influenza viruses and determine when it becomes 
essential to produce new vaccine candidates for the NPIVS. 
Strategically, it was determined that pre-pandemic vaccines and 
adjuvant could be stored longer in bulk format, instead of in final 
form, and then could be rapidly filled into final formulation as 
needed. BARDA works closely with FDA on the regulatory process for the 
review and consideration for use for these materials. Most of the 
vaccines held in the NPIVS are affiliated with an FDA-approved, pre-EUA 
(Emergency Use Authorization) dossier and are based on the foundation 
of FDA-licensed seasonal influenza vaccines.
    In December, ASPR concluded the ``BARDA Ready in Times of 
Emergency'' study to ascertain how long vaccine components would 
continue to be safe and effective. The study concluded that the vaccine 
remain safe and immunogenic. The oldest stockpiled vaccine saw no drop 
in immunogenicity (Oshanksy, CM, et.al., Vaccine, 37 (2019), pp 435-
443).
    Question. Dr. Kadlec, The PHEMCE Multi-Year Budget outlined $1.2 
billion in funds needed for the Strategic National Stockpile (SNS) in 
fiscal year 2020. These funds are needed for replenishment of existing 
countermeasures and procurement of new products in the prior year's 
plan. If Congress were to fund the SNS at $620 million, what 
replenishments and new procurements would be delayed or cancelled as a 
result of this shortfall in funding? In addition, what is the cost of 
new requirements to support new or emerging health or countermeasure 
issues?
    Answer. At the fiscal year 2020 President's Budget level of $620 
million, the Office of the Assistant Secretary for Preparedness and 
Response (ASPR) will replace the highest priority expiring 
countermeasures identified through an HHS requirements setting process. 
This includes $61.4 million for two products are transitioning to the 
SNS from Project BioShield funded contracts (a thermal burn bandage and 
smallpox antiviral drug).
    SNS currently relies on the Biomedical Advanced Research and 
Development Authority (BARDA) to make initial procurements of most 
products developed through Project BioShield investment. At the fiscal 
year 2020 Budget level, several products will continue to be funded 
under Project BioShield, specifically, two anthrax therapeutic drugs 
(obiltoxaximab and raxibacumab), a smallpox vaccine that may be used by 
immunocompromised patients, and botulism antitoxin.
    Question. Dr. Kadlec, it has been stated from multiple health 
leaders such as the head of the National Institute of Allergies and 
Infectious Diseases to the head of the Centers for Disease Control and 
Prevention, that what keeps them awake at night is a pandemic flu 
epidemic. Each stating that is a matter of when, not if, we will have a 
flu pandemic. Do you agree?
    Answer. ASPR agrees that pandemic influenza is a serious threat, 
and this is reflected in the actions we are taking every day to improve 
our preparedness. First, ASPR is working to enhance current 
capabilities to improve pandemic influenza detection and response 
through BARDA investments. Beyond basic procurement of MCMs and medical 
equipment, ASPR is working to prepare the Nation for the threat of 
pandemic influenza on a number of other fronts. BARDA is enhancing our 
current capability to improve pandemic influenza detection and response 
through three primary efforts. BARDA believes in a true end-to-end 
approach to improving our Nation's preparation and response to pandemic 
influenza; it goes beyond simply designing a new MCM and incorporates 
improvements on how and when MCMs should be used to most effectively 
save lives. First, BARDA is investing in efforts to expand domestic 
capacity for modern, rapid, and flexible production of the licensed 
recombinant influenza vaccine, vaccine adjuvant and final vaccine 
formulation and filling for use. Sustaining and expanding domestic 
production capabilities will ensure supplies and vaccines are available 
to America, should an influenza pandemic occur and there is global 
demand for these products. Second, BARDA, through public-private 
partnerships is developing improved vaccines that allow faster and 
better response and novel influenza antivirals and therapeutics to 
address antiviral resistance and to provide treatment options to the 
severely ill. Third, BARDA leveraging innovation for early 
identification of influenza, including development of home-based 
influenza diagnostics and development of wearable technologies with the 
goal of identifying infections like influenza before symptoms appear, 
to empower individuals to take action seek treatment to improve their 
clinical outcome as well as reduce the transmission to others in the 
home, community and Nation. BARDA is also challenging scientists and 
innovators to completely rethink traditional face masks and respirators 
to modernize respiratory protection to something that is comfortable, 
fits all ages and facial shapes, and reusable while still being 
effective. To date, BARDA has collaborated with colleagues across HHS 
and with numerous industry partners to support the development to FDA 
approval of 23 influenza vaccines, antivirals, devices, respirators, 
personal protective equipment, and diagnostics to address this risk. 
With support and collaboration from USG and industry, BARDA's goal is 
to continue this progress until we have implemented a full end-to-end 
preparation and response system for pandemic influenza and emerging 
infectious diseases. To ensure ASPR's National Disaster Medical System 
personnel are prepared and ready to support a pandemic influenza 
outbreak or other infectious disease incident, ASPR is supporting 
targeted comprehensive training initiatives in coordination with NETEC. 
Specifically, 400 NDMS personnel will complete training for isolation, 
simulation, and quarantine as well as highly infectious disease patient 
transport in 2019 using funds from the 2014 Ebola supplemental 
appropriation. While this training does focus on Ebola outbreaks, it is 
applicable to pandemic influenza since similar quarantine and isolation 
skills are needed to mitigate spread.
    To support regional preparedness efforts for a pandemic influenza 
outbreak, ASPR funded two regional disaster health response system 
(RDHRS) pilots in fiscal year 2018. While HPP focuses on preparing the 
healthcare system to coordinate, respond as a whole, and protect its 
workers, the RDHRS pilots build upon that focus by coordinating intra- 
and interstate healthcare systems and by enhancing the clinical 
expertise for specialized care (e.g., trauma, burns, pediatrics, 
chemical, biological, radiological, nuclear, and explosives (CBRNE)) to 
increase medical surge and enhance the survival rates of the affected 
populations.
    Question. Dr. Kadlec, I recently received a paper about pandemic 
flu. Estimates based on CDC data and modeling state that between 63.7 
million and 94 million cases of influenza could happen during a 
pandemic. In addition, between 1.9 million and 4.7 million Americans 
would need to be hospitalized. With little excess capacity in the 
United States for IV saline and other medical supplies, how prepared is 
the strategic national stockpile to help ensure that Americans have the 
treatments they need in the time of a pandemic? How can we move forward 
to ensure all Americans affected by a pandemic influenza could be 
treated effectively and in a timely manner?
    Answer. ASPR is working every day to bolster our public health 
security capacity and preparedness and ability to respond to an 
influenza pandemic.
    The risk of a severe influenza pandemic represents a serious threat 
to public health. There is a robust commercial market for the types of 
medical supplies that would be most needed during pandemic influenza 
outbreak. The SNS partners with major industry trade associations to 
improve access to medical countermeasures; improve coordination; and 
reduce redundant distribution during an emergency like pandemic 
influenza. Additionally, the SNS currently holds a variety of products 
that could be deployed nationally when and if needed. Products include: 
antiviral drugs (whose use may be extended through the Shelf Life 
Extension Program), ventilators, and personal protective equipment such 
as face masks and N-95 respirators.
    Beyond basic procurement of MCMs and medical equipment, ASPR is 
working to prepare the Nation for the threat of pandemic influenza on a 
number of other fronts. BARDA is enhancing our current capability to 
improve pandemic influenza detection and response through three primary 
efforts. BARDA believes in a true end-to-end approach to improving our 
Nation's preparation and response to pandemic influenza; it goes beyond 
simply designing a new MCM and incorporates improvements on how and 
when MCMs should be used to most effectively save lives. First, BARDA 
is investing in efforts to expand domestic capacity for modern, rapid, 
and flexible production of the licensed recombinant influenza vaccine, 
vaccine adjuvant and final vaccine formulation and filling for use. 
Sustaining and expanding domestic production capabilities will ensure 
supplies and vaccines are available to America, should an influenza 
pandemic occur, and there is global demand for these products. Second, 
BARDA, through public-private partnerships is developing improved 
vaccines that allow faster and better response and novel influenza 
antivirals and therapeutics to address antiviral resistance and to 
provide treatment options to the severely ill. Third, BARDA is 
leveraging innovation for early identification of influenza, including 
development of home-based influenza diagnostics and development of 
wearable technologies with the goal of identifying infections like 
influenza before symptoms appear, to empower affected individuals to 
take action seek treatment to improve their clinical outcome as well as 
reduce transmission to others in the home, community and Nation. BARDA 
is also challenging scientists and innovators to completely rethink 
traditional face masks and respirators to modernize respiratory 
protection into those that are comfortable, fit all ages and facial 
shapes, and reusable while still being effective. To date, BARDA has 
collaborated with colleagues across HHS and with numerous industry 
partners to support the development to FDA approval of 23 influenza 
vaccines, antivirals, devices, respirators, personal protective 
equipment, and diagnostic s to address this risk. With support and 
collaboration from USG and industry, BARDA's goal is to continue this 
progress until we have implemented a full end-to-end preparation and 
response system for pandemic influenza and emerging infectious 
diseases.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
    Question. Dr. Kadlec, multiple health experts have stated that what 
keeps them awake at night is a pandemic flu epidemic. Do you agree? The 
Strategic National Stockpile (SNS) is part of the United States 
immediate response to this type of outbreak. Is the stockpile 
adequately funded for foundational products such as saline and other 
medical supplies to meet the needs of a pandemic flu?
    Answer. The risk of a severe influenza pandemic represents a 
serious threat to public health. There is a robust commercial market 
for the types of medical supplies that would be most needed during 
pandemic influenza outbreak. The SNS partners with major industry trade 
associations to improve access to medical countermeasures; improve 
coordination; and reduce redundant distribution during an emergency 
like pandemic influenza. Additionally, the SNS currently holds a 
variety of products that could be deployed nationally when and if 
needed. Products include: antiviral drugs (whose use may be extended 
through the Shelf Life Extension Program), ventilators, and personal 
protective equipment such as face masks and N-95 respirators.
    Beyond basic procurement of MCMs and medical equipment, ASPR is 
working to prepare the Nation for the threat of pandemic influenza on a 
number of other fronts. The Biomedical Advanced Research and 
Development Authority (BARDA) is enhancing our current capability to 
improve pandemic influenza detection and response through three primary 
efforts. BARDA believes in a true end-to-end approach to improving our 
Nation's preparation and response to pandemic influenza; it goes beyond 
simply designing a new MCM and incorporates improvements on how and 
when MCMs should be used to most effectively save lives. First, BARDA 
is investing in efforts to expand domestic capacity for modern, rapid, 
and flexible production of the licensed recombinant influenza vaccine, 
vaccine adjuvant and final vaccine formulation and filling for use. 
Sustaining and expanding domestic production capabilities will ensure 
supplies and vaccines are available to America, should an influenza 
pandemic occur, and there is global demand for these products. Second, 
BARDA, through public-private partnerships is developing improved 
vaccines that allow faster and better response and novel influenza 
antivirals and therapeutics to address antiviral resistance and to 
provide treatment options to the severely ill. Third, BARDA is 
leveraging innovation for early identification of influenza, including 
development of home-based influenza diagnostics and development of 
wearable technologies with the goal of identifying infections like 
influenza before symptoms appear, to empower affected individuals to 
take action seek treatment to improve their clinical outcome as well as 
reduce transmission to others in the home, community and nation. BARDA 
is also challenging scientists and innovators to completely rethink 
traditional face masks and respirators to modernize respiratory 
protection into those that are comfortable, fit all ages and facial 
shapes, and reusable while still being effective. To date, BARDA has 
collaborated with colleagues across HHS and with numerous industry 
partners to support the development to FDA approval of 23 influenza 
vaccines, antivirals, devices, respirators, personal protective 
equipment, and diagnostics to address this risk. With support and 
collaboration from USG and industry, BARDA's goal is to continue this 
progress until we have implemented a full end-to-end preparation and 
response system for pandemic influenza and emerging infectious 
diseases.
    Question. Dr. Kadlec, recent estimates based on CDC data and 
modeling indicate that between 63.7 million and 94 million cases of 
influenza could happen during a pandemic. In addition, between 1.9 
million and 4.7 million Americans would need to be hospitalized.With 
little excess capacity in the United States for IV saline and other 
medical supplies, how prepared is the strategic national stockpile to 
help ensure that Americans have the treatments they need in the time of 
a pandemic? How can we move forward to ensure all Americans affected by 
a pandemic influenza could be treated effectively and in a timely 
manner?
    Answer. Every day, staff at the SNS are building partnerships with 
the private sector partners within the supply chain. These 
relationships ensure that products are available for procurement if/
when needed. Through these partnerships, we have: improved monitoring 
of commercial supply chain inventory and performance; improved public 
access to medical countermeasures; reduced redundant distribution of 
medical countermeasures, information, and materiel; improved 
coordination of the timing and quantity of release of SNS assets to 
best support a response; and, educated partners on the challenges 
associated with over-ordering or hoarding of needed materiel during a 
public health incident. These efforts all support efficient response 
operations to mitigate public health and medical shortfalls during 
emergencies.
    Relatedly, ASPR's Critical Infrastructure Protection (CIP) program 
coordinates HHS's role as the sector-specific agency under Presidential 
Policy Directive 21 (Critical Infrastructure Security and Resilience) 
for healthcare and public health. The healthcare and public health 
systems of the U.S. rely on a complex network of staff, supplies, 
systems, and space to provide care. CIP enhances the security and 
resilience of the Nation's healthcare and public health critical 
infrastructure through a voluntary public-private partnership between 
all levels of government and the private sector.
    Recently, Hurricane Maria greatly impacted a large portion of the 
medical product manufacturing industry in Puerto Rico and led to 
several national shortages of products related to sterile saline. As 
the influenza season proved to be difficult, with numerous 
hospitalizations, CIP coordinated between government and private sector 
partners to identify impacts of the saline shortage on our ability to 
respond to severe influenza, or another disaster with national impact. 
While the health system was able to nimbly adapt to those shortages and 
provide care throughout the influenza surge, CIP identified areas where 
slight changes in availability could severely impact the ability of the 
healthcare system to respond.
    Finally, ASPR engages with the Pandemic Supply Chain Network 
(PSCN), a platform that connects public and private sectors to build 
global supply chain to support an effective and equitable global 
pandemic response in support of U.S., regional, and global pandemic 
response efforts. ASPR is working with PSCN and the North American Plan 
for Animal and Pandemic Influenza (NAPAPI) to improve influenza 
preparedness and response capacities in North America (U.S., Canada, 
and Mexico) with ensuring a robust regional supply chain during the 
next influenza pandemic as a key priority.
    Question. Dr. Kadlec, your office took control of the SNS this 
fiscal year at nearly the same time that the Food and Drug 
Administration approved the first new antiviral flu treatment in nearly 
20 years that works in a new and different way. I know we worry that a 
potential pandemic influenza strain might deliver resistance to the 
influenza antivirals we have in the stockpile now.
    How would adding new influenza antivirals to the stockpile that 
work differently help address this concern?
    Answer. Adding new influenza antivirals would provide treatment 
options to address influenza virus resistant to current antivirals.
    Question. What's your timeline and plan for diversifying the SNS 
and what's the optimal ratio of influenza antivirals you'd like to 
achieve?
    Answer. The ratio of antiviral drugs in the SNS is assessed at 
regular intervals based on antiviral resistance patterns and based on 
availability of new antiviral drugs. The SNS has achieved the ratio of 
drugs recommended by the most recent review conducted in November 2018. 
The latest review recommended a ratio of 70:30 for drugs for 
oseltamivir-susceptible strains to drugs for oseltamivir-resistant 
strains.
    Question. Optimally, how many total courses of influenza antiviral 
treatment would you stockpile in the SNS?
    Answer. Current SNS holdings, including product awaiting Shelf Life 
Extension Program testing, will provide more than 66 million outpatient 
treatment courses.
                                 ______
                                 
              Questions Submitted by Senator Tammy Baldwin
    Question. I was serving in the House of Representatives during the 
2009 H1N1 pandemic and in 2004 when we saw a dangerous shortage of 
influenza vaccines due in part to our insufficient domestic production 
capabilities. We have made some progress in our preparedness 
capabilities--for one, the FDA recently approved the first new-acting 
antiviral flu treatment in 20 years. And, researchers at FluGen, in my 
home State of Wisconsin, are on the cutting-edge working to develop the 
first universal flu vaccine.
    However, the threat of another, more severe pandemic flu outbreak 
has not gone away. That's why I worked to authorize our pandemic 
influenza program as part of legislation to reauthorize Federal 
Pandemic and All-Hazards Preparedness programs, and I am concerned that 
Congress has not yet passed this measure.
    Dr. Kadlec, I continue to hear concerns that a potential pandemic 
influenza strain might develop resistance to the influenza antivirals 
we have in the strategic national stockpile (SNS) now.
    Is our stockpile currently sufficient, up to date and diverse 
enough to address the next pandemic flu outbreak?
    Answer. The risk of a severe influenza pandemic represents a 
serious threat to public health. There is a robust commercial market 
for the types of medical supplies that would be most needed during 
pandemic influenza outbreak. SNS partners with major industry trade 
associations to: improve access to medical countermeasures; improve 
coordination; and reduce redundant distribution during an emergency 
like pandemic influenza. Additionally, the SNS currently holds a 
variety of products that could be deployed nationally when and if 
needed. Products include: antiviral drugs (which may be extended 
through the Shelf Life Extension Program), ventilators, and personal 
protective equipment such as face masks and N-95 respirators.
    Your concern about the potential for influenza viruses to become 
resistant to any specific class of antiviral drugs is valid. We have 
previously seen all circulating viruses become resistant to adamantanes 
and we continue to see resistance to neuraminidase inhibitors emerge in 
both human and avian influenza viruses, including the H7N9 virus group 
that has infected people across China. For this reason, it is critical 
to maintain a diversified portfolio of antiviral drugs with different 
mechanisms of action in the SNS to be able to respond to all forms of 
influenza viruses. The recent approval of a new influenza antiviral 
drug with a new mechanism that will enable it to work in the presence 
of resistance to other antiviral drugs is a remarkable advancement.
    Question. Can you discuss your plans for diversifying the SNS, 
including adding new-acting antivirals?
    Answer. To determine new acquisitions for SNS procurement, 
including potential new-acting antivirals, HHS utilizes a requirements 
process that leverages public health consequence modeling, subject 
matter expert evaluations, and estimates of current national response 
capabilities. Public health response and medical consequence modeling 
conducted by HHS calculates the rate of morbidity and mortality because 
of such exposures. Groups of HHS subject matter experts assess the 
mitigated consequence modeling and identified the number of casualties 
that could benefit from intervention with pharmaceutical and non-
pharmaceutical MCMs (i.e., the need-based quantity). The capabilities 
of the medical and public health systems to effectively utilize broad 
categories of MCMs (e.g., oral or parenteral) are then assessed to 
arrive at the operational quantity. Finally, these inputs, along with 
the development of desired product characteristics, lead to the 
stockpiling goal recommended for an MCM class. Stockpiling goals may 
include both centrally stockpiled and alternatively stockpiled MCMs. 
The MCM requirement process and subsequent stockpiling goals are based 
upon sound scientific, medical, and epidemiological principles.
    The ratio of antiviral drugs in the SNS is assessed at regular 
intervals based on antiviral resistance patterns and based on 
availability of new antiviral drugs. The SNS has achieved the ratio of 
drugs recommended by the most recent review conducted in November 2018. 
The latest review recommended a ratio of 70:30 for drugs for 
oseltamivir- susceptible strains to drugs for oseltamivir-resistant 
strains. New antiviral medications will be considered for inclusion 
within the stated ratios above.
    Question. What can Congress do to help address any of these 
pandemic influenza preparedness gaps?
    Answer. Beyond basic procurement of MCMs and medical equipment, 
ASPR is working to prepare the Nation for the threat of pandemic 
influenza on a number of other fronts. BARDA is enhancing our current 
capability to improve pandemic influenza detection and response through 
three primary efforts. BARDA believes in a true end-to-end approach to 
improving our Nation's preparation and response to pandemic influenza; 
it goes beyond simply designing a new MCM and incorporates improvements 
on how and when MCMs should be used to most effectively save lives. 
First, BARDA is investing in efforts to expand domestic capacity for 
modern, rapid, and flexible production of the licensed recombinant 
influenza vaccine, vaccine adjuvant and final vaccine formulation and 
filling for use. Sustaining and expanding domestic production 
capabilities will ensure supplies and vaccines are available to 
America, should an influenza pandemic occur, and there is global demand 
for these products. Second, BARDA, through public-private partnerships 
is developing improved vaccines that allow faster and better response 
and novel influenza antivirals and therapeutics to address antiviral 
resistance and to provide treatment options to the severely ill. Third, 
BARDA is leveraging innovation for early identification of influenza, 
including development of home-based influenza diagnostics and 
development of wearable technologies with the goal of identifying 
infections like influenza before symptoms appear, to empower 
individuals to take action seek treatment to improve their clinical 
outcome as well as reduce the transmission to others in the home, 
community and Nation. BARDA is also challenging scientists and 
innovators to completely rethink traditional face masks and respirators 
to modernize respiratory protection to something that is comfortable, 
fits all ages and facial shapes, and reusable while still being 
effective. To date, BARDA has collaborated with colleagues across HHS 
and with numerous industry partners to support the development to FDA 
approval of 23 influenza vaccines, antivirals, devices, respirators, 
personal protective equipment, and diagnostics to address this risk. 
With support and collaboration from USG and industry, BARDA's goal is 
to continue this progress until we have implemented a full end-to-end 
preparation and response system for pandemic influenza and emerging 
infectious diseases.
                                 ______
                                 
            Questions Submitted to Robert R. Redfield, M.D.
                Questions Submitted by Senator Roy Blunt
    Question. Dr. Redfield, surveillance challenges of Ebola in the 
Democratic Republic of Congo (DRC) raise concerns that Ebola will cross 
the DRC boarder. How prepared are the neighboring countries of Uganda, 
Rwanda, and South Sudan to manage an Ebola patient or outbreak and what 
gaps remain for CDC to devote technical resources?
    Answer. To date, no cases of Ebola have been detected outside of 
the DRC in this outbreak. CDC is on the ground in neighboring Uganda, 
Rwanda, and South Sudan to assess and enhance border health capacity 
for surveillance and response, and these countries are conducting 
border screenings to detect potential Ebola cases. CDC's country 
offices in Uganda, Rwanda, and South Sudan support local ministries of 
health to prepare for and respond to outbreaks, including but not 
limited to Ebola. More specifically, CDC staff have been helping these 
countries prevent, detect, and respond to any potential Ebola outbreak 
by:
  --Implementing surveillance systems to detect suspected Ebola cases 
        as quickly as possible.
  --Building local Ebola laboratory testing capacity.
  --Improving infection prevention and control in healthcare 
        facilities.
  --Improving border health measures at points of entry.
  --Prioritizing and planning preventive vaccination of healthcare 
        workers.
    As we move forward, CDC will continue to focus on strengthening 
these countries' core public health capacities of surveillance, 
laboratory capacity, disease detection, and emergency response.
    Question. A 2014 WHO DRC assessment found that only 37 percent of 
healthcare facilities had access to a water source within 500 meters of 
the facility, only 41 percent had access to improved sanitation and 
only 58 percent had access to soap and water or alcohol-based hand rub 
for handwashing. How is CDC currently addressing the issue of WASH in 
healthcare facilities and communities in the DRC and elsewhere, in 
order to mitigate the severity outbreaks of Ebola or the next unknown 
infectious disease?
    Answer. CDC has engaged with partners to assess and improve water, 
sanitation and hygiene (WASH) in healthcare facilities, communities, 
and schools across Africa and the globe. CDC has collaborated with WHO, 
UNICEF, and other partners to develop global, national and local 
guidance on WASH in healthcare facilities and infection prevention and 
control (IPC), including helping to develop and pilot-test assessment 
tools.
    Related to the current Ebola outbreak, efforts have included WASH 
training in DRC, as well as efforts to improve WASH in healthcare 
facilities in surrounding countries, including Tanzania and Uganda. CDC 
is closely engaged in supporting infection prevention and control 
improvements in healthcare facilities in DRC in order to stop 
healthcare-associated transmission in the current Ebola outbreak. CDC 
has also supported IPC strengthening for Ebola preparedness in the 
surrounding at-risk countries, including Rwanda, South Sudan and 
Uganda.
    CDC recognizes the importance of WASH in healthcare facilities and 
communities. Water is a necessary resource for hand hygiene and for 
environmental cleaning and disinfection to prevent transmission of 
infectious disease, including Ebola and many other pathogens that can 
be spread in healthcare facilities and may be resistant to antibiotics. 
Without clean water in healthcare facilities, IPC is not possible. CDC 
is working with partners such as WHO, UNICEF, Ministries of Health and 
Water, non-governmental organizations, and others to help address this.
                     global health security agenda
    Question. ``Phase I'' of the GHSA will be complete at the end of 
fiscal year 2019. How will the U.S. help ensure that the progress made 
with the $1 billion investment is maintained?
    Answer. Protecting Americans through building the health security 
capacity globally is a core mission of the CDC. The fiscal year 2020 
President's Budget request includes $100 million for CDC for global 
health security, which will help to build a long-term and sustainable 
platform for these activities. These funds will allow CDC to provide 
targeted bilateral support to countries to help build critical public 
health capacity to detect and respond to global health threats, enhance 
regional cooperation on priority threats such as viral hemorrhagic 
fevers and respiratory diseases, address cross-cutting vulnerabilities 
such as access to diagnostic tests and laboratory reagents, and 
facilitate rapid deployment of technical support to address emerging 
public health challenges.
    The United States Government remains committed to the Global Health 
Security Agenda (GHSA) and CDC continues to be an active partner 
through the next phase, GHSA 2024. The focus of this next phase 
includes enhancing accountability for delivering on commitments, 
measuring progress, and increasing country governments' domestic 
support their own health security, including through enhanced 
partnerships with the non-governmental sector.
    Progress will continue to be monitored through WHO's Monitoring and 
Evaluation Framework, which includes Joint External Evaluations (JEE), 
which assess the status of country capacity to prevent, detect and 
respond to outbreaks, and National Action Plans for Health Security 
(NAPHS), which chart paths forward for countries to address gaps 
identified by the JEE. CDC continues strong engagement with the JEE 
process, contributing experts to participant in the assessment process 
in more than 60 percent of the 95 JEEs completed, as of April 2019.
    The United States is a permanent member of the GHSA Steering Group, 
and leads or co-leads GHSA Task Forces on stakeholder engagement, 
accountability and results. CDC works with other high-income GHSA 
member countries to align funding toward the gaps identified in JEEs 
and the activities planned in NAPHS. CDC is also collaborating with the 
World Bank and other partners to encourage and enable country 
governments to make their own domestic commitments to health security. 
For example, CDC is working with World Bank to ensure that funding 
focuses not only on emergency response but ensures long-term, 
sustainable preparedness.
    Question. How do CDC and USAID prevent overlap while working 
together to improve health infrastructure in GHSA countries?
    Answer. GHSA country work plans are developed collaboratively by 
USG country teams, which include CDC and USAID at the country level, 
and are reviewed by interagency GHSA leadership. As part of this 
process, the country work plans are reviewed for possible duplication 
and overlap, and adjustments are made to ensure complementarity of 
efforts across the USG.
    Question. Will the funding requested in the budget support Phase II 
countries already identified?
    Answer. Geographic focus for USG implementation of the next phase 
of GHSA is still under discussion. The White House's National Security 
Council staff facilitates these interagency discussions.
    Question. Will Phase I countries continue to receive direct 
funding?
    Answer. Geographic focus for USG implementation of the next phase 
of GHSA is still under discussion.
                       public health preparedness
    Question. In just the last year, we have had concerning outbreaks 
of measles and AFM. How is CDC monitoring and responding to these 
outbreaks and what can we do to prevent them from happening in the 
future?
    Answer. CDC works with State and local health departments to 
monitor and respond to outbreaks of measles and acute flaccid myelitis 
(AFM) in the United States. When requested, CDC provides rapid, on-site 
assistance during outbreak investigations to State public health 
departments and supports States with risk communication during 
emergency responses. To help quickly detect and respond to measles 
cases, CDC supports States by testing laboratory specimens from both 
routine and complex suspected measles cases and helps interpret 
laboratory results. CDC's Public Health Emergency Preparedness (PHEP) 
cooperative agreement supports critical public health infrastructure, 
training staff to effectively respond to outbreaks and other emergency 
responses.
    CDC provides key information on measles to both the public, 
healthcare providers, and industry partners. CDC alerts clinicians, 
healthcare facilities, and public health officials around the country 
about current measles outbreaks and gives vaccine policy and clinical 
guidance for healthcare providers. CDC distributes information to the 
public, parents, and healthcare providers through a variety of media 
including the CDC website, e-mails, and webinars, and through 
professional associations. CDC develops and disseminates travel notices 
regarding countries with measles outbreaks so that travelers are aware 
of vaccination recommendations.
    To address cases of AFM, CDC is working closely with national 
experts, academic institutions, healthcare providers, and State and 
local health departments to thoroughly investigate AFM. We are looking 
for possible risk factors and causes, monitoring AFM cases nationwide, 
and updating possible treatment options.
    CDC established an AFM Task Force to investigate the causes of AFM 
and identify ways to improve treatment for AFM patients. The task force 
brings together experts from a variety of scientific and medical 
disciplines to shed light on this critical public health issue. The 
task force shared research priorities with the CDC Office of Infectious 
Diseases Board of Scientific Counselors at a meeting on December 6, 
2018. The main areas of focus include the current epidemiology of AFM, 
neurologic and clinical presentation, virology and pathogen discovery, 
host immune response and immune-mediated pathogenesis, and host risk 
factors. The task force will continue to meet regularly via 
teleconference and will reconvene for a second in-person meeting in May 
2019.
    CDC is also working with multiple partners on several AFM research 
projects to further understand the causes, risk factors, and long-term 
outcomes of AFM. CDC is also working with seven pediatric hospitals to 
obtain better estimates of patients presenting with limb weakness and 
obtain better and earlier samples for lab testing. There are also 
several ongoing collaborative laboratory-based studies to look for 
markers of AFM in patients and for antibodies to enteroviruses in the 
spinal fluid. We also have a collaboration with university medical 
center laboratories to look for novel and known viruses in AFM cases.
    CDC continues to work with healthcare provider organizations 
representing the specialties that are most likely to encounter AFM 
patients for ongoing education and partnership efforts. Communication 
with healthcare providers is key to early diagnosis and reporting of 
AFM cases.
    Question. Where are the highest priority areas to address gaps in 
the ability of the health workforce to respond to future outbreaks?
    Answer. CDC's world-class capabilities and scientific expertise 
build upon each other to create an effective model for rapid and 
targeted deployment of public health resources to combat threats today, 
while building the public health infrastructure (labs, emergency 
response centers, and disease tracking systems) to prevent the 
outbreaks of tomorrow.
    CDC works 24/7 to monitor and detect existing and emerging threats 
both domestically and globally. CDC's world-class data and highly 
specialized laboratories make it possible to diagnose known threats and 
quickly develop tests to identify unknown ones. Additionally, CDC's 
continuous improvement of data collection enable a rapid and scalable 
response. Critical systems such as the Laboratory Response Network, 
funded by the Public Health Emergency Preparedness (PHEP) are critical 
CDC assets to monitor and detect public health threats and conduct 
outbreak investigations.
    CDC places a high priority on the readiness of the public health 
workforce to respond during any type of public health emergency. The 
agency has made important improvements over the last 5 years, although 
some gaps remain. CDC has provided surge workforce support to respond 
rapidly to public health concerns, both within the United States and 
around the world. CDC staff helped in over 100 responses to cholera, 
yellow fever, Ebola, measles, polio, and natural disasters.
    CDC also has developed 15 public health preparedness capabilities 
for the United States, which comprise a national standard for preparing 
for and responding to public health emergencies. The highest priority 
capability areas include medical countermeasures (MCM) planning and 
operational readiness. CDC has set a target goal that all 50 States and 
the directly funded localities must demonstrate by June 2022 that they 
are operationally ready to execute their plans to distribute and 
dispense life-saving MCMs to their communities in response to a public 
health emergency.
    Another priority for CDC, and a critical component to address gaps 
in the public health workforce, is the Epidemic Intelligence Service, a 
2-year experiential service fellowship. EIS officers serve throughout 
the United States, while learning more innovative and practical ways to 
apply epidemiology to understand and stop future disease threats and 
gain practical skills to become future public health leaders.
                                 ______
                                 
             Questions Submitted by Senator Lamar Alexander
    Question. Is there enough supply of the investigational Ebola 
vaccines to prevent people currently at risk from contracting the virus 
and those that may become at risk if the virus continues to spread?
    Answer. To date, we have not experienced a gap in the availability 
of vaccine doses required in DRC. USG and Gavi, the Vaccine Alliance 
remain in close coordination with WHO and Merck monitoring the 
situation. WHO monitors the situation on a weekly basis and adjusts the 
estimates on demand for doses based on emerging epidemiologic 
information.
    As of April 9, the available doses seem sufficient based on the 
current outbreak epidemiology and the recommended strategy for 
vaccination (ring vaccination). If there are important changes in the 
course of the outbreak, such as a decrease in effective case isolation, 
a shift in the vaccine strategy, or an improvement in the 
implementation of the current vaccine strategy, it may affect vaccine 
availability. We are regularly reviewing the anticipated demands and 
availability, and assessing ways to help if a change in strategy leads 
to an insufficient supply.
    Question. What are the challenges in distributing the Ebola vaccine 
in the Democratic Republic of the Congo (DRC) and surrounding 
countries?
    Answer. The current Ebola outbreak in the DRC is occurring in a 
complex humanitarian context--in a security-compromised zone with heavy 
cross-border movement, and in a country experiencing cholera, vaccine-
derived poliovirus, measles, monkeypox, and other highly infectious 
disease outbreaks. Incidents of violence and pockets of community 
resistance continue to affect civilians and frontline workers, 
requiring the response to continually adapt to the situation.
    Question. What affect would a redeployment of CDC or USAID health 
officials have on the spread of Ebola?
    Answer. The ordered departure of USG staff in the Democratic 
Republic of Congo (DRC) was in effect from December 2018 until late 
January 2019. Since the ordered departure policy was lifted, CDC has 
collaborated with the Department of State to increase CDC Ebola 
response staff in DRC, and has maintained a few responders in Kinshasa 
supporting the national Ebola response.
    Since February, a small contingent of CDC staff are now supporting 
the new Strategic Coordination Centre in Goma, allowing us to work in 
close coordination with DRC Ministry of Health and international 
partners in an area that is nearer to the outbreak. CDC staff have 
recently deployed to support Ebola case investigation in Bunia, Ituri 
Province, with approval from State Department; and are remotely 
supporting Ministry of Health and WHO responders in other affected 
areas. However, the current security environment in the highly-affected 
outbreak areas remains extremely challenging.
    Question. Before we could redeploy U.S. health officials, would a 
new assessment of the security requirements needed to protect health 
officials in the DRC need to be completed?
    Answer. CDC works closely with the Department of State to ensure 
the safety of our personnel, and we support their expertise in 
determining locations where it is safe to position our staff. As of 
April 8, 2019, 31 CDC staff were deployed to support the outbreak 
response in the following locations: DRC (15), Uganda (5), Rwanda (4), 
South Sudan (1), and WHO Headquarters in Geneva (6). Areas of support 
include border health, communications, coordination, data management, 
epidemiology, infection prevention & control, geographic information 
systems, laboratory and vaccination.
    Question. Do you intend to request that assessment to be completed? 
If so, when? If not, why?
    Answer. CDC defers to the Department of State for any consideration 
of future security assessments.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
    Question. Dr. Redfield the Ebola outbreak in the Democratic 
Republic of the Congo is the second largest on record. However, the 
disease is not showing any signs of slowing down. Given the growing 
numbers of those infected with Ebola and the increasing likelihood that 
new cases will appear outside of DRC, what resources--financial, 
technical and human--are necessary to ensure it is contained within 
DRC, that adequate healthcare treatment is readily available and 
accessible to those in need, and the virus is eradicated?
    Answer. CDC is taking a strategic three-pronged approach to the 
response, working closely with: (1) the DRC Ministry of Health, (2) the 
World Health Organization (WHO), both in Geneva and on-the- ground, and 
(3) USAID through the Disaster Assistance Response Team (DART), which 
includes disaster and health experts from both CDC and USAID. The 
outbreak in DRC is occurring in a region where there is armed conflict, 
outbreaks of violence, and other problems that complicate public health 
response activities and increase the risk of disease spread both 
locally within DRC and to neighboring countries. While the situation 
remains difficult, CDC and its partners continue to work to ensure the 
Ebola outbreak response is well-coordinated.
    CDC is closely monitoring the situation and using available 
resources in the most efficient and effective way possible. The more 
quickly and more effectively responders trace contacts and isolate 
infections, the faster the outbreak will end. Based on experience from 
previous outbreaks, an effective response depends on ascertaining and 
isolating 70 percent of all cases and sustaining this for several 
months. Currently, CDC has resources to continue supporting a small 
team in DRC.
                                 ______
                                 
                Questions Submitted by Senator Jack Reed
    Question. During the hearing, you discussed vaccine hesitancy and 
how that has been problematic in encouraging more people to get the flu 
vaccine. Can you provide additional information about what CDC is doing 
to fight back against misinformation regarding vaccines?
    Answer. While confidence in vaccines remains consistently high at 
the national level, pockets of people who are vaccine hesitant remain. 
Vaccine hesitancy is rooted in misinformation about the risk of disease 
and the safety and efficacy of vaccines. The World Health Organization 
even named vaccine hesitancy as one of the top ten threats to global 
health in 2019. The specific issue fueling the hesitancy often varies 
by community. Regardless of the reason for an individual's hesitancy, 
CDC's goal is not just to convince people to get a vaccine because they 
are scared of disease, but rather to re-establish their trust in 
vaccines, so they protect themselves and their family members from all 
vaccine-preventable diseases.
    It is critical for parents and anyone seeking information on 
vaccines to become informed health consumers. Unfortunately, some of 
the information about vaccines online may be inaccurate. CDC advocates 
tirelessly to protect the American public from disease and other health 
threats, including vaccine preventable diseases. We are a critical 
source for credible health information and committed to providing up-
to-date, science-based recommendations that anyone, including parents, 
kids, health departments, businesses, and healthcare providers, can use 
to make informed health decisions. Additionally, CDC's online 
information is in the public domain and free for anyone to access, use 
or repurpose. This includes Internet, digital and social media 
stakeholders like Facebook and others.
    When CDC engages in social media, we aim to consistently provide 
science-based and timely information in plain language to help educate 
audiences so that they can make informed decisions. We customize our 
outreach efforts based on the best channels to use for certain 
audiences, if we have visual elements, what messages resonate with a 
specific audience, what information is new or newsworthy, and what 
additional information or links they might need. Parents and anyone who 
has questions about vaccines should make sure to talk to their 
healthcare provider.
    Question. As you know, the Section 317 Immunization Program is 
critical in not only paying for vaccines, but in funding vaccine 
infrastructure enabling public health departments across the country to 
better respond to outbreaks and prevent outbreaks in the first place. 
In August 2016, CDC submitted a report to Congress concluding that the 
Section 317 program requires additional funding to carry out its 
essential public health mission of protecting Americans from 
preventable diseases, totaling over $1 billion. Would you agree that 
this program still needs additional resources to carry out its work? Is 
the need greater now?
    Answer. Immunization continues to be one of the most cost-effective 
public health interventions. For each dollar invested in the U.S. 
childhood immunization program, there are $10 of societal savings and 
$3 in direct medical savings. From 1994 to 2016, the childhood 
immunization has prevented 381 million illnesses, 855,000 deaths, and 
nearly $1.65 trillion in societal costs. The Section 317 Immunization 
Program plays a critical public health role in protecting communities 
from vaccine preventable diseases, including providing a safety net for 
uninsured adults, responding to outbreaks, and ensuring a 
scientifically sound and robust immunization infrastructure. Coverage 
for many childhood vaccinations are at, near, or above 90 percent , and 
reported cases for most vaccine-preventable diseases (VPDs) have 
decreased by 90 percent or more in the United States. However, as 
recent outbreaks of measles, hepatitis and influenza illustrate, 
outbreaks of vaccine-preventable diseases continue to be an ongoing 
challenge for the public health system.
    At the request of Congress, in February 2018, CDC provided Congress 
with its professional judgment of what is necessary to support a fully 
implemented, comprehensive immunization program.
                                 ______
                                 
             Questions Submitted to Anthony S. Fauci, M.D.
                Questions Submitted by Senator Roy Blunt
    Question. The National Institute of Allergy and Infectious Diseases 
is currently working with the World Health Organization to evaluate the 
effectiveness of an Ebola vaccine as well as several therapeutics. How 
is the trial effectively managed in a region of conflict, with little 
or no ability to follow-up with those vaccinated or treated?
    Answer. The public health and research responses to the Ebola 
outbreak in the Democratic Republic of the Congo (DRC) face challenges 
due to political and security issues in the region, including recent 
attacks on the Ebola Treatment Units (ETUs) in Katwa and Butembo, DRC. 
Despite these issues, the National Institute of Allergy and Infectious 
Diseases (NIAID) at the National Institutes of Health (NIH) remains 
committed to maintaining the integrity of the clinical research it is 
supporting in the Democratic Republic of the Congo (DRC). NIAID, in 
partnership with the World Health Organization (WHO) and the DRC 
National Institute of Biomedical Research (INRB), is supporting an 
ongoing Phase 2/3 randomized controlled trial (RCT) of investigational 
Ebola therapeutics at Ebola Treatment Units (ETU) sites in the DRC. 
NIAID is fully engaged with its partners in the trial, including in-
country partners at the INRB, and is prepared to respond rapidly to 
emerging situations, including security incidents.
    NIAID supports the Ebola therapeutics trial through a joint NIH/
INRB base of operations outside of the conflict zone in Kinshasa, the 
capital city of the DRC, and coordinates and monitors trial activities 
at the ETUs. Staff from INRB and the various non-governmental 
organizations working at the ETUs are essential to the conduct of the 
RCT. NIAID provides training sessions in Kinshasa for clinical trial 
staff conducting the RCT and facilitates the availability of additional 
local staff as needed. Despite security concerns, the commitment and 
efforts of clinical trial staff on-site in the DRC have allowed the 
trial to proceed with excellent follow-up of study participants to 
date.
    At this time, NIAID is not supporting clinical trials of candidate 
Ebola vaccines in the DRC. The WHO, non-governmental organizations, 
Ministry of Health and local clinicians are collaborating to administer 
the experimental rVSV-ZEBOV Ebola vaccine as part of a ring vaccination 
campaign to prevent the transmission of Ebola. The early-stage 
development of the rVSV-ZEBOV vaccine candidate was enabled by Phase 1 
clinical trials conducted by NIAID and the Department of Defense (DoD) 
to evaluate its safety and ability to generate an immune response. The 
ongoing ring vaccination campaign in the DRC is not a traditional 
clinical trial, but rather an ``expanded access'' protocol--a public 
health effort that offers the experimental vaccine under informed 
consent to contacts of confirmed Ebola cases, contacts of contacts, and 
those at occupational risk of Ebola infection such as healthcare 
workers.
    Question. Without a control group, how do you judge the 
effectiveness of the treatments?
    Answer. The investigational monoclonal antibody cocktail ZMappTM 
serves as the control in the ongoing RCT in the DRC. The clinical 
outcomes observed in trial participants following treatment with the 
other three candidate therapeutics (the broad-spectrum antiviral 
remdesivir, a cocktail of monoclonal antibodies known as REGN-EB3, and 
a single monoclonal antibody mAb114) will be compared to the outcomes 
observed following treatment with ZMappTM in the control group of the 
trial. As ZMappTM was shown to be safe and appeared to be beneficial 
during the 2014-2016 Ebola outbreak, the use of ZMappTM as a control 
for the current RCT was determined by an international group of 
clinical trial experts to be more appropriate than enhanced standard of 
care alone.
    Question. ZMapp takes three infusions of treatment, each lasting 
several hours, to administer. Remdesivir affects the liver and those 
patients who receive this treatment will need to have their liver 
function analyzed regularly. How do you do you ensure patients are 
following these guidelines in a conflict area where it is difficult to 
receive treatment and without any US personnel on-the-ground?
    Answer. NIAID is working closely with its partners in-country, 
including INRB and NGO staff, to ensure that all participants in the 
RCT receive high-quality care and follow-up. As part of the protocol 
for this trial, all participants are being monitored for liver 
function, which will allow staff to follow-up on any potential issues. 
NIAID has provided portable clinical chemistry analyzers to facilitate 
liver function monitoring during the trial. NIAID staff also are 
available remotely to answer questions and address issues as they 
arise. Due to the efforts of in-country partners, care and follow-up of 
subjects enrolled in the study has been excellent, despite the 
challenges that have occurred due to conflict in the region.
    Question. Congress has put a considerable amount of investment 
toward combatting antibiotic resistance. Last year's bill included 
roughly $900 million, with the majority of that funding ($550 million) 
provided to NIH. How are these investments responding to this growing 
problem and what progress has been made in developing new antibiotic 
options?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID) has utilized recent funding increases for antimicrobial 
resistance research provided by Congress to build upon longstanding 
research to better understand the biology of antimicrobial-resistant 
pathogens and develop countermeasures to diagnose, treat, and prevent 
drug-resistant infections. NIAID has expanded its basic research 
portfolio that informs the development of new and innovative approaches 
to combat antibiotic-resistant bacteria, including the discovery and 
development of new antibiotics, non-antibiotic therapies, vaccines, and 
improved diagnostics. This research increases our understanding of the 
mechanisms involved in the development of drug resistance and provides 
new tools to address the priorities and goals in the trans-Federal 
National Action Plan for Combating Antibiotic-Resistant Bacteria 
(CARB).\1\
---------------------------------------------------------------------------
    \1\ National Action Plan for Combating Antibiotic-Resistant 
Bacteria (CARB). 2015.
    https://www.cdc.gov/drugresistance/pdf/
national_action_plan_for_combating_antibotic-resistant_bacteria.pdf.
---------------------------------------------------------------------------
    NIAID's investments in research on antimicrobial resistance are 
advancing the development of promising new therapeutic candidates for 
drug-resistant infections. NIAID-supported researchers have developed a 
new state-of-the-art chemistry to synthesize novel tetracyclines, a 
broad-spectrum class of antibiotics that are not susceptible to 
existing tetracycline resistance mechanisms in bacteria. NIAID support 
has enabled the development of more than 2,000 novel tetracyclines. One 
of these compounds, XERAVATM, was recently approved by the Food and 
Drug Administration (FDA) to treat complicated intra-abdominal 
infections. NIAID funding also has led to the discovery of a new class 
of antibiotics, malacidins, originally identified in soil. These 
compounds are being investigated for further therapeutic development. 
Additionally, a NIAID-supported Phase 2 clinical trial demonstrated 
that the novel oral antibiotic zoliflodacin was well-tolerated and 
successfully cured most cases of uncomplicated gonorrhea. NIAID also 
provides support for the CARB Accelerator (CARB-X), a public-private 
partnership led by the Biomedical Advanced Research and Development 
Authority (BARDA). CARB-X has contributed to the development of 28 
novel therapeutic candidates, including 10 new antibiotic classes, to 
date.
    NIAID also supports research to develop new treatment regimens 
using existing antibiotics, as well as novel non-antibiotic 
therapeutics and preventative strategies. NIAID funds the Antibiotic 
Resistance Leadership Group (ARLG) charged with overseeing clinical 
research on antibiotic resistance. The ARLG is exploring several 
repurposed and alternative therapies for drug- resistant infections, 
including plans for a Phase 1 clinical trial to evaluate a novel 
combination therapy for carbapenem-resistant Enterobacteriaceae. NIAID-
supported scientists also are investigating the feasibility and 
efficacy of using protective bacterial strains and fecal microbiota 
transplant to prevent and treat bacterial infections. In addition, 
NIAID intramural investigators have identified a potential host-
directed therapy against carbapenem-resistant Klebsiella pneumoniae 
that uses an antibody to boost the activity of neutrophils, a type of 
white blood cell involved in the immune response to infection. In 
addition to therapeutics, NIAID supports the development of novel 
vaccine candidates to prevent bacterial infections, including research 
on experimental vaccines against Candida and Staphylococcus aureus. 
These vaccines could be beneficial for individuals at high risk of 
infection, including those with weakened immune systems or who have an 
increased incidence of recurrent infections.
    As part of NIAID's comprehensive programs to combat antibiotic-
resistant bacteria, NIAID supports the development of novel diagnostic 
assays. These laboratory tools can help to rapidly identify 
microorganisms causing infections and to guide appropriate antibiotic 
treatment. NIAID support has led to the development of a new FDA-
cleared pneumonia diagnostic that detects a number of different 
bacterial and viral species as well as seven genetic markers of 
antimicrobial resistance. NIAID also funded the development of a 
sensitive diagnostic test to identify antibiotic resistance genes from 
more than 300 bacteria known to cause disease in people. NIH, in 
partnership with BARDA, continues to support the Antimicrobial 
Resistance Diagnostic Challenge competition. The goal of the 
competition is to advance the development of innovative, rapid point-
of-need laboratory diagnostic tests to identify drug-resistant bacteria 
and improve antibiotic stewardship thus preventing the further spread 
of drug resistant bacteria. Submissions for Step 3 of the Challenge are 
due in January 2020, and final results of the competition are 
anticipated in July 2020.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
    Question. Dr. Fauci, after a 4-year moratorium on research that 
modifies bird flu in ways that can make it more risky to humans, the 
National Institute of Allergy and Infectious Diseases has decided to 
fund that sort of research again. How do you balance the need for 
research to improve preparedness with concerns about accidental release 
of these modified viruses? What safeguards are in place to making sure 
that the virus is properly contained?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID) is the lead for National Institutes of Health (NIH) research on 
emerging and re-emerging infectious diseases, including pathogens with 
pandemic potential (PPPs). Many of these PPPs, such as avian influenza, 
can be rapidly evolving and pose a threat to public health. Controlled 
experiments that may enhance the transmissibility and/or virulence of 
potential pandemic pathogens (enhanced PPPs), commonly known as ``gain-
of- function'' experiments, are critical for helping us identify, 
understand, and develop strategies and medical countermeasures against 
evolving pandemic threats. The benefits of the knowledge gained from 
these experiments must be balanced with the ability to conduct such 
research safely.
    In order to help ensure the safe conduct of such research, the U.S. 
Government issued a pause on funding certain gain-of-function research 
in October 2014 and undertook an extensive, public deliberative process 
to assess the relative benefits and risks of these types of 
experiments. Following this process, the Department of Health and Human 
Services (HHS), based on policy guidance provided by the Office of 
Science and Technology Policy (OSTP), laid out a framework to consider 
the potential scientific and public health benefits, biosafety and 
biosecurity risks, and appropriate risk mitigation strategies to help 
inform agency decisions. In December 2017, HHS announced its Framework 
for Guiding Funding Decisions about Proposed Research Involving 
Enhanced Potential Pandemic Pathogens (HHS P3CO Framework).\2\ The HHS 
P3CO Framework outlines a pre-funding, multidisciplinary review process 
as well as criteria for guiding agency funding decisions for research 
proposals that involve, or are anticipated to involve, create, 
transfer, or use enhanced PPPs. Some of the criteria considered in the 
review include that the investigator and the institution where the 
research would be carried out have the demonstrated capacity and 
commitment to conduct it safely and securely; and have the ability to 
respond rapidly, mitigate potential risks, and take corrective actions 
in response to laboratory accidents, lapses in protocol and procedures, 
and potential security breaches.
---------------------------------------------------------------------------
    \2\ U.S. Department of Health and Human Services. Framework for 
Guiding Funding Decisions about Proposed Research Involving Enhanced 
Potential Pandemic Pathogens. 2017.
    https://www.phe.gov/s3/dualuse/Documents/p3co.pdf.
---------------------------------------------------------------------------
    Much of the work involving enhanced PPPs falls within the category 
of ``Select Agent Research.'' A Select Agent is a pathogen or toxin 
that has the potential to pose a severe threat to public health and 
safety. Research involving Select Agents must be conducted with proper 
safeguards for containment within specialized biosafety laboratories 
under stringent safety and security requirements. These requirements 
are designed to prevent release of the Select Agent, as well as protect 
the scientists conducting the experiments. In addition to working 
within specialized laboratory space, researchers working with Select 
Agents also must follow specific precautions to minimize the risk of 
accidental release of the pathogen being studied. These precautions 
include specified exit and entry protocols to access the lab, 
specialized training related to biocontainment and research safety, and 
the requirement to wear specialized protective clothing while studying 
Select Agents.
    It is important to note that changes can arise naturally in PPPs 
that result in enhanced transmissibility and/or virulence. Controlled 
gain-of-function experiments assist in preparedness to address enhanced 
PPPs, whether these changes arise naturally or are deliberately 
introduced as an act of bioterrorism. NIAID is committed to maintaining 
safeguards for all NIAID-supported research and transparent processes 
for funding decisions, including for research involving enhanced PPPs.
                                 ______
                                 
             Questions Submitted to Rear Admiral Tim Zimer
             Questions Submitted by Senator Lamar Alexander
    Question. What affect would a redeployment of CDC or USAID health 
officials have on the spread of Ebola?
    Answer. In an ideal world the U.S. Centers for Disease Control and 
Prevention (CDC) and USAID experts would deploy into highly affected 
areas of North Kivu and Ituri provinces to help coordinate and improve 
the response; however, the current security environment is not 
permissive in Beni or Butembo.
    Question. Before we could redeploy U.S. health officials, would a 
new assessment of the security requirements needed to protect health 
officials in the DRC need to be completed?
    Answer. The U.S. Government is considering its approach for 
additional or prolonged deployments to Goma, and USAID and CDC are 
working closely with the responders on the ground in affected areas, 
including the hundreds of UN, local, and non-governmental organization 
workers--many of whom have extensive expertise responding to Ebola in 
prior outbreaks.
    Question. Do you intend to request that assessment to be completed? 
If so, when? If not, why?
    Answer. Security assessments and reviews are conducted regularly by 
U.S. Government security experts. USAID defers to the U.S. Department 
of State on security assessments and guidance related to access, 
including for consideration of redeployment of U.S. Government 
responders and future assessments. We kindly refer you to the U.S. 
Department of State for any consideration of future assessments.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
    Question. Admiral Ziemer, with the exception of the Office of U.S. 
Foreign Disaster Assistance (OFDA) within USAID, all donors in the 
current outbreak, with the World Bank being the largest, are channeling 
money through the World Health Organization (WHO) and UNICEF who in 
turn funding implementing agencies in coordination with the Ministry of 
Health. What can the United States be doing to encourage donors to fund 
directly implementing partners that that can best deliver with speed 
and quality in a fragile and ever fluid situation like the DRC?
    Answer. USAID is working closely with other key donors to rapidly 
fund programs and mobilize partners and resources to help bring this 
outbreak to an end as soon as possible. In particular, USAID is 
engaging the European Union's European Civil Protection and 
Humanitarian Aid Operations (ECHO), the Department for International 
Development (DFID) of the United Kingdom, and the World Bank to 
coordinate response funding and develop strategies to expand the number 
of donors that are contributing to this response, in coordination with 
the U.S. Department of Health and Human Services' Office of Global 
Affairs and the U.S. Department of State. In these discussions, USAID 
encourages funding to fill priority gaps, including direct funding to 
implementing partners that support response activities outlined in the 
GDRC/WHO Strategic Response Plan, where possible.
    Question. Admiral Ziemer, a major barrier to Ebola eradication is 
the lack of trust and dialogue between affected communities and 
government actors with the government's increasingly relying on 
security backup from local police, the Congolese Army, or United 
Nations peacekeepers in the affected regions, this has stoked alarm and 
hesitation among those needing medical treatment. It is important that 
the safety of everyone is addressed, but the current use on security 
forces is undermining Ebola response effectiveness. Some Congolese 
refuse to seek medical care from Ebola responders because they are 
afraid they will be hurt or killed by security forces. Given the 
history of government forces committing violence against its own 
people, including in the context of the Ebola response, how will you 
help foster trust between these two important groups so civilians feel 
comfortable seeking treatment?
    Answer. Experience in other humanitarian responses shows that 
community acceptance can be the best form of security. We recognize 
that community distrust is rooted in decades of exploitation and 
violence, driven by the area's complex internal and external geo-
political dynamics. USAID continues to seek ways to build trust with 
communities, and we have advocated against any militarization of the 
response that could deepen the distrust that communities have towards 
response actors. USAID and other response actors face the challenge of 
community reticence towards critical Ebola response activities. We 
further note the distinction between insecurity related to armed 
groups--who may have political or other objectives--and more 
spontaneous community resistance.
    The United Nations Organization Stabilization Mission in the 
Democratic Republic of the Congo (MONUSCO) does offer armed escorts for 
humanitarian and health organizations operating in insecure areas upon 
request. However, use of armed escorts is typically used as a last 
resort for humanitarian action. USAID and its partners will continue to 
coordinate closely with the Government of the Democratic Republic of 
the Congo (DRC) Ministry of Health and MONUSCO to advocate against any 
increasing militarization of the response that could further degrade 
trust between these groups.
    Question. Admiral Ziemer, communities impacted by Ebola have raised 
their concerns about the response, but their voices are not reaching 
those able to act on those critical gaps in addressing the virus. The 
result is an erosion of trust in the response, which can lead to 
violence against individuals and treatment centers, as has recently 
taken place in Butembo and Katwa. How do you propose to engage 
community actors and prioritize their feedback so the response can be 
inclusive and maximally effective?
    Answer. We recognize that community distrust is rooted in decades 
of exploitation and violence driven by the area's complex internal and 
external geo-political dynamics. There is no silver bullet, but USAID 
and all response partners are learning that the approach needs to shift 
from community engagement to community dialogue, to first listen to 
communities to understand their unique concerns and beliefs, and then 
work in partnership on all response activities. USAID and its partners 
have directly engaged community actors, established community networks, 
worked with local leaders, conducted workshops to strategize community 
engagement, and advocated with national level response actors to 
prioritize soliciting and responding to community feedback.
    Additionally, USAID partners are striving to build up community 
acceptance by mainstreaming community engagement through all Ebola 
virus disease (EVD) interventions and hiring more locals to be a part 
of the response in their own communities; this is one means to provide 
tangible benefits and an active voice to affected communities. 
Furthermore, USAID is expanding assistance to increase the emphasis on 
community dialogue, as well as involvement of more local faith based 
organizations. Other USAID partners are using community feedback loops 
and radio to combat myths and rumors about EVD. We are working to apply 
lessons learned and best practices from the early period of the 
response, while also adapting to new local contexts.
    Question. Admiral Ziemer, women and girls are two groups 
disproportionately affected by the outbreak. Since the beginning of the 
epidemic, women comprise approximately 59 percent of cases yet their 
voices are often unheard. Women and women's groups also have the 
capacity to advance response activities through socialization and 
education in their communities, yet little outreach is being done to 
this critical group. What existing and new mechanisms are there for 
maximizing the role of women in the response, and how will you support 
those?
    Answer. USAID is supportive of the new efforts highlighted in the 
Strategic Response Plan 3.0 to expand access of the investigational 
vaccine to pregnant and lactating women and children over 6 months who 
are contacts or contacts of contacts, as well as strengthening 
implementation of the expanded World Health Organization and Government 
of the Democratic Republic of the Congo (DRC) vaccination program for 
maximum coverage of those most at risk of exposure to Ebola. Targeting 
pregnant and lactating women for the investigational vaccine will 
ensure this vulnerable group is a priority under critical prevention 
strategies.
    Regarding community engagement approaches generally: USAID partners 
are listening to and working alongside communities to build trust, 
including engaging faith-based and traditional leaders, which will 
include female leaders, increasing local hires, and delivering Ebola 
virus disease (EVD) messages in multiple local languages. USAID is 
supporting 12 partners to facilitate community engagement and dialogue, 
working directly with faith leaders in affected areas, promoting safe 
burials through community dialogue and engaging trusted leaders, using 
community feedback to counter rumors about Ebola, and working through 
various media-- including through 25 radio stations--to deliver Ebola-
related messages.
    In Goma Health Zone, a USAID-funded partner uses women-led behavior 
change communicators through pre-established care groups to inform the 
local populace about EVD and the response. Another partner is 
implementing protection activities for vulnerable populations in 
Butembo Health Zone, including children and individuals at risk of 
gender-based violence by setting up safe spaces. A USAID Office of U.S. 
Foreign Disaster Assistance (USAID/OFDA)- supported partner is working 
on community engagement in EVD response and recovery programs, 
including reintegration of EVD survivors, with a focus on expanding 
engagement of women and youth. And through case management another 
partner is making sure that children are provided a safe environment if 
their primary caregiver or parent is taken for treatment in an EVD 
treatment unit (ETU) also ensuring that a balanced ratio of 
participation of women and men hired/deployed in the building and 
management of the ETU. Another partner will mobilize, train and deploy 
women's and youth associations as EVD awareness champions to further 
spread EVD awareness messages with vulnerable populations in targeted 
communities through peer-to-peer communication strategies.
                                 ______
                                 
                Questions Submitted by Senator Jack Reed
    Question. As discussed in your testimony, USAID is building on the 
lessons learned during the 2014 outbreak of Ebola in West Africa and 
working closely with the World Health Organization and the government 
of the Democratic Republic of the Congo (DRC).
    Please provide additional information on how cooperation with 
international partners and local stakeholders could be improved. Do you 
need additional authorities or resources?
    Please provide information, not already included in your written or 
oral testimony, on how the lessons learned during the 2014 outbreak of 
Ebola in West Africa have improved the United States response to the 
current outbreak in the DRC.
    How are your efforts working to prevent the current outbreak from 
expanding beyond the DRC, and in particular preventing further 
outbreaks in areas like West Africa, where the health systems have 
already been decimated by previous outbreaks?
    Answer. Improving cooperation with international partners and local 
stakeholders. USAID and all response partners are faced with the 
challenge of community reticence. During the week of March 25, 2019, 
the U.S. Government's USAID's Disaster Assistance Response Team (or 
DART) joined the U.S. Centers for Disease Control and Prevention (CDC), 
World Health Organization (WHO) and implementing partners in DRC's Goma 
town for a two-day Partners Workshop on Risk Communication, Community 
Engagement to develop collective strategies for community engagement. 
The workshop identified deficiencies in engaging key influencers in 
communities, highlighted the need for improved coordination and 
consistency across response actors, and agreed to adopt analysis of 
community feedback into all response approaches. Another outcome of the 
workshop is to deliver Ebola prevention messages in local languages 
through trusted agents, which will be more effective in promoting life-
saving behavior change. USAID hopes that the request for NGOs to co-
lead Ebola response sub-commissions will generate improvements in 
coordination and adoption of these and other lessons learned into 
response programs.
    USAID partners are striving to build up community acceptance by 
mainstreaming community engagement in all EVD interventions and hiring 
more locals to be a part of the response in their own communities; this 
is one means to provide tangible benefits and an active voice to 
affected communities. USAID is expanding assistance to increase the 
emphasis on community dialogue, as well as involvement of more local 
faith based organizations. USAID is supporting 12 partners to 
facilitate community engagement and dialogue, working directly with 
faith leaders in affected areas, promoting safe burials through 
community dialogue and engaging trusted leaders, using community 
feedback to counter rumors about Ebola, and working through various 
media-- including through 25 radio stations--to deliver Ebola-related 
messages. USAID just committed over $500,000 for a partner to work 
directly with faith leaders in the affected areas.
    Improving the response with lessons learned from the 2014 outbreak. 
As a result of lessons learned from the 2014 West Africa Ebola virus 
disease (EVD) outbreak, USAID has learned how to improve patient 
isolation and treatment to provide better care and reduce risk to 
patients and health workers. A current example of this is how USAID 
partners have changed the design of EVD Treatment Units (ETUs) in the 
Democratic Republic of the Congo (DRC) outbreak response to improve 
communication, isolation, and care. Newly designed Biosecure Emergency 
Care Units for Outbreaks (CUBEs) are designed to provide maximum 
protection for patient and medical personnel, while reducing the 
overall number of personnel and quantity of supplies required. CUBEs 
can be nimbly assembled, decontaminated, and re-assembled for use in 
other areas. While maximizing isolation, the CUBE design improves 
communication for patients with medical personnel and their families.
    USAID continues to adapt to the unique dynamics in the DRC, which 
are different from Liberia, Sierra Leone, and Guinea. Previous outbreak 
responses in the DRC showed that local health responders can be 
equipped and trained to successfully respond through capacity building 
and preparedness efforts.
    Successes in previous hotspot areas show that an integrated 
response approach--relying on community engagement, infection 
prevention and control, surveillance and contact tracing, vaccinations, 
safe burials, and case management activities--works. Lessons from Beni 
Health Zone are being used for the Katwa Health Zone response, while 
also adapting to Katwa's specific local context and high levels of 
insecurity and community reticence. Lessons learned include the need to 
have all key response components, including community engagement, 
surveillance, infection prevention and control, vaccinations, and safe 
burials in place and working in sync to be effective. Moving forward, 
the response needs to focus on improving the quality and coordination 
of those interventions, and ensuring robust community support so 
additional hotspots are addressed quickly and comprehensively to reduce 
further spread.
    Preventing expansion of the outbreak beyond the DRC. The widespread 
use of investigational Ebola vaccine in the DRC outbreak is an 
important intervention that supplements the other critical response 
tools, including active surveillance, contact tracing, case management, 
infection prevention and control, and community engagement. USAID and 
the USG have advocated for an aggressive vaccine strategy that will 
protect the most vulnerable persons, including healthcare workers, 
contacts of cases, and contacts of contacts. In response to our and 
others' advocacy, WHO and the Government of the DRC further expanded 
its vaccination strategy in the Strategic Response Plan 3.0 (released 
in late January). Pregnant and lactating women who are contacts or 
contacts of contacts should receive the vaccine, as well as children 
over 6 months old. USAID will continue to work with WHO and Government 
of the DRC to promote the optimal use of this important intervention.
    There remains a risk for spread to neighboring countries, and USAID 
is ready to support a response in other countries, if necessary. USAID 
is already supporting preparedness activities in Uganda, Rwanda, South 
Sudan, and Burundi, strengthening local border-screening capacity, 
training in case detection, and improving infection prevention and 
control in prioritized health facilities.
    Question. Global health infrastructure created by vaccination 
campaigns, including efforts to eradicate polio, have played a critical 
role in addressing many global health crises. Could you provide 
information on how efforts to provide vaccinations, have improved the 
ability of USAID to counter Ebola?
    Answer. The widespread use of the investigational Ebola vaccine in 
the Democratic Republic of the Congo (DRC) outbreak is an important 
intervention that supplements other critical response tools, including 
active surveillance, contact tracing, case management, infection 
prevention and control, and community engagement. USAID and the U.S. 
Government have advocated for an aggressive vaccine strategy that will 
protect the most vulnerable persons, including healthcare workers, 
contacts of cases, and contacts of contacts. In response to USAID's and 
others' advocacy, the World Health Organization (WHO) and the 
Government of the DRC further expanded its vaccination strategy in the 
Strategic Response Plan 3.0 (released in late January 2019). Pregnant 
and lactating women who are contacts or contacts of contacts should 
receive the vaccine, as well as children over 6 months old. USAID will 
continue to work with WHO and the Government of the DRC to promote the 
optimal use of this important intervention.
    Question. Please discuss your preparations for an event similar in 
scale to the influenza pandemic of 1918 and what additional steps could 
be taken to improve USAID's ability to counter such a pandemic?
    Answer. USAID over the past 15 years has focused much of its 
influenza work in building systems and capacities that allow for the 
early identification of potential pandemic viral threats while they are 
still circulating in animals and controlling their spread and by 
extension reducing the risk of the emergence of a pandemic virus. 
Simultaneously, USAID's Emerging Pandemic Threats Program (EPT) is 
working to put in place the systems and capacities required for the 
early detection of and rapid response to an emergent influenza virus 
and other pandemic threats. Since 2014, USAID has supported the Global 
Health Security Agenda programs in partnership with other Federal 
agencies, the World Health Organization, the Food and Agricultural 
Organization and the International Federation of Red Cross and Red 
Crescent Societies, as well as a broad coalition (spanning 30 
countries) of international experts, national leaders, the private 
sector, non- governmental organizations, universities and community 
advocates to put in place the systems and capacities required for the 
early detection of and rapid response to an emergent influenza virus 
and other pandemic threats. Achievements to date include:
  --19 countries across Africa and Asia have in place GHSA national 
        preparedness and response plans for selected priority disease 
        threats, including influenzas;
  --Nearly 29,000 professionals have been trained in core skills 
        required to successfully implement these plans;
  --162 schools of public health, medical and veterinary health, 
        forestry, and nursing in Africa and Asia have trained an 
        additional 10,000 future professionals;
  --97 labs across Asia and Africa are able to accurately test for 
        influenzas and other priority emerging diseases ensuring rapid 
        detection; and
  --200,000 personal protective kits and other critical commodities for 
        first responders have been pre-positioned for rapid deployment.
    In addition, USAID's EPT and GHSA programs have supported nearly 
400 responses to emerging disease outbreaks over the past 5 years, 
allowing for the critical testing and refinement of our overall 
readiness capabilities.
    Along with existing interagency and international collaboration, 
these investments have made major improvements to essential systems and 
capacities required to make the world safer from future pandemic and 
epidemic threats.

                          SUBCOMMITTEE RECESS

    Senator Blunt. The committee stands in recess.
    [Whereupon, at 11:23 a.m., Thursday, March 14, the 
subcommittee was recessed, to reconvene subject to the call of 
the Chair.]