[Senate Hearing 113-869]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 113-869
 
   EBOLA IN WEST AFRICA: A GLOBAL CHALLENGE AND PUBLIC HEALTH THREAT

=======================================================================

                             JOINT HEARING

                               BEFORE THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                                AND THE

                         SUBCOMMITTEE ON LABOR,
                       HEALTH AND HUMAN SERVICES,
                     EDUCATION AND RELATED AGENCIES

                                 OF THE

                      COMMITTEE ON APPROPRIATIONS
                          UNITED STATES SENATE

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                                   ON



  EXAMINING EBOLA IN WEST AFRICA, FOCUSING ON A GLOBAL CHALLENGE AND 
                          PUBLIC HEALTH THREAT

                               __________

                           SEPTEMBER 16, 2014

                               __________

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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                       TOM HARKIN, Iowa, Chairman
BARBARA A. MIKULSKI, Maryland        LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington             MICHAEL B. ENZI, Wyoming
BERNARD SANDERS (I), Vermont         RICHARD BURR, North Carolina
ROBERT P. CASEY, JR., Pennsylvania   JOHNNY ISAKSON, Georgia
KAY R. HAGAN, North Carolina         RAND PAUL, Kentucky
AL FRANKEN, Minnesota                ORRIN G. HATCH, Utah
MICHAEL F. BENNET, Colorado          PAT ROBERTS, Kansas
SHELDON WHITEHOUSE, Rhode Island     LISA MURKOWSKI, Alaska
TAMMY BALDWIN, Wisconsin             MARK KIRK, Illinois
CHRISTOPHER S. MURPHY, Connecticut   TIM SCOTT, South Carolina
ELIZABETH WARREN, Massachusetts
                      Derek Miller, Staff Director
        Lauren McFerran, Deputy Staff Director and Chief Counsel
               David P. Cleary, Republican Staff Director
                                 ------                                

                                  (ii)


                      COMMITTEE ON APPROPRIATIONS

                BARBARA A. MIKULSKI, Maryland, Chairman
PATRICK J. LEAHY, Vermont            RICHARD C. SHELBY, Alabama
TOM HARKIN, Iowa                     THAD COCHRAN, Mississippi
PATTY MURRAY, Washington             MITCH McCONNELL, Kentucky
DIANE FEINSTEIN, California          LAMAR ALEXANDER, Tennessee
RICHARD J. DURBIN, Illinois          SUSAN COLLINS, Maine
TIM JOHNSON, South Dakota            LISA MURKOWSKI, Alaska
MARY L. LANDRIEU, Louisiana          LINDSEY GRAHAM, South Carolina
JACK REED, Rhode Island              MARK KIRK, Illinois
MARK L. PRYOR, Arkansas              DANIEL COATS, Indiana
JON TESTER, Montana                  ROY BLUNT, Missouri
TOM UDALL, New Mexico                JERRY MORAN, Kansas
JEANNE SHAHEEN, New Hampshire        JOHN HOEVEN, North Dakota
JEFF MERKLEY, Oregon                 MIKE JOHANNS, Nebraska
MARK BEGICH, Alaska                  JOHN BOOZMAN, Arkansas
CHRISTOPHER A. COONS, Delaware         
                   Charles E. Kieffer, Staff Director
             William D. Duhnke III, Minority Staff Director
                                 ------                                

   Subcommittee on Labor, Health and Human Services, Education, and 
                            Related Agencies

                       TOM HARKIN, Iowa, Chairman
PATTY MURRAY, Washington             JERRY MORAN, Kansas, Ranking
MARY L. LANDRIEU, Louisiana          THAD COCHRAN, Mississippi
RICHARD J. DURBIN, Illinois          RICHARD C. SHELBY, Alabama
JACK REED, Rhode Island              LAMAR ALEXANDER, Tennessee
MARK L. PRYOR, Arkansas              LINDSEY GRAHAM, South Carolina
BARBARA A. MIKULSKI, Maryland        MARK KIRK, Illinois
JON TESTER, Montana                  MIKE JOHANNS, Nebraska
JEANNE SHAHEEN, New Hampshire        JOHN BOOZMAN, Arkansas
JEFF MERKLEY, Oregon

                           Professional Staff

                            Adrienne Hallett
                              Mark Laisch
                             Lisa Bernhardt
                            Michael Gentile
                             Robin Juliano
                              Kelly Brown
                      Laura A. Friedel (Minority)
                      Jennifer Castagna (Minority)
                          Chol Pak (Minority)
                         M.V. Young (Minority)

                         Administrative Support

                              Teri Curtin
  


                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                      TUESDAY, SEPTEMBER 16, 2014

                                                                   Page

                           Committee Members

Harkin, Hon. Tom, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Alexander, Hon. Lamar, a U.S. Senator from the State of 
  Tennessee, opening statement...................................     3
Moran, Hon. Jerry, a U.S. Senator from the State of Kansas, 
  opening statement..............................................     4
Reed, Hon. Jack, a U.S. Senator from the State of Rhode Island...    32
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................    34
Murray, Hon. Patty, a U.S. Senator from the State of Washington..    36
Isakson, Hon. Johnny, a U.S. Senator from the State of Georgia...    38
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania...................................................    40
Boozman, Hon. John, a U.S. Senator from the State of Arkansas....    42
Bennet, Hon. Michael F., a U.S. Senator from the State of 
  Colorado.......................................................    43
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................    46
Durbin, Hon. Richard J., a U.S. Senator from the State of 
  Illinois.......................................................    47
Mikulski, Hon. Barbara A., a U.S. Senator from the State of 
  Maryland, opening statement....................................    49

                           Witnesses--Panel I

Bell, Beth P., M.D., MPH, Director, National Center for Emerging 
  and Zoonotic Infectious Diseases, Centers for Disease Control 
  and Prevention, Atlanta, GA....................................     5
    Prepared statement...........................................     7
Fauci, Anthony S., Director, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health, Bethesda, 
  MD.............................................................    11
    Prepared statement...........................................    13
Robinson, Robin A., Ph.D., Director, Biomedical Advanced Research 
  and Development Authority, Deputy Assistant Secretary for 
  Preparedness & Response, U.S. Department of Health and Human 
  Services, Washington, DC.......................................    23
    Prepared statement...........................................    25

                          Witnesses--Panel II

Brantly, Kent, M.D., Former Medical Director, Samaritan's Purse 
  Ebola Care Center in Monrovia, Liberia, Ebola Survivor, Fort 
  Worth, TX......................................................    52
    Prepared statement...........................................    55
Charles, Ishmael Alfred, Program Manager, Sierra Leone Healey 
  International Relief Foundation, Freetown, Sierra Leone........    59
    Prepared statement...........................................    61

                                  (iv)
  

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Response by Beth P. Bell, M.D., MPH to questions of:
        Senator Casey............................................    70
        Senator Bennet...........................................    71
        Senator Whitehouse.......................................    72
        Senator Shaheen..........................................    74
        Senator Baldwin..........................................    76
        Senator Warren...........................................    77
        Senator Alexander........................................    80
        Senators Alexander and Burr..............................    83
        Senator Moran............................................    84
        Senator Cochran..........................................    86
        Senator Shelby...........................................    87
        Senator Burr.............................................    88
        Senator Kirk.............................................    91
        Senator Enzi.............................................    92
    Response by Anthony S. Fauci, M.D., and Robin A. Robinson, 
      Ph.D., to questions of:
        Senator Casey............................................    94
        Senator Bennet...........................................    95
        Senator Whitehouse.......................................    96
        Senator Baldwin..........................................    97
        Senator Warren...........................................    98
        Senator Alexander........................................    99
        Senator Moran............................................   101
        Senator Shelby...........................................   102
        Senator Cochran..........................................   103
        Senator Burr.............................................   104
        Senator Kirk.............................................   105
    Response by Ishmael Alfred Charles to questions of:
        Senator Casey............................................   107
        Senator Warren...........................................   108



  


   EBOLA IN WEST AFRICA: A GLOBAL CHALLENGE AND PUBLIC HEALTH THREAT

                              ----------                              


                      TUESDAY, SEPTEMBER 16, 2014

                         U.S. Senate Joint Hearing,
   Committee on Health, Education, Labor, and Pensions, and
    Appropriations Subcommittee on Labor, Health and Human 
                 Services, Education, and Related Agencies,
                                                    Washington, DC.
    The committees met, pursuant to notice, at 2:52 p.m. in 
room SH-216, Hart Senate Office Building, Hon. Tom Harkin, 
chairman of the committee and the subcommittee, presiding.
    Present: Senators Harkin, Mikulski, Alexander, Moran, 
Murray, Casey, Franken, Bennet, Whitehouse, Baldwin, Warren, 
Durbin, Reed, Pryor, Burr, Isakson, Cochran, Johanns, and 
Boozman.

                  Opening Statement of Senator Harkin

    The Chairman. The Committee on Health, Education, Labor, 
and Pensions and the Appropriations Subcommittee on Labor, 
Health and Human Services, Education and Related Services will 
come to order.
    In March of this year, public health officials reported an 
outbreak of Ebola virus in the West African country of Guinea. 
Unlike past Ebola outbreaks that have been efficiently and 
effectively stopped, this outbreak has spread in ways that are 
potentially catastrophic for the world. Due to the gravity of 
the situation and the danger it poses not only to the affected 
region, but also to our country, I have taken the unusual step 
of calling together this joint hearing of both the authorizing 
committee I chair and the Appropriations subcommittee, which I 
also chair. We've come together today to learn all we can so we 
can work together effectively over the coming weeks to stop 
this deadly plague.
    The extent of this epidemic is tragic and it grows more 
serious with each passing day. The death toll is already far 
greater than all other previous Ebola outbreaks combined. The 
World Health Organization estimates that 20,000 people may 
become infected by December if current control efforts are not 
strengthened, and we know the fatality rate, the mortality 
rate, is close to 50 percent, 40 to 50 percent.
    We have other estimates that are much higher. And of 
course, the constant concern that as this virus spreads it 
could also start to mutate and become even more deadly or have 
other means of transmission other than through bodily fluids.
    Ebola is just one example of a threat from infectious 
disease. Others include Avian flu, and the Middle East 
Respiratory Syndrome, or MERS. In today's globalized system of 
air travel and trade, health threats easily crisscross the 
planet. That's why I've worked hard to strengthen, all of us on 
both of these committees, to strengthen investments in public 
health preparedness and response capabilities at home.
    Last year the bipartisan Pandemic and All-Hazards 
Preparedness Reauthorization Act was signed into law. That came 
through this committee, and of course I see Senator Burr here, 
who led a lot of effort on that on his side. Senator Alexander, 
Senator Enzi, Senator Casey all worked very hard on this bill. 
It advances national health security by strengthening CDC's 
public health preparedness response capabilities and ensuring 
that the Biomedical Advanced Research and Development 
Authority, BARDA, has the authority it needs to support the 
development of critical treatments and vaccines.
    In the Appropriations Committee, we have worked together 
for years to secure additional funding at CDC to set up a 
network of disease detection centers across the globe. We now 
have 10, including three in Africa. We need one in every 
country in Africa. It is these centers that are now deploying 
trained epidemiologists and other staff to help in epidemic 
areas and those at high risk, and we'll have more discussion on 
that when we get to our witnesses with CDC.
    I hope and expect that in the next day or two the Senate 
will vote in favor of the $88 million that Senator Moran and I 
worked to secure in the continuing resolution (CR) to do just 
that. This is a crucial investment that will enable 100 CDC 
scientists to continue working in West Africa. It will keep the 
ZMapp and vaccine candidates moving quickly through clinical 
trials.
    But, as important as this is, it's just a first step. I 
hate to say this, but Ebola will not be conquered in the 10-
weeks of the continuing resolution. When we come back to 
negotiate the fiscal year 2015 appropriations bills, the fight 
to contain Ebola must continue to be an urgent priority.
    The subcommittee passed a Senate Labor-HHS bill that 
includes a new $40 million global health security initiative. 
We must carefully consider the size and goals of this 
initiative in light of the Ebola outbreak, while maintaining 
our commitment to CDC staff in the field. As this crisis 
illustrates, we must stop chasing diseases after the fact and 
start building public health systems around the globe capable 
of detecting and stopping diseases before they cross borders.
    Last year, with the help of Senator Moran, we were able to 
start a new global initiative called the National Public Health 
Institute to do just that. This program needs to be expanded in 
light of this epidemic.
    With these big challenges ahead of us, today's hearing is 
absolutely critical. We have a distinguished group here to 
educate us and advise us.
    I will now turn to Senator Alexander and also to Senator 
Moran, but before that I request the record be kept open for 10 
days for Senators to submit statements and questions. With 
that, I'll recognize Senator Alexander.

                 Opening Statement of Senator Alexander

    Senator Alexander. Thanks, Mr. Chairman, and thanks to the 
witnesses for coming here today.
    We must take the dangerous, deadly threat of Ebola as 
seriously as we take ISIS. Let me say that again, we must take 
the dangerous, deadly threat of the Ebola epidemic as seriously 
as we take ISIS. I think I have a reputation as a Senator who's 
not given to overstatement. I don't believe that's an 
overstatement.
    The spread of this disease deserves a more urgent response 
from our country and other countries around the world than it's 
now getting. This is one of the most explosive, deadly 
epidemics in modern time if we do not do what we know how to do 
to control it. It will require a huge and immediate response. 
There is no known cure. There is no vaccine. Half of those who 
get sick die. Each sick person, according to the Centers for 
Disease Control and Prevention, could infect 20 or more others, 
including caregivers, friends, and family.
    Samantha Power, the U.N. Ambassador, said to me earlier 
this week in a briefing that she's trying to get other 
countries to view this with the same urgency that we do. This 
is an instance, she said, when we should be running toward the 
burning flames with our fireproof suits on. Ebola is killing 
people in West Africa at alarming rates and picking up speed.
    It's hard to say exactly what the number of cases is. There 
is an official number, a little less than 5,000 Ebola cases in 
Guinea, Liberia, and Sierra Leone. But the worry is that one-
half of those cases were reported in the last 3 weeks. You 
don't have to know very much about mathematics to know that, 
whatever the number, if it doubles every 3 weeks, that very 
soon we have an out of control epidemic. And we can see easily 
what would happen if a single infected traveler reaches another 
country and begins to infect others in that country.
    We'll learn more today about what we know how to do. We'll 
hear from a doctor who has contracted Ebola and who has 
recovered from it and who is here to talk about it. It's not 
like the flu. It can only be spread by bodily fluids, often 
contracted by caring for someone who's sick or through burial 
practices.
    But with global travel, we're only one airplane ride away 
from a person exposed to Ebola getting on a plane to the United 
States and then becoming sick once they arrive, and then the 
mathematics of that infection could begin to develop in this 
country.
    There's human tragedy in Africa, but it affects the rest of 
the world and it affects the United States. Our State is known 
as the Volunteer State and Dr. Brantly, who will testify here, 
is an Ebola patient. He was working for Samaritan's Purse. He's 
not a Tennessean, but his parents are graduates of Lipscomb 
University, which is in Nashville. He, like many Americans, go 
on mission trips around the world to help people who need help.
    I will support the Administration's request for the $30 
million Senator Harkin talked about, for the $58 million for 
the Biomedical Advanced Research and Development Authority. 
That's for vaccines and cures and treatments. That should pass 
this week. There is a request to address $500 million of 
reprogramming in the Defense Department. Some have asked, why 
should our military be involved? Because they have to be 
involved if we want to deal with the problem. There's no way 
for the doctors and the nurses and the health care workers to 
deal with it.
    I'm pleased that on both sides of the aisle we have leaders 
who are beginning to recognize the severity of this epidemic. 
Dr. Frieden and United Nations Ambassador Power are taking the 
lead. We look forward to learning all we can about the severity 
of the epidemic and what we must do to control it. But I'll end 
where I started, we must take the deadly, dangerous threat of 
the Ebola epidemic as seriously as we take ISIS.
    The Chairman. Thank you, Senator Alexander.
    Senator Moran.

                   Opening Statement of Senator Moran

    Senator Moran. Mr. Chairman, thank you very much. I very 
much appreciate you and your leadership, working with the 
Senator from Tennessee and me together, to make certain that 
this hearing take place.
    It's very discouraging to see and know what's taking place 
in Africa, but it's very encouraging to know that we have the 
ability to make a significant difference in the outcome of 
what's occurring. Sometimes we face problems and we don't know 
exactly what to do. While I realize we haven't invented and 
discovered all the cures and treatments, we know a lot can be 
done that will save people's lives and prevent the spread of 
Ebola to other places in Africa and around the globe.
    The encouraging thing to me is that this is an example of 
something where the U.S. Senate or the Congress and the 
President can come together and actually make a difference, 
something that we ought to take some satisfaction in if we are 
able to accomplish that.
    I appreciate the leadership here today. We need to declare 
a war on Ebola. It's real and yet it's something that, with 
that war, with that campaign, we have the ability to change the 
people's lives who are affected and to diminish the number of 
people whose lives are affected in the future. This requires a 
global response and the United States needs to provide the 
necessary leadership to make certain that the war is won.
    Mr. Chairman, thank you very much.
    The Chairman. Thank you, Senator Moran.
    We have a distinguished panel, our first panel. I'll 
introduce them and then we'll move ahead with the statements. 
First is Dr. Beth Bell, Director of the National Center for 
Emerging and Zoonotic Infectious Diseases at the Centers for 
Disease Control and Prevention. Dr. Bell is responsible for 
CDC's efforts in responding to a broad range of emerging and 
established threats. Since March, Dr. Bell has helped lead 
CDC's response to the Ebola outbreak in West Africa. 
Previously, Dr. Bell served in multiple leadership roles at 
CDC, including during the agency's response to the 2001 anthrax 
attacks and the 2009 H1N1 influenza pandemic.
    Dr. Anthony Fauci, Director of the National Institute of 
Allergy and Infectious Diseases at the National Institutes of 
Health, a position he's held since 1984, for 30 years, and has 
provided outstanding leadership there. At NIH Dr. Fauci 
oversees a wide portfolio of basic and applied research to 
improve our understanding of infectious diseases and applying 
this knowledge to develop new detection, prevention, and 
treatment strategies.
    Dr. Fauci serves as one of the key advisers to the White 
House and Department of Health and Human Services on 
initiatives to bolster medical and public health preparedness 
against emerging infectious disease threats.
    Finally, we extend the committee's welcome to Dr. Robin 
Robinson, Director of the Biomedical Advanced Research and 
Development Authority, BARDA, in the Office of the Assistant 
Secretary for Preparedness and Response at the Department of 
Health and Human Services. Dr. Robinson is responsible for the 
advanced development and acquisition of innovative medical 
countermeasures, including vaccines, drugs, and diagnostic 
tools, to protect against both man-made and naturally occurring 
health threats. BARDA has played a key role in ensuring the 
ongoing research and development of experimental Ebola 
treatments, and we thank you also for being here today, Dr. 
Robinson.
    I would just ask consent that all of your statements be 
made a part of the record in their entirety.
    Dr. Bell, we'll start with you. I know we're going to have 
a lot of questions from Senators, so if you sum up in 5 to 7 
minutes we'd sure appreciate it.

STATEMENT OF BETH P. BELL, M.D., MPH, DIRECTOR, NATIONAL CENTER 
  FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES, CENTERS FOR 
          DISEASE CONTROL AND PREVENTION, ATLANTA, GA

    Dr. Bell. I will. Good afternoon, Chairman Harkin, Ranking 
Members Alexander and Moran, and members of the committees. I 
am Dr. Beth Bell, Director of the National Center for Emerging 
and Zoonotic Infectious Diseases at the CDC. I appreciate the 
opportunity to be here today to discuss the current epidemic of 
Ebola in West Africa, which illustrates in a tragic way the 
need to strengthen global health security.
    Dr. Frieden has asked me to extend his sincere regret for 
not being here in person and also to express his appreciation 
for your continuing support for CDC, enabling us to build and 
sustain the capacity to respond to health threats like Ebola.
    The Ebola epidemic in Guinea, Liberia, and Sierra Leone is 
ferocious and spreading exponentially. The current outbreak is 
the first that has been recognized in West Africa and the 
biggest and most complex Ebola epidemic ever documented. As of 
last week, the epidemic surpassed 4,400 cumulative reported 
cases, including nearly 2,300 documented deaths, though we 
believe there is considerable underreporting and expect that 
the actual numbers would be two to three times higher.
    We have now also seen cases imported into Nigeria and 
Senegal from the initially affected areas, and other countries 
are at risk of similar exportations as the outbreak grows. 
There is an urgent need to help bordering countries to better 
prepare for cases now and to strengthen detection and response 
capabilities throughout Africa.
    The secondary effects of this outbreak now include the 
collapse of the underlying health care systems, resulting, for 
example, in an inability to treat malaria or to safely deliver 
an infant, as well as non-health impacts such as economic and 
political instability and increased isolation of this area of 
Africa. These impacts are intensifying and not only signal a 
growing humanitarian crisis, but also have direct impacts on 
our ability to respond to the Ebola epidemic itself.
    There is a window of opportunity to control the spread of 
this disease, but that window is closing. If we do not act now 
to stop Ebola, we could be dealing with it for years to come, 
affecting larger areas of Africa. Ebola is currently an 
epidemic, the worst Ebola outbreak in history, but we have 
tools to stop it and an accelerated global response is urgently 
needed.
    It is important to note that we do not view Ebola as a 
significant public health threat to the United States. The best 
way to protect the United States is to stop the outbreak in 
West Africa. But it is possible that an infected traveler might 
arrive in the United States. Should this occur, we are 
confident that our public health and health care systems can 
prevent an Ebola outbreak here and recognize that the 
authorities in investments provided by your committees have put 
us in this strong position.
    Many challenges remain, particularly since there is 
currently no therapy or vaccine shown to be safe and effective 
against Ebola. We need to strengthen the global response, which 
requires close collaboration with the World Health 
Organization, additional assistance from international 
partners, and a strong and coordinated U.S. Government 
response.
    CDC has over 100 staff in West Africa currently and 
hundreds of additional staff are supporting this effort from 
Atlanta. CDC will continue to work with our partners across the 
U.S. Government and elsewhere to focus on five pillars of 
response:

     establishing effective emergency operations 
centers in countries;
     rapidly ramping up isolation and treatment 
facilities;
     helping promote safe burial practices;
     strengthening infection control and other elements 
of the health care systems; and
     improving communication about the disease and how 
it can be contained.

    Controlling the outbreak will be costly and will require 
sustained effort by the United States and the world community. 
Within HHS, the administration recently proposed that the 
Congress provide $30 million for CDC's response during the 
continuing resolution period and for efforts to develop 
countermeasures, which my colleagues will describe. And last 
week the President indicated that the unique logistics and 
material capabilities of the U.S. military would be engaged in 
this response, and we are working across the U.S. Government to 
assess the full range of resources that can be leveraged to 
change the trajectory of this epidemic.
    Working with our partners, we have been able to stop every 
previous Ebola outbreak and we are determined to stop this one. 
It will take meticulous work and we cannot take shortcuts. As 
CDC Director Tom Frieden has noted, fighting Ebola is like 
fighting a forest fire. Leave behind one burning ember, one 
case undetected, and the epidemic could reignite. Ending this 
epidemic will take time and continued intensive effort.
    This tragedy also highlights the need for stronger public 
health systems around the world. There is worldwide agreement 
on the importance of global health security, but the Ebola 
epidemic demonstrates that there is much more to be done. Any 
vulnerability can have widespread impact if not stopped at the 
source. As you are aware, the fiscal year 2015 President's 
budget includes an increase of $45 million to strengthen 
fundamental public health capacities around the globe. If these 
people, facilities, and labs had been in place in these 
countries currently battling Ebola, the early outbreaks would 
not have grown to what we are facing today. Stopping outbreaks 
where they occur is the most effective and least expensive way 
to protect people's health.
    I know that many of you have traveled to Africa to see our 
work in global health, as have I, and we all come away with an 
appreciation of the enormous challenges many people and 
countries face. These may never have been more evident than in 
the current Ebola epidemic. Each day of the past several 
months, I have been in personal contact with our teams in the 
field. Their experiences reinforce the dire need and put real 
stories and faces on a tragedy that can't simply be reduced to 
numbers and facts. But these stories from the field also 
reinforce the unique and indispensable role that CDC and our 
partners are playing and the sense that with an intensified 
global focus we can make a real difference.
    Thank you again for the opportunity to appear before you 
today and for making CDC's work on this epidemic and other 
health threats possible.
    [The prepared statement of Dr. Bell follows:]

               Prepared Statement of Beth Bell, M.D., MPH

    Good afternoon Chairman Harkin, Ranking Members Alexander and 
Moran, and members of the Health, Education, Labor, and Pensions and 
Appropriations Committees. Thank you for the opportunity to testify 
before you today and for your ongoing support for the Centers for 
Disease Control and Prevention's (CDC) work in global health. I am Dr. 
Beth Bell, Director of the National Center for Emerging and Zoonotic 
Infectious Diseases at the CDC. I appreciate the opportunity to be here 
today to discuss the current epidemic of Ebola in West Africa, which 
illustrates in a tragic way the need to strengthen global health 
security.
    We do not view Ebola as a significant public health threat to the 
United States. It is not transmitted easily, does not spread from 
people who are not ill, and cultural norms that contribute to the 
spread of the disease in Africa--such as burial customs--are not a 
factor in the United States. We know how to stop Ebola with strict 
infection control practices which are already in widespread use in 
American hospitals, and by stopping it at the source in Africa. There 
is a window of opportunity to tamp down the spread of this disease, but 
that window is closing. CDC is committing significant resources both on 
the ground in West Africa and through our Emergency Operations Center 
here at home. But this is a whole of Government response, with agencies 
across the U.S. Government committing human and financial resources.
    To date, the U.S. Government has spent more than $100 million to 
address the Ebola epidemic, and just last week the U.S. Agency for 
International Development (USAID) announced plans to make available up 
to $75 million in additional funding. In addition, we have just 
proposed that the Congress provide an additional $88 million through 
the continuing resolution process. This funding would allow us to 
support development and manufacturing of Ebola therapeutic and vaccine 
candidates for clinical trials and to send additional response workers 
from CDC as well as lab supplies and equipment. If the Congress 
includes this additional funding, it would bring our total commitments 
to date to over $250 million. Last week, the President indicated the 
need to engage the unique logistics and materiel capabilities of the 
U.S. military on this response.
    We need to, and are, working with our international partners, to 
scale up the response to the levels needed to stop this epidemic.
    Ebola is a severe, often fatal, viral hemorrhagic fever. The first 
Ebola virus was detected in 1976 in what is now the Democratic Republic 
of Congo. Since then, outbreaks have appeared sporadically. The current 
epidemic in Guinea, Liberia, and Sierra Leone is the first that has 
been recognized in West Africa and the biggest and most complex Ebola 
epidemic ever documented. We have now also seen cases imported into 
Nigeria and Senegal from the initially affected areas, which is of 
concern.
    Ebola has an abrupt onset of symptoms similar to many other 
illnesses, including fever, chills, weakness and body aches. 
Gastrointestinal symptoms such as vomiting and diarrhea are common and 
severe, and can result in life threatening electrolyte losses. In 
approximately half of cases there is hemorrhage--serious internal and 
external bleeding. There are two things that are very important to 
understand about how Ebola spreads. First, the current evidence 
suggests human-to-human transmission of Ebola only happens from people 
who are symptomatic--not from people who have been exposed to, but are 
not ill with the disease. Second, everything we have seen in our 
decades of experience with Ebola indicates that Ebola is not spread by 
casual contact; Ebola is spread through direct contact with bodily 
fluids of someone who is sick with, or has died from Ebola, or exposure 
to objects such as needles that have been contaminated. While the 
illness has an average 8-10 day incubation period (though it may be as 
short as 2 days and as long as 21 days), we recommend monitoring for 
fever and signs of symptoms for the full 21 days. Again, we do not 
believe people are contagious during that incubation period, when they 
have no symptoms. Evidence does not suggest Ebola is spread through the 
air. Catching Ebola is the result of exposure to bodily fluids, which 
we are seeing occur in West Africa, for example, in hospitals in weaker 
health care systems and in some African burial practices. Getting Ebola 
requires exposure to bodily fluids of someone who is ill from--or has 
died from--Ebola.
    The early recorded cases in the current epidemic were reported in 
March of this year. Following an initial response that seemed to slow 
the early outbreak for a time, cases flared again due to weak systems 
of health care and public health and because of challenges health 
workers faced in dealing with communities where critical disease-
control measures were in conflict with cultural norms. As of last week, 
the epidemic surpassed 4,400 cumulative reported cases, including 
nearly 2,300 documented deaths, though we believe these numbers may be 
under-reported, by a factor of at least two- to threefold. The effort 
to control the epidemic in some places is complicated by fear of the 
disease and distrust of outsiders. Security is tenuous and unstable, 
especially in remote isolated rural areas. There have been instances 
where public health teams could not do their jobs because of security 
concerns.
    Many of the health systems in these countries are weak or have 
collapsed entirely, and do not reach into rural areas. Health care 
workers may be limited (for example, we are aware of one nurse for 90 
patients in one hospital in Kenema, Sierra Leone), or may not reliably 
be present at facilities, and those facilities may have limited 
capacity. Poor infection control in routine health care, along with 
local traditions such as public funerals and cultural mourning customs 
including preparing bodies of the deceased for burial, make efforts to 
contain the illness more difficult. Furthermore, the porous land 
borders among countries and remoteness of many villages have greatly 
complicated control efforts. The secondary effects now include the 
collapse of the underlying health care systems resulting for example, 
an inability to treat malaria, diarrheal disease, or to safely deliver 
a child, as well as non-health impacts such as economic and political 
instability and increased isolation in this area of Africa. These 
impacts are intensifying, and not only signal a growing humanitarian 
crisis, but also have direct impacts on our ability to respond to the 
Ebola epidemic itself.
    There are three key things which we need to respond to this 
epidemic. The first is resources--this epidemic will take a lot of 
resources to confront. That is why the U.S. Government is putting our 
resources into this effort and asking the Congress for your assistance. 
The United Nations believes the cost of getting supplies needed to West 
African countries to get the Ebola crisis under control will be at 
least $600 million. I personally believe that to be an underestimate. 
The second is technical experts in health care and management to assist 
in country. Last, is a coordinated, global unified approach, because 
this is not just a problem for Africa. It's a problem for the world, 
and the world needs to respond.
    Fortunately, we know what we must do. In order to stop an Ebola 
outbreak, we must focus on three core activities: find active cases, 
respond appropriately, and prevent future cases. The use of real-time 
diagnostics is extremely important to identify new cases. We must 
support the strengthening of health systems and assist in training 
healthcare providers. Once active cases have been identified, we must 
support quality patient care in treatment centers, prevent further 
transmission through proper infection control practices, and protect 
healthcare workers. Epidemiologists must identify contacts of infected 
patients and followup with them every day for 21 days, initiating 
testing and isolation if symptoms emerge. And, we must intensify our 
use of health communication tools to disseminate messages about 
effective prevention and risk reduction. These messages include 
recommendations to report suspected cases and to avoid close contact 
with sick people or the deceased, and to promote safe burial practices. 
In Africa, another message is to avoid bush meat and contact with bats, 
since ``spillover events,'' or transmission from animals to people, in 
Africa has been documented through these sources.
    Many challenges remain. While we do know how to stop Ebola through 
meticulous case finding, isolation, and contact tracing, there is 
currently no cure or vaccine shown to be safe or effective for Ebola. 
We need to strengthen the global response, which requires close 
collaboration with WHO, additional assistance from our international 
partners, as well as a coordinated U.S. Government response. At CDC, we 
activated our Emergency Operations Center to respond to the initial 
outbreak, and are surging our response. One of the surge objectives was 
initial deployment of 50 disease-control experts in 30 days to the 
region to support partner governments, WHO, and other partners working 
in the region. We surpassed that goal, and as of last week, CDC has 
over 100 staff in West Africa, and more than 300 staff in total have 
provided logistics, staffing, communication, analytics, management, and 
other support functions. CDC will continue to work with our partners 
across the U.S. Government and elsewhere to focus on five pillars of 
response:

     Effective incident management--CDC is supporting countries 
to establish national and sub-national Emergency Operations Centers 
(EOCs) by providing technical assistance and standard operating 
procedures and embedding staff with expertise in emergency operations. 
All three West African countries at the center of the epidemic have now 
named and empowered an Incident Manager to lead efforts.
     Isolation and treatment facilities--It's imperative that 
we ramp up our efforts to provide adequate space to treat the number of 
people afflicted with this virus.
     Safe burial practices--Effectively shifting local cultural 
norms on burial practices is one of the keys to stopping this epidemic. 
CDC is providing technical assistance for safe burials.
     Health care system strengthening--Good infection control 
will greatly reduce the spread of Ebola and help control future 
outbreaks. CDC has a lead role in infection control training for health 
care workers and safe patient triage throughout the health care system, 
communities, and households.
     Communications--CDC will continue to work on building the 
public's trust in health and government institutions by effectively 
communicating facts about the disease and how to contain it, 
particularly targeting communities that have presented challenges to 
date.

    The public health response to Ebola rests on the same proven public 
health approaches that we employ for other outbreaks, and many of our 
experts are working in the affected countries to rapidly apply these 
approaches and build local capacity. These include strong surveillance 
and epidemiology, using real-time data to improve rapid response; case-
finding and tracing of the contacts of Ebola patients to identify those 
with symptoms and monitor their status; and strong laboratory networks 
that allow rapid diagnosis.
    CDC's request for an additional $30 million for the period of the 
continuing resolution will support our response and to allow us to ramp 
up efforts to contain the spread of this virus. More than half of the 
funds are expected to directly support staff, travel, security and 
related expenses. A portion of the funds will be provided to the 
affected area to assist with basic public health infrastructure, such 
as laboratory and surveillance capacity, and improvements in outbreak 
management and infection control. Should outbreaks recur in this 
region, they will have the experience and capacity to respond without 
massive external influx of aid, due to this investment. The remaining 
funds will be used for other aspects of strengthening the public health 
response such as laboratory supplies/equipment, and other urgent needs 
to enable a rapid and flexible response to an unprecedented global 
epidemic. CDC will continue to coordinate activities directly with 
critical Federal partners, including USAID and non-governmental 
organizations.
    Though the most effective step we can take to protect the United 
States is to stop the epidemic where it is occurring, we are also 
taking strong steps to protect Americans here at home. For example, it 
is possible that infected travelers may arrive in the United States, 
despite all efforts to prevent this; therefore we need to ensure the 
United States' public health and health care systems are prepared to 
rapidly manage cases to avoid further transmission. We are confident 
that our public health and health care systems can prevent an Ebola 
outbreak here, and that the authorities and investments provided by 
your committees have put us in a strong position to protect Americans. 
To make sure the United States is prepared, as the epidemic in West 
Africa has intensified, CDC has:

     Assisted with extensive screening and education efforts on 
the ground in West Africa to prevent ill travelers from getting on 
planes.
     Developed guidance for monitoring and movement of people 
with possible exposures, and guidance and training for partners 
(including airlines, Customs and Border Protection officers, and 
Emergency Medical Systems personnel).
     Provided guidance for travelers, humanitarian 
organizations, and students/universities.
     Advised United States' health care providers to consider 
Ebola if symptoms present within 3 weeks of a traveler returning from 
an affected area.
     Provided guidance for infection control practices in 
hospitals to prevent further spread to United States health care 
workers and communities.
     Developed response protocols for the evaluation, isolation 
and investigation of any incoming individuals with relevant symptoms.
     Expanded the capacity of our Laboratory Response Network 
to rapidly test suspected cases so that appropriate measures can be 
taken.

    Working with our partners, we have been able to stop every prior 
Ebola outbreak, and we will stop this one. It will take meticulous work 
and we cannot take short cuts. It's like fighting a forest fire: leave 
behind one burning ember, one case undetected, and the epidemic could 
re-ignite. For example, in response to the case in Nigeria, 10 CDC 
staff and 40 top Nigerian epidemiologists rapidly deployed, identified, 
and followed 1,000 contacts for 21 days. Even with these resources, one 
case was missed, which resulted in a new cluster of cases in Port 
Harcourt.
    Ending this epidemic will take time and continued, intensive 
effort. The fiscal year 2015 President's Budget includes an increase of 
$45 million to strengthen lab networks that can rapidly diagnose Ebola 
and other threats, emergency operations centers that can swing into 
action at a moment's notice, and trained disease detectives who can 
find an emerging threat and stop it quickly. Building these 
capabilities around the globe is key to preventing this type of event 
elsewhere and ensuring countries are prepared to deal with the 
consequences of outbreaks in other countries. We must do more, and do 
it quickly, to strengthen global health security around the world, 
because we are all connected. Diseases can be unpredictable--such as 
H1N1 coming from Mexico, MERS emerging from the Middle East, or Ebola 
in West Africa, where it had never been recognized before--which is why 
we have to be prepared globally for anything nature can create that 
could threaten our global health security.
    There is worldwide agreement on the importance of global health 
security, but as the Ebola epidemic demonstrates, there is much more to 
be done. All 194 World Health Organization Member States have adopted 
the International Health Regulations (IHR). Progress has occurred over 
the past years, but 80 percent of countries did not claim to meet the 
IHR capacity required to prevent, detect, and rapidly respond to 
infectious disease threats by the June 2012 deadline set by WHO. No 
globally linked, inter-operable system exists to prevent epidemic 
threats, detect disease outbreaks in real-time, and respond 
effectively. Despite improved technologies and knowledge, concerning 
gaps remain in many countries in the workforce, tools, training, 
surveillance capabilities, and coordination that are crucial to protect 
against the spread of infectious disease, whether naturally occurring, 
deliberate, or accidental. The technology, capacity, and resources 
exist to make measurable progress across member countries, but focused 
leadership is required to make it happen. If even modest investments 
had been made to build a public health infrastructure in West Africa 
previously, the current Ebola epidemic could have been detected 
earlier, and it could have been identified and contained. This Ebola 
epidemic shows that any vulnerability could have widespread impact if 
not stopped at the source.
    Earlier this year, the U.S. Government joined with partner 
governments, WHO and other multilateral organizations, and non-
governmental actors to launch the Global Health Security Agenda. Over 
the next 5 years, the United States has committed to working with at 
least 30 partner countries (with a combined population of at least four 
billion people) to improve their ability to prevent, detect, and 
effectively respond to infectious disease threats--whether naturally 
occurring or caused by accidental or intentional release of pathogens. 
As part of this Agenda, the President's fiscal year 2015 Budget 
includes $45 million for CDC to accelerate progress in detection, 
prevention, and response, and we appreciate your support for this 
investment. The economic cost of large public health emergencies can be 
tremendous--the 2003 Severe Acute Respiratory Syndrome epidemic, known 
as SARS, disrupted travel, trade, and the workplace and cost to the 
Asia-Pacific region alone $40 billion. Resources provided for the 
Global Health Security Agenda can improve detection, prevention, and 
response and potentially reduce some of the direct and indirect costs 
of infectious diseases.
    Improving these capabilities for each nation improves health 
security for all nations. Stopping outbreaks where they occur is the 
most effective and least expensive way to protect people's health. 
While this tragic epidemic reminds us that there is still much to be 
done, we know that sustained commitment and the application of the best 
evidence and practices will lead us to a safer, healthier world. With a 
focused effort and resources proposed in the fiscal year 2015 
President's Budget, we can stop this epidemic, and leave behind strong 
systems in West Africa and elsewhere to prevent Ebola and other health 
threats in the future.
    Thank you again for the opportunity to appear before you today. I 
appreciate your attention to this terrible outbreak and I look forward 
to answering your questions.

    The Chairman. Thank you very much, Dr. Bell.
    Dr. Fauci, welcome. Please proceed.

    STATEMENT OF 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, members of the committee. I appreciate the opportunity 
to be able to speak to you today about the role of the National 
Institute of Allergy and Infectious Diseases in research 
addressing the Ebola virus disease. I have some handouts that 
your staff has put in front of you and it's on the visuals 
there.
    The involvement of the NIH and NIAID in Ebola really dates 
back to the tragic events of 9-11-2001, which was followed 
closely by the anthrax attacks through the mail in letters to 
United States Senators as well as to members of the press, 
because this led to a broad, multi-agency endeavor to develop 
what we call biodefense against threats, not only of deliberate 
threats, but of unexpected naturally emerging and reemerging 
threats.
    As you see on the right-hand side of this, there was an 
agenda, a research agenda involving what we called category A 
agents. They're listed there and they're familiar to you. 
They're anthrax, botulism, plague, smallpox, tularemia, and on 
the bottom bullet you see a category called the viral 
hemorrhagic fever viruses, which are Ebola, as well as Marburg, 
Lassa, and others.
    The reason why these viral hemorrhagic fever viruses were 
so important and so deadly and so in need of countermeasures is 
that, as you mentioned in your introductory remarks, as have 
the other Senators, they have a high degree of lethality and 
infectivity. Unfortunately, the therapy is essentially mostly 
supportive, without specific antiviral drugs directed against 
the microbes in question. As we know, a vaccine for any of 
these is not available at present.
    This is an electron micrograph of the Ebola virus, which is 
a filovirus, given the name because of the filamentous 
appearance that it has when one looks at it.
    The NIH's Countermeasure Research and Development Program 
is ongoing and has been for several years. But before I even 
mention that, I wanted to underscore something that Dr. Bell 
said, is that right now today the best way to contain this 
epidemic, this outbreak, is by intensifying infection control 
capabilities, what we're seeing now evolve and what we've seen 
for some time, the ability to isolate, identify, contact trace, 
and protect our health care workers with personal protective 
equipment.
    But if we want to be prepared in a durable way, we need 
countermeasures, and that's what I'm going to spend the next 
couple of minutes telling you about. What we do is basic and 
clinical research, but we also supply the resources for 
researchers in industry and in academia to get to our end game, 
which is better diagnostics and, of course, therapeutics and 
vaccines.
    The product development pipeline is not unidimensional. The 
NIH is fundamentally responsible for developing the early 
concepts, doing what we call preclinical studies and early 
clinical studies, which I'll mention in a moment. We partner 
with our colleagues from BARDA, which you mentioned, who are 
involved in the advanced development to hand the baton over to 
industry for commercial manufacturing, with ultimate regulation 
and approval by the U.S. FDA, among other regulatory agencies, 
and you'll hear from Dr. Robinson shortly.
    Let me spend a moment outlining some of the promising 
therapeutics. You mentioned and you've heard of ZMapp from Mapp 
Biopharmaceuticals. This is a combination of three artificially 
produced antibodies directed against the Ebola virus. It has 
been shown to be very promising in an animal model and, as you 
will hear from the next witnesses when Dr. Brantly speaks, that 
this was given for the first time in humans.
    It is very, very important that we understand whether it 
truly works, how well it works, what's the proper dose, and is 
it safe. Anecdotal, we have determined that it looks like under 
circumstances it could be beneficial, but we don't know that, 
and it's our job to prove it so that we can have it readily 
available for larger numbers of people.
    On this slide there's another couple among several 
interventions, one by the company BioCryst, which we're 
collaborating with, which is one of several novel drugs that 
interfere with the reproductive process of the virus. Then our 
Department of Defense is in collaboration with a company called 
Tekmira to get a drug which is actually a small inhibitory 
molecule, again interfering with the replication of the virus.
    As I mentioned, ZMapp has been administered to seven 
individuals. This is probably, when you look at the animal 
model, a very encouraging result that we've seen in the 
animals. As we know, this has the potential, because it can 
block the virus, to do something that we hope we will be able 
to capitalize on, again with research ahead.
    Then finally, there's the issue of vaccines. This is 
something that traditionally in infectious diseases has been 
the stalwart of preventing and protecting people. We have been 
working on an Ebola vaccine for several years in an iterative 
process that we've improved upon. We have favorable results in 
an animal model using one of a few candidates, and the one I 
will mention in closing is the NIAID GlaxoSmithKlein candidate, 
which was developed at the NIH in collaboration with 
GlaxoSmithKlein and looked very good in an animal study. But as 
I have told you, Mr. Chairman and others on the committee, many 
times, the proof is in the pudding to show scientifically that 
it works.
    We have actually started that process. On September 2d at 
the NIH Clinical Center in Bethesda, we started the first phase 
I study of this vaccine, aimed at vaccinating 20 normal 
volunteers. So far 10 of the 20 volunteers have been vaccinated 
and thus far there have been no red flags. Following this, 
which will likely end at the end of November, the beginning of 
December, we will expand these studies to try and prove in fact 
that we have a safe and effective vaccine.
    In closing I'd like to reiterate what I refer to as the 
dual mandate of NIH and NIAID research when it comes to 
infectious diseases. It's our responsibility to maintain a 
robust basic and applied research portfolio in microbiology and 
infectious diseases. But also we have the other mandate, to 
have to respond rapidly and efficiently to emerging and 
reemerging infectious diseases with the kinds of 
countermeasures that would prevent morbidity and mortality and 
would have our citizens feel safe both home and abroad, and 
clearly Ebola is one of the most daunting of those reemerging 
infectious diseases. It's our aim over the next months to years 
to make sure that we do have the countermeasures to prepare us 
to address this problem.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Dr. Fauci follows:]

              Prepared Statement of Anthony S. Fauci, M.D.

    Mr. Chairman and members of the committees, thank you for the 
opportunity to discuss the National Institutes of Health (NIH) response 
to the global health emergency of Ebola virus disease. I direct the 
National Institute of Allergy and Infectious Diseases (NIAID), the lead 
institute of the NIH for conducting and supporting research on 
infectious diseases, including viral hemorrhagic fevers such as those 
caused by Ebola virus infection.
    For over six decades, NIAID has made important contributions to 
advancing the understanding of infectious, immunologic, and allergic 
diseases, from basic research on mechanisms of disease to applied 
research to develop diagnostics, therapeutics, and vaccines. NIAID has 
a dual mandate that balances research addressing current biomedical 
challenges with the capacity to respond quickly to newly emerging and 
re-emerging infectious diseases, including bioterror threats. Critical 
to these efforts are NIAID's partnerships with academia, pharmaceutical 
companies, international organizations such as the World Health 
Organization, and collaborations with other Federal entities, 
particularly the Centers for Disease Control and Prevention, the Food 
and Drug Administration (FDA), the Biomedical Advanced Research and 
Development Authority (BARDA), and the Department of Defense (DoD).
                    overview of ebola virus disease
    Viral hemorrhagic fevers are severe illnesses that can be fatal and 
are caused by a diverse group of viruses including Marburg virus, Lassa 
virus, and Ebola virus. Infection with Ebola virus typically causes 
fever, severe vomiting, diarrhea, rash, profound weakness, electrolyte 
loss, impaired kidney and liver function, and in some cases internal 
and external bleeding. Since the discovery of Ebola virus in 1976, 
outbreaks of hemorrhagic fever caused by Ebola virus have had fatality 
rates ranging from 25 percent to 90 percent, depending on the species 
of virus and the availability of medical facilities to care for 
infected patients. West Africa is currently experiencing the most 
severe Ebola epidemic ever recorded. As of last week, the epidemic 
surpassed 4,400 cumulative reported cases, including nearly 2,300 
documented deaths according to CDC. The ongoing Ebola epidemic in 
Guinea, Liberia, Sierra Leone, Nigeria, and Senegal has generated more 
cases and deaths than the 24 previous Ebola outbreaks combined.
    The ongoing public health crisis in West Africa demands a major 
amplification of efforts to identify and isolate infected individuals, 
perform contact tracing, and provide personal protective equipment for 
healthcare workers involved in the treatment of infected individuals. 
This still remains the time-proven approach to controlling and 
ultimately ending the epidemic. However, there is also a critical need 
to develop improved diagnostics, as well as safe and effective 
therapeutics and vaccines for Ebola since there are no such FDA-
approved interventions available at this time. In this regard, NIAID 
has a longstanding commitment to advancing research to combat Ebola 
while ensuring the safety and efficacy of potential medical 
countermeasures such as treatments and vaccines.
   history of niaid ebola virus research: relationship to biodefense 
                                research
    The ability to safely and effectively prevent and treat Ebola virus 
infection is a longstanding NIAID priority. Since the 2001 anthrax 
attacks, NIAID has vastly expanded its research portfolio in biodefense 
and naturally emerging and re-emerging infectious diseases. This 
research targets pathogens that pose high risks to public health and 
national security. NIAID has designated pathogens with high mortality 
such as anthrax, plague, smallpox, and Ebola virus as NIAID Category A 
Priority Pathogens to highlight the need for medical countermeasures 
against these dangerous microbes.
    NIAID's expanded efforts in biodefense and emerging and re-emerging 
infectious diseases were undertaken with specific objectives. The first 
is to advance basic and translational research and facilitate 
development of effective products to combat deadly diseases such as 
Ebola. The second is to employ innovative strategies, such as broad 
spectrum vaccines and therapeutics, to prevent and treat a variety of 
related infectious diseases. The third is to strengthen our 
partnerships with biotechnology and pharmaceutical companies to help 
accelerate the availability of needed products for affected and at risk 
individuals.
    Since 2001, NIAID's biodefense research has supported the 
development and testing of numerous candidate products to prevent or 
treat viral hemorrhagic fevers, including those caused by Ebola and 
other related viruses. The progress we have made with candidate 
vaccines, therapeutics, and diagnostics for Ebola virus would not be 
possible had we not made this important investment.
        development and testing of ebola medical countermeasures
    In response to the Ebola public health emergency in West Africa, 
NIAID is accelerating ongoing research efforts and partnering with 
governments and private companies throughout the world to speed the 
development of medical countermeasures that could help control the 
current epidemic and future outbreaks. NIAID research on Ebola virus 
focuses on basic research to understand how Ebola virus causes illness 
in animals and in people as well as applied research to develop 
diagnostics, vaccines, and therapeutics.
                              diagnostics
    Accurate and accessible diagnostics for Ebola virus infection are 
needed for the rapid identification and treatment of patients in an 
outbreak because the symptoms of Ebola can be easily mistaken for other 
common causes of fever in affected areas, such as malaria. NIAID 
continues to provide resources to investigators attempting to develop 
Ebola diagnostics. With NIAID support, Corgenix Medical Corporation is 
developing diagnostics for Ebola virus using recombinant DNA 
technology. NIAID also is advancing development of diagnostics, 
including those using novel technologies, which are capable of 
detecting multiple viruses including Ebola. Such innovative approaches 
can provide information critical to the creation of point-of-care 
diagnostics that could be distributed and used in areas where Ebola 
virus outbreaks occur. Intramural scientists from NIAID's Rocky 
Mountain Laboratories (RML) in Hamilton, MT, and Integrated Research 
Facility in Frederick, MD, have responded to the epidemic by providing 
technical diagnostic support in Liberia.
                              therapeutics
    Currently, supportive care, including careful attention to fluid 
and electrolyte replacement, is the only effective medical intervention 
for patients with Ebola virus disease; no drugs are available 
specifically to treat Ebola virus infection. Experts are now evaluating 
whether drugs licensed or approved for the treatment of other diseases 
should be reevaluated for potential treatment of patients with Ebola in 
the current epidemic on an emergency basis. In parallel, NIAID is 
supporting the development of novel therapeutics targeting Ebola virus. 
These investigational candidate therapeutics could possibly be used in 
clinical trials in the current epidemic and hopefully will prove to be 
safe and effective; if so, such treatments could be more widely 
available for future outbreaks. It is important to note that NIAID-
supported candidate therapeutics are in early development and are 
currently available only in limited quantities.
    NIAID has provided support to and collaborated with Mapp 
Biopharmaceutical, Inc., to develop MB-003, a combination of three 
antibodies that prevents Ebola virus disease in monkeys when 
administered as late as 48 hours after exposure. An optimized product 
derived from MB-003, known as ZMapp, has shown to be substantially more 
effective in animal models than earlier combinations and protected 
monkeys from death due to Ebola virus up to 5 days after infection, 
according to Mapp Biopharmaceutical, Inc. NIAID's preclinical services 
are now being used to provide pivotal safety data to support the use of 
ZMapp for clinical trials in humans. Mapp Biopharmaceutical, Inc., has 
announced that ZMapp was recently administered to humans for the first 
time as an experimental treatment to several Ebola-infected patients, 
including two Americans. It is not possible at this time to determine 
whether ZMapp benefited these patients. NIAID is working closely with 
partners at DoD, BARDA, and FDA to advance development and testing of 
ZMapp to determine whether it is safe and effective. BARDA has recently 
announced plans to optimize and accelerate the manufacturing of ZMapp 
so that clinical safety testing can proceed as soon as possible.
    NIAID also has funded BioCryst Pharmaceuticals to develop and test 
BCX4430, a novel drug that interferes with the reproductive process of 
the virus and has activity against a broad spectrum of viruses. 
According to BioCryst, BCX4430 has protected animals against infection 
by Ebola virus and the related Marburg virus. BioCryst has announced 
that a Phase 1 clinical trial of this drug is expected to begin in late 
2014 or early 2015.
    In related work, NIAID intramural scientists at RML are working on 
therapeutics that might be effective against all hemorrhagic fever 
viruses including the filoviruses Ebola and Marburg and the arenavirus 
Lassa. Ribavirin, a drug currently used to treat hemorrhagic fever 
viruses such as Lassa virus, is being examined for its potential use in 
combination therapy to treat Ebola virus infection. NIAID scientists 
also are studying human interferons as Ebola therapies. Other 
therapeutics being examined by scientists at RML are in early stages of 
study and if successful, will advance to animal model testing.
                                vaccines
    A safe and effective Ebola vaccine could be a critically important 
tool to help prevent Ebola virus disease and help contain future 
outbreaks. The hope is that such a vaccine could be licensed and used 
in the field to protect frontline healthcare workers and individuals 
living in areas where Ebola virus exists. Two Ebola vaccine candidates 
are entering Phase 1 clinical testing this fall. NIAID will play a 
critical role in advancing these Ebola vaccine candidates. The results 
of these Phase 1 studies will inform essential discussions about 
whether and how such vaccines could be of use in the current epidemic 
or future Ebola outbreaks.
    The NIAID Vaccine Research Center (VRC) has a robust viral 
hemorrhagic fever vaccine development program. Since 2003, the VRC has 
evaluated three early generation Ebola vaccine candidates and one 
Marburg vaccine candidate in Phase 1 clinical trials at the NIH campus. 
An additional Phase 1 clinical trial was conducted in Kampala, Uganda, 
in collaboration with DoD. None of the early generation candidates 
raised safety concerns in these small trials; however, they did not 
elicit the level of immune response thought to be needed to provide 
protection against exposure to the virus. The data from those trials 
have contributed directly to the VRC's current Ebola vaccine 
collaboration with the pharmaceutical company GlaxoSmithKline (GSK). 
VRC and GSK have developed an experimental vaccine that uses a 
chimpanzee virus (similar to the common cold virus), Chimp Adenovirus 3 
(CAd3), as a carrier, or vector, to introduce Ebola virus genes into 
the body; these genes code for Ebola proteins that stimulate an immune 
response. The vaccine candidate has shown promising results in animal 
models against two Ebola virus species, including the Zaire Ebola 
species responsible for the current epidemic in West Africa. A small 
Phase 1 study to examine the safety and ability of this candidate to 
induce an immune response in humans began on September 2, 2014, at the 
NIH Clinical Center in Bethesda, MD. Results from the study are 
anticipated by the end of this calendar year, and will help inform 
future development of the vaccine.
    Additional Phase 1 clinical trials of Ebola vaccine candidates are 
expected to launch before the end of 2014. In October, testing will 
begin in the United States on a vaccine candidate derived from the 
CAd3-vector designed to protect against a single Ebola virus species, 
the Zaire Ebola virus. NIAID and GSK also will donate doses of this 
vaccine candidate to enable testing by NIAID partners in the United 
Kingdom and the West African country of Mali, where existing NIAID 
research infrastructure will support the vaccine trial. Also this fall, 
NIH is collaborating with DoD and NewLink Genetics Corporation on Phase 
1 safety studies of an investigational Ebola vaccine based on vesicular 
stomatitis virus (VSV). The VSV vaccine will serve as a vector or 
carrier for an Ebola gene similar to how the Chimp adenovirus served as 
a vector or carrier as described above for the NIAID/GSK vaccine. This 
vaccine candidate was developed by and licensed from the Public Health 
Agency of Canada.
    In addition to these Ebola candidates entering Phase 1 trials in 
2014, NIAID supports a broad portfolio of Ebola vaccine research, 
including partnering with biopharmaceutical companies. NIAID also makes 
preclinical services such as animal testing to advance product 
development available to researchers in academia and industry. More 
than 30 different filovirus vaccine formulations have been evaluated 
through NIAID's preclinical services since 2011 using animal models and 
assays that NIAID has developed over many years.
    NIAID has supported the biopharmaceutical company Crucell to 
develop a recombinant adenovirus-vectored Ebola vaccine. In animal 
studies, this vaccine candidate protected against filovirus infection, 
including Ebola virus. NIAID has played an instrumental role in the 
recent announcements by Johnson & Johnson (parent company of Crucell) 
and Bavarian Nordic that they will collaborate on a two dose (prime-
boost) vaccination regimen that will begin Phase 1 testing in 2015.
    NIAID intramural scientists are collaborating with Thomas Jefferson 
University investigators to produce a vaccine candidate based on an 
existing rabies vaccine. The researchers aim to generate immunity to 
Ebola, Marburg, and rabies viruses, important diseases in certain 
regions in Africa. The investigators plan to pursue a version of the 
vaccine for human and veterinary use as well as a version for use in 
African wildlife. The wildlife vaccine could help prevent transmission 
of Ebola virus from animals to humans. The vaccine candidate for use in 
humans is undergoing preclinical testing and has demonstrated 
protection against infection by rabies and Ebola viruses in animal 
models. NIAID is currently partnering with DoD to produce sufficient 
quantities of the vaccine candidate to begin clinical testing in early 
2015.
    NIAID also is supporting the biotechnology company Profectus 
BioSciences, Inc., to investigate a second recombinant VSV-vectored 
vaccine candidate against Ebola and Marburg viruses. Profectus is 
pursing preclinical testing of the vaccine in preparation for a future 
Phase 1 clinical trial. Additionally, NIAID is collaborating with the 
Galveston National Laboratory & Institute for Human Infections and 
Immunity at the University of Texas Medical Branch at Galveston to 
further progress made by NIAID intramural scientists on a 
paramyxovirus-based vaccine against Ebola and Marburg viruses.
    Other NIAID-supported efforts include Ebola virus vaccine 
candidates in early development, such as a DNA vaccine targeting Ebola 
and Marburg viruses, an adenovirus-5-based intranasal Ebola vaccine, 
and a combination virus-like particle/DNA vaccine targeting Ebola and 
Marburg viruses to be delivered by microneedle patch. Knowledge gained 
through these studies will further the goal of the ultimate deployment 
of a safe and effective vaccine that will prevent this deadly disease.
                            clinical trials
    It is important to balance the urgency to deploy investigational 
medical countermeasures in an emergency such as the current Ebola 
outbreak with the need to ensure the maximal safety and to determine 
the efficacy of candidate drugs and vaccines for Ebola. We will do this 
with the strictest attention to safety considerations, established 
scientific principles, and ethical considerations and compassion for 
and realization of the immediate needs of the affected populations. The 
U.S. Government, working in partnership with industry, has an 
established mechanism for testing and reviewing the safety and efficacy 
of potential medical interventions. We also have an emergent crisis in 
West Africa that demands a quick and compassionate response.
    NIAID is committed to working with our partners to evaluate 
candidate drugs and vaccines for safety and efficacy. We are working to 
generate the evidence to show whether potential interventions are safe 
and effective to reassure affected communities that we are pursuing the 
tools needed to prevent and treat this deadly disease. Our partnerships 
with industry will be critical to move these products expeditiously 
along the development pipeline into clinical trials. NIAID is currently 
working to accelerate the vaccines discussed above into Phase 1 
clinical trials in healthy volunteers. The data from these trials will 
help demonstrate whether candidate Ebola vaccines are safe in humans 
and are capable of generating the desired immune response. Candidate 
Ebola treatments will be similarly evaluated for safety and markers of 
potential efficacy. If successful, these candidates will be advanced to 
further testing in larger numbers of people. As we proceed through 
clinical testing, we will continue to work with our partners in the FDA 
to accelerate development of and speed access to the products, while 
also protecting the safety and rights of study volunteers.
                               conclusion
    While NIAID is an active participant in the global effort to 
address the public health emergency occurring in West Africa, it is 
important to recognize that we are still in the early stages of 
understanding how infection with the Ebola virus can be treated and 
prevented. As we continue to expedite research while enforcing high 
safety and efficacy standards, the implementation of the public health 
measures already known to contain prior Ebola virus outbreaks and the 
implementation of treatment strategies such as fluid and electrolyte 
replacement are essential to preventing additional infections, treating 
those already infected, protecting health care providers, and 
ultimately bringing this epidemic to an end. We will continue to work 
with biopharmaceutical companies and public health agencies throughout 
the world to develop and distribute medical countermeasures for Ebola 
virus disease as quickly as possible. NIAID remains committed to 
fulfilling its dual mandate to balance research on current biomedical 
challenges with the capability to mobilize a rapid response to newly 
emerging and re-emerging infectious diseases.
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    The Chairman. Thank you, Dr. Fauci.
    Dr. Robinson, please proceed.

  STATEMENT OF ROBIN A. ROBINSON, PH.D., DIRECTOR, BIOMEDICAL 
 ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, DEPUTY ASSISTANT 
    SECRETARY FOR PREPAREDNESS AND RESPONSE, UNITED STATES 
    DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC

    Mr. Robinson. Good afternoon. Thank you, Chairman Harkin, 
Ranking Members Alexander and Moran, and other distinguished 
members of the committee. We thank you for your generous 
appropriations over the years and the opportunity to speak with 
you today about our government's Ebola response efforts. I'm 
Dr. Robin Robinson, BARDA Director and ASPR Deputy Assistant 
Secretary in HHS.
    BARDA, which was created by the Pandemic and All-Hazards 
Preparedness Act in 2006, is the government agency responsible 
for supporting advanced development and procurement of novel 
and innovative medical countermeasures, such as vaccines, 
therapeutic drugs, diagnostics, and medical devices for the 
entire Nation. BARDA exists to address the medical consequences 
of biothreats and emerging infectious diseases. BARDA has 
supported medical countermeasure development for manmade 
threats on a routine basis under Project Bioshield and 
responded to emerging threats like the HIN1 pandemic in 2009 
and the Avian H7N9 outbreak last year with CDC, FDA, and NIH.
    Today we face Ebola, which is simultaneously a biothreat 
and a material threat determination by the Department of 
Homeland Security in 2006 and an emerging infectious disease. 
As Dr. Fauci and Dr. Bell have said, when it comes to Ebola as 
a biothreat the best way to protect our country is to address 
the current epidemic in Africa, the worst in history.
    BARDA works with its Federal partners to transition medical 
countermeasures from early development at NIH and Department of 
Defense and to advance development toward ultimate FDA 
approval. Since 2006 we have built an advanced development 
pipeline of more than 150 medical countermeasures for chemical, 
biological, radiological, and nuclear threats, and pandemic 
influenza. Seven of these products have received FDA approval 
in just the last 2 years. Today we are transitioning several 
promising Ebola vaccine and therapeutic candidates from early 
development under NIH and DoD support to advanced development.
    BARDA, in concert with our Federal partners, utilizes 
public-private partnerships with industry to ensure that we 
have countermeasures to protect our citizens. Over the past 5 
years, BARDA, with NIH, CDC, and FDA and industry partners, we 
have built a flexible and rapid response infrastructure to 
develop and manufacture medical countermeasures.
    As a result of the Pandemic and All-Hazards Preparedness 
Reauthorization Act, an improved framework of medical 
countermeasures development has been afforded to Federal and 
industry partners. Indeed, last year we utilized these 
partnerships to design, develop, manufacture, test, and 
stockpile five vaccine candidates in record time for the H7N9 
outbreaks in China.
    In the current Ebola response, we are working with a wider 
array of partners, including Canada, the U.K., West African 
countries, the World Health Organization, the Gates Foundation, 
and many others to make and test these Ebola product 
candidates.
    BARDA has established a medical countermeasures 
infrastructure to assist product developers on a daily basis 
and to respond immediately in a public health emergency. Today 
we're using our Animal Studies Network to conduct critical 
animal challenge studies, our Centers for Innovation in 
Advanced Development and Manufacturing to expand production of 
Ebola monoclonal antibodies, and our Fill-Finish Manufacturing 
Network to fill Ebola antibody and vaccine products into vials.
    Additionally, our Modeling Division, which develops 
computer models of the medical consequences of manmade threats 
on a routine basis, is coordinating international and Federal 
modeling efforts on the current Ebola epidemic and possible 
impacts of non-medical and medical interventions. Last, BARDA 
supports a large-scale production of medical countermeasures as 
a response measure for public health emergencies.
    BARDA led the vaccine manufacturing responses in the H1N1 
pandemic in 2009 and the H7N9 outbreak in 2013. Today we are 
assisting the Ebola vaccine and therapeutic manufacturers with 
scaled-up manufacturing. Specifically, we are supporting the 
development and manufacture of the ZMapp monoclonal antibody 
therapy for clinical studies at one manufacturer; additionally, 
expanding overall manufacturing capacity of ZMapp by enlisting 
the help of other tobacco plant-based manufacturers; and third, 
seeking alternative Ebola monoclonal candidates to expand the 
production capacity.
    Additionally, BARDA is working with the NIH and DoD and 
industry partners to scale up the manufacturing of two 
promising Ebola candidates, one of which Dr. Fauci talked 
about, for clinical studies in Africa next year.
    The fiscal year 2015 continuing resolution and 
appropriations are needed now to fund investments in these 
medical countermeasures candidates. BARDA faces challenges in 
the coming weeks and months with the manufacturing of these 
medical countermeasures, but the bottom line is that BARDA, 
with our Federal and industry partners, will use our collective 
capabilities to address today's Ebola epidemic and to be better 
prepared for future Ebola outbreaks or bioterrorism events 
going forward.
    We thank the committee and subcommittee for your generous 
and continued support and the opportunity to testify, and I 
look forward to your questions. Thank you.
    [The prepared statement of Mr. Robinson follows:]

             Prepared Statement of Robin A. Robinson, Ph.D.

    Good afternoon. Chairman Harkin, Ranking Members Alexander and 
Moran, and other distinguished members of the committees, thank you for 
the opportunity to speak with you today about our Government's Ebola 
epidemic response efforts. I am Dr. Robin Robinson, Director of the 
Biomedical Advanced Research and Development Authority (BARDA) and 
Deputy Assistant Secretary to the Assistant Secretary for Preparedness 
and Response (ASPR) of the Department of Health and Human Services 
(HHS).
    In 2006, the Pandemic and All-Hazards Preparedness Act (PAHPA) 
created BARDA and its parent organization, ASPR. Two years ago, the 
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) 
established the Public Health Emergency Medical Countermeasures 
Enterprise (PHEMCE). BARDA is the Government agency mandated to support 
advanced research and development and procurement of novel and 
innovative medical countermeasures such as vaccines, antimicrobial 
drugs, diagnostics, and medical devices for the entire Nation to 
address the medical consequences of chemical, biological, radiological, 
and nuclear agents of terrorism (``biothreats'') and naturally 
occurring and emerging threats like the H1N1 pandemic, the H7N9 
influenza outbreak last year, and the current Ebola epidemic.
    BARDA exists to address the medical consequences of these threats 
and to bridge the gap between early development and procurement of 
medical countermeasures for novel threats. Ebola is simultaneously a 
biothreat (with a Material Threat Determination issued in 2006 by the 
Department of Homeland Security) and an emerging infectious disease. 
The current Ebola epidemic is the worst on record. As CDC has said, we 
do not view Ebola as a significant public health threat to the United 
States. The best way to continue to protect our country from any 
domestic threat posed by Ebola is to take action to address the 
epidemic in Africa.
    BARDA works with our PHEMCE partners in HHS and other Federal 
agencies to transition medical countermeasures from early development 
into advanced development and ultimately to Food and Drug 
Administration (FDA) regulatory review and approval. Advanced 
development includes critical steps needed for a product to be ready to 
use, such as optimizing manufacturing processes so products can be made 
in quantity to scale, creating and optimizing assays to assure product 
integrity, conducting late-stage clinical safety and efficacy studies, 
and carrying out pivotal animal efficacy studies that are often 
required for approval. Since 2006, BARDA has managed the advanced 
development of more than 150 medical countermeasures for chemical, 
biological, radiological, and nuclear threats and pandemic influenza. 
Seven of these products have received FDA approval in the last 2 years 
alone.
    Over the last decade, the PHEMCE has supported basic research and 
early stage development of numerous Ebola and Marburg virus medical 
countermeasure candidates. Now, as a result of this work, several 
promising Ebola vaccine and therapeutic candidates have matured enough 
for BARDA to transition them rapidly from early development to advanced 
development. Our aim is to have products we can use in time to make a 
difference in the current Ebola epidemic. We seek to have FDA-approved 
medical countermeasures as soon as it is feasible. Specifically, BARDA 
is now providing assistance for the development and scaled-up 
manufacturing of the ZMapp monoclonal antibody therapeutic and two 
Ebola vaccine candidates, early development of which has been supported 
by the National Institutes of Health's (NIH) National Institute of 
Allergy and Infectious Diseases (NIAID) and the Department of Defense's 
(DoD) Defense Threat Reduction Agency (DTRA).
    Working in conjunction with PHEMCE partners, BARDA uses public-
private partnerships with industry to ensure that we have the medical 
countermeasures to protect the emergency health security of the United 
States. Over the past 5 years, BARDA--with NIH, CDC, FDA, and industry 
partners--has built a flexible and rapidly responsive infrastructure to 
develop and manufacture medical countermeasures. Last year, for 
example, in response to the H7N9 influenza outbreaks in China, the 
PHEMCE mobilized these partnerships to design, develop, manufacture, 
clinically evaluate, and stockpile several vaccine candidates in record 
time. In the current Ebola response, the PHEMCE is working with a wider 
array of partners in addition to our Federal partners. They include 
other countries, specifically the affected and at-risk African 
countries; the World Health Organization (WHO); the Bill and Melinda 
Gates Foundation; and others. These expanded partnerships are critical 
to our efforts to address the current Ebola epidemic.
    BARDA has established a medical countermeasure infrastructure to 
assist product developers on a daily basis. The medical countermeasure 
infrastructure also allows for BARDA to respond immediately in a public 
health emergency. Today, BARDA is using this infrastructure to respond 
to the current Ebola epidemic by helping to develop and manufacture 
several investigational Ebola therapeutics and vaccines. BARDA's Animal 
Studies Network is conducting critical animal challenge studies for 
promising investigational Ebola therapeutic candidates. BARDA's Centers 
for Innovation in Advanced Development and Manufacturing, established 
in 2012, are positioned to accelerate production of Ebola monoclonal 
antibodies, like those in ZMapp, in tobacco plants and mammalian cells 
if clinical trials demonstrate that ZMapp is safe and effective. BARDA 
will monitor ZMapp throughout the development cycle, and, if necessary, 
can shift funds to test other candidate therapeutics. Our Fill-Finish 
Manufacturing Network, established last year for pandemic preparedness, 
stands ready to formulate and fill Ebola antibody and vaccine products 
into vials for studies and other uses. The investments we have made to 
create this infrastructure over the past 4 years are helping us respond 
to the current epidemic.
    BARDA also supports large-scale production of medical 
countermeasures as a response measure for public health emergencies. 
BARDA led the manufacturing of vaccine and antiviral drugs in response 
to the H1N1 pandemic in 2009 and of vaccines as a preparedness measure 
for H7N9 in 2013. In the current Ebola epidemic, BARDA is providing 
assistance to vaccine and therapeutic manufacturers to scale up 
production from pilot scale, in which a handful of doses can be made, 
to commercial scale. For ZMapp, we are currently supporting the 
manufacture of enough doses for clinical safety studies, but we need to 
start now to expand the number of domestic manufacturers who can 
produce Ebola monoclonal antibodies using tobacco plants. Therefore, 
the Administration is requesting funding for this purpose through an 
anomaly to the fiscal year 2015 continuing resolution. Additionally, we 
are looking at alternative Ebola monoclonal antibody production 
systems, including those used for similar families of products in the 
commercial market, as a means of further expanding production capacity 
for this product. With respect to vaccines,
    BARDA is working with NIH/NIAID, DoD/DTRA, and industry partners to 
scale up the manufacturing of the two promising investigational Ebola 
vaccine candidates. To enable the conduct of clinical efficacy studies 
for investigational Ebola therapeutics and vaccines in Africa 
throughout the next year, we need appropriations to fund investments in 
these medical countermeasure candidates now as proposed through the 
continuing resolution anomaly.
    BARDA faces significant challenges in the coming weeks and months 
with the manufacturing of these medical countermeasures. The major 
challenge is being able to provide sufficient quantities soon enough to 
support clinical studies. BARDA is prepared to meet those challenges 
and provide resources, expertise, and technical assistance for other 
promising investigational Ebola vaccine and therapeutic candidates. We 
are working with our U.S. Government partners, new and existing 
industry partners, the WHO, non-governmental organizations, African 
countries, and others to meet these challenges.
    In conclusion, BARDA has established a solid track record in 
developing medical countermeasures. With the rest of the PHEMCE, we are 
using all of our capabilities to address the Ebola epidemic in Africa, 
and have identified crucial additional steps that can be supported 
through the fiscal year 2015 continuing resolution. BARDA's investments 
today into Ebola medical countermeasures will address not only the 
current epidemic and any future Ebola outbreaks, but they will also 
help the United States to become better prepared for bioterrorism. 
Again, I would like to thank the committee and subcommittee for your 
generous and continued support, and for the opportunity to testify. I 
look forward to your questions.

    The Chairman. Thank you very much, Dr. Robinson. Thank you 
all for your very succinct summations of your statements. We'll 
start a round of 5-minute questions. I'm going to ask people to 
try to adhere to that. We have another panel that's going to be 
very interesting also, Dr. Brantly, who is a survivor, and 
Ishmael Charles, who is a worker on the ground in western 
Africa. We would like to get to that panel this afternoon.
    I'll start a 5-minute round. Dr. Bell, these disease 
outbreaks seem to be becoming more common because of the close 
proximity of humans and animals, because of the close proximity 
of humans. Travel is common, and what's happened in West Africa 
I believe is due to a failure of the public health system or 
the nonexistence of a public health system in those countries.
    A couple of years ago, in traveling through Africa with Dr. 
Frieden it occurred to me that in some of these countries they 
need a CDC. They need an entity that is culturally sensitive, 
that involves people of that country, that can detect these 
early, do the epidemiological work, isolate and control at the 
beginning. And they need to be connected with our CDC so that 
we can work together. Last year, Senator Moran and I put money 
in the appropriations bill--I forget how much it was, $10 
million or something like that--to start expanding this.
    Would you speak to this, and how important is it for these 
other countries to create their own version of the CDC so that 
these outbreaks can be controlled right from the beginning? In 
other words, every country having their own CDC.
    Dr. Bell. Yes, thank you, Senator. You make some very 
important points. There are some fundamental capabilities that 
we at the CDC almost take for granted because they're so 
fundamental, that are really absent in many of these countries: 
basic laboratory capacity, rapid response teams, some 
understanding of what it takes to investigate an outbreak, 
emergency operations centers where we understand the structure 
that one needs in order to control, to identify and control an 
outbreak, telecommunications systems, some very basic 
capabilities.
    These are capabilities that we agree with you really need--
they're fundamental and really every country needs these 
capabilities. In many ways, that's what the Global Health 
Security Agenda is about.
    I might give you an example from another country in Africa 
by way of contrast. We're in the midst now of the largest and 
extremely challenging Ebola outbreak, but we at the CDC have 
actually been investigating and stopping Ebola outbreaks in 
East Africa for actually quite a long time. One of the 
countries in which we've been working is Uganda. If you look at 
the list of Ebola outbreaks of the past, you'll see that many 
of them were in Uganda, some of the largest ones involving 
hundreds of people, which of course at that time we thought was 
a lot.
    Over the last decade or so, we've been working with Uganda, 
with the Ministry of Health and with the Uganda Virus Research 
Institute to build capacity there. They now have a laboratory, 
which allows them to do their own testing and detect Ebola and 
other viral hemorrhagic fevers. They have a transportation 
network, which allows them to move specimens around the country 
and get them to the laboratory. They have rapid response teams 
that know how to find Ebola outbreaks and stop them.
    Consequently, what we've seen in Uganda over the last few 
years is more outbreaks being detected, which is good because 
we know that they're going on, and then they're much smaller, 
to the point where a year or two ago there was an outbreak of 
Ebola which involved one person. They were able to stop it 
after one person. Most of these are small clusters which are 
stopped quickly.
    This is an example of building the kind of capacity that 
you're talking about, which is of benefit to the country. It 
helps the country solve some very fundamental health problems 
that they have. This is an example of the kind of thing that we 
think, we agree with you, really needs to be built in every 
country.
    The Chairman. I hope this Congress and the one to follow--I 
won't be here, but the one that follows--will really take this 
up. We have spent lots of taxpayers' dollars in shoring up 
military operations around the globe so people could defend 
themselves against insurgencies, could defend themselves. Yet 
on this one aspect we have been woefully inadequate. It's like 
we expect our CDC to do everything. It can do a lot, as we've 
shown, but we need those other CDC's in those countries out 
there. Think about those as forward outposts where people can 
defend themselves and in turn defend us from the rapid 
transmission of these viruses.
    I thank you very much. I thank Dr. Frieden and all of you 
down there for your great leadership. I hope that in the next 
few years we can see CDC replicated in countries around the 
globe.
    Thank you, Dr. Bell.
    Senator Alexander.
    Senator Alexander. Dr. Bell, you and the other witnesses 
have carefully explained that we know what to do about Ebola 
and we've demonstrated that it can be controlled. However, in 
talking with you and Dr. Frieden, without putting words in your 
mouth, I can tell you feel like this epidemic, this outbreak, 
is a very, very serious problem that we ought to jump all over.
    Let me try to put that into some perspective. You said a 
moment ago that a few hundred cases would have been a big 
outbreak. Today the official report says you have identified a 
little less than 5,000 cases, correct? But it might be higher 
than that. Is that right? What are the chances that that's 
underreporting the number of cases in West Africa?
    Dr. Bell. Quite likely, Senator.
    Senator Alexander. Quite likely higher. It's also true 
that, of those cases that you reported, half of them were 
reported in the last 3 weeks, is that correct?
    Dr. Bell. More or less, yes, sir.
    Senator Alexander. So if the number were 10,000 or 15,000 
instead of 5,000, perhaps half those cases would have been 
reported in the last 3 weeks.
    Dr. Bell. Quite possibly.
    Senator Alexander. The danger is the rapid infection. Why 
such a worry? Is it that the infection spreads more rapidly? Is 
that the concern? We've had many kinds of epidemics, but why 
such a grim outlook about this epidemic? Why does CDC say it 
may be the most dangerous epidemic of modern times if it's not 
controlled?
    Dr. Bell. Yes, sir. Thank you, Senator. As you've heard, 
Ebola actually is not easily transmitted. It isn't transmitted 
through the air and it requires direct contact with bodily 
fluids, with dead bodies. But what we're seeing in this 
outbreak is, because of right now insufficient capacity to 
isolate patients with Ebola, we are seeing these chains of 
transmission. You can imagine, as the number of cases grows, 
the number of contacts for each case, that these chains of 
transmission continue to propagate. That's how the number of 
cases grows and continues to grow faster as the number of cases 
increase.
    It's really a matter of arithmetic, and it brings me to the 
point of what is the critical issue right now, especially in 
Liberia, but really in all of these countries. That is that we 
must come up with some ways to effectively isolate and treat 
Ebola patients. Right now our capacity----
    Senator Alexander. But first you have to find them, right? 
You have to chase down every infected person or person who 
might be infected, right?
    Dr. Bell. Right now, Senator, certainly in Liberia there 
are patients that we know about and there are no Ebola 
treatment units in which to house them. So yes, we must do 
meticulous contact tracing. We must identify all the potential 
cases, isolate them, check their temperatures for 21 days to 
make sure that they're not infected. But right now, especially 
in Liberia, the problem that we have is that we don't have 
measures to effectively isolate cases that we do identify. 
That's right now the limiting factor, I would say, in Liberia.
    Senator Alexander. So the new cases seem to appear to 
double in 3 weeks, and half those infected die?
    Dr. Bell. Right now it appears that's the mortality rate, 
that's right, sir.
    Senator Alexander. Dr. Fauci, I have one question for you. 
Dr. Bell pointed out that you don't catch Ebola by breathing on 
someone. It's bodily fluids, usually when someone is infected 
and has symptoms.
    Dr. Fauci. Right.
    Senator Alexander. Or someone is dead. And those two 
instances are most of the infections. You were quoted recently 
as saying it's not likely that Ebola will change how it's 
transmitted, which produces an even more serious set of 
possibilities. Are you tracking the virus in this outbreak as 
it affects more and more people to see if in fact it's mutating 
and changing in the way it's transmitted, so that we're not 
deceived by that?
    Dr. Fauci. Very important question, Senator. So let me just 
first answer the question and then I'll tell you what we're 
doing to make sure we're on top of this. Right now the Ebola 
virus is not transmitted by the respiratory route. There has 
been some discussion that since the virus replicates a lot--
whenever you have an RNA virus, the more it replicates the 
greater the possibility of it mutating is. And most mutations 
are irrelevant mutations. They're not associated with a 
biological change or a biological function. So even though you 
see a lot of mutations, it is unlikely that there will be a 
change, but there's a possibility that there will be a change.
    Usually when you have a change in function it could get a 
little bit more virulent, a little bit less virulent, be 
efficiently spread in the way it usually is spread or less 
efficient. It is an unusual situation where a mutation would 
completely change the way a virus is transmitted. It's not 
impossible, but it would be unlikely.
    We never take anything like that lightly, we follow it 
very, very carefully. In fact, in direct answer to your first 
question, we have an arrangement with one of the best microbial 
sequencing groups in the world at the Broad Institute in Boston 
that is getting samples and looking at the evolution of the 
mutations to try and make sure that mutations are not occurring 
that would have an important impact on what we call a 
biological function, like transmissibility.
    The reason I made that comment is that I wanted to make 
sure that people understand that changing transmissibility so 
that it could be transmitted by the respiratory route is 
obviously something that could be a frightening thing. I want 
to make sure that people understand that we're watching that 
carefully, but that's an unlikely event, not an impossible 
event, unlikely.
    What is likely is that if we don't do what we're doing now 
in the sense of a major ramping up of infection control 
capabilities, including what we're hearing about getting the 
military heavily involved with all of the things they bring to 
the table, it is very likely if we don't stop this epidemic 
it's just going to get worse and worse, the way Dr. Bell said. 
That's the more likely phenomenon, so that's the reason why we 
concentrate on getting it under control so you don't give it 
the opportunity to mutate any more.
    A virus that doesn't replicate can't mutate. So if we just 
put the lid on this, that'll be it.
    Senator Alexander. Thank you, Mr. Chairman.
    The Chairman. Thank you.
    I will recognize Ranking Member Moran next, and in order of 
appearance I have here, I have then Senator Warren, Senator 
Burr, Senator Reed, Senator Isakson, Senator Murray, Senator 
Cochran, Senator Casey, Senator Johanns, Senator Bennet, 
Senator Boozman, and then Senator Whitehouse, Senator Pryor, 
and Senator Durbin.
    Senator Moran.
    Senator Moran. Chairman Harkin, thank you.
    Dr. Bell, thank you to you and Dr. Frieden for the visit we 
had in Atlanta a few days back and for the visit I had with Dr. 
Frieden in my office this week. At that point in time, I 
expressed to Dr. Frieden my request that he express gratitude 
on behalf of me and all of us in this country for the efforts 
by the people who work at CDC, who are working now globally, 
trying to contain and change lives. We're very grateful for 
what you have undertaken.
    Let me ask first a question. Dr. Fauci just indicated about 
the potential response of use of the military. Is there 
something that you can say to the American people that assures 
them that our military men and women will be safe and secure 
from Ebola in the new tasks that they're now being asked to 
undertake?
    Dr. Bell. Thank you, Senator, and thank you for the kind 
words about the CDC.
    The CDC already has more than 100 people in the field, and 
this question of safety and security of our own staff or any 
staff or any members of the U.S. Government or many of our 
colleagues here, their safety and security is really our No. 1 
priority. We've been actually paying a lot of attention to this 
issue, certainly, as I say, starting with our own staff, with 
making sure that the staff understands what the situation is 
like on the ground before they go, having them understand very 
clearly what are the interventions that they need to take, 
making sure they have the right kind of personal protective 
equipment, that they understand some basic strategies in terms 
of distancing, and that they know what to look for should they 
start to feel ill.
    I think that the bottom line here is that it is a very dire 
situation. We are concerned about safety and security. We are 
taking that very seriously and have taken a lot of steps to do 
everything that we can to minimize the risk. But it is a very 
difficult situation and this is something that I worry about 
certainly every day with my own staff that are out there on the 
front lines.
    Senator Moran. Let me expand my expression of gratitude to 
the private religious charitable organizations and health care 
organizations that are working globally, at significant risk to 
themselves.
    What kind of coordination, education, training, do you 
understand either has taken place in regard to our military and 
their preparation for this assignment?
    Dr. Bell. Senator, I don't have any specific information 
about the preparation of the Department of Defense, but I will 
say that this is one of the areas that we at CDC have actually 
been working quite closely on, that being in training. Next 
week we'll be hosting a course in Aniston, AL, at the FEMA 
facility there, which is a 3-day safety training for health 
care workers who are planning to deploy to work for 
nongovernmental organizations in Liberia, Sierra Leone, or 
Guinea.
    This is a course that our colleagues at Medecins Sans 
Frontieres, Doctors Without Borders, helped us develop, and the 
precise purpose is to explicitly teach--these are health care 
workers; they already know, supposedly, about infection 
control--but explicitly teach them about the important 
principles that they need to know in order to safely care for 
Ebola patients. There's a mock facility there and, as I say, 
we're hoping to actually have this course weekly over the next 
period of months. Our first course is actually completely full. 
There's a lot of interest. And we think that this kind of 
training is really pivotal before Americans deploy to work in 
treatment facilities in the region in order, to your point, to 
make sure that they can care for patients safely.
    Senator Moran. Dr. Bell, let me ask a broader question. How 
would you describe the best case scenario in regard to Ebola 
and its spread and consequences and the worst case scenario, 
and what is the difference--what is the item that makes the 
worst case scenario not happen, and the best case scenario to 
occur?
    Dr. Bell. The best case scenario is that over the coming 
months we're able to effectively isolate and treat Ebola 
patients, we're able to effectively trace all of the contacts, 
make sure they're all followed for 21 days, and we're able to 
do something about safe burial practices so that we don't have 
bodies in the street and people are able to respectfully bury 
their dead and not put themselves at risk, so that over a 
period of the coming months we're able to interrupt chains of 
transmission and start to see this increase in cases that 
Senator Alexander was talking about, bend that curve in the 
other direction.
    The worst case scenario is that we continue to see the 
exponential rise in cases that we're currently seeing. An 
important corollary of that is exportation to other countries. 
As I mentioned, we've already had exportation to Nigeria and 
Senegal. I will say that the situation in Nigeria was one that 
we were extremely concerned about. You could imagine, in a 
country like Nigeria, should we have Ebola get out of control 
how incredibly dangerous this would be. It was an enormous 
effort in order to get the situation in Nigeria to the point 
that it is today, which is that, while we're not completely out 
of the woods, we do not think that there's uncontrolled 
transmission happening in Nigeria.
    But just for an example, this involved following up on 
thousands of contacts, hundreds of people working in the 
emergency operations center in Lagos and then in Port Harcourt. 
So one exportation like that, it requires an enormous amount of 
work.
    If this outbreak spirals out of control, we can expect many 
more of these exportations to other countries. Each one of 
those, as I say, requires a huge amount of work, and we have no 
guarantee that we'll be successful. You could imagine the 
outbreak spreading outside of the borders of the countries that 
are currently affected as certainly part of a worst case 
scenario.
    Senator Moran. Thank you, Dr. Bell.
    The Chairman. I'm going to recognize Senator Reed. Before I 
do it, I just have one clarification. Dr. Fauci, you said this 
was non-respiratory communicable. But what if someone sneezes 
on somebody?
    Dr. Fauci. Mr. Chairman, there is no evidence, with a lot 
of experience over multiple outbreaks, including the current 
outbreak, that respiratory spread occurs, or if it does it's 
extraordinarily rare. You never say never in biology, but 
people who have been in situations in which that particular 
phenomenon would have been noticed clearly indicate that that's 
not the case.
    The Chairman. Got it. Thank you.
    Senator Reed.

                       Statement of Senator Reed

    Senator Reed. Thank you very much, Mr. Chairman.
    Let me first thank you and your colleagues for your 
extraordinary service to the Nation and to the world. One of 
the reasons that this issue is so important in Rhode Island is 
that we have a large Liberian community, probably the largest 
Liberian community per capita in the United States, and they 
are hardworking and they are terribly concerned about their 
families in Liberia.
    I want to thank, Dr. Bell, you and Dr. Moro, because Dr. 
Moro actually participated in a conference call with our 
Liberian leaders. Senator Whitehouse and I were both involved 
in setting it up. Thank you very, very much.
    I also want to join Senator Moran in saluting those 
volunteers. We have two doctors on the Brown University 
faculty, Dr. Tim Flanagan and Adam Levine, who are in the 
country giving their skills and courageously working on behalf 
of the people of Liberia. Thank you for that.
    One other point I'll make, and this is something of an 
aside. A number of the Liberians in Rhode Island and across the 
country are here legally on a status of deferred enforced 
departure, but let me make the point: That status expires 
September 30th unless the President extends it. I would hope 
that he would do so because to send people back to this, 
literally, danger would be I think inappropriate.
    But let me ask Dr. Fauci and Dr. Robinson, you talked about 
a vaccine. Do you have sort of a sense of how fast this could 
be deployed in West Africa? And second, would you reach the 
point where you basically said, it's a huge risk, but it has to 
be done, even if you don't have all of the usual protocols 
completed?
    Dr. Fauci. Excellent question, Senator Reed. The standard 
way of implementing a vaccine in the field and deploying it is 
to go through a series of steps of what I just described--phase 
I, show is it safe and does it or does it not induce unexpected 
reaction, a hypersensitivity reaction or whatever; then find 
out what the right dose is and does it induce the right immune 
response. Then you go to larger numbers of people, because now 
you're pretty sure it's safe, you can do larger numbers of 
people in what's called a phase IIA or IIB.
    Then, depending on the disease, you can go out in the field 
and test if it works, because the worst thing that you'd want 
is have a vaccine that you're deploying that you think works, 
but it doesn't work, or even one that would be even more 
terrible is a vaccine that actually makes things worse.
    So we have to consider all of that. But when you have an 
emergent situation like this, where you have the desire to get 
people protected if in fact the vaccine is protective, there 
are ways to get the answers, not as definitively as if you did 
a pristine type of a trial, but if you would then employ the 
people who are needing the vaccine as part of the clinical 
trial, where you either compare one vaccine against another or 
one dose against another, so that you accomplish two things. 
You try and determine if it's safe and effective, even though 
it isn't as definitive as the pristine trial, but at the same 
time by getting people into these expanded trials you actually 
make it available.
    Right now the thought is once we get this situation where 
we can say we know what the dose is and we know it's safe, to 
have an expanded trial and within the context of that trial 
more people would get the opportunity to be vaccinated.
    I might say that the target of the vaccinations is clearly 
directed, among others, to the health care workers, the people 
on the front line, the emergency responders, because those are 
the ones that put themselves at risk, as did Dr. Brantly, in 
taking care of individuals.
    Senator Reed. So if you can prove, which is what you're 
trying to do right now, that it's safe, but I don't know if 
it's effective, you can try to prove its effectiveness by 
inoculating the health care workers and others.
    Dr. Fauci. Right.
    Senator Reed. It's better than nothing, but it's not quite 
definitive.
    Dr. Fauci. Right. Fully knowing that you're not going to 
get a definitive answer. But still, when you're in an emergent 
situation you've got to do the best with what you have.
    Senator Reed. Briefly, any further comments, Dr. Robinson?
    Mr. Robinson. Commensurate with those clinical trials that 
Dr. Fauci is talking about is that we have to have the product 
there, the vaccines, to be made available. Part of that is 
taking these products that are very early in development, that 
are pilot scale, and making sure we can go to commercial scale 
and produce those in large quantities, so that these studies 
can be done and after that, if they are shown to be well 
tolerated and immunogenic and protective, that there's more 
vaccine available.
    Senator Reed. Thank you all for your extraordinary work, 
and please thank your colleagues, particularly those who are in 
the field at risk.
    Thank you.
    The Chairman. Thank you very much.
    Senator Burr.

                       Statement of Senator Burr

    Senator Burr. Mr. Chairman, thank you.
    Thank you to this panel, the next panel, and thousands who 
will be called into action over the next weeks and months, 
hopefully not years.
    Dr. Bell, you said if we don't act now. Can you define 
``now'' for me from the standpoint of a time line? At what 
point will we have reached where we said we've missed our 
opportunity? How long is that?
    Dr. Bell. Senator, I wish I had a crystal ball and could 
tell you precisely the answer to that. But the situation is 
quite fluid and I think it's quite hard to predict with any 
kind of precision. I certainly can say that speed and scale is 
of the essence.
    Senator Burr. You used the term several times ``controlling 
the outbreak.'' Is controlling the outbreak the same or do you 
use that the same way you do ``containment''?
    Dr. Bell. Yes, sir, more or less, yes.
    Senator Burr. How do you achieve containment on a disease 
that's already broken the containment?
    Dr. Bell. You can think of this as bending a curve. A curve 
is going in one direction. We want to make it go in the other 
direction. In order to do that, what we have to do is break 
these chains of transmission. The way we break the chains of 
transmission is by having effective ways, to isolate patients 
so that they can't transmit and to make sure that there isn't 
ongoing transmission happening, for example in health care 
facilities or from unsafe burial practices.
    Senator Burr. Let's just take Liberia as an example, 1,383 
cases in the last 21 days, and we're surging through DoD the 
capacity for 1,700 beds in a country where they have zero now. 
My math is not great, but my math says we're going to be behind 
the eightball on day one because we won't have enough beds.
    Dr. Fauci, I'm told the most infectious tool or method in 
these countries today is the back of a cab, where individuals 
ride with their family to find that there are no beds in the 
clinic and they ride home. Let me ask you, how long can the 
virus survive, whether it's on a cab seat or whether it's on a 
sheet or whether it's on a table? How long can it infect 
somebody?
    Dr. Fauci. There have not been definitive studies giving a 
timeframe. It is not very durable, it's somewhat of a fragile 
virus. But we do know that people get infected from touching 
the dead bodies of people who have the virus--probably 
contaminated with blood or bodily fluids. It certainly is 
within the timeframe of when someone dies to a funeral, because 
that's when people have been documented to get infected.
    I don't think we could go, Senator Burr, beyond, giving you 
days, weeks, or whatever. But it clearly is not instantaneous, 
where once the virus gets out of the body it's gone, because we 
know people have been infected at funerals by touching the 
body.
    Senator Burr. I understand on previous Ebola outbreaks 
we've seen five generations of transmission. How many 
generations of transmission have we seen so far with this 
epidemic and how many mutations are we seeing as the virus 
continues to spread with each chain of transmission?
    Dr. Fauci. I can't give you a number on that, but when you 
have an RNA virus it notoriously is a bad reproducer. It makes 
mistakes, and when it makes mistakes it mutates. Most of the 
mutations don't mean anything. They're just irrelevant. They're 
called synonymous mutations. They don't mean anything.
    Some of them, rarely, do mean something. Sometimes it means 
that it kills the virus. Other times it maybe modifies some of 
its biological function.
    I can't tell you how many generations, but that could 
mathematically likely be figured out on the basis of a paper 
that just came out about a couple of weeks ago from Boston, 
where they looked at 78 people and the virus taken from them, 
and if you did a mathematical computerized informatics you'd be 
able to say how many replications. I don't have that number for 
you now, but you can determine that.
    Senator Burr. If you'd get that to us, I'd appreciate it.
    Dr. Fauci. I will.
    Senator Burr. Dr. Bell, in recent days there have been 
reports of modeling that suggest we could see 20,000 cases a 
month and that the outbreak may last 12 to 18 months, which 
would calculate to roughly 360,000 cases. Again, I think we 
continue to be a step behind up until this point, this response 
point. On what projected number of cases and period of outbreak 
did the administration base its response strategy to date and 
the latest actions announced today?
    Dr. Bell. As you say, Senator, there have been a number of 
models out there and we ourselves have been working on a model, 
and I think it is certainly true that a number of these models 
predict without additional effective interventions that we 
could see hundreds of thousands of cases. So all of those 
modeling exercises I think have certainly been taken into 
account as we've been calling for additional interventions in 
these countries.
    I think the critical point here is that those models for 
the most part, as I say, are based on not scaling up and what 
we're doing right now is scaling up. In addition to all the 
things that the U.S. Government is doing to scale up, including 
the announcements from the Department of Defense, there are 
also many other international partners who are also scaling 
up--the World Health Organization, other countries, many 
nongovernmental organizations, some of our colleagues here that 
will be testifying in the next panel. There's also more 
financing that's become available, for example from the World 
Bank. The United Nations is becoming involved.
    I think that it's fair to say that there is a general 
mobilization of forces here and what we're looking for is, with 
that mobilization of forces, these models, what they're 
predicting is not in fact what we're going to see happen.
    Senator Burr. Dr. Bell, I appreciate that and follow it 
very closely, and I know the mobilization of most other 
countries and the United Nations is not near the timeframe that 
ours is, and that's why it scares me to death.
    Mr. Chairman, thank you for your generosity, but let me ask 
Dr. Robinson, does BARDA have the resources it needs?
    Mr. Robinson. To begin the medical countermeasure 
development or advanced development, yes, for this fall. We 
don't have going forward for Ebola next year to produce more 
vaccines and more therapeutics if we actually want to do more 
than just Zmapp for therapeutics. There are others that we have 
under consideration that Dr. Fauci has talked about. So we and 
others will need more funding, there's no doubt about that.
    Senator Burr. Thank you.
    Thank you, Mr. Chairman.
    The Chairman. Thank you.
    Senator Murray.

                      Statement of Senator Murray

    Senator Murray. Thank you very much to the panel and Mr. 
Chairman for having this hearing.
    I'm very proud to represent a State that is producing some 
truly incredible research in the biomedical field, including 
several ongoing studies and efforts that are aimed at curing 
Ebola. We've got World Vision, which is supporting the 
Ministries of Health, the Geneva Foundation, which is working 
on a treatment drug. Washington State University's Paul G. 
Allen School for Global Animal Health, they're looking at some 
culturally appropriate ways to prevent further transmissions; 
and of course the University of Washington Katz Lab which is 
looking at some vaccines and drug development. We're doing a 
lot out there.
    But the reality is that we all have to do more. I think 
it's important to mention that one of the reasons I fought so 
hard to roll back sequestration in the Bipartisan Budget Act 
was to provide certainty for organizations like NIH and CDC, 
which have had to deal with, as we all know, some very steep 
and harmful budget cuts. I believe it's going to be very 
critical that we continue to focus on rolling back this trend 
of disinvestment in research and development so we can ensure 
that our country continues to produce the kind of live-saving, 
world-changing research that we know we're capable of. But I am 
very concerned--I just need to say this--that fiscal austerity 
and the return of sequestration is going to continue to weaken 
our ability to respond to needs like this.
    Dr. Fauci, while you're here, I wanted to ask you, can you 
talk a little bit about how the lack of budget certainty and 
sequestration and the budget fights of the last 2 years have 
really impacted the U.S.'s ability to respond to the Ebola 
situation?
    Dr. Fauci. Thank you for the question, Senator Murray. I'd 
have to tell you, honestly, it's been a significant impact on 
us, as you well know, and I know you've been fighting for us 
for quite a long period of time. Our budget has been flat since 
the end of the doubling in 2003, with the 2-plus percent 
inflationary index, that over a 10-year period we've lost about 
22 percent in our purchasing power.
    That was the left hook. The right cross was the 
sequestration that came in and pulled out a significant amount 
of money, $1.5 billion, of which we got reconstituted not all 
of it. We try to preserve the fundamental basic research of the 
investigators, the bright ideas that people have. If you want 
to preserve that, the money that you have for initiatives such 
as the development of vaccines and the development of drugs 
suffers, because it's a balance. There's programmatic 
initiatives and there's investigator-initiated awards, and when 
you shrink the budget or don't give even an inflationary 
increase all of that starts to whittle away and you get even 
secondary effects, like disincentives of getting bright people 
involved from your State or any State, who feel that there's a 
disincentive to get involved.
    It has both in an acute and in a chronic insidious way 
eroded our ability to respond in the way that I and my 
colleagues would like to see us be able to respond to these 
emerging threats. In my Institute particularly, that's 
responsible for responding on the dime to an emerging 
infectious disease threat, this is particularly damaging.
    Senator Murray. I hope that all of us keep that in mind 
moving forward.
    Again, I'm proud of the folks in my State. The Bill and 
Melinda Gates Foundation gave $50 million to scale up emergency 
operations. Paul G. Allen Foundation has contributed $9 million 
to open emergency operations sites in three of the most 
affected countries.
    Dr. Robinson, Director Bell, knowing that the Gates and 
Allen Foundations have stepped up that way and the money that 
is going to be included in this CR--thank you to our 
Appropriations chair who's sitting next to me--is that enough 
money and global support to stop this outbreak?
    Dr. Bell. I'll answer, Senator, for the CDC. We do 
appreciate the $30 million that's in the CR. That amount of 
money is enough to keep us operating through the end of the 
continuing resolution on December 11th. It will allow us to 
keep our people in the field, to pay for our staff, and to 
begin to scale up in a way that we think is necessary.
    We will be kind of considering over the time period of the 
CR what additional resources we will need for the rest of the 
fiscal year in order to fulfil our responsibilities and 
response to the Ebola outbreak in the way that we need to.
    Senator Murray. Dr. Robinson.
    Mr. Robinson. The $50 million that we requested will get us 
through this fall. If we want more vaccines and more 
therapeutics, there will have to be more funding for us to go 
forward.
    Senator Murray. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murray.
    Senator Isakson.

                      Statement of Senator Isakson

    Senator Isakson. Thank you, Mr. Chairman.
    Dr. Bell, I want to echo what Senator Moran, Senator 
Harkin, Senator Alexander, and Senator Reed said about how 
proud we are of CDC. As one of Georgia's two Senators, however, 
I want to add how proud we are of Emory University and Dr. Jim 
Wagner and the staff there--I know Dr. Brantly would probably 
feel the same way--as well as Phoenix Air, which I believe was 
the contractor from Bartow County, Georgia, that brought the 
patients back from Liberia to the United States. That was a 
tremendous effort.
    For the committee's benefit, Saxby was gone when this 
happened, so I was the only Senator reachable by the press the 
day it was announced they were coming to Emory University. The 
press immediately looked for the wisdom in bringing an Ebola 
patient back to the United States, whether or not we had the 
capability of preventing the disease from spreading while we 
were treating Ebola patients. Emory University and the CDC did 
a marvelous job of making those transfers seamless and complete 
and proving to the media, that was trying their best to start a 
riot, I think, that the Ebola virus was going to be safely 
contained, that they were in the best place in the world. So 
you deserve a tremendous amount of credit. I just wanted to say 
that. I just wanted to say that publicly to you.
    Dr. Bell. Thank you, Senator.
    Senator Isakson. Tell me. You said this is by far the worst 
outbreak you've ever seen. What was the next worst before it in 
terms of numbers?
    Dr. Bell. Let's see.
    Dr. Fauci. Uganda in 2000.
    Dr. Bell. Yes. That was about 400 and some cases.
    Senator Isakson. Here's my question, what makes this one so 
different?
    Dr. Bell. There are a number of factors, Senator, that has 
made this one quite a bit different. No. 1, this is the first 
time we've seen Ebola in a large urban setting. Our previous 
experience with Ebola outbreaks has been primarily in rural 
areas, and there are many, many different factors that come 
into play when you have Ebola in a situation with people packed 
very closely together in a large city. That's one thing.
    Another issue that has been challenging is that the area, 
the sort of three-country area where the outbreak sort of began 
and has been propagating from, is an area with communities that 
are sometimes not very receptive to interventions by either 
government or by public health officials.
    A third point is that these are countries with very, very 
weak infrastructure to start with. They've just been emerging 
from decades of war. They have very weak health systems and 
very little capabilities, to Senator Harkin's point about 
public health capabilities, but even health care capabilities, 
so very little with which to battle this outbreak from the 
beginning.
    Senator Isakson. I've traveled extensively in West Africa 
and I've seen firsthand exactly--they're almost bereft of 
health care facilities, of anything close to what we would 
consider to be reasonable.
    Which brings me to this question. When you described 
containment, you described a very labor-intensive process. You 
talked about people taking temperatures for 21 days to see if 
somebody who's been exposed had been infected. You talked about 
monitoring. You talked about isolating. We're sending 3,000 
American troops to West Africa as I understand it. We've got 
100 CDC personnel. We have NGO's and other volunteers. But it 
seems like to me it's going to take a lot bigger labor force 
just to contain the disease at its current level; am I correct?
    Dr. Bell. Yes, sir. There's lots of different settings that 
we can talk about, but for example in the Ebola treatment units 
90 percent of the staff are local. I think it is important to 
remember that the governments, the people in the countries and 
the governments themselves, are stepping up and, with 
assistance from those of us that have the technical 
capabilities, are really able to fill many of these roles and 
responsibilities. As I say, some of the work in the treatment 
units, much of this going out into communities every day and 
checking in with contacts to see how they're doing, these are 
roles that the people themselves, the local people themselves 
in these countries, can undertake, as I say, with some 
technical guidance from some of us that have this experience.
    This is not to minimize the scale of the human resources 
that will be needed to contain this. But as I say, I think that 
there are many of these sorts of functions that we're already 
seeing the local people help with. There's also other groups 
around Africa, the African Union, many of our field training 
programs from around Africa, that are also stepping up.
    It is an enormous job, but it's a job where I think there 
are lots of different sectors and parts of the local community 
in addition to the international community that can work 
together to address this.
    Senator Isakson. I know my time's up, but I wanted to make 
a comment. At the Africa Summit, which was here just about a 
month ago, I had the privilege of participating in a lot of 
that with some of the West Africa leaders. I noted how they 
were begging--not begging, but they were wanting so much 
American knowledge, CDC, NIH, all the technology, but they 
seemed very--even the bordering countries seemed like they were 
very willing to provide manpower, but they badly needed 
leadership in terms of health care. Is that correct?
    Dr. Bell. Yes, sir. We've actually made quite a bit of 
progress in that regard over the last month or so and are 
working very closely with the African Union to have them deploy 
staff to the area.
    Senator Isakson. Thank you very much.
    Thank you, Mr. Chairman.
    The Chairman. Thank you.
    Before I recognize Senator Casey, you mentioned all these 
different entities. Addressing this we have CDC, USAID, State 
Department, World Health Organization, and Doctors Without 
Borders. Can you tell us who's in charge of coordinating our 
government's response effort in Africa?
    Dr. Bell. Yes, sir. In terms of the U.S. Government, in 
each of the countries there is the Disaster Assistance Response 
Teams, the DART. This is a USAID umbrella under which all of 
the U.S. Government efforts are coordinated. We are quite well 
coordinated with the USG organizations.
    In the larger sort of undertaking, in each of these 
countries people are getting organized, generally speaking with 
the government.
    The Chairman. The USAID is in charge intra-country, in a 
country. But overall who is in charge of coordinating?
    Dr. Bell. The three countries together are all under the 
umbrella of the USAID DART.
    Senator Mikulski. Of USAID?
    Dr. Bell. Yes.
    The Chairman. I'm startled to find that out, that USAID 
would be in charge of coordinating.
    Dr. Bell. Well, it's a disaster. When a disaster is 
declared--I don't know; as we scale up, I'm sure that there'll 
be other mechanisms for the various parts of the government to 
collaborate and coordinate with each other. But there is this 
kind of structure on the ground which is meant to----
    The Chairman. I think this requires further looking into by 
this committee, by both these committees.
    Senator Casey.
    Senator Mikulski. I would concur, Mr. Chairman.
    The Chairman. Thank you.

                       Statement of Senator Casey

    Senator Casey. Mr. Chairman, thank you very much.
    I want to thank the members of the panel, Dr. Bell, Dr. 
Fauci, and Dr. Robinson, for being here. I also want to note 
the good work that's been done by this committee and members of 
this committee for a lot of years, the chairman, Chairman 
Harkin, Senator Mikulski as well with her experience; grateful 
to work with them; Senator Burr, who has spent a lot of time on 
this and a lot of time on these issues and has become such a 
leading voice on this.
    I don't want to plow ground that's already been plowed 
through. I apologize for having to juggle two hearings. But I 
wanted to ask Dr. Bell. I know that one of the fundamental 
questions you're asked is what's the threat to the United 
States, if any, and how you articulate that. Let's just say--
for purposes of process and the mechanics of confronting this 
kind of a threat were it to arise here--pick a town in 
Pennsylvania. I won't pinpoint one, but if there was a patient 
at a hospital in that town and they tested positive for Ebola, 
what would be the steps that would be undertaken at that point?
    Dr. Bell. Yes, thank you, Senator. We have been working 
quite closely here in the United States to prepare for this 
sort of eventuality that you describe. As we've mentioned, 
Ebola really is not easily transmitted.
    I think in terms of helping to understand the context to 
answering this question, I just want to say a word or two about 
what a hospital in these countries in Africa looks like, as a 
way of contrasting. When we think of a hospital, we think of a 
shiny, clean building with lots of equipment. Most of the 
hospitals in this region, as many of you that have traveled to 
this area are aware, oftentimes there's no running water, there 
is no soap, there may not even be beds. There may be mattresses 
on the floor. Every health care worker is caring for a large 
number of patients. There'll be beds around them. They may not 
have the appropriate personal protective equipment, like gloves 
and gowns and masks.
    That's the environment in Africa where Ebola is currently 
raging. In the United States, by contrast, we have many, many 
protocols in place, and with these protocols most hospitals 
that can isolate a patient in a private room with their own 
bathroom and can follow very strict and meticulous infection 
control practices which have been well outlined and which 
health care workers are quite aware of, can safely take care of 
Ebola patients.
    I'll mention that, while we haven't taken care of any Ebola 
patients prior to this outbreak here in the United States, we 
have safely cared for at least five patients in recent years 
who have had other viral hemorrhagic fever, what we call 
Marburg virus and Lassa fever. In each of these circumstances, 
these patients were cared for quite safely in our hospitals 
around the country and we didn't see any ongoing transmission.
    While this is certainly something to be taken quite 
seriously and we're doing a lot to educate health care workers, 
to educate laboratory workers, and to answer people's 
questions, to sensitize them to these issues, really most 
hospitals in the United States with these sort of basic 
capabilities should be able to safely care for Ebola patients.
    Senator Casey. Thank you, doctor.
    I have limited time, but I wanted to ask Dr. Fauci one 
question. You noted in your testimony there are a number of 
Ebola therapeutics and vaccines in development. Recognizing 
that all these products are still rather early in their 
development, do any of them have clear advantages or 
disadvantages over the others? Can you make that assessment 
yet?
    Dr. Fauci. No, I don't think, honestly, Senator Casey, we 
can say that, because apart from ZMapp and one other perhaps, 
they have not really been in humans. We have in the past had 
experience where things look really good in an animal and then 
when they get into the human for one reason or other it doesn't 
work or it's too toxic.
    It would be premature--I can say that there are a number of 
candidates that look favorable enough in an animal model that 
we're enthusiastic about moving them into a phase I and then 
beyond that. So there are a number of candidates that have a 
favorable profile in an animal model. But I think it would be 
unwise to say this one looks a little better than this one, 
because it just is too premature to do that.
    Senator Casey. I know I'm out of time, but I hope there's 
nothing that the Congress has not done, not been able to 
achieve, that would be an impediment for you to be able to 
answer that question down the road and to be able to make the 
progress you want to make on these developments, because we 
have an obligation, I believe, to fund NIH and to fund this 
research in a manner that leads to the result that we hope. I 
think that's a bipartisan obligation and I say it for the 
record.
    Thanks, doctor.
    Dr. Fauci. Thank you. We appreciate it very much, sir.
    Senator Casey. Thank you.
    The Chairman. Thank you, Senator.
    Senator Boozman.

                      Statement of Senator Boozman

    Senator Boozman. Thank you, Mr. Chairman, and thank you 
very much for having this hearing, you and the rest of the 
leadership on both sides. This is so important.
    To you all, we appreciate you being here. All of you have 
just sterling, excellent reputations and we appreciate the fact 
that you're working very, very hard to keep us safe.
    From what I've read and from the testimony, it seems like 
speed is important, education is important, coordination is 
important. We have the CDC involved. We have the NIH. We have 
the DoD. We have the Department of State. Samantha Power is 
calling the Security Council for the first time ever in an 
event like this.
    I would like to get into this a little deeper--we heard 
that USAID was distributing stuff over there. Who's in charge 
of all of that at the Washington level? Who's taking this on so 
that we can get coordination, so we can get speed and get the 
education component done? Is that CDC? Are you doing that, Ms. 
Bell? Dr. Bell, I'm sorry.
    Dr. Bell. That's OK. We at CDC have the lead on the public 
health aspects of the response. The DoD and USAID have the lead 
on logistics and material. The National Security Council is 
coordinating, certainly from Washington, and it's really 
important that we draw on all of our assets from all of the 
different agencies working in our particular lanes and 
coordinating all together.
    There is very strong inter-agency coordination. The NSC is 
deeply involved in bringing all the agencies together, and we 
at CDC take the lead in the public health aspect.
    Senator Boozman. Good. I hope we get this worked out where 
we actually have somebody that we can point to, an individual 
that's kind of in charge of coordinating, because the same 
thing that's going on on the ground, that needs to be going on 
over there, is simply not going to happen without that 
happening here.
    One thing that's happened, Dr. Bell, Dr. Fauci, there's an 
Ebola outbreak going on in the Democratic Republic of the 
Congo. Is that related to this or is this a whole separate 
thing that we've seen in the past?
    Dr. Bell. I'll say something. I'm sure Dr. Fauci can add. 
This outbreak is not related to what we're seeing in West 
Africa. As you say, Senator, this area of DRC is an area in 
which we've seen many Ebola outbreaks in the past, and this 
outbreak is of a strain that's quite similar to those 
outbreaks. So while we are taking it very seriously, and 
actually CDC have sent a team into that area, we don't think 
that that outbreak is at all connected. We're actually aware of 
the individual case that began that outbreak and it had no 
relationship to what's been going on in West Africa.
    Dr. Fauci. I agree with Dr. Bell that that will be 
determined. It does not look like it's the same. The 
extraordinary ability to do rapid deep sequencing of the genome 
of these viruses can actually pinpoint whether or not they're 
related. It's very interesting that the study that was done and 
published very recently showed the exact point introduction of 
what we're seeing in West Africa and how it went from Guinea to 
Sierra Leone to Liberia, and it doesn't look like the strain 
that is in the Democratic Republic of the Congo is in that 
lineage, even though it's the same general strain.
    Senator Boozman. Dr. Bell, can you reassure the--I know the 
public is concerned about bringing it into the country. Can you 
talk to us a little bit about the steps with helping those that 
are at the airports and identifying people that possibly have 
the virus?
    Dr. Bell. Yes, Senator. It's certainly quite understandable 
why people would be concerned. The images that we're seeing are 
quite alarming. As you know, we have been working in the 
countries to improve their abilities to do exit screening. We 
have teams in each of the countries and we've really been able 
to help them improve their capability to do exit screening 
considerably over the last month or so and are quite pleased 
with the progress in these countries.
    They have equipment. They understand what they're supposed 
to do. They have the protocols in place and they are really 
moving forward.
    In addition, I'll mention that we also have been doing a 
lot of work with our own border agencies, so with the TSA and 
with the CBP, to train them so that they understand what to 
look for and they understand when they need to call on us--as 
you know, CDC has quarantine stations in the major airports 
around the country--so that they also are sensitized to what 
needs to be done.
    Then the final point I guess I would make on this topic to 
Senator Casey's point is that we've done a lot of work here in 
the United States with health care providers, even with just 
citizens, so that they know what to look for, to remember to 
ask for a travel history. There are a number of our Laboratory 
Response Network laboratories around the country who now have 
the capacity to test for Ebola, and then the health care 
facilities themselves are very tuned into the appropriate 
isolation methods that would be needed should they have a 
suspected Ebola patient.
    Senator Boozman. Thank you, Mr. Chairman.
    Thank you.
    The Chairman. Thank you, Senator Boozman.
    Senator Bennet.

                      Statement of Senator Bennet

    Senator Bennet. Thank you, Mr. Chairman. Thank you very 
much for holding this hearing.
    Dr. Bell, you mentioned in your opening comments a 
particular problem in Liberia of there being a lack of 
isolation capacity. I wonder if you could describe for us--if 
everything actually worked the way it's supposed to work to 
make the decision, to make these fundings, first of all, what 
the experience of somebody today who's infected with Ebola is 
in Liberia if they don't have access to an isolation chamber; 
and then second, what you would expect to be the progress 
points we need to see in order to know that we're actually 
creating an infrastructure that really can change the outcomes, 
the course of the disease?
    Dr. Bell. Yes, thank you, Senator. As you mentioned, there 
are not enough treatment facilities, isolation facilities, in 
Liberia right now to take care of all of the cases. Because of 
that, there is ongoing transmission that's occurring because we 
can't isolate them. So we're working on this in a number of 
fronts.
    First, as many of the Senators have mentioned, we will be 
building more Ebola treatment units, and in addition a number 
of other entities, including the government of Liberia, are 
also building Ebola treatment units. So there will be a scale-
up of Ebola treatment units. Medecins Sans Frontieres is 
building another. There's a number of groups that are actually 
working to scale it up.
    In the mean time, there are a number of interim measures 
that we're also going to be taking so that people can be 
isolated safely not in a treatment unit. So there's a number of 
ways to approach that. There are community sort of holding 
centers, for lack of a better term, where people can be 
isolated safely with one caregiver and that caregiver can be 
provided with the appropriate personal protective equipment 
that they need to prevent transmission to themselves.
    There are also some efforts afoot to do that in households, 
where a caregiver in a household would be given a kit which 
provided all the equipment that the person would need to 
protect themselves and also some of the medications, such as 
oral rehydration for example, Tylenol to help with fever, that 
the patient themselves could use during their illness.
    There's a number of different kinds of interim measures 
that we're working to scale up now at the same time as we're 
working on building additional isolation facilities in Liberia.
    Senator Bennet. How are you or with whom are you working to 
make sure that that work is actually happening, rather than 
just being thought about?
    Dr. Bell. There is actually quite a bit going on right now. 
Actually, USAID has been working with a number of 
nongovernmental organizations, including MSF. They've actually 
produced tens of thousands of these kits and have a plan in 
place to scale them up to hundreds of thousands in the near 
future.
    Senator Bennet. Thank you. In his first question or one of 
his first questions the chairman talked about the need to have 
a CDC or something like it in every country, and that is 
something I think we ought to aspire to. We have a long way to 
go to get there. I just wondered if you could talk a little bit 
about the efforts that you're making to create a more global, 
interoperable network of real-time detection of diseases and 
collaboration among these various countries in our response?
    Dr. Bell. Yes. Part of our response here is to buildup 
these basic capacities in these countries. In addition, right 
now as an urgent matter we're working to buildup these 
capacities in the bordering countries--laboratory capacity, 
emergency operations centers, rapid response teams, beginning 
planning on what they would need to do in terms of isolation 
should they need to do that, working on culturally appropriate 
burial practices.
    In those bordering countries that's an urgent priority for 
us. Then across the rest of Africa we're also working to harden 
the countries' ability to be able to recognize imported cases, 
to know who is the incident manager, how is their emergency 
operations center going to work, and what are the steps that 
they would take in order to respond to an additional case. Do 
they know how to do contact tracing? Who would be responsible 
for the contact tracing? Where would they isolate the patients? 
These are all things that we're working on now in the context 
of this outbreak.
    In the bigger picture, these are basic capabilities that 
the Global Health Security Agenda, for example, has been 
calling for. As you probably know, we at CDC have been working 
with a number of countries in a pilot kind of way over the last 
couple of fiscal years to show the proof of principle of what 
global health security can mean, to detect, to respond, and to 
prevent these outbreaks with basic capabilities around 
laboratory capacity, around communications strategies, around 
emergency operation centers, basic epidemiology.
    These are all fundamental capabilities that country by 
country we really need to build if we want to prevent this kind 
of thing from happening again in the future.
    Senator Bennet. Thank you. I appreciate that testimony. 
Thank you for your testimony.
    Thank you, Mr. Chairman.
    The Chairman. I would say to my colleague from Colorado 
that last year the Appropriations Committee put in $6 million 
to start this process of establishing CDC's in key countries 
designated by CDC. I understand that some time this fall, the 
CDC will announce those initial grants.
    We put $10 million in the appropriations bill this year to 
continue that effort. In light of the Ebola outbreak and 
others, I am hopeful that maybe we can take a second look at 
this if in fact we do have an omnibus appropriations bill that 
we can do, that we might want to put some more in there, 
understanding of course you can't do it all at once, but still 
so that the pipeline is there, that we can start bringing 
people to train them, train them in laboratory procedures, 
start buying the equipment they need, to kind of get a jump 
start on even more countries next year.
    Senator Bennet. I appreciate that. I think there are a 
number of us that would love to work with you and the chair of 
the Appropriations Committee on this.
    The Chairman. We need the money, that's right. Thank you 
very much.
    Senator Whitehouse.

                    Statement of Senator Whitehouse

    Senator Whitehouse. Two questions. I'm not expert in 
epidemics and I don't know if there are accepted stages in the 
acceleration of an epidemic, when it goes from just an outbreak 
to a full epidemic to a raging out of control forest fire. If 
there are, what are the red flags that we should be looking for 
that this epidemic has gone to the next stage in terms of the 
threat that it presents?
    Dr. Bell. There are some key indicators that we use. It 
sort of depends on the situation what the indicators are. In 
this situation, certainly there are some basic indicators, like 
the number of cases and the number of cases per week, as 
Senator Alexander has discussed. There are other indicators, 
for example the number of cases in health care workers. We 
should not be seeing cases in health care workers if our 
infection control interventions are working.
    After that, I think that we are working to track things 
like whether patients that need to be isolated have a way to be 
appropriately isolated, whether or not we stop seeing bodies 
that can't be picked up in a timely fashion, and a number of 
different sort of indicators like that that we use to help us 
understand if in fact we're bending the curve and whether it's 
going in the right direction.
    Senator Whitehouse. When you consider the existing effort, 
which has been heroic, but measured against the threat has 
obviously not kept it from accelerating, how many multiples of 
the existing level of effort do you think are required to be 
able to get ahead of this and bring it back under control? Ten 
times the effort, a hundred times the effort?
    Dr. Bell. I would say a very large increase in the effort, 
and also a very large increase in the effort with a sense of 
urgency, so that the increase happens very quickly. It's hard 
to say how many multiples, but there needs to be--and I think 
we can safely say that there is----
    Senator Whitehouse. We're not even close to meeting the 
threat right now?
    Dr. Bell. I would say that the sorts of interventions and 
scale-up that we've been hearing about in recent days is the 
sort of scale that we need in order to address this outbreak, 
this epidemic.
    Senator Whitehouse. Dr. Fauci I guess might be the best 
person to answer this question. Is this a virus that is capable 
of being manipulated by humans? Could one go into it if one had 
a sample of the Ebola virus and meddle with a portion of the 
DNA strain that relates to how it's transmitted? Could somebody 
up to mischief try to make something that was more 
transmittable out of this existing virus?
    Dr. Fauci. Theoretically, you can manipulate almost any 
virus to change it any way you want. That's a question that 
always raises red flags about it, but the fact is yes. The only 
trouble is it wouldn't be easy for somebody to do that in their 
laboratory backyard. They would probably kill themselves doing 
that.
    Senator Whitehouse. It would take a nation State to do 
that?
    Dr. Fauci. Yes, it would take a state-type thing. I don't 
know whether you were here when I made my opening presentation, 
Senator Whitehouse, but I mentioned that our getting involved 
in the hemorrhagic fever viruses was part of a biodefense 
agenda because way back during the cold war it was clear from 
intelligence and proven that the Soviets were stockpiling 
hemorrhagic fever viruses and things like that for just the 
purpose that you make.
    So it would have to be a State thing. I don't think you're 
going to get some rogue person being able to do that.
    Senator Whitehouse. Senator Burr and Senator Casey and 
others and I, would love to work with you on trying to explore 
that further. Thank you very much.
    The Chairman. Thank you, Senator.
    Senator Durbin.

                      Statement of Senator Durbin

    Senator Durbin. Dr. Bell, is CDC working with the World 
Health Organization?
    Dr. Bell. Yes, we are, Senator, very, very closely.
    Senator Durbin. It is my understanding that the President 
submitted the name of Dr. Frieden from the CDC to be our 
representative to the World Health Organization in July of this 
year and it is still lost somewhere in the U.S. Senate. I would 
hope before this week ends and we return home that we might 
consider bringing this to the floor on a bipartisan basis and 
expedite the appointment of Dr. Frieden, whom we know well and 
we have studied, we know his background, so that he can be with 
the WHO and not wait for 2 months or more for us to return and 
consider that nomination. I'd like to suggest that to the 
chairman and see if we can get that done.
    I'd like to ask a second question of Dr. Fauci, following 
up on what Senator Casey said, which was:

          ``I hope that there's nothing that's been done on a 
        budgetary basis that has slowed down the development of 
        an Ebola vaccine or a response that might be helpful.''

You've talked about a 22 percent decline in the funding in NIH 
research over the last 10 years and the impact of 
sequestration. Has there been to your knowledge any shortage of 
funds which has led to a delay in testing or development of an 
Ebola vaccine?
    Dr. Fauci. I think one could say honestly, Senator, that 
everything really over the last several years, with few 
exceptions, has been at a level less productive than we would 
been, purely on the basis of significant constraints. I don't 
think we can say that there's been a serious delay in this 
particular vaccine. I think that would be an overexaggeration. 
I would have to put it under the umbrella of the entire effort 
that we've been putting forth over the last several years have 
had to be muted somewhat by a budget that in real dollars is 
shrinking.
    Senator Durbin. It's my understanding, based on WHO 
statistics that I've read, about the physicians per capita that 
in my home town of Springfield, IL, with about a population of 
100,000, there would be expected to be 240 physicians, in 
Sierra Leone two physicians for 100,000 people, and in Liberia 
one physician for 100,000 people.
    That I think is an indication, at least a few years ago, a 
snapshot of the scarcity of medical professionals at the 
highest level, doctors and such. I have been working and we 
included in the immigration bill which passed the U.S. Senate a 
provision which provided in one respect if you are medically 
trained in Africa and have promised to serve in Africa for a 
certain period of time before going anywhere else that we would 
honor that, respect that, and not allow people to be recruited 
into the United States when they still had an obligation to 
their country; and second, that doctors in the United States 
would be able to serve in these crisis situations overseas 
without jeopardizing their immigration status. That passed the 
Senate. That was in the immigration bill. It was never called 
for consideration in the House of Representatives.
    Speak to, not just the terrible infrastructure when it 
comes to hospitals, but the medical professionals and the 
health workers available in these countries that are facing 
this.
    Dr. Bell. Yes, Senator, you're right that the number of 
doctors in Liberia and in Sierra Leone is extremely small. In 
Liberia I think the number of doctors before the outbreak 
numbered in the hundreds, as you say. Tragically, because of 
sort of the lack of infection control and the very, very poor 
conditions in the health care facilities and the inability of 
the health care workers to recognize Ebola patients when they 
came with a fever, and you think it's malaria, it turns out 
it's Ebola, and the fact that the health care workers were not 
able to protect themselves, tragically, a lot of these sort of 
scarce health care workers have died in the context of the 
Ebola outbreak.
    Many of these facilities now, that already were very 
rudimentary, are closed. This is one of the things that we need 
to do, is to train in infection control, provide appropriate 
personal protective equipment, and get the facilities back up 
and running safely, so that we don't continue this spiral of 
not only the Ebola outbreak, but also many other conditions 
that are actually not getting treated right now in these 
countries.
    Senator Durbin. We've learned the hard way that these 
countries with very few medical resources, when they face this 
kind of epidemic challenge, are only a 10-hour plane ride away 
from the United States.
    Thank you.
    The Chairman. Senator Durbin, I must say that when you 
talked about Dr. Frieden's nomination I thought that we'd 
dropped the ball on this. How could we have dropped the ball on 
something like this? I just found out that it does not come to 
this committee, but to the Foreign Relations Committee. So 
hopefully, hopefully----
    Senator Alexander. Mr. Chairman, the information we have is 
the President didn't nominate him until the end of July. We 
were gone in August. The Foreign Relations Committee staff is 
meeting with him tomorrow. They're doing that in a bipartisan 
way. They could move him. I heard Senator McConnell say on the 
floor this morning that he supported President Obama's 
proposals to deal with Ebola. I know of no reason why the 
Majority Leader and the Whip couldn't work with Senator 
McConnell and bring it up before we leave.
    I would hope so, and I would be glad to support that, as I 
imagine the chairman would.
    The Chairman. I would support him. I'm not on the 
committee, but you know, one of those little meetings in back 
of the Senate floor, like we do all the time; get that job done 
in a hurry.
    Our wonderful chairman of the full Appropriations 
Committee, Senator Mikulski.

                 Opening Statement of Senator Mikulski

    Senator Mikulski. Thank you very much, Mr. Chairman. First 
of all, thank you for organizing this hearing of both the 
authorizing and the appropriations committee, and to my 
colleagues for such strong bipartisan participation in this.
    I want to thank the people at the head table and all who 
work behind them for the outstanding job they're doing to 
organize the American government's response to this, and also 
to Dr. Brantly and Mr. Charles, representatives of the people 
who are really in Africa trying to help people in this most 
horrific of challenges facing not only the countries, but the 
people, and particularly the workers who are there that must be 
facing just incredible stress.
    This is such a grim, horrific proportion, and they're 
working 36-hour days, just as you are. We want to acknowledge 
that and thank them.
    Mr. Charles, it's wonderful to have you here. Dr. Brantly 
and Mrs. Brantly, good to see you. What's so great about seeing 
you, Dr. Brantly, is, one, that you're well enough to be here, 
you were well enough to travel here, and you're well enough 
that we're not afraid to have you here. We can smile, but this 
is a stunning, stunning, stunning accomplishment. But again, 
we're glad to see you.
    Mrs. Brantly, you look so much like Samantha Power, I said, 
what is Samantha Power doing sitting next to Dr. Brantly? We 
could send you to the U.N. and I bet you'd have a lot to say 
that would shake them up in helping them respond. We're glad 
that you're here.
    I want to make a couple of comments and then a few 
questions if I could. First of all on this issue of who's in 
charge that was raised by both Senator Harkin and Senator 
Boozman, I think USAID is in charge of responding in a 
disaster--an earthquake, in Haiti, the many disasters--and 
they're to be acknowledged for their ability to do that. But 
the size and scope and multiple government agencies involved in 
this I think needs a higher authority that actually can command 
personnel and organize, working with us on, again, a bipartisan 
basis, for the kind of resources to do this, because just 
listening to what we're doing today, we need the HELP 
Committee, we need Labor. Now go to the Appropriations 
Committee. We're going to need Foreign Ops and we're going to 
need DoD. Within the Labor-HHS subcommittee, it's CDC, it's 
NIH, it's FDA.
    Mr. Chairman, working across the aisle, we should ask the 
President, through whatever mechanism they're going to say, we 
need a point person in addition to OMB, which will be here, to 
do this.
    Dr. Bell, do you want to comment?
    Dr. Bell. I thank you, Senator. I just wanted to make sure 
that I didn't create a misconception in what I said about the 
DART. What I meant was on-the-ground coordination in the middle 
of that area USAID is coordinating. But I take your point and I 
think----
    Senator Mikulski. Well, here is my point.
    Dr. Bell. Yes, ma'am.
    Senator Mikulski. That presuming that there is a bipartisan 
group and there is the will here--we have one of the leading 
Senators within the Republican Party. Senator Burr has been one 
of the leading experts on biohazards. We worked together to 
create BARDA. If we wanted to meet with the person in charge, 
who would be the person in charge? AID? Frieden? Dempsey? 
Kerry?
    Dr. Bell. I take your point, Senator.
    Senator Mikulski. Dr. Rice? We want to maximize and 
leverage everything we have and also create that sense of 
urgency.
    Let's talk about resources. I'll be leaving shortly, so, 
Dr. Brantly, if you see me go before you give your testimony 
it's because I'm going to work on the continuing resolution so 
we can, on a bipartisan basis, bicameral basis, pass that.
    But I'm looking ahead to December 11th and also the 2016 
fiscal year. So the CR is really a down payment to keep your 
current response functioning, but it is not of the size and 
scope that you need to respond in Africa and prevent it from 
spreading globally. Am I correct in that?
    Dr. Bell. From the CDC perspective, yes. The CR will allow 
us to continue our field operations through the end of the CR, 
but the situation is very fluid and we're assessing what we 
would need for the rest of the year.
    Senator Mikulski. Dr. Bell, when did you have to submit to 
OMB your fiscal 2016 request?
    Dr. Bell. I'm sorry, Senator. I don't know the answer to 
that question.
    Senator Mikulski. Well, let me tell you.
    Dr. Bell. I thought you might be able to.
    [Laughter.]
    Senator Mikulski. It was a few months ago. So whatever Dr. 
Frieden told OMB and the White House that he needed for CDC, it 
is really 3 to 5 months behind. As we get ready to work, we're 
encouraging OMB--this is our administration here--to go back 
and say, what is it that you need for the CR and omnibus, which 
I hope we can achieve, but also a look ahead at fiscal 2016, 
presuming we can find a way to cancel sequester.
    I would say to all of the agencies involved, look at that 
and revisit that. And it's our job to get OMB to give you the 
latitude to come back because of this new need.
    Dr. Fauci, wherever there's been an infectious disease 
crisis you've been in the forefront of trying to find solutions 
for 30 years, since AID to now. We're so lucky to have you in 
all of these. But you spoke to us eloquently a few years ago 
about a pandemic, that when you have a global infectious 
disease crisis you need to have an infrastructure to be able to 
respond. Am I correct?
    Dr. Fauci. Correct.
    Senator Mikulski. This is contained to one continent and 
one part of a continent. Do you think we're heading to a 
pandemic with this?
    Dr. Fauci. No, I don't, Senator Mikulski, because, as we 
have mentioned, the spread of this in the West African 
countries is really a reflection of the extraordinary disparity 
of lack of health care infrastructure--to be able to handle an 
outbreak, to get the people isolated, taken care of, contact 
traced, so that you don't have essentially unfettered spread.
    In a country like the United States and other developed 
countries, we may, and it's entirely conceivable, have someone 
get on a plane infected in a West African country, be 
asymptomatic and land in Washington or New York or Paris or 
London, get out of the plane, get sick, and perhaps go to an 
emergency room, and even infect a person or two because someone 
didn't take a travel history. But at that point, once it's 
recognized, the kinds of capabilities we have would make it 
almost impossible to have the kind of outbreak that you're 
seeing in a country in which the outbreak is driven by a lack 
of ability to handle infection control, and we have that.
    Senator Mikulski. Well then, let's go to the disease. If 
this disease mutates, would mutation be of concern to you? And 
if it would mutate, do the current suggested treatments, 
possible treatments, become ineffective because it's a new 
disease, and then could it even become airborne?
    Dr. Fauci. Any hypothetical you say, we'd have to say it's 
not impossible, though I think as a person who's been dealing 
with viruses for so long, do I think that this is likely that 
this is going to happen? No. You never rule anything out, 
Senator. You always keep an eye out on it, and we are following 
the genetic moveability or mutation of this very, very 
carefully.
    When people ask me this question, I say what I know will 
happen, not hypothetical, is that unless we get control of this 
it will continue to not only devastate, but it will be much 
more difficult to ultimately get in control. So although we 
always in the back of our mind are concerned about mutations, 
right now today, in September 2014, mutation is not the 
problem. The problem is the full court press we need to put on 
getting this under control by standard classical infection 
control methods.
    Senator Mikulski. Which is a public health infrastructure--
--
    Dr. Fauci. Exactly.
    Senator Mikulski [continuing]. In this country and helping 
other countries?
    Dr. Fauci. Quite correct.
    Senator Mikulski. Thank you very much, Mr. Chairman.
    The Chairman. Thank you very much, Senator Mikulski.
    I want to thank this panel. We're running very late, but 
it's been very informative. We thank you all very, very much 
for your great leadership, and the record will remain open, as 
I said, for 10 days, and I hope that we can continue to call 
upon you for advice and consultation as we move ahead on this.
    Dr. Fauci. Thank you.
    The Chairman. Thank you, Dr. Fauci.
    Dr. Bell. Thank you very much.
    The Chairman. Thank you, Dr. Bell.
    Mr. Robinson. Thank you, chairman.
    The Chairman. Now we'll call our second panel, Dr. Kent 
Brantly and Ishmael Charles. Dr. Brantly served as the Medical 
Director for the Samaritan's Purse Ebola Care Center in the 
Liberian capital of Monrovia. In July, Dr. Brantly's life 
changed abruptly when he contracted the Ebola virus while 
treating patients in Liberia. We're thankful that he's 
recovered and is feeling well enough to offer his unique 
insight as both a provider and a patient. Dr. Brantly, as 
Senator Mikulski pointed out, is joined today by his wife Amber 
and we welcome you here also. Dr. Brantly, thank you for being 
here.
    Ishmael Charles is a survivor of Sierra Leone's 11-year 
brutal civil war. He is a Program Manager for Healey 
International Relief Foundation in Sierra Leone. In that 
capacity he manages and monitors all Healey International 
Relief Foundation projects in Sierra Leone, including an Ebola 
awareness and prevention project in 11 communities in the rural 
western district of Sierra Leone. Thank you, Mr. Charles, also 
for being here today.
    We'll start again with Dr. Brantly. Dr. Brantly, your 
statement will be made a part of the record in its entirety, as 
will yours, Mr. Charles. Again, I apologize for the long 
period, but, as you can tell, people here are very interested 
in what's happening with Ebola, and you do bring a very unique 
perspective. You had, you've contracted Ebola. You're alive and 
well today. You are a provider. Dr. Brantly, welcome. Please 
proceed as you so desire.

   STATEMENT OF KENT BRANTLY, M.D., FORMER MEDICAL DIRECTOR, 
 SAMARITAN'S PURSE EBOLA CARE CENTER IN MONROVIA, LIBERIA, AND 
                         EBOLA SURVIVOR

    Dr. Brantly. Chairman Harkin, esteemed Senators, guests of 
this committee, I'm grateful for the opportunity to testify 
before you today about the unprecedented Ebola virus outbreak 
that's occurring in West Africa, that has already claimed 
thousands of lives and threatens to kill tens of thousands 
more.
    Let me also take this opportunity to thank each and every 
one of you. I know there were many people, maybe some of you on 
this committee, who helped play a role in bringing me home when 
I was so sick, and I just want to say thank you.
    On October 16, 2013, I moved to Liberia with my family to 
serve as a medical missionary at ELWA Hospital in the capital 
city of Monrovia. I worked as a physician to support the 
woefully inadequate health care system in a country that is 
still struggling to recover from a brutal civil war. In late 
March of this year, we learned that there were cases of Ebola 
in our region and we began preparing our staff as well as our 
facility to be ready to care for patients in the safest way 
possible should that need arise.
    Three months later in June, our hospital had the only 
available Ebola treatment unit in southern Liberia and I was 
one of only two physicians to treat the first infected 
individuals in that area. From June 11th when we received our 
first patient until July 20th, the number of cases continued to 
grow at an incredible rate. The disease was spiraling out of 
control and it was clear that we were not equipped to fight it 
effectively on our own. We began to call for more international 
assistance, but our pleas appeared to fall on deaf ears.
    As the Ebola virus continued to consume my patients, I 
witnessed the horror that this disease visits upon its victims, 
the intense pain and humiliation of those who suffer with it, 
the irrational fear and superstition that pervades communities, 
and the violence and unrest that now threatens entire nations.
    Then, on July 23d I fell ill. Three days later, I learned 
that I had tested positive for Ebola virus disease and I came 
to understand firsthand what my patients had suffered. I was 
isolated and unsure if I would ever see my family again. Even 
though I knew most of my caregivers, I could see nothing but 
their eyes through their protective goggles when they came to 
treat me. I experienced the humiliation of losing control of my 
bodily functions and I faced the horror of vomiting blood, a 
sign of the internal bleeding that could have led to my death.
    I'm grateful to the team that worked tirelessly to keep me 
alive in Liberia, despite a severe lack of medical resources. 
They were courageous.
    I was then evacuated to Emory University Hospital, where I 
eventually became one of the few to recover from Ebola. As a 
survivor, it is not only my privilege, but it is my duty, to 
speak out on behalf of the people of West Africa who continue 
to face unspeakable devastation because of this horrific 
disease.
    This unprecedented outbreak received very little notice 
from the international community until those events of mid-July 
when Nancy Writebol and I became infected. Since that time, 
there has been intense media attention and increased awareness 
of the situation on the ground in West Africa. The response to 
date, however, has remained sluggish and unacceptably out of 
step with the scope and the size of the problem that is now 
before us. The U.S. Government has been closely following these 
events in West Africa since that time, if not before, and only 
now are we seeing a significant commitment to a solution.
    I had the privilege and honor of meeting with President 
Obama this morning and we discussed his commitment of more 
military and medical resources to fight this epidemic. He has 
also requested increased funding for the CDC. I thanked him for 
entering into this battle with us in a larger way. Now it is 
imperative that these words are backed up by immediate action.
    To control this outbreak and save the lives of thousands of 
West Africans and possibly many Americans, we need the promised 
Ebola treatment units, the surge in health care workers, the 
U.S. military regional command and control center, and we need 
it immediately. We also need the 400,000 home treatment kits 
that have been committed to be sent without delay.
    There is no time to waste if we are to contain Ebola and 
adequately care for the thousands of people that 
epidemiologists are now predicting will fall victim in just the 
next few weeks. The U.S. military must establish and maintain 
an air bridge to deliver critically needed personnel and 
medical supplies and to continue bringing in more resources in 
the future. We cannot turn the tide of this disease without 
regular flights of personnel and large cargo loads of equipment 
and supplies.
    I am grateful to the President for his decision to send 
tens of thousands of Ebola test kits to the region, but these 
will only be helpful if we also deploy all available mobile 
laboratories and increase funding for more to be built as 
quickly as possible. During my time in Liberia, the laboratory 
we used to confirm Ebola virus infection in patients was 45 
minutes away from our hospital and it was inadequately staffed. 
The turnaround time to positively identify an Ebola case was 
anywhere from 12 to 36 hours after the blood was drawn. If a 
patient is not infected with the virus, that can be a life-
threatening delay. More kits are not effective unless we have 
the facilities and the staffing to use them.
    As the first human being to ever receive the experimental 
drug ZMapp, I am a strong advocate for the CDC and the NIH as 
they research vaccines and drugs, as we've just heard about, 
and these drugs can give patients hope for recovery. I'm deeply 
grateful to the personnel at Mapp Biopharmaceuticals who, even 
before this outbreak, dedicated their lives to combating Ebola.
    We cannot wait, however, for a magic bullet to halt the 
spread of this virus in West Africa. The current epidemic is 
beyond anything we have seen before and it's time to think 
outside the box. I realize that home health care interventions 
can be controversial. However, we know that many Ebola-positive 
people are staying at home and even hiding after they become 
infected. Because of fear and superstition, their families 
either abandon them or they lovingly care for them in ways that 
almost always result in infection of the caregivers. This is a 
major contributor to the spread of Ebola and we cannot contain 
the disease without addressing this problem head on.
    Caregivers must be trained in safety measures and supplied 
with basic protective equipment so they can care for their 
loved ones while protecting themselves. As the number of 
survivors increases, these individuals should be mobilized to 
help educate and support their own communities. They would be a 
powerful witness that the disease is not 100 percent fatal and 
they could provide much-needed support to those who are trying 
to do what is best for their family members.
    Admittedly, home care is less ideal than treatment in an 
isolation unit. In the home it's impossible to administer IV 
fluids and other supportive medical interventions. However, 
there are not enough beds in the Ebola treatment units right 
now and many infected people are choosing to suffer and die at 
home. The least we can do is try to give their caregivers the 
information and resources they need to protect themselves from 
this deadly virus.
    All of these interventions that are needed to stop this 
horrendous transnational outbreak require significant funding 
and budgets must be adjusted appropriately. This is not simply 
a matter of providing humanitarian aid. It is very much a 
national security concern.
    One of my patients in Liberia was a man named Francis. Like 
most patients, at first he was fearful. But eventually he 
shared the story of how he contracted the disease. He said to 
me:

          ``Doc, I remember who the man was that I got this 
        infection from. He was sick at home and his condition 
        worsened, and when he began vomiting blood everyone 
        around him fled.''

But his wife was determined to get him to the hospital. Since 
no one else was around to help, Francis went to this man's 
house and helped carry him out of the house and put him in a 
taxi. On the way to the hospital, that man died.

    If someone had come alongside Francis and given him a 
little bit of education and provided him with the personal 
protective equipment he needed, his family would still have 
their father and their son and their brother, and the world 
might still have this good samaritan. But unfortunately, 
Francis fell victim to Ebola and died.
    Many, including one of the Senators today, used the analogy 
of a fire burning out of control to describe this unprecedented 
Ebola outbreak. Indeed, it is a fire. It is a fire straight 
from the pit of hell. We cannot fool ourselves into thinking 
that the vast moat of the Atlantic Ocean will protect us from 
the flames of this fire. Instead, we must move quickly and 
immediately to deliver the promises that have been made and to 
be open to practical, innovative interventions. This is the 
only way to keep entire nations from being reduced to ashes.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Dr. Brantly follows:]

                Prepared Statement of Kent Brantly, M.D.

                                summary

Background

    In July of this year, my organization, Samaritan's Purse, took over 
responsibility for all direct clinical care of those infected with 
Ebola in the Nation of Liberia. I was appointed Medical Director of 
what would become the only isolation unit in the Monrovia area.
    On July 26, I learned that I had tested positive for Ebola Virus 
Disease. Eventually, I was evacuated to Emory University Hospital where 
I was given world-class medical treatment and beat the odds to become 
one of the few who recover from Ebola.
    As a survivor of this horrific disease, I feel it is my duty to 
speak out on behalf of the people of West Africa. The response of the 
international community is still unacceptably out-of-step with the size 
and scope of the problem now before us. The only way to combat this 
unprecedented outbreak is for the U.S. Government to take the lead.

Key Points

     The United States must begin providing large treatment 
facilities, skilled personnel, medical supplies, logistical support, 
mobile laboratories, and security. This will require the deployment of 
military personnel and other assets. Congress must also increase 
funding for the Centers for Disease Control and other agencies.
     We have to consider the role of home-based care and other
outside-of-the-box methods as critical community interventions. Those 
caring for family members at home must be trained and given basic 
equipment--gloves and masks at a minimum--to protect themselves. The 
United States should provide advisors and experts and support the 
delivery of supplies to affected areas.
     The U.S. military is the only global force with the 
capacity to immediately mobilize the kind of support needed to defeat 
the scourge of Ebola. If we do not deploy military assets now, the 
situation could quickly become a matter of U.S. national security--
whether that means a regional war in West Africa or the spread of Ebola 
into America.

Closing

    Many have used the analogy of a fire burning out of control to 
describe this unprecedented Ebola outbreak. Indeed it is a fire--a fire 
straight from the pit of hell. We cannot fool ourselves into thinking 
that the vast moat of the Atlantic Ocean will keep the flames away from 
our shores. Instead, we must take the lead and mobilize the resources 
needed to keep entire nations from being reduced to ashes.
                                 ______
                                 
    Chairman Harkin, esteemed Senators, and fellow guests of this 
committee, I am grateful for the opportunity to testify in front of you 
today about the unprecedented Ebola virus outbreak that has already 
claimed thousands of lives in West Africa and threatens to kill tens of 
thousands more.
    On October 16, 2013, I moved to Liberia with my family to serve as 
a medical missionary at ELWA Hospital in the capital city, Monrovia. I 
worked as a physician to support the woefully inadequate healthcare 
system of a country still struggling to recover from a brutal civil 
war. Resources were limited, and we often saw patients die of diseases 
that would be easily treatable in the United States. It was a 
challenging job to provide quality care even before the Ebola virus 
tore through the country.
    In late March, we learned that there were cases of Ebola in our 
region, and we began preparing our staff and the ELWA facility so that 
we would be ready to care for patients in the safest way possible 
should the need arise. Three months later, our hospital had the only 
available Ebola Treatment Unit, also known as an isolation center, and 
I was one of two physicians to treat the first Ebola-infected 
individuals in southern Liberia.
    From June 11 to July 20, the number of Ebola patients we saw 
increased exponentially. During that time, my organization, Samaritan's 
Purse, took over responsibility for all direct clinical care of those 
infected with the disease. I was appointed Medical Director of what 
would become the only isolation unit in the Monrovia area.
    We opened a new, larger Ebola Treatment Unit and brought in 
patients from the government hospital. During that time, the number of 
cases continued to grow at an incredible rate. Within days, our 20-bed 
facility was housing 30 patients, and there was no end in sight. The 
disease was spiraling out of control, and it was clear that we were not 
equipped to fight it effectively on our own. We began to call for more 
international assistance, but our pleas seemed to fall on deaf ears.
    As the Ebola virus continued to consume my patients, I witnessed 
the horror that this disease visits upon its victims--the intense pain 
and humiliation of those who suffer with it, the irrational fear and 
superstition that pervades communities, and the violence and unrest 
that now threatens entire nations.
    Then on July 23, I started to feel ill. Three days later, I learned 
that I had tested positive for Ebola Virus Disease. I became a patient, 
and I came to understand firsthand what my own patients had suffered. I 
was isolated from my family, and I was unsure if I would ever see them 
again. Even though I knew most of my caretakers, I could see nothing 
but their eyes through their protective goggles when they came to treat 
me. I experienced the humiliation of losing control of my bodily 
functions and faced the horror of vomiting blood--a sign of the 
internal bleeding that could have eventually led to my death.
    I received the best care possible in Liberia, and I am grateful for 
the team that worked tirelessly to keep me alive despite a severe lack 
of medical resources and other limitations. I was then evacuated to 
Emory University Hospital where I was given world-class medical 
treatment and eventually beat the odds to become one of the few who 
recover from Ebola. As a survivor, it is not only my privilege but also 
my duty to speak out on behalf of the people of West Africa who 
continue to face unspeakable devastation because of this horrific 
disease.
    This unprecedented outbreak began 9 months ago but received very 
little attention from the international community until the events of 
mid-July when my friend and colleague, Nancy Writebol, and I became 
infected. Since that time, there has been intense media attention and 
therefore increased awareness of the situation on the ground in 
Liberia, Guinea, Sierra Leone and neighboring countries. The response, 
however, is still unacceptably out-of-step with the size and scope of 
the problem now before us.
    On September 7, President Obama committed U.S. military support in 
the fight against Ebola in West Africa. He also is requesting an 
additional $88 million for the Centers for Disease Control to send in 
more personnel, equipment, and laboratory supplies. This is great news, 
and I applaud his willingness to enter into this battle with us. Now it 
is imperative that these words are backed up by immediate, decisive 
action. We need more than just a 25-bed Ebola Treatment Unit and 
training for local security forces. To control this outbreak and save 
the lives of thousands of West Africans--and possibly even more 
Americans--we need the United States to take the lead in providing 
large treatment facilities, skilled personnel, medical supplies, 
logistical support, mobile laboratories, and security. We also need to 
implement innovative community programs to stop the spread of the 
virus.
    In a recent Washington Post op-ed, the International President of 
Doctors Without Borders, Joanne Liu, called for a ``large-scale 
deployment of highly trained personnel who know the protocols for 
protecting themselves against highly contagious diseases and who have 
the necessary logistical support to be immediately operational.'' She 
went on to say, ``Private aid groups simply cannot confront this 
alone.'' I agree with her assessment of the desperate need for medical 
boots on the ground.
    Treating Ebola patients is not like caring for other patients. It 
is grueling work. The personal protective equipment (PPE) we wore in 
the Ebola Treatment Unit becomes excruciatingly hot, with temperatures 
inside the suit reaching up to 115 degrees. It cannot be worn for more 
than an hour and a half. Because of the elaborate safety protocols 
involved in treating an Ebola patient, each one takes an average of 30 
minutes of time from a team of three to five people. It is easy to see 
that a significant influx of medical personnel will be needed to 
adequately care for the thousands of people that epidemiologists now 
are predicting will fall victim to the disease in the coming weeks.
    The U.S. military also must establish an ``air bridge'' for the 
delivery of critically needed personnel and supplies. Right now, those 
who are fighting this disease are forced to rely on commercial airlines 
even as flights into and out of the affected countries are scarce and 
unreliable. Our military is the only global force with the capacity to 
immediately and effectively mobilize this kind of logistical support. 
We cannot turn the tide of this disease without regular flights of 
personnel and large cargo loads of equipment and supplies.
    The use of our military is a legitimate and defensible request 
because if we do not do something to stop this outbreak now, it quickly 
could become a matter of U.S. national security--whether that means a 
regional war that gives terrorist groups like Boko Haram a foothold in 
West Africa or the spread of the disease into America. Fighting those 
kinds of threats would require more from the Department of Defense than 
what I am asking for today.
    A surge in medical treatment capacity also must include the 
deployment of all available mobile laboratories and increased funding 
for more to be built as quickly as possible. During my time in Liberia, 
ELWA Hospital was the only Ebola Treatment Unit for all of Monrovia and 
the surrounding area--serving a population of more than 1 million. The 
laboratory we used to confirm Ebola Virus Disease in patients was 45 
minutes away and inadequately staffed. A patient would arrive at our 
center in the afternoon, and their blood specimen would not be 
collected until the following morning. We would receive results later 
that night at the earliest. This means that the turn-around time to 
positively identify Ebola cases was anywhere from 12 to 36 hours after 
the blood was drawn. If a patient is not infected with the virus, that 
can be a life-threatening delay.
    I remember one patient who presented with symptoms of Ebola--fever, 
diarrhea, and vomiting. She was in our unit 36 hours before we received 
confirmation that she was not infected with the virus. We were then 
able to determine that she was actually suffering from diabetic 
ketoacidosis. Her treatment had been delayed for a day and a half 
because of inadequate laboratory support. Amazingly, she survived, but 
she was in a coma for 3 weeks. That didn't have to happen.
    These laboratory delays can have an even greater--and deadlier 
consequence. The longer it takes to confirm a positive result, the 
longer an Ebola-infected patient is left in the ``suspected'' side of 
the isolation unit. Every precaution is taken to protect people in that 
part of the facility from cross-contamination, but there is always the 
potential that those without the disease can become infected if they 
are in close proximity to an Ebola-positive person.
    As you have heard today, I am a strong advocate for sending large 
numbers of medical personnel and supplies to increase capacity for 
Ebola treatment. I also believe we must do more to support the Centers 
for Disease Control and the National Institutes of Health as they 
research vaccines and drugs that can give patients hope for recovery. I 
am deeply grateful to the personnel at Mapp Biopharmaceuticals who even 
before this outbreak had devoted their lives to combating Ebola. I hope 
that the devastating impact of the current epidemic will result in new 
discoveries for treatments and vaccines in the future, but we cannot 
wait for a magic bullet to halt the spread of Ebola in West Africa. The 
current epidemic is beyond anything we have ever seen, and it is time 
to think outside of the box.
    Historically, Ebola outbreaks have been contained through the 
identification and isolation of suspected cases, and this has worked 
extremely well to stop the disease. Today, however, the number of cases 
and rate of transmission are surpassing the ability of these 
traditional interventions to bring the situation under control. 
Intensive medical care is important, but it is given only to patients 
in isolation units. We know that the virus is being spread primarily by 
those who are unwilling or unable to go to an Ebola Treatment Unit.
    Many Ebola-positive people are staying at home and even hiding when 
they become ill. Because of fear and superstition, their family members 
either abandon them or lovingly tend to them in ways that almost always 
result in the infection of the caregivers. We have to consider the role 
of home care as we seek to stop the transmission of Ebola.
    Caregivers must be trained in safety measures and supplied with 
basic protective equipment--gloves and masks at a minimum--so that they 
can care for their loved ones while protecting themselves. As the 
number of survivors increases, these individuals should be mobilized to 
help educate and support their own communities. They would be a 
powerful witness that this disease is not 100 percent fatal and provide 
much-needed support to those who are trying to do what is best for 
their loved ones.
    Survivors are sometimes unable to return home because of stigma in 
their communities, but the great majority of them are looking for ways 
to be useful to society again. They can be given important roles in 
educating home caregivers and disseminate the facts about Ebola with 
their communities.
    These are just normal people. Yes, sometimes they are doctors and 
nurses, but they are also uneducated day laborers and children. Mothers 
and other respected members of society can play an especially critical 
role. They have to be trained and given resources.
    To effectively execute this strategy, a technical and logistical 
infrastructure would have to be put in place. The United States should 
provide advisors and experts to train survivors and others and support 
the delivery of supplies to affected areas. We must also ensure the 
personal safety of these outreach workers so that they can do this 
potentially life-saving job confidently. That may require security 
forces to protect them. I am not suggesting that we have troops staring 
people down with guns. They have seen too much of that in their recent 
history. We just need to make sure that these community workers are 
safe.
    Admittedly, homecare is less ideal than the treatment provided in 
an isolation unit. It would be impossible to administer I.V. fluids and 
provide other supportive medical interventions. However, there are not 
enough beds in the Ebola Treatment Units, and many infected people are 
choosing to suffer and die at home anyway. The least we can do is to 
try to give their caregivers the information and resources to protect 
themselves from this deadly virus.
    The World Health Organization has laid out a roadmap similar to 
what I have just described, but they are so bound up by bureaucracy 
that they have been painfully slow and ineffective in this response. 
Their recommendations for home care were made August 28, and I am not 
aware of any significant progress in the implementation of their plan 
to date. It is imperative that the United States take the lead instead 
of relying on other agencies.
    The U.S. military is highly trained with a clear chain of command. 
They are experienced in responding to complex international crises such 
as what we are facing now. I believe they are the only force capable of 
mounting an immediate, large-scale offensive to defeat this virus 
before it lays waste to all of West Africa.
    All of the interventions needed to stop this horrendous 
transnational outbreak also require significant funding, and budgets 
must be adjusted appropriately. This is not simply a matter of 
providing humanitarian aid, it is very much a national security 
concern.
    One of my patients in Liberia was a man named Francis. Initially, 
the lab told us that he was positive for Ebola, but the written report 
we received said ``Negative.'' Everything about his clinical case said 
that he was infected, so we made plans to retest him. We then received 
word that there was a typo on the first report and that his test was 
indeed positive.
    Like most patients at first, he was fearful, but he eventually 
shared the story of how he contracted the disease. ``Doc, I remember 
who the man was,'' he said. ``His condition worsened in his home, and 
his wife made the decision to take him to the hospital. Everyone around 
them fled, so I helped his wife carry him to the taxi.'' On his way to 
the hospital that man died. Had someone come alongside Francis with 
training and some basic personal protective equipment, his family might 
still have their husband, father, and son, and the world might still 
have this Good Samaritan.
    Many have used the analogy of a fire burning out of control to 
describe this unprecedented Ebola outbreak. Indeed it is a fire--a fire 
straight from the pit of hell. We cannot fool ourselves into thinking 
that the vast moat of the Atlantic Ocean will keep the flames away from 
our shores. Instead, we must mobilize the resources needed to keep 
entire nations from being reduced to ashes.

    The Chairman. Thank you, Dr. Brantly. Thank you for your 
courage and for being here, being an example. Thank you.
    We'll get on to questions, but, Mr. Charles, welcome and 
please proceed.

 STATEMENT OF ISHMAEL ALFRED CHARLES, PROGRAM MANAGER, SIERRA 
LEONE, HEALEY INTERNATIONAL RELIEF FOUNDATION, FREETOWN, SIERRA 
                             LEONE

    Mr. Charles. Thank you very much. Chairman Harkin, 
honorable Senators, Dr. Kent Brantly, and fellow guests of this 
committee, thank you for the opportunity to allow me to come 
all the way from West Africa and testify in front of you today.
    My name is Ishmael Alfred Charles, a resident of Freetown, 
Sierra Leone. I'm married and a father of two children, two 
girls, 9 months and 10 years. I arrived yesterday morning 
around 2 a.m. to share with you what my country is currently 
dealing with on a daily basis with the current Ebola outbreak, 
while still trying to rebuild from the brutal civil war. Unlike 
the civil war, in Sierra Leone the outbreak creates more fear 
to the entire population at one go. In the civil war it was at 
a time a certain population would be afraid of the attack. 
Today the general atmosphere in my country and among all 
Africans within the West African region, they are afraid of 
fear--the biggest crisis that we have ever faced, bigger than 
even the civil war.
    As a former child soldier, I was able to survive the war. 
But I fear that this is going to be worse than the war.
    The Healey International Relief Foundation, based in 
Lumberton, NJ, supports the rebuilding of health care services 
in Sierra Leone and provided relief and other supports to war-
torn countries like Sierra Leone, and they have been working in 
Sierra Leone for more than 12 years. The foundation's mission 
is to invest and support families and individuals affected by 
disaster, war, and adverse socioeconomic conditions, through 
the delivery of health care, food, and training and other kinds 
of programs. Hence, the mandate is to empower communities and 
build the capacity to become self-sustaining.
    The foundation partners with Caritas Freetown, which I am 
placed with, and Caritas Freetown runs all the foundation's 
projects in Sierra Leone. Caritas Freetown, whose mission is to 
eradicate poverty, corruption, injustice, improve equality, 
advance good governance, and achieve peace and human rights, 
empower women and the disabled.
    As the spokesperson for the Healey International Relief 
Foundation in Sierra Leone, I feel privileged to share with you 
our experience on the ground in the war front. As it is today, 
Sierra Leone is considered to be a war front, and so is 
Liberia, Guinea, and the other West African countries that are 
threatened. Since the outbreak, we have been implementing the 
Ebola Outbreak Response Project in the western area rural and 
urban districts. We work closely with the Ministry of Health 
and Sanitation, Ministry of Social Welfare, and the Emergency 
Operations Centers.
    What this essentially shows is that small organizations 
with lower human capacity and budgets are able to make impacts 
at the lowest community level because they live within the 
community and they understand the reality on the ground.
    As part of this project, we have been working with a number 
of communities in the western area rural districts with a 
catchment of about 219,000 people, raising awareness, providing 
chlorine, which serves as a detergent to kill the virus, soap 
and buckets to police stations and police posts. In addition, 
we have a strong national media campaign in collaboration with 
our counterpart Caritas organizations in the other regions of 
the country.
    The growing number of cases recorded on a daily basis has 
made the situation in Sierra Leone very scary. Each day the 
situation becomes worse and the effect of Ebola cannot be 
overemphasized, as Dr. Brantly has painted a picture very 
clearly for you to see.
    When I was about to leave, my 10-year-old daughter asked 
me, she said:

          ``Dad, are you going to leave us in this country and 
        go to America, where they say there is no Ebola?'' I 
        stared at her for a minute and said, ``Maa''--as I call 
        her--``my trip is for the general good of the family 
        and for your future. I will be back in 2 weeks.'' And 
        she said again, ``Are you sure, because every day 
        flights are being canceled?''

As I speak, there are only two flights going to Sierra Leone or 
Liberia.
    Similarly, my wife said:

          ``Dear, the money you used to leave normally when you 
        travel is not going to be enough this time around, 
        because the price of commodities has tripled.''

    What I'm trying to say in essence, the situation in Sierra 
Leone is getting very difficult every day, and so it is in the 
other countries that have been faced with the current outbreak 
challenge. And the economic burden is getting very heavy on a 
number of people.
    As I was about to leave, my biggest stress was in the 
situation if anyone gets sick behind me, the health system is 
not functional. When you go to a hospital, the doctors are not 
there any more. And even when they are there, they deny that 
they are doctors, because they are afraid that they might be 
infected and they're not sure what sort of sickness a patient 
might have come in with.
    The Ebola phobia is increasing. Even people who do not have 
Ebola are being stigmatized. We have suffered equally, not to 
talk about those who have tested positive.
    The State is overwhelmed and unable to coordinate 
effectively the Ebola response. People are losing their 
confidence every day. The Ebola crisis has escalated into 
widening economic situations and has damaged further the health 
care systems, which are not prepared to manage such a difficult 
situation.
    Harvests have been canceled because too many farmers are 
dying. In the capital, Freetown, hotels have very few number of 
guests. A very big hotel that might have the capacity to house 
300 guests will only have 4 guests or even less. And these 
hotels keep dropping their staff every day because they don't 
have the money, the resources, to take care of the staff. And 
this staff that they're dropping are parents who have families 
they need to take care of.
    In a country with 70 percent illiteracy, schools have been 
closed indefinitely because of Ebola. We have no idea when 
we're going to reopen schools. Our country has a high orphan 
population and Ebola is increasing that on a daily basis. 
Through the foundation, we are able to make donations to the 
Ministry of Social Welfare and support the Ministry of Social 
Welfare, who are currently taking care of the Ebola orphans, 
while we are also very careful that these orphans will be 
stigmatized and at the same time could be positive. It's a very 
delicate situation.
    People do not have the free will to bury their loved ones 
any more and show the compassion and care and emotional love to 
those who are sick which normally help people to recover very 
fast when you know that you have a social support around you.
    Flights have been canceled. The economic situation is 
getting worse every day. As a result, households are 
struggling. Not just the Ebola is killing people in Sierra 
Leone. Poverty, hunger, lack of medical facilities. Families go 
hungry when the breadwinner dies or gets sick or loses their 
job, which is happening on a daily basis.
    With the support of the United States, the international 
community, and the spirit of Sierra Leoneans, we believe we 
will put Ebola at our back. However, a decade's progress will 
have been lost, especially so when already the health 
facilities were in bad shape before the outbreak.
    I plead to this house and to the United States and the 
international community not to leave Sierra Leone when the 
outbreak may subside. We will need help investing in Sierra 
Leone so that we can be able to be self-reliant again because 
we will not need to continue to rely on international support. 
But if we are self-sustainable, we will be able.
    I've heard about the CDC report that Dr. Bell spoke about. 
She gave a number of incidents or instances specifically 
talking about Liberia. Every picture that she painted is 
equally as devastating in Sierra Leone and probably even worse. 
The numbers that the government gives on a daily basis of 
infected people, is definitely much less than what is really 
happening on the ground, for various reasons, and the health 
facilities or the support that we have currently does not 
really match with the number of infections that we have.
    Last, I want to thank this house for listening to me, and 
please, we will look forward to the continued support of the 
United States in Sierra Leone. I thank you very much for your 
attention and for the privilege you give me in listening to me. 
Thank you.
    [The prepared statement of Mr. Charles follows:]

              Prepared Statement of Ishmael Alfred Charles

    Good afternoon, my name is Ishmael Alfred Charles, a resident of 
Freetown, Sierra Leone, married and a father of two children, 9 months 
and 10 years. I arrived yesterday morning to share with you what my 
country is dealing with on a daily basis with the current Ebola 
outbreak, while still rebuilding after a brutal civil war; unlike the 
civil war, the outbreak creates more fear to the entire population.
    Today there is a general atmosphere of fear. This is the biggest 
crisis we have faced since the end of our civil war.
    As a former Child soldier, I was able to survive the war, and now I 
fear, ``This is going to be worse than the war.''
    The Healey International Relief Foundation, based in Lumberton, NJ, 
supports the rebuilding of Sierra Leone's healthcare system and has 
provided relief services to our country since the end of our civil war, 
over 12 years ago.
    The Foundation Mission is to invest and support families and 
individuals affected by war, disaster and adverse socio-economic 
conditions through the delivery of healthcare, clean water, food, 
training and other programs, hence it's mandate is to empower 
communities and build their capacity to become self-sustaining.
    The foundation partners with Caritas Freetown on all its projects 
in Sierra Leone.
    Caritas Freetown whose mission is to eradicate poverty, corruption, 
and injustice; to improve equality, advance good governance, achieve 
peace and human rights, empower women, youth and the disabled.
    As the spokesperson for the Healey International Relief Foundation 
in Sierra Leone, I feel privileged to share with you our experience. 
Since the outbreak, we have implemented the ``Ebola Outbreak Response 
Project'' in the rural and urban districts of Sierra Leone. We work 
closely with the Ministry of Health and Sanitation, Ministry of Social 
Welfare and the Emergency Operation Center.
    As part of this project, we have been working in a number of 
communities within the Western Area Districts with a catchment area of 
about 219,000 people, raising awareness and providing chlorine, soaps 
and tap buckets to all police stations and posts. In addition we have a 
strong national media campaign in collaboration with our counterpart 
Caritas organizations in the other regions.
    The growing number of cases recorded on a daily basis has made the 
situation in Sierra Leone very scary. Each day the situation becomes 
worse and the effects of the Ebola cannot be over emphasized. When I 
was about to leave, my 10-year-old daughter asked ``Dad are you leaving 
us here in this difficult situation with this Ebola, they said there is 
no Ebola in America, why can't you take us along?'' I starred at her 
for a minute and said ``Maa,'' as I call her, ``my trip is for the 
general good of all our family and your future. I will be back in 2 
weeks.'' She asked again, ``Are you sure when flights are being cutoff 
daily?''
    Similarly, my wife said, ``Dear the money you normally leave when 
traveling will not be enough as the cost of commodities has tripled.'' 
This was another difficult situation.
    As I leave, my biggest stress is if anyone gets sick while I am 
away, the health system is not functional.
    The Ebola phobia is increasing. Even people who do not have Ebola 
are being stigmatized, not to talk about those who are tested positive.
    The state is overwhelmed and unable to effectively coordinate the 
Ebola response and people are losing their confidence. The Ebola crisis 
has escalated quickly and has led to the widespread fallout of the 
healthcare system:

     Harvests are being canceled because so many farmers had 
died;
     In the capital, Freetown, patrons are sparse at hotels and 
restaurants especially those catering to the expatriates. Hotel 
occupancy rates have dropped and large hotels have only 4 guests and 
these hotels are laying off staff daily;
     In a country with 70 percent illiteracy, schools are 
closed indefinitely;
     Our country's high orphan population, is increasing every 
day;
     People do not have the free will to bury their loved ones, 
and even the sick ones are deprived of the emotional care from their 
family needed to recover;
     Many companies are laying off staff amidst the slowdown in 
commerce, restrictions on travel and decrease in other economic 
activity.

    As a result, households are struggling with food shortages and 
increase costs due to panic buying.
    Families go hungry when the bread winner dies, gets sick or loses 
his or her jobs.
    With the support of the United States, the International Community 
and the survival spirit of the people of Sierra Leone, I am confident 
we will defeat this deadly virus. However, a decade of progress will be 
lost, especially so when the health care was already in bad shape 
before the outbreak.
    I plead not to leave once the crisis is over and help us rebuild 
our country physically and economically by investing in Sierra Leone to 
empower our people to become self-reliant.
    I thank you for your attention.

    The Chairman. Thank you, Mr. Charles. It's always important 
to put a human face on matters like this. I think people read 
about it, you get the numbers, you say it's horrible. But one 
has to understand the human impact and what this is doing to 
families in your country, in Liberia, and other countries, and 
the nature that I am now beginning to understand is, if we 
don't get it controlled soon, it will spiral out of control and 
it will have the devastating effects that Mr. Charles is 
talking about. No more people will go there. Business will end. 
The whole economy will start grinding to a halt.
    Dr. Brantly, I'm sure I can speak for many in America and 
around the world when I say thank you. Thank you for being such 
an example for all of us on how to serve others. We regularly 
thank our soldiers for marching into harm's way, rightfully so. 
Let me say this is no different. You and others like you run 
toward the risk to help those standing in the path of this 
terrible disease. So I want to include you and others like you 
in that pantheon of American heroes. You do us proud, real 
proud.
    I have so many questions, but I know we're running out of 
time. Dr. Brantly, what I would ask you first is, with all that 
you know, and you've been there with your family, you know what 
the situation is like, give me one, two, three, what's the most 
important thing we could do now? What's the most important 
response that we could do now?
    Dr. Brantly. Thank you, Mr. Chairman.
    The Chairman. If you were in charge and you had a magic 
wand, what would you do with it?
    Dr. Brantly. I think one of the most important points is in 
your very question. We have to do it now. This has been in the 
eye of the government for months. We can't afford to wait 
months or even weeks to take action, to put people on the 
ground, to begin opening those logistical bridges and pathways, 
to begin going out into the communities and educating 
caregivers.
    It's not that we're trying to keep people at home, but we 
need to increase the capacity to care for them in facilities. 
And that means not only creating more beds, but having the 
staff to care for them in those beds. Putting them in a bed may 
keep them from giving the disease to someone else, but it does 
nothing to improve their chances of survival unless they're 
receiving good quality supportive care.
    So we need more capacity in Ebola treatment units, but we 
must have the staff for those units as well. And we need to 
start educating people right now in their communities about how 
to safely care for their family members who are hiding at home 
and dying from Ebola and ashamed or scared of their own 
situation.
    The Chairman. You must have a valuable perspective on 
Liberian culture and society, having been there. We send in a 
lot of people. Maybe they're not culturally sensitive. I don't 
know exactly what I mean by that, but they don't understand the 
situation; and could people actually become more afraid of the 
workers that we send in if they're not adequately trained and 
equipped?
    Dr. Brantly. I think that's a very real possibility, Mr. 
Chairman. I think that, yes, Liberia's civil war ended 10 years 
ago, but think about the situation in the United States 10 
years after our own Civil War. There was still a lot of 
tension, and in Liberia there is still a lot of tension between 
people, groups, and society in general, and there's a sense of 
distrust, distrust of government, distrust of authority, 
distrust of foreigners.
    So yes, people will be resistant to help. But I think 
because of the devastation of this outbreak even those people 
who have been resistant to help are starting to see the need 
for some assistance. I think that's why it's important that we 
don't just march in there with our military and take over, but 
we partner with the NGO's, like Doctors Without Borders and 
Samaritan's Purse, and the Ministry of Health of Liberia, so 
that it's a partnership and we're using people like the 
survivors from Ebola.
    There are more and more survivors every day in places where 
they can get good, supportive care, and those survivors are the 
ones who can go out and, in what you refer to as a culturally 
appropriate way, educate and support the communities and 
distribute the needed personal protective equipment to protect 
those home care providers. I think that is very much an 
important part of the strategy.
    But again, it has to start now. It has to start in a matter 
of days. From the time I fell sick just less than 2 months ago, 
the death toll has tripled. If we take 2 months to get our 
response up and going, even if we only maintain that rate of 
growth, we're looking at thousands and tens of thousands. And 9 
months down the road, we're looking at hundreds of thousands of 
not only cases of Ebola, but deaths. And we can't afford that.
    The Chairman. That's where I hope our military airlift 
capability will come in and start moving material and personnel 
over there.
    Senator Alexander.
    Senator Alexander. Dr. Brantly, Mr. Charles, let me thank 
you both. Mr. Charles, thank you for your work in prevention 
and bringing awareness here. Dr. Brantly, thanks for your being 
a good samaritan. We greatly admire what you've done.
    You're a survivor of Ebola. Is that like cancer? Is that in 
remission, or are you cured, or do you know?
    Dr. Brantly. Thank you, Senator. I'm cured from Ebola.
    Senator Alexander. So you don't have it--it's gone from 
you?
    Dr. Brantly. Yes. When a person survives Ebola, when they 
recover they're not a carrier of the virus. Dr. Ribner at Emory 
University was very clear to say that Nancy Writebol and I 
posed no public health risk. So there's no risk to the public 
from a survivor. There's a lot of stigma attached to being a 
survivor of Ebola, but we----
    Senator Alexander. Can an Ebola survivor become infected 
once again, or are you immune then from Ebola?
    Dr. Brantly. In theory and I think in practice, I am immune 
to the strain of Ebola that I was infected with. But there are 
five different strains of Ebola, so if I went to the Democratic 
Republic of the Congo I may not be immune to the strain that's 
causing the outbreak there.
    Senator Alexander. You talk about how you treated a lot of 
patients. Would you say it's accurate that about half the 
patients who are infected died, or is it higher or lower than 
that?
    Dr. Brantly. Unfortunately, Senator, in my experience we 
did not have a 50 percent mortality rate of 50 percent survival 
rate in our facility. As we saw patients early on in the 
outbreak, they were usually showing up very late in their 
course, and in the month and a half that I was treating Ebola 
patients we had one survivor.
    Senator Alexander. From the time you discover an infection 
until death, how long is that typically?
    Dr. Brantly. That varies greatly depending on how early the 
person seeks care. We had some people who came and died in a 
matter of hours from the time they presented, and we had others 
who were under our care for a matter of days, 4 or 5 or 6 days, 
before they passed away.
    Senator Alexander. But it's not months?
    Dr. Brantly. No. The illness generally is a 2-week course, 
and by the end of 2 weeks the person has either died or they're 
on the road to recovery.
    Senator Alexander. Which is one reason there's such 
concern, because it's so explosive, it moves so rapidly. Is 
that right? As I listen to you, I hear you talking about lots 
of people at home sick for a variety of reasons. We've heard 
the official statistics say there are less than 5,000 
infections. It sounds to me like there might be many more.
    Dr. Brantly. I think that's very accurate, sir. As many of 
the witnesses today have said, those numbers are based on the 
cases we have tested and identified or are housing in isolation 
units. But there are many, many more at home.
    Senator Alexander. So there are many more, and what you're 
saying is the course of the disease might run a couple of weeks 
and you're either dead or a survivor after that period of time. 
In your experience, all but one died. Others, they say half. 
The official statistics say the cases have doubled over the 
last 3 weeks. So you don't have to do much math to see that the 
numbers, as you say, can quickly go to tens of thousands, 
hundreds of thousands, if we don't get control.
    Am I correct that the home health kits are primarily for 
the benefit of the caregivers, that it's to keep the infection 
from spreading? Does it make the home sort of a hospice for the 
infected person with Ebola?
    Dr. Brantly. I think that's a fair way to look at it. As I 
said, you can't carry out complicated medical interventions in 
a home, but you can give people oral rehydration solution. You 
can give them Tylenol to help with their fever and pain. But 
the most important part of that kit is the part that offers 
protection to the caregiver, because without that we're not 
stopping transmission, and that's what has to happen to control 
this epidemic, is to stop the transmission of this disease.
    Senator Alexander. You took a great risk in going there and 
it's obvious from the testimony of you and Mr. Charles and 
others that we'll need hundreds, thousands of people, in 
addition to the soldiers who are going. What would you say to 
others, people like yourself? We have a tradition in this 
country of Doctors Without Borders, Samaritan's Purse, of which 
you were a part. What would you say to Americans who are seeing 
this and trying to decide whether to go to West Africa to help 
control this disease?
    Dr. Brantly. Thank you, Senator. This is a topic very dear 
to my heart. I think the International President of Doctors 
Without Borders said it very well in a recent article. She 
said,

          ``Comparing Ebola to a fire, this is not the time to 
        run away; this is the time to put on our protective 
        gear and run into the burning building.''

    Physicians and health care professionals, even if it's just 
symbolic, have taken an oath. In many institutions they still 
take the Hippocratic Oath, and that oath is to the service of 
mankind. I think if we can help people overcome the fear of 
facing a deadly disease and remember that this is not just a 
disease, these are people who need help, societies that are 
collapsing because of the weight of this burden, we just need 
people to go help.
    The Chairman. Senator Burr.
    Senator Burr. Thank you, Mr. Chairman.
    Dr. Brantly, Mr. Charles, thank you for being here. Mr. 
Charles, when you go back and see your daughters, I hope you'll 
share with them that the purpose of this committee is to try to 
make sure we can process enough fact to make sure that we can 
provide what's needed from a standpoint of the resources. There 
are other parts of government that has the responsibility to 
get them there, to train, to equip. But we have to make sure 
that we have the resources. And what you've shared with us, 
both of you, is invaluable from a standpoint of how we look at 
it. As I think both Senators said, to see the human face behind 
the issue is absolutely crucial to those of us who sit on this 
committee and in this institution and ask taxpayers to in turn 
fund things for people that they'll never meet.
    But I do have a couple of questions. Dr. Brantly, are you 
convinced that ZMapp played a role in your cure?
    Dr. Brantly. Thank you, Senator Burr. My opinion----
    Senator Burr. I take for granted that from a standpoint of 
good supportive care, since you knew them, you were getting it.
    Dr. Brantly. I was receiving the best care that they could 
afford to give me in Liberia.
    My own opinion is that ZMapp, I believe, had a beneficial 
effect in my treatment. But, as Dr. Fauci very clearly said, 
this is an experimental drug, that my story is an anecdote and, 
while a very convincing one, it's just one. And it really 
requires more extensive testing of an experimental drug to 
prove whether or not it is beneficial on a large scale. I'm 
very thankful for Mr. Zetland and all the people at Mapp 
Biopharmaceuticals because I think it was helpful to me, and I 
think it will be helpful in future Ebola outbreaks, because 
there will be more Ebola outbreaks.
    Senator Burr. Let me say, Dr. Brantly, when the chairman 
said he was concerned this might spiral out of control, I think 
we've already spiraled. I think we're in that spiral now. I 
think had we had more time with Robin Robinson we would 
understand that we're probably January at the earliest for 
therapy, and that's without extensive clinical trials, as you 
can imagine. We're January, first quarter, with potentially 
some vaccine product, and that's with--doctor, you know, if 
we're talking about a 5-month clinical trial process, we have 
accelerated it greatly.
    We're going to break every fail-safe that exists at the 
FDA, just like they did in the decision to administer ZMapp to 
you. And because that's jurisdictionally under this committee, 
it's important that we all understand. We're going to sort of 
recreate the wheel, because this is an extraordinary 
circumstance.
    I guess I'm asking for your medical opinion and your 
opinion as somebody that knows the folks that are being 
affected. If we choose to go before we know everything with 
some type of therapeutic response, is that the best course for 
us to follow, or should we be prudent and take longer, knowing 
that we know a little more about the therapy or the vaccine?
    Dr. Brantly. I think WHO came out with a statement several 
weeks ago saying they believe it's ethical to use experimental 
drugs in circumstances such as this. I would agree with them 
that if we know--in my case, we didn't even know if it would be 
harmful or not. I think if you're going to start giving it to 
people who don't have the background to be able to give really 
understood informed consent, it's important that we know that 
what we're giving them is safe and potentially beneficial.
    But I think those types of drugs, especially vaccines--I 
think the other panelists spoke to that better than I can, but 
I think they would have a role, especially if we don't have 
this thing under control by January.
    Senator Burr. The numbers that we look at suggest for every 
infected individual that they will infect somewhere between 5 
and 20 additional individuals. The multiples are huge. I think 
I heard both of you say that when we look at Sierra Leone, 
1,620 cases, 653 in the last 21 days, Liberia 2,407, 1,383, you 
think those are woefully understating the size of the problem. 
Did I hear both of you correctly?
    Mr. Charles. Yes, Senator.
    Senator Burr. OK.
    Dr. Brantly. Senator, may I speak just a moment on that?
    Senator Burr. Sure.
    Dr. Brantly. I think those numbers may be underestimated 
for sure, but I think what you're seeing is a representation of 
how quickly this thing is growing when you compare what the 
numbers were to how fast they're growing now. And those 
experimental drugs don't have anything to do with the 
transmission. That's why we need to intervene in the 
communities to disrupt the transmission of this disease.
    Senator Burr. When CDC said act now, I sort of agree with 
your definition of ``now.'' ``Now'' is like tomorrow. I'm not 
sure that we've ever had that type of turnaround out of 
government. So facing the reality of what's in front of us is 
also important.
    Last question, and you've been very patient to stick with 
us as long as you have. What are the possibilities of using 
social media as our communication tool in West Africa, and can 
that be effective?
    Mr. Charles. Yes, the use of social media has a lot of 
effects in Sierra Leone specifically, especially among young 
people who are literate, maybe the school-going population and 
those who also have access to mobile phones. But the cost of 
communication is tremendously expensive compared to what I can 
access in America on my cellphone at the cost and what I can 
access in Sierra Leone on a monthly basis for the same 
cellphone. It's very expensive. But it definitely has a very 
big impact because a lot of information is being--it's 
sometimes misleading also. That's another negative aspect. But 
the fact is a lot of this information, good information, is 
also being transmitted and communicated through WhatsApp and 
Facebook especially.
    Senator Burr. Dr. Brantly, you agree?
    Dr. Brantly. I agree. I think even up until this point 
Liberia has been using social media and radio and print media 
to reach the population. There's even a really catchy tune that 
they play on the radio about Ebola, reminding people that Ebola 
is real and they need to protect themselves and protect their 
families, and that talks about how the disease is spread. I 
think it's a very important means of reaching people.
    Senator Burr. I want to thank both of you. I especially 
want to thank Samaritan's Purse. Whenever you have a tragedy 
somewhere in the world, they are certainly there. They're part 
of the story. I think a lot of the presence in North Carolina 
and I think a lot of Franklin and the vision and the 
commitment. Not to say that we don't have a lot of good NGO's 
around the world that respond, but they're certainly 
consistently there, and for that we're grateful.
    I thank you both.
    Dr. Brantly. Thank you.
    Senator Alexander. Thanks to both of you for coming. We're 
at the end and Senator Harkin will end this in a minute. But I 
want to make sure I understood something you said. You said you 
began to treat patients on June 11 and became ill on July 20, 
is that right?
    Dr. Brantly. July 23d, yes.
    Senator Alexander. You became ill on July 23d. About how 
many patients did you treat?
    Dr. Brantly. I believe during that time we had about 45 or 
50 patients come through our unit. Not every one of those was 
positive for Ebola, but even many of them who were negative for 
Ebola died because of the severe illness they came to our 
hospital with.
    Senator Alexander. So of the 45 or 50, all but one died?
    Dr. Brantly. No, sir. There were some who tested negative 
and we discharged them from the unit.
    Senator Alexander. Of those 45 or 50, some had Ebola?
    Dr. Brantly. I can't remember the numbers exactly, but I 
would say of those 45 probably 20 of them had Ebola and 
probably 10 or 12 of them were tested negative and discharged. 
So that would leave another five or so who came to us with 
something other than Ebola, but unfortunately died because of 
the severity of their illness.
    Senator Alexander. Now, you became ill on July 23d. You 
were tested on July 26th. You said something about a 2-week 
course. Does that mean that within 2 weeks you know whether 
you're going to recover or die if you have Ebola? Is that 
right?
    Dr. Brantly. In general. Most people with Ebola, they 
usually, if they die from it, they die between days four and 
ten. But it can be a 14 or 16-day illness. So you can't just 
say, oh, you're on day ten, you're out of the woods. That's not 
the case. It was day nine when I was the sickest and almost 
died.
    Senator Alexander. So you become infected, you don't infect 
others until you have symptoms, correct?
    Dr. Brantly. Correct.
    Senator Alexander. So there's a period of time of about 
maybe 2 weeks, a week or two, when you can infect other people, 
plus the time after--if you die, there's that period of time.
    Dr. Brantly. Correct. You contract the virus and you have a 
2 to 21-day window before you become symptomatic. Once you 
become symptomatic, your illness may run from 3 days, where you 
die after 3 days, or you may be sick for 2 weeks. In my case, I 
was sick for almost 4 weeks before the CDC decided that my test 
was negative enough consecutive times that they could discharge 
me from the hospital.
    So you're correct, people are infectious during their 
illness and usually that is less than a 2- or 3-week period.
    Senator Alexander. So what's really different about this 
epidemic is how fast it moves, is that right?
    Dr. Brantly. The virus moves--it kills quickly. Like Dr. 
Fauci and Dr. Bell said, it's not so contagious like the flu 
virus that someone will get it by sitting near you. But it 
kills its victims quickly.
    Senator Alexander. So within that 2-week period or so of 
infection, to use Senator Burr's figures, one might infect 5 to 
20 other people. They have an incubation period of 2 to 21 days 
and then they may have a 2-week period of infection during 
which they might infect 5 to 20 more people. So that all 
happens very, very rapidly if it happens.
    Dr. Brantly. Yes, sir.
    Senator Alexander. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Alexander. Senator Burr, 
thank you.
    Again, both of you, thank you very much for being here, for 
your patience, and for sharing with us your personal stories.
    The Obama administration is moving rapidly on this. Today 
President Obama went to the CDC. We are ourselves working here 
to do everything we can to rapidly respond and to support the 
President in this effort. I think you're right, time is of the 
essence, but it has to be done correctly rather than rushing in 
and doing things that may even make it worse. Certainly we need 
to get the equipment there, the personal protection gear for 
home health and health care workers in these countries. We need 
to do a rapid series of educational programs so that the local 
populace begins to know what to do and how to respond and not 
to be afraid. That needs to be done rapidly.
    I trust that there are NGO's like the one you are with, Mr. 
Charles, there are NGO's there that could be very helpful on 
this, I believe, and who have been there for some time and who 
have good relations with people in these countries. I'm hopeful 
that as we do this rapidly, we will learn from, lean on, ask 
the help of the NGO's that are in these countries. They can be 
extremely helpful. Do you concur with that? We need to really 
ask them for their help.
    Thank you very much, and I hope and trust, Mr. Charles, 
that your wife and your daughters are safe, and if they hear 
any of this at all I want to assure them that you're going to 
be back home and you'll be safe.
    Mr. Charles. Thank you very much.
    The Chairman. Thank you. And thank you, Dr. Brantly, again 
for your great example.
    The record will remain open for 10 days. Thank you very 
much. We'll stand adjourned.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

  Response by Beth P. Bell, M.D., MPH to Questions of Senator Casey, 
 Senator Bennet, Senator Whitehouse, Senator Shaheen, Senator Baldwin, 
Senator Warren, Senator Alexander, Senators Alexander and Burr, Senator 
Moran, Senator Cochran, Senator Shelby, Senator Burr, Senator Kirk, and 
                            Senator Enzi \1\
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    \1\ Note: Content accurate as of October 15, 2014. Responses do not 
reflect enactment of the $1.777 billion for CDC in emergency funding to 
prevent, detect, and respond to the Ebola Epidemic.
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                             senator casey
    Question 1. What is the CDC's plan to communicate with the public 
regarding the current threat posed by Ebola, and how will these 
communications change should Ebola reach the United States?
    Answer 1. CDC educates Americans on ways to protect themselves when 
traveling in numerous ways, such as:

     Issuing travel health notices advising U.S. citizens to 
avoid nonessential travel and to take enhanced precautions if they are 
visiting the affected West African nations.\2\ The recommendation to 
avoid nonessential travel is intended to help control the outbreak and 
prevent continued spread by:
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    \2\ For more information about travel notices to the West Africa 
region and other countries, please visit CDC's Travelers' Health 
website.

        1. Protecting U.S. residents who may be planning travel to the 
        affected areas, and
        2. Enabling the government of the affected countries to respond 
        most effectively to contain this outbreak.

     Working closely with Customs and Border Protection (CBP) 
in the Department of Homeland Security (DHS) and other partners to 
enhance practices at U.S. ports of entry to use routine procedures to 
identify travelers who show signs of infectious disease. In response to 
the outbreak, these procedures have been enhanced through guidance and 
training. CDC's quarantine station staff respond as needed, for example 
by evaluating ill travelers identified by CBP officers.
     Providing comprehensive information to travelers at U.S. 
ports of entry through airport messaging to outbound and inbound 
travelers, CDC website, and social media. Ebola-specific travel 
messages have been developed for electronic monitors and posted to 
reach travelers from West Africa, and posters have been displayed in 
Transportation Security Administration (TSA) screening areas of 
airports to reach outbound travelers. Furthermore, CDC maintains 
detailed and updated actions for travelers to take before international 
travel on the CDC website, including Ebola-related recommendations.
     Developing interim guidance to provide public health 
authorities and other partners with a framework for evaluating people's 
level of exposure to Ebola and initiating appropriate public health 
actions on the basis of exposure level and clinical assessment. 
Specifically, CDC developed ``Interim Guidance about Ebola Virus 
Infection for Airline Flight Crews, Cleaning Personnel, and Cargo 
Personnel,'' As well as ``Interim U.S. Guidance for Monitoring and 
Movement of Persons with Potential Ebola Virus Exposure.''
     Issuing advice for colleges, universities, and students 
about study abroad, foreign exchange, and other education-related 
travel, as well as advice for students who have recently traveled from 
a country in which an Ebola outbreak is occurring.
     Developing guidance for humanitarian aid organizations 
whose employees or volunteers are working in countries where an Ebola 
outbreak is occurring. Humanitarian aid workers play a vital role in 
the Ebola outbreak response, and CDC encourages them to continue the 
important work being done to stop the disease's spread at its source.

    CDC will continue to update its communication products and webpages 
with new information on the Ebola outbreak for the general public and 
specific audiences to share credible, factual information and to dispel 
misconceptions about Ebola.

    Question 2. You noted in your testimony that there are three key 
things that we need to respond to this epidemic: resources, technical 
experts, and a coordinated, global unified approach. Which of these 
things do you feel we are currently doing well? Which of them do you 
feel we are currently doing poorly, and how do you suggest we improve 
our efforts?
    Answer 2. We are continuously evaluating all three of these areas. 
On resources, we continue to work across the U.S. Government to 
determine the resource needs to ramp up the response and stop this 
epidemic globally while protecting the United States. The U.S. 
Government also is actively coordinating with other donors to support 
these efforts. For technical expertise, CDC has been fighting this 
disease for decades, and along with our partners, we have the technical 
expertise to stop this. We need to transfer some of that expertise to 
countries experiencing the epidemic and those at risk, so that our pool 
of experts is larger and is on the ground when outbreaks occur. Global 
coordination continues to improve. We are doing our best to respond to 
the current epidemic both by working intensively in the countries 
currently experiencing the epidemic as well as by preparing nearby 
countries to be ready to respond to imported cases. CDC has identified 
11 countries at high risk for importation and potential outbreaks and 
is working intensively with these countries to improve their 
surveillance, laboratory, and other pivotal capabilities.

    Question 3. Is there a sufficient supply of personal protective 
equipment (PPE) available (or capable of being procured) to supply the 
affected West African nations? Do we also have a sufficient supply of 
PPE available should Ebola reach the United States?
    Answer 3. CDC is aware that challenges remain with the supply of 
PPE in West Africa. The United Nations Logistics Cluster has been 
activated to assist with PPE needs and supplies. WHO and MSF also 
communicate directly with the largest PPE manufacturers to ensure that 
they can produce the necessary PPE for the response. Thus far, the 
manufacturers have not had problems producing PPE supplies in 
sufficient quantities; however, procurement and distribution remain 
challenging.
    In the United States, as of October 15, 2014, there have been no 
reported shortages of PPE. Hospitals have reported sufficient 
quantities for health care workers who might treat suspect or confirmed 
patients with Ebola virus disease (EVD). Moreover, as we understand it, 
manufacturers are aware that there may be increased demand, and they 
are preparing for that demand.
                             senator bennet
    Question 1. Dr. Bell, in your testimony you say that ``the 
technology, capacity, and resources exist to make measurable progress 
across member countries, but focused leadership is required to make it 
happen.'' Can you expand upon what kind of focused leadership you think 
is needed here?
    Answer 1. The importance of having a well-functioning incident 
management system in an Emergency Operations Center (EOC) in each 
affected country cannot be overemphasized. It is critical that there be 
strong coordination and communication among countries, with clear 
delineation of responsibilities. For its part, CDC has activated its 
EOC to help coordinate technical assistance and control activities with 
partners. On August 6, 2014, CDC elevated the EOC to a Level 1 
activation, its highest level, because of the significance of the 
outbreak. CDC supports countries in establishing their own national and 
sub-national EOCs. Each of the three West African countries at the 
center of the epidemic now have an Incident Manager, reporting to the 
President of the country, to lead response efforts.

    Question 2. There are many charities and volunteers here that want 
to help end this outbreak and care deeply about the outcome. For 
example, in my home State, the Centennial-based Project CURE has been 
working with local volunteers and high schools, like Valor Christian 
High School in Highlands Ranch, to send medical supplies to West 
Africa. They have already sent four large containers of supplies for 
medical workers there. They want to know that their government is 
showing a coordinated response to this effort, and that their work will 
not be in vain. Can you give them and other volunteers across the 
country some peace of mind that their work is helping and you all are 
doing everything you can to coordinate an effective response to this 
outbreak?
    Answer 2. The U.S. Government's goal is to enable the most 
effective and coordinated international response possible, using our 
governmentwide capabilities to fight the Ebola epidemic on a regional 
basis. In September 2014, President Obama announced a scaled-up U.S. 
response to the crisis, building on a whole-of-government response 
across the U.S. Agency for International Development (USAID), the 
Department of Defense (DoD), Department of State, CDC, and other 
Federal Departments and Agencies. The United States also is working 
intensively on this effort with the United Nations, the governments of 
the affected countries, and other donor partners.
    We continue to appreciate the efforts of the Congress and concerned 
American citizens to raise awareness and get involved in the response 
to this crisis. USAID is coordinating all kinds of donations and 
volunteers, and suggests a list of charities for the public at http://
www.usaid.gov/ebola. These efforts make a tremendous difference.\3\
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    \3\ For further information on the organizations working to combat 
the crisis, additional ways to volunteer or contribute, or more 
information on the response, please visit USAID's Center for 
International Disaster Information website.

    Question 3. Given the emergence of Ebola as a significant public 
health threat--and the level of funds understandably being allocated in 
response--I am concerned about our ability to respond to other 
emergencies, such as pandemic influenza, which are far more common 
threats. In particular, I'm concerned that we are jumping from crisis 
to crisis and failing to adequately budget for rapid response 
capabilities to public health pandemics, like Ebola, pandemic 
influenza, and MERS. Just earlier this month, for instance, a DHS OIG 
report highlighted that our pandemic influenza stockpiles have not been 
effectively managed, and I'm concerned that we may be falling behind on 
these other types of preparedness issues. How are you assuring that we 
are adequately prepared and not compromising our ability to rapidly 
respond to address other public health crises, like pandemic influenza, 
in addition to emerging threats like Ebola?
    Answer 3. The emergence of a novel, pandemic strain of influenza 
represents a continued threat to global health. To address this threat, 
CDC has developed plans and capabilities to respond to pandemic 
influenza at any time, regardless of other ongoing response activities. 
Since the 2009 H1N1 pandemic, we have enhanced our capabilities with 
more robust domestic and international surveillance systems, improved 
communication with partners, and increased public health laboratory 
capacity at the State, local and international levels. CDC is prepared 
to address public health crises, but the agency would be concerned 
about the ability to respond effectively to multiple, large-scale, 
concurrent events.
    With respect to the referenced report by the DHS Office of the 
Inspector General, CDC cannot speak to the work product of another 
department. However, it is important to note that this report 
encompasses a review of DHS preparedness to continue critical 
operations of DHS activities during an influenza pandemic. This report 
does not evaluate the nationwide preparedness to respond to such a 
pandemic.
                           senator whitehouse
    Question 1. Several commentators have cited distrust of health care 
officials by people in affected regions as one of the barriers to 
receiving care. What steps has CDC taken to overcome this mistrust? How 
are CDC and the World Health Organization partnering with trusted local 
leaders and communications outlets to disseminate information?
    Answer 1. CDC has deployed several teams of public health experts 
to the West Africa region to work directly with local leaders and 
stakeholders who can inform on the best ways to foster trust and reach 
communities. CDC's health promotion teams, consisting of health 
communicators and public health advisors deployed to Guinea, Liberia, 
and Sierra Leone, are working closely with country embassies, UNICEF, 
WHO, ministries of health, and nongovernment organizations to develop 
public health messages and implement social mobilization activities. In 
all three countries, CDC health communicators are meeting with local 
community leaders beyond capital cities.

    Question 2. In Rhode Island, public health officials at the 
Department of Health and elsewhere are working with local residents 
from West Africa to help them communicate to their family and friends 
on ways to stay safe. Do you recommend outreach and education efforts 
of this kind? Will you be supporting and spreading this approach to 
other States that are part of the Liberian diaspora in the United 
States like Minnesota, Pennsylvania, Maryland, Georgia, and Washington, 
DC?
    Answer 2. CDC has engaged and continues to engage in outreach 
directly to West African communities and organizations serving the West 
African diaspora across the country, including groups in Dallas/Dallas 
County, Rhode Island, California, Minnesota, and the Bronx. CDC's 
specific activities include:

     CDC is helping counter stigma during the Ebola response 
and encourages our public health partners to do so as well. CDC has 
developed messaging on avoiding stigma in West African populations in 
the United States and shared it with all State health departments and 
others. CDC has also created guidance for social service and community-
based organizations in the United States serving immigrant communities, 
including additional guidance on preventing stigma for sharing with the 
population they serve. 
     CDC has hosted several calls for West African community 
groups to provide the most up to date information on Ebola and 
opportunities for these groups to support Ebola response efforts, 
delivery of key health messages and CDC resources, and securing CDC 
speakers for special events. Participants have included faith-based 
groups and national organizations serving Liberians, Sierra Leoneans, 
and Guineans in the United States. For example, two calls were held on 
September 30, 2014 with groups representing the West African diaspora 
population. One call was organized by Congressman David Cicilline's 
office for the diaspora in Rhode Island, and the other call was open to 
diaspora groups and individuals across the country. CDC is planning to 
continue this type of outreach on an ongoing basis.
     CDC is collaborating with a private partner, AudioNow, to 
deliver PSAs on their call-to-listen platform popular with West African 
communities in the United States. Several PSAs have been developed 
targeting this group, with a focus on how to inform relatives in the 
West African region about Ebola, and travel related issues (e.g., 
visitors coming from and traveling to the region). These are in 
production now in four languages for 72 radio stations that are 
identified as reaching large groups of West Africans in the United 
States. CDC has also worked with President Jimmy Carter and the Carter 
Center to develop some specific messages, building on their existing 
relationships and portfolio of work in Liberia. 

    CDC will continue to take measures to ensure that geographic areas 
with large West African populations receive timely information and make 
available resources as needed. CDC has a cadre of experts who have 
experience reaching immigrant populations, including individuals that 
speak Hausa and Fulani, two of the major non-English and non-French 
languages in the region, to provide consultation on linguistic and 
cultural issues.

    Question 3. What do you advise State and local health officials to 
do to protect their populations? What additional resources are needed 
at the State and local level to insure that Ebola from any imported 
case is not spread?
    Answer 3. CDC has created plans outlining its course of action for 
when a laboratory-confirmed Ebola diagnosis occurs in the United States 
and continues to work with other Federal, State, and local health 
governments and private organizations to strengthen U.S. readiness for 
detecting and preventing Ebola cases.
    Recognizing that even a single case of Ebola diagnosed in the 
United States is a concern, CDC is working with medical and public 
health professionals and health care facilities across the country to 
prepare and respond and to safely manage a patient with suspected Ebola 
Virus Disease. This includes engagement in the following activities:

     Enhancing surveillance and laboratory testing capacity to 
detect cases domestically;
     Developing guidance and tools, such as checklists for 
health departments, hospitals, emergency medical services, and health 
care coalitions to conduct public health investigations;
     Providing recommendations for health care infection 
control and other measures to prevent disease spread;
     Providing guidance for flight crews, emergency medical 
units at airports, and U.S. CBP officers about reporting ill travelers 
to CDC;
     Coordinating with maritime authorities to assess the 
potential risk to the United States from cargo vessels from the four 
affected West African countries; and
     Disseminating up-to-date information about the epidemic to 
the general public, international travelers, and public health 
partners.

    Since July, CDC's Health Alert Network has issued seven notices on 
Ebola, reaching hundreds of thousands of clinicians and others.
    CDC also is working to prepare U.S. healthcare facilities for safe 
management of patients with suspected Ebola virus and to educate health 
care professionals across the country about important precautionary 
measures related to Ebola. CDC communicates with health care workers on 
an ongoing basis through the HAN, Clinician Outreach and Communication 
Activities, and a variety of other existing tools and mechanisms.
    In regards to what private health organizations can do to prepare 
for such a public health emergency, CDC recommends the following steps 
to assist in any potential response:

     Health care organizations can encourage U.S. hospitals to 
be prepared to identify and initially manage patients with Ebola;
     Health care providers can increase their understanding of 
Ebola, using the latest healthcare guidance; and
     Health care organizations can support health care provider 
requests to work in West Africa assisting those affected by the Ebola 
epidemic. USAID provides information on volunteer needs on its website.

    Finally, CDC has issued advice for colleges, universities, and 
students about study abroad, foreign exchange, and other education-
related travel, as well as advice for students who have recently 
traveled from a country in which an Ebola outbreak is occurring. CDC 
advises that all non-essential travel, including education-related 
travel, to Guinea, Liberia, and Sierra Leone be postponed until further 
notice. Students, faculty, and staff who have recently traveled to 
countries where the Ebola outbreaks are occurring should consult with 
school authorities on what instructions to follow, and monitor their 
health for 21 days after returning. CDC advises colleges and 
universities to identify students, faculty, and staff who, within the 
past 21 days, have been in countries where Ebola outbreaks are 
occurring and conduct a risk assessment for each person to determine 
his or her level of risk exposure, as well as the appropriate public 
health response and medical care based on CDC's Interim Guidance for 
Monitoring and Movement of Persons with Ebola Virus Disease Exposure.
                            senator shaheen
    Question 1. How can we apply the lessons we are learning in the 
current global emergency response to better leverage our resources to 
support a long-term local epidemiologic infrastructure operated and 
staffed by local scientists and public health officials?
    Answer 1. The global response to Ebola underscores the need for 
well-functioning and effective health and public health systems across 
the world. The current response shows that capacities outlined in the 
Global Health Security (GHS) Agenda to prevent, detect, and respond to 
public health emergencies are critical in a country's ability to lessen 
the impact of infectious disease outbreaks. Several components of the 
immediate response to Ebola are key areas for GHS implementation--an 
EOC, laboratory capacity, surveillance, and workforce development.
    In this epidemic, we have seen that some countries, even with 
nascent detection and response capacities, were able to successfully 
contain and eradicate the outbreak after experiencing cases in their 
countries. An example is Nigeria, which used its existing EOC developed 
for the polio response and Field Epidemiology Training Program to 
monitor operations, conduct surveillance and contact tracing, showing 
that improvements to core public health systems are critical to 
responding to emerging threats.
    Some of the work we are currently doing for the response, including 
surveillance, information systems, workforce strengthening, EOC 
development, and laboratory services, will serve as the foundation for 
longer term GHS strengthening.

    Question 2. Among the various challenges that we face with this 
ongoing epidemic is collecting real time data in a rapidly changing 
situation. Further, sharing this information between corroborating 
agencies in an international context is challenging. How is CDC keeping 
pace with the data and making sure that decisionmakers have the best up 
to date information available to inform their planning?
    Answer 2. CDC has activated its EOC to help coordinate technical 
assistance and control activities with partners. On August 6, 2014, CDC 
elevated the EOC to a Level 1 activation, its highest level, because of 
the significance of the outbreak. CDC supports countries in 
establishing their own national and sub-national EOCs. Each of the 
three West African countries at the center of the epidemic now has an 
Incident Manager, reporting to the President of the country, to lead 
response efforts.
    Hundreds of CDC staff members have provided logistics, staffing, 
communication, analytics, management, and other support functions for 
the response. CDC has deployed several teams of public health experts 
to the West Africa region. CDC staff are deployed to Guinea, Liberia, 
Nigeria, Senegal, and Sierra Leone to assist with response efforts, 
including surveillance, contact tracing, data management, laboratory 
testing, and health education. CDC continues to send additional public 
health experts to the affected and neighboring countries. CDC experts 
have been deployed to non-affected border countries, including Cote 
d'Ivoire, to conduct assessments of Ebola preparedness in those 
countries.
    Through the Disaster Assistance Response Team (DART), led by USAID 
with CDC staff embedded, and regular communication with on-the-ground 
staff, the CDC EOC maintains daily interaction to obtain the most up-
to-date data from the field. This data feeds directly to each Ebola 
response team to shape plans and allow for nimble changes in tactics to 
address evolving situations in each affected country.
    In the United States, CDC has data collection and tracking 
mechanisms in place to monitor any potential case of the disease. CDC, 
along with other Federal agencies, has created and implemented a 
response plan to manage a laboratory-confirmed case of EVD in the 
United States, and is providing guidance to health care facilities 
about how to safely manage a patient with suspected EVD. This includes 
engagement in the following activities:

     Enhancing surveillance and laboratory testing capacity to 
detect cases domestically.
     Developing guidance and tools for health departments to 
conduct public health investigations.
     Providing recommendations for healthcare infection control 
and other measures to prevent disease spread.
     Providing guidance for flight crews, emergency medical 
units at airports, and U.S. CBP officers about reporting ill travelers 
to CDC.
     Coordinating with maritime authorities to assess the 
potential risk to the United States from cargo vessels from the four 
affected West African countries.
     Disseminating up-to-date information about the outbreak to 
the general public, international travelers, and public health 
partners.

    Question 3. Is CDC employing the latest mobile technologies and 
software to record and disseminate information?
    Answer 3. CDC employs extensive surveillance and sophisticated 
modeling techniques to gather, analyze and act on data and information, 
in cooperation with global partners.
    The Department of Health and Human Services (HHS), and in 
particular CDC, is working closely with the World Health Organization 
(WHO), the United Nations, the Ministries of Health in affected 
countries, and other international partners to respond to the current 
Ebola outbreak in West Africa. CDC receives regular updates of 
morbidity and mortality to evaluate the spread of the disease and 
combines this information with reports from CDC's staff deployed to the 
area. Hundreds of CDC staff members have provided logistics, staffing, 
communication, analytics, management, and other support functions for 
the response. CDC continues to commit significant staffing and 
financial resources to the international Ebola response both on the 
ground in West Africa and through its domestic EOC. CDC's health 
promotion teams, consisting of health communicators and public health 
advisors deployed to Guinea, Liberia, and Sierra Leone, are working 
closely with country embassies, UNICEF, WHO, ministries of health, and 
nongovernment organizations to develop public health messages and 
implement social mobilization activities. CDC is partnering with major 
telecommunications companies in the affected countries to disseminate 
messages across the countries (ORANGE and Cellcom in Guinea; Africell 
in Sierra Leone; and Cellcom and Lonestar in Liberia). CDC engaged with 
UNICEF and Focus 1000 in the development of a Knowledge, Attitudes, and 
Practices study and preliminary report in Sierra Leone and is using 
this report to inform future message strategies.
    CDC continues to update its communication products and webpages 
with new information on the Ebola outbreak for the general public and 
specific audiences. CDC is using social media as a way to share 
credible, factual information and to dispel misconceptions about Ebola.

    Question 4. Our Nation's intensive care units are at the forefront 
of caring for the most critically ill patients including during times 
of widespread medical emergencies such as pandemics. While we know that 
Ebola is not affecting a large number of Americans today, we do know 
that the next pandemic could be just around the corner and we need to 
ensure that our critical care system is equipped to respond. Dr. Bell 
and Dr. Robinson, does our hospital system currently have the necessary 
critical care infrastructure in place for this type of virus, such as 
appropriate critical care containment rooms?
    Answer 4. Any U.S. hospital should be prepared to identify, assess 
and isolate a patient with Ebola. CDC developed guidance documents and 
checklists to help U.S. hospitals prepare for, test, and treat patients 
with Ebola, and works to keep the health care system informed of new 
developments. CDC uses its HAN to provide information and guidance to 
U.S. healthcare workers and hospitals regarding EVD. CDC distributed a 
HAN notice August 1, 2014, and five updates have followed. The most 
recent HAN notice about Ebola was distributed on October 2, 2014.
    CDC created and implemented an operational plan outlining the 
course of action for the first 72 hours to manage a laboratory-
confirmed Ebola diagnosis in a patient. Plan activities include rapid 
dissemination of news regarding the Ebola case(s) to key public health, 
healthcare system, and emergency management partner organizations; 
providing current and timely information to State, local, and 
territorial public health departments; and coordinating critical issues 
management regarding State and local needs for the CDC EOC incident 
manager and other response task force teams.
    CDC has redoubled its efforts to educate American health care 
workers about how to isolate patients and how to protect themselves 
from infection, including developing and disseminating resources, 
hosting informational calls, and creating trainings. CDC has:

     Hosted Clinician Outreach and Community Activity calls for 
clinical professionals to provide information about what U.S. hospitals 
need to know to prepare for EVD.
     Created guidance about EVD for clinicians in U.S. health 
care settings.
     Posted a Medscape Expert Commentary for healthcare 
providers whose patients are travelers with concerns about Ebola. The 
commentary includes information about the Ebola outbreak in West 
Africa, the transmission Ebola virus, and how to talk to travelers 
about their risk.
     Created guidance for U.S. healthcare workers on 
``Infection Prevention and Control Recommendations for Hospitalized 
Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S. 
Hospitals.''
     Developed a checklist for hospitals to aid in Ebola 
preparedness that can be found on the CDC website.
     Built a Safety Training Course for Healthcare Workers 
Going to West Africa in Response to the 2014 Ebola Outbreak. The 
primary purpose of the course is to ensure that clinicians intending to 
provide medical care to patients with Ebola have sufficient knowledge 
of the disease and its transmission routes to work safely and 
efficiently in a well-designed Ebola Treatment Unit (ETU).
     Collated the Top 10 Ebola Response Planning Tips: Ebola 
Readiness Self-Assessment for State and Local Public Health Officials 
to help guide planning and readiness for Ebola response at State and 
local levels and assist health officials in assessing their 
jurisdictions' level of readiness for a potential Ebola response.
                            senator baldwin
    Question. The President recently outlined a comprehensive response 
to combat this epidemic that includes the efforts of an estimated 3,000 
U.S. forces and a strong partnership with the United Nations and our 
other international partners. The first cases of Ebola were reported in 
March; it is now October and the Ebola crisis is only worsening. Why 
did we not initiate this response in March? In hindsight, what should 
have been the United States' first action item when cases were first 
reported, and what can we learn from this to prevent the world from 
seeing such tragedy again?
    Answer. CDC is incorporating lessons learned as the response 
evolves, and, as is done after all large-scale responses, the agency 
will conduct a comprehensive ``after-action'' review to learn 
additional lessons that will prepare the agency to better respond to 
future events.
    CDC initiated the first stages of response in March 2014 when it 
activated its EOC to help coordinate technical assistance and control 
activities with partners. On August 6, 2014, CDC elevated the EOC to a 
Level 1 activation, its highest level, because of the significance of 
the outbreak. CDC supports countries in establishing their own national 
and sub-national EOCs. Each of the three West African countries at the 
center of the epidemic now has an Incident Manager, reporting to the 
President of the country, to lead response efforts.
    Hundreds of CDC staff members have provided logistics, staffing, 
communication, analytics, management, and other support functions for 
the response. CDC has deployed several teams of public health experts 
to the West Africa region. CDC staff are deployed to Guinea, Liberia, 
Nigeria, Senegal, and Sierra Leone to assist with response efforts, 
including surveillance, contact tracing, data management, laboratory 
testing, and health education. CDC continues to send additional public 
health experts to the affected and neighboring countries. CDC experts 
have been deployed to non-affected border countries, including Cote 
d'Ivoire, to conduct assessments of Ebola preparedness in those 
countries.
    Through the Global Disease Detection (GDD) program, CDC develops 
and strengthens global capacity to rapidly detect, accurately identify, 
and promptly contain emerging infectious disease and bioterrorist 
threats that occur internationally. The GDD Operations Center, 
implemented in 2007, is a surveillance system that enables the ongoing, 
systematic collection, management, analysis, interpretation, and 
dissemination of health-related data.
                             senator warren
    Question 1. If the Global Security Agenda had been launched 5 years 
ago, and we already had these pieces in place, would this epidemic have 
been better contained?
    Answer 1. The global response to Ebola underscores the need for 
well-functioning and effective health and public health systems across 
the world. The current response shows that capacities outlined in the 
Global Health Security Agenda (GHSA) to prevent, detect, and respond to 
public health emergencies are critical in a country's ability to lessen 
the impact of infectious disease outbreaks. Had these capacities been 
developed, the course of this outbreak would likely have resulted in 
earlier containment, fewer deaths and decreased economic ramifications.
    Several components of the immediate response to Ebola are key areas 
for GHSA implementation--EOC, laboratory capacity, surveillance, and 
workforce development. In this epidemic, we have seen that some 
countries, even with nascent detection and response capacities, were 
able to successfully contain the outbreak after experiencing cases in 
their countries. An example is Nigeria, which used its existing EOC and 
Field Epidemiology Training Program to monitor operations, conduct 
surveillance, and conduct contact tracing, proving that even basic 
improvements to public health systems can be effective in responding to 
emerging threats.
    Some of CDC's work in this response, including surveillance, 
information systems, workforce strengthening, EOC development, and 
laboratory services will serve as the foundation for longer-term, 
broad, global health security strengthening.

    Question 2. How will the Agenda help to address the challenges of 
political instability, the lack of infrastructure, and the lack of 
basic health care resources that have all played a huge role in the 
continued spread of this epidemic?
    Answer 2. The vision of the Global Health Security Agenda is a 
world safe and secure from global health threats posed by infectious 
diseases--where we can prevent or mitigate the impact of naturally 
occurring outbreaks and intentional or accidental releases of dangerous 
pathogens, rapidly detect and transparently report outbreaks when they 
occur, and employ an interconnected global network that can respond 
effectively to limit the spread of infectious disease outbreaks in 
humans and animals, mitigate human suffering and the loss of human 
life, and reduce economic impact.
    Ebola is the most tangible--and tragic--example so far for why the 
global community must work together to make the world safer from 
infectious disease outbreaks. The Ebola crisis in West Africa is 
precisely the kind of complicated disease eruption the Global Health 
Security Agenda is designed to address. The GHSA will help prevent, 
detect and respond to infectious disease outbreaks in the following 
ways:

     Coordination and communication among nations will be 
strengthened and streamlined, allowing disease outbreaks to be 
discovered and characterized at the earliest possible moment.
     Laboratory capacity will be increased and operating 
standards strengthened so that potential diseases can be accurately and 
precisely identified. Then treatment protocols can be established more 
quickly to effectively treat patients and protect health care workers.
     New disease detectives will be trained around the world 
and deployed to close gaps in surveillance and provide early detection.
     More countries will be equipped with networked EOCs 
governed by a universal set of standards and rules that will allow a 
unified and effective response.
     The availability of more detailed information sooner will 
allow a more unified response and, if needed, the ability of partner 
countries to surge experts to affected areas so disease outbreaks are 
contained at the earliest possible moment and while they are still 
small in scope.

    Ultimately, having better information around disease detection and 
response enables more timely and accurate communication with the 
public. This can help limit unease and panic that affects commerce, 
travel, political stability and public health.

    Question 3. How would the effectiveness of the Agenda be maximized 
by investments to improve the basic healthcare infrastructure of 
developing nations?
    Answer 3. The GHSA outlines nine objectives to accelerate progress 
toward a world safe and secure from infectious disease threats in 
partnership with other nations, international organizations and public 
and private stakeholders. Several of these address the investments 
related to improve health care systems:

     Reduce the number and magnitude of infectious disease 
outbreaks. Establish effective programs for vaccination against 
epidemic-prone diseases and for nosocomial infection control.
     Train and deploy an effective disease surveillance 
workforce. Build capacity for trained and functioning biosurveillance 
workforce, with trained disease detectives and laboratory scientists.
     Improve global access to medical and non-medical 
countermeasures during health emergencies. Strengthen capacity to 
produce or procure personal protective equipment, medications, 
vaccines, and technical expertise, as well as the capacity to plan for 
and deploy non-medical countermeasures. Strengthen policies and 
operational frameworks to share public and animal health and medical 
personnel and countermeasures with partners.

    Question 4. Who do you think should be ultimately responsible for 
the international coordination and financing of outbreak responses when 
local governments are unable to do so?
    Answer 4. To respond adequately to a major crisis such as the Ebola 
Outbreak in West Africa, multiple actors are needed and, in fact, are 
now responding. They include U.N. agencies (such as WHO, UNICEF, World 
Bank), the U.S. Government, other countries, NGO's (such as MSF and the 
International Red Cross), as well as other entities within the private 
sector. Within the West Africa region affected by the Ebola outbreak, 
USAID continues to lead the United States' overseas response, while the 
Department of Defense, CDC, Department of State, and other departments 
and agencies are supporting the whole-of-government approach to this 
national security priority. USAID has deployed a DART to coordinate 
planning, operations, logistics and other components of the interagency 
effort. CDC staff is working with Ministries of Health to improve 
surveillance, contact tracing, laboratory capacity, emergency 
operations planning and other critical capabilities.
    HHS, and in particular CDC, is working closely with the World 
Health Organization (WHO), the United Nations, the Ministries of Health 
in affected countries, and other international partners to respond to 
the current Ebola outbreak in West Africa. The Ebola epidemic reminds 
us that our global efforts to build the capacity to prevent, detect, 
and rapidly respond to infectious disease threats like EVD have never 
been more vital.
    In February 2014, the United States came together with nations 
around the world to launch the Global Health Security Agenda (GHSA) as 
a 5-year effort to accelerate action. On September 26, 2014, President 
Obama met with leaders of 40 nations as well as top Administration 
officials to advance progress in the GHSA.
    CDC receives regular updates of morbidity and mortality to evaluate 
the spread of the disease and combines this information with reports 
from CDC's staff deployed to the area. Hundreds of CDC staff members 
have provided logistics, staffing, communication, analytics, 
management, and other support functions for the response. CDC continues 
to commit significant staffing and financial resources to the 
international Ebola response both on the ground in West Africa and 
through its domestic EOC.
    CDC has activated its EOC to help coordinate technical assistance 
and control activities with partners. CDC supports countries in 
establishing their own national and sub-national EOCs. Each of the 
three West African countries at the center of the epidemic now has an 
Incident Manager, reporting to the President of the country, to lead 
efforts.
    CDC continues to send additional public health experts to the 
affected countries. CDC staff are assisting with setting up an 
emergency response structure, contact tracing, providing advice on exit 
screening and infection control at major airports, and providing 
training and education in the affected countries.
    The below mechanisms for coordination have been developed to direct 
their support to the target population in West Africa. At the 
international level, the United Nations has established its Mission for 
Ebola Emergency Response (UNMEER) in Ghana, and is serving as a 
regional hub for logistics and coordination of the U.N. Bodies 
(including WHO, UNICEF, and others), while working closely with the 
Governments of Guinea, Liberia and Sierra Leone.
    WHO-AFRO has established a Regional Outbreak Coordination Center in 
Conakry, Guinea.
    Within countries, through their country offices, WHO is 
coordinating support to the national operational plans. The United 
States has established DARTs in each of the affected countries for 
coordination of U.S. Government planning, operations, logistics, 
administrative issues and other critical areas related to the U.S. 
Government interagency response. These efforts are all done in direct 
coordination with national governments, given that they have 
responsibility for coordinating their respective national response 
efforts.
    Private sector resources also may be called upon to support lead 
agencies and directly impacted areas. For the private sector, this 
includes companies lending their core competencies and assets on the 
ground as well as providing financial resources to support other 
priorities. The private sector also can contribute by maintaining 
operations in impacted countries/regions as they are an important part 
of local economies.

    Question 5. What is the ideal design for an international response 
system for future outbreaks?
    Answer 5. The International Health Regulations (IHR, 2005) provide 
the legally binding framework for the coordination of the management of 
events that may constitute a public health emergency of international 
concern. IHR aims to improve the capacity of all countries to detect, 
assess, notify, and respond to public health threats. While IHR was 
signed by the 194 member states of the World Health Organization, fewer 
than 20 percent of those countries reported in 2012 that they have 
fully achieved compliance with IHR and are fully prepared to detect and 
respond to disease threats. The aim of the Global Health Security 
Agenda is to close this gap.
    The Global Health Security Agenda (GHSA) is an effort by nations, 
international organizations, and civil society to accelerate progress 
toward a world safe and secure from infectious disease threats; to 
promote global health security as an international priority; and to 
spur progress toward full implementation IHR and other relevant global 
health security frameworks.

    Question 6. What is the ideal design for our national response 
system for future international outbreaks?
    Answer 6. CDC is fully supportive of the National Response 
Framework (updated in 2013) and the National Incident Management System 
(NIMS) outlined within it. The guiding principles of NIMS are: engaged 
partnership; tiered response; scalable, flexible, and adaptable 
operational capabilities; unity of effort through unified command; and 
readiness to act.
    The National Response Framework works best when State and local 
health departments are fully staffed and well trained and have robust 
surveillance and laboratory capacity. Strong clinical networks that 
local health departments can link into for novel or unfamiliar global 
infectious disease outbreaks and a stockpile of medical countermeasures 
are also important as scalable resources. Another scalable resource 
that is needed for international and domestic outbreaks is a cadre of 
highly trained public health workers, including disease detectives, 
capable and ready to respond. CDC supports these goals domestically 
through the Public Health Emergency Response (PHEP) and Epidemiology 
and Laboratory Capacity (ELC) cooperative agreements, the Strategic 
National Stockpile (SNS), and support for the Laboratory Response 
Network (LRN) as well as internationally through programs such as the 
Field Epidemiology Training Program (FETP), Global Disease Detection 
Centers, and the Global Health Security Agenda.

    Question 7. How would long term investments to improve the basic 
healthcare infrastructure of developing nations help to improve our 
ability to respond to new outbreaks and epidemics?
    Answer 7. Health care services are a part of every nation's public 
health system, and they play a crucial role. There are linkages between 
Global Health Security and health care services. The Global Health 
Security Agenda takes a public health, or systems-level approach. 
Through the Agenda, the United States commits to working with at least 
30 partner countries (containing at least 4 billion people) to prevent, 
detect and effectively respond to infectious disease threats, whether 
naturally occurring or caused by accidental or intentional releases of 
dangerous pathogens. The objectives of the agenda emphasize systems-
level interventions in the three areas: Prevent, Detect, and Respond. 
Select activities include:

     Prevent: Countries will have systems, policies and 
procedures in place to prevent or mitigate avoidable outbreaks.
     Detect: Countries will have real-time biosurveillance and 
effective modern diagnostics in place that are able to reliably conduct 
at least five of the 10 core tests.
     Respond: Countries will have a public health EOC 
functioning according to minimum common standards.

    Investing in global health security means investing in public 
health systems, and systems such as these provide critical information 
needed to inform health care practice. For instance, reliable nation-
wide laboratory networks are needed for the detection of priority 
pathogens. These same networks also are needed for the accurate 
diagnosis of priority pathogens in individuals. In addition, 
information gathered through public health surveillance can help inform 
decisions about how limited healthcare resources could be targeted to 
be most impactful.

    Question 8. How are the United States and international aid 
organizations helping to take care of health care needs besides Ebola 
in the epidemic regions?
    Answer 8. The U.S. Government is making investments in the region 
to address multiple health issues such as HIV and AIDS, maternal and 
child health, nutrition, malaria, and vaccine preventable diseases, 
including polio. Relationships on the ground, nurtured in part by CDC's 
work in the region have proven to be important assets in addressing the 
current Ebola outbreak. CDC also continues to support priority 
activities in the region as well.
    The United States and international organization partners continue 
to support the President's Malaria Initiative in the epidemic regions 
ensuring that planned malaria prevention activities, such as long-
lasting insecticide treated bed net distributions, health indicator 
surveys, and healthcare working trainings are minimally disrupted. CDC 
is sending staff to support in-country national malaria control 
programs while the Resident Advisors are engaged in the Ebola response. 
Recently, CDC/WHO revised guidance for the diagnosis of malaria in 
Ebola countries to respond to the needs of the healthcare workers and 
partner organizations by recommending treatment options for specific 
populations in the Ebola affected areas to reduce the incidence of 
febrile illnesses.
    CDC plays a critical role in helping Ministries of Health in 
partner countries build strong, sustainable programs that respond 
effectively to the HIV/AIDS epidemic. CDC provides support to more than 
60 countries as a key partner in the U.S. President's Emergency Plan 
for AIDS Relief (PEPFAR). CDC through PEPFAR, is working to achieve 
that inspiring goal through proven science, smart investments, and 
shared responsibility with partner countries.
    CDC also is continuing immunization activities in the region. CDC 
is working with partners at WHO and UNICEF to maintain high levels of 
polio immunity there as part of the global effort to eradicate polio. 
CDC also supports measles vaccination and related immunization 
activities there. The worsening epidemic has slowed immunization 
activities in Ebola affected areas; however, the networks established 
by immunization activities are being used to provide education and 
information about stopping the spread of Ebola.
    In addition, CDC's expertise in responding to the polio epidemic in 
Nigeria was leveraged to assist in establishing emergency response 
operations in that country to stop the spread of Ebola. The threat to 
Nigeria posed by the arrival in Lagos of a patient acutely ill with 
Ebola was potentially enormous, but the virus does not appear to have 
been widely spread there. The limited spread against the backdrop of 
the large, dense, urban environment suggests early response efforts 
were successful. CDC provided key guidance, and leadership, in a 
variety of areas, including incident management, contact tracing, 
public messaging and information, and port security to encourage a 
quick and effective response.
                           senator alexander
    Question 1. The United States has pledged support to help fight 
Ebola, and there are other countries stepping up to the plate as well. 
How are these efforts being coordinated and is it effective? Who is on 
the flagpole?
    Answer 1. Within the West Africa region affected by the Ebola 
outbreak, USAID continues to lead the United States' overseas response, 
while CDC, the Department of Defense, Department of State, and other 
Federal Departments and Agencies are supporting the whole-of-government 
approach to this national security priority. USAID has deployed a DART 
to coordinate planning, operations, logistics and other components of 
the interagency effort. CDC staff is working with Ministries of Health 
to improve surveillance, contact tracing, laboratory capacity, 
emergency operations planning and other critical capabilities.
    HHS, and in particular CDC, is working closely with the World 
Health Organization (WHO), the United Nations, the Ministries of Health 
in affected countries, and other international partners to respond to 
the current Ebola outbreak in West Africa. The Ebola epidemic reminds 
us that our global efforts to build the capacity to prevent, detect, 
and rapidly respond to infectious disease threats like EVD have never 
been more vital. In February 2014, CDC came together with nations 
around the world to launch the GHSA as a 5-year effort to accelerate 
action. On September 26, 2014, President Obama met with leaders of 40 
nations as well as top Administration officials to advance progress in 
the GHSA.
    CDC receives regular updates of morbidity and mortality to evaluate 
the spread of the disease and combines this information with reports 
from CDC's staff deployed to the area. Hundreds of CDC staff members 
have provided logistics, staffing, communication, analytics, 
management, and other support functions for the response. CDC continues 
to commit significant staffing and financial resources to the 
international Ebola response both on the ground in West Africa and 
through its domestic EOC.
    CDC has activated its EOC to help coordinate technical assistance 
and control activities with partners. CDC supports countries in 
establishing their own national and sub-national EOCs. Each of the 
three West African countries at the center of the epidemic now has an 
Incident Manager, reporting to the President of the country, to lead 
efforts.
    CDC continues to send additional public health experts to the 
affected countries. CDC staff are assisting with setting up an 
emergency response structure, contact tracing, providing advice on exit 
screening and infection control at major airports, and providing 
training and education in the affected countries.

    Question 2. Dr. Frieden cautioned that, ``The window of opportunity 
to stop Ebola from spreading widely through Africa and becoming a 
global threat for years to come is closing, but it is not yet 
closed.''Is that window still open? What do we need to be doing to keep 
that window open?
    Answer 2. CDC continues to increase our efforts, and strongly 
encourage global partners, to ``keep the window open.'' The global 
community still has an opportunity to reverse the course of the 
epidemic in the three affected countries and prevent the spread of 
Ebola to other countries in Africa and throughout the world, but 
coordinated leadership and unwavering support must be brought to bear. 
HHS, and in particular CDC, is working closely with the World Health 
Organization (WHO), the United Nations, the Ministries of Health in 
affected countries, and other international partners to respond to the 
current Ebola outbreak in West Africa.
    CDC continues to commit resources at never-before seen levels to 
support the U.S. Government response to the Ebola outbreak. CDC has 
activated its EOC to help coordinate technical assistance and control 
activities with partners. CDC supports countries in establishing their 
own national and sub-national EOCs. Each of the three West African 
countries at the center of the epidemic now has an Incident Manager, 
reporting to the President of the country, to lead response efforts. 
CDC is also:

     Providing hundreds of CDC staff members for logistics, 
staffing, communication, analytics, management, and other support 
functions for the response. CDC has deployed several teams of public 
health experts to the West Africa region. CDC staff are deployed to 
Guinea, Liberia, Nigeria, Senegal, and Sierra Leone to assist with 
response efforts, including surveillance, contact tracing, data 
management, laboratory testing, and health education. CDC staff are 
assisting with setting up an emergency response structure, contact 
tracing, providing advice on exit screening and infection control at 
major airports, and providing training and education in the affected 
countries. CDC experts have also been deployed to non-affected border 
countries, including Cote d'Ivoire, to conduct assessments of Ebola 
preparedness in those countries.
     Working with airlines, airports, and ministries of health 
in West Africa to provide technical assistance for developing exit 
screening and travel restrictions in the countries where Ebola 
outbreaks are occurring.
     With CBP, conducting enhanced entry screening to detect 
possible cases of Ebola in travelers who have traveled to the United 
States from or through Guinea, Liberia, and Sierra Leone. Enhanced 
entry screening at five U.S. airports (New York-JFK, Washington-Dulles, 
Newark, Chicago-O'Hare, and Atlanta) will evaluate travelers from the 
affected countries in West Africa.
     Redoubling its efforts to educate U.S. healthcare workers 
on how to isolate patients and how to protect themselves from 
infection. Resources for U.S. healthcare workers are available on the 
CDC website. Over the coming days and weeks, CDC will be working with 
other Federal, State, and local governments and private organizations 
to strengthen U.S. readiness for the detecting and preventing 
additional cases of Ebola in this country. These efforts include the 
aforementioned enhanced entry screening at five U.S. ports of entry and 
enhanced outreach to healthcare workers and hospitals to improve their 
infection control practices and policies.

    Question 3. How is this outbreak testing the boundaries of what we 
know? In what manner will we need to alter the response given the 
different characteristics of this epidemic?
    Answer 3. The epidemic is unprecedented in size, scope, and 
complexity, but the fundamental risk factors and primary modes of 
transmission are the same as in previous Ebola outbreaks. The core 
public health interventions that have worked to stop previous Ebola 
outbreaks--surveillance, case identification and contact tracing, 
isolation and treatment, safe burials--will work to stop this epidemic. 
CDC along with other parts of the U.S. Government and global partners 
are working on multiple fronts to expand capacity to meet this 
challenge.

    Question 4. We know that there is desperate need for doctors and 
nurses to care for people sick with Ebola. Estimates suggest a facility 
treating 70 Ebola patients' needs a minimum of 250 health care staff, 
but Liberia didn't even have that many doctors in its country even 
before the outbreak. The United States Agency for International 
Development has created a website where health professionals can sign 
up to help with the Ebola response.
    How are you coordinating with USAID? What are you doing to prepare 
these volunteers? Please describe any training provided to these 
volunteers.
    Answer 4. Within the West Africa region affected by the Ebola 
outbreak, USAID continues to lead the United States' overseas response, 
while CDC, the Department of Defense, Department of State, and other 
Federal Departments and Agencies are supporting the whole-of-government 
approach to this national security priority. USAID deployed a DART to 
coordinate planning, operations, logistics and other components of the 
interagency effort. USAID is the lead Agency for recruiting and 
coordinating volunteers for the response.
    Humanitarian aid workers play a vital role in the Ebola outbreak 
response, and CDC encourages them to continue the important work being 
done to stop the disease's spread at its source. CDC developed guidance 
for humanitarian aid organizations whose employees or volunteers are 
working in countries where an Ebola outbreak is occurring to help them 
plan for safe deployment. The recommendations include steps to take 
before departure, during travel, and upon return to the United States.
    CDC also created a Safety Training Course for healthcare workers 
going to West Africa in response to the 2014 Ebola outbreak. The 
primary purpose of the course is to ensure that clinicians intending to 
provide medical care to patients with EVD have sufficient knowledge of 
the disease and its transmission routes to work safely and efficiently 
in a well-designed Ebola Treatment Unit (ETU). In addition, CDC 
developed an introductory training course for licensed clinicians 
(e.g., nurses, physicians, and other healthcare providers) intending to 
work in an ETU in Africa to ensure that these clinicians have 
sufficient knowledge of the disease and its transmission routes to work 
safely and efficiently. The 3-day course is being given weekly and is 
already full for the next few months.
    Question 5. Since the hearing, we have had a patient land in the 
United States one airplane ride away from a person who was exposed to 
Ebola landing in the United States and becoming ill. What is the 
Department of Health and Human Services doing to prepare?
    There are four specialized medical isolation units in the United 
States that have been reported to be available to treat Ebola patients. 
Three of these have been used to treat the patients or exposed 
individuals brought back to the United States. If these fill to 
capacity and other individuals sick with Ebola are in need of care, how 
prepared are our hospitals to take care of Ebola patients?
    Answer 5. CDC has created plans outlining its course of action for 
when a laboratory-confirmed Ebola diagnosis occurs in the United 
States. The operational plans include assistance to State, tribal, 
territorial and local officials and the domestic health care community, 
and leverage CDC's expertise and resources in epidemiology, 
surveillance, coordination of laboratory testing, health promotion and 
communication, healthcare and infection control, traveler health and 
screening.
    CDC's response to a diagnosed case follows three key public health 
tenets: prevention, detection and response. The concept of prevention 
focuses on actions which can affect the spread of the disease. 
Detection centers on activities to find the disease through 
surveillance and contact tracing. CDC's response efforts include its 
agency-wide incident management and response capabilities in support of 
domestic requirements. CDC, along with other Federal agencies, has 
created and implemented a response plan to manage a laboratory-
confirmed case of EVD in the United States and is providing guidance to 
health care facilities about how to safely manage a patient with 
suspected EVD. This includes engagement in the following activities:

     Enhancing surveillance and laboratory testing capacity to 
detect cases domestically.
     Developing guidance and tools for health departments to 
conduct public health investigations.
     Providing recommendations for healthcare infection control 
and other measures to prevent disease spread.
     Providing guidance for flight crews, emergency medical 
units at airports, and CBP officers about reporting ill travelers to 
CDC.
     Coordinating with maritime authorities to assess the 
potential risk to the United States from cargo vessels from the four 
affected West African countries.
     Disseminating up-to-date information about the outbreak to 
the general public, international travelers, and public health 
partners.

    CDC has developed guidance documents and checklists to help U.S. 
hospitals prepare for, test, and treat patients with Ebola, and works 
to keep the health care system informed of new developments. CDC uses 
its Health Alert Network (HAN) to provide information and guidance to 
U.S. healthcare workers and hospitals regarding EVD. A HAN notice was 
distributed by CDC on August 1, 2014, and five updates have followed. 
The most recent HAN notice about Ebola was distributed on October 2, 
2014.
    CDC has redoubled its efforts to educate American health care 
workers about how to isolate patients and how to protect themselves 
from infection, including developing and disseminating resources, 
hosting informational calls, and creating trainings. CDC has:

     Hosted Clinician Outreach and Community Activity calls for 
clinical professionals to provide information about what U.S. hospitals 
need to know to prepare for EVD.
     Created guidance about EVD for clinicians in U.S. health 
care settings.
     Posted a Medscape Expert Commentary for healthcare 
providers whose patients are travelers with concerns about Ebola. The 
commentary includes information about the Ebola outbreak in West 
Africa, the transmission of the Ebola virus, and how to talk to 
travelers about their risk.
     Created guidance for U.S. healthcare workers on 
``Infection Prevention and Control Recommendations for Hospitalized 
Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S. 
Hospitals.''
     Developed a checklist for hospitals to aid in Ebola 
preparedness, which can also be found on the CDC website.
     Built a Safety Training Course for Healthcare Workers 
Going to West Africa in Response to the 2014 Ebola Outbreak. The 
primary purpose of the course is to ensure that clinicians intending to 
provide medical care to patients with Ebola have sufficient knowledge 
of the disease and its transmission routes to work safely and 
efficiently in a well-designed ETU.
     Collated the Top 10 Ebola Response Planning Tips: Ebola 
Readiness Self-Assessment for State and Local Public Health Officials 
to help guide planning and readiness for Ebola response at State and 
local levels and assist health officials in assessing their 
jurisdictions' level of readiness for a potential Ebola response.

    CDC also is working with additional hospitals to ready their 
facilities for additional patients with Ebola. Any U.S. hospital should 
be prepared to identify, assess and isolate a patient with Ebola. CDC 
developed guidance documents and checklists to help U.S. hospitals 
prepare for, test, and treat patients with Ebola, and works to keep the 
health care system informed of new developments. CDC uses its HAN to 
provide information and guidance to U.S. healthcare workers and 
hospitals regarding Ebola. CDC distributed a HAN notice August 1, 2014, 
and five updates have followed. The most recent HAN notice about Ebola 
was distributed on October 2, 2014.
    CDC created plans outlining its course of action for when a 
laboratory-confirmed Ebola diagnosis occurs in the United States. The 
operational plans include assistance to State, tribal, territorial and 
local officials and the domestic health care community, and leverage 
CDC's expertise and resources in epidemiology, surveillance, 
coordination of laboratory testing, health promotion and communication, 
healthcare and infection control, traveler health and screening.
    CDC's response to a diagnosed case follows three key public health 
tenets: prevention, detection and response. The concept of prevention 
focuses on actions which can affect the spread of the disease. 
Detection centers on activities to find the disease through 
surveillance and contact tracing. CDC's response efforts include its 
agency-wide incident management and response capabilities in support of 
domestic requirements.
                   senator alexander and senator burr
    Question. You State in your testimony, ``We do not view Ebola as a 
significant public health threat to the United States.'' Could you 
please reconcile this statement with the fact that in 2006 then 
Secretary of Homeland Security Michael Chertoff determined, pursuant to 
Section 319F-2 of the Public Health Service Act that the Ebola virus 
presents a material threat against the United States population 
sufficient to affect national security, and that in August of this year 
the Secretary used this determination to authorize emergency use of a 
diagnostic for identification of Ebola virus.
    Answer. The difference between the two statements is that the 
former deals with the natural transmission of Ebola as a public health 
concern, whereas the latter primarily has to do with Ebola's potential 
for harm if artificially disseminated in a bioterrorist attack. In the 
United States, while there may be secondary cases among contacts of an 
imported Ebola case, the public health system will stop Ebola before an 
outbreak occurs. From a public health perspective, we know how to 
contain Ebola and we have the systems to do so. A DHS Material Threat 
Determination is made based on the risk of a terrorist using Ebola as a 
bio-weapon. DHS has determined that in certain scenarios the 
intentional use of the Ebola virus as a weapon could affect national 
security, even recognizing the public health system's ability to 
control outbreaks. CDC is working closely with the Food and Drug 
Administration (FDA) to approve Emergency Use Authorizations (EUAs) 
that make available diagnostic and therapeutic medical devices to 
diagnose and respond to public health emergencies, whether of natural 
or deliberate origin. As a result, FDA has enacted several EUAs for 
laboratory tests to aid in detecting the Ebola virus.
                             senator moran
Global Health Security
    Question 1. Dr. Bell, the Administration requested a new Global 
Health Security Initiative in fiscal year 2015. This Initiative would 
strengthen the capacity to prevent the introduction and spread of 
global health threats in 12 countries: Uganda, Vietnam, India, Kenya, 
South Africa, Kazakhstan, Georgia, Thailand, Tanzania, Jordan, 
Philippines, and Ethiopia. Given the need for this kind of program in 
West Africa, would the list of 12 countries change given the Ebola 
outbreak?
    Answer 1. As part of the Ebola response, CDC is working to build 
key components of the Global Health Security Agenda (GHSA), but the 
scope and impact is much greater than just stopping the Ebola outbreak. 
The vision of the Global Health Security Agenda is to create a world 
safe and secure from global health threats posed by infectious 
diseases--where we can prevent or mitigate the impact of naturally 
occurring outbreaks and intentional or accidental releases of dangerous 
pathogens, rapidly detect and transparently report outbreaks when they 
occur, and employ an interconnected global network that can respond 
effectively to limit the spread of infectious disease outbreaks in 
humans and animals, mitigate human suffering and the loss of human 
life, and reduce economic impact.
    We want to be sure to increase country capacity throughout the 
world so that another Ebola-like crisis can be averted. We don't know 
where the next public health emergency will occur, so it is imperative 
to assist as many countries as possible to be able to prevent, detect 
and respond to emerging threats.
    We are expanding our efforts in West Africa and exploring 
opportunities to engage with Ministries of Health on GHSA once the 
acute needs of the Ebola response are met.

    Question 2. If so, which countries will receive funding in fiscal 
year 2015 if the Global Health Security Initiative is funded?
    Answer 2. The requested funding will reduce risks to Americans by 
enhancing capacity for vulnerable countries to prevent disease 
outbreaks, detect them early, and swiftly respond before they become 
epidemics that threaten our national security. We will prioritize 
urgently needed investments in vulnerable nations, transport hubs, and 
States without the capacity to prevent global spread of Ebola or stem 
the tide of future threats. It is important to maintain the flexibility 
to make adjustments given the dynamic national and global health 
security environment in these countries. We also expect that other key 
donor partners will leverage this effort under the Global Health 
Security Agenda to complement our funding.
Ebola Response Plan
    Question 3. Dr. Bell, what is the plan for a U.S. Government 
response? How do we help get the Ebola outbreak under control? Which 
agency is in charge of the response efforts?
    Answer 3. Public health knows how to stop the spread of 
communicable diseases. To halt the spread of Ebola, the links of 
transmission between people must be interrupted. Public health does 
that by making sure that every person with Ebola is promptly diagnosed 
and promptly isolated and that their contacts are identified and 
actively monitored every day for 21 days. If any of the contacts 
develop symptoms or fever, we follow the same process again. That is 
how public health authorities have stopped every Ebola outbreak in 
history except the one currently in West Africa.
    HHS, and in particular CDC, is working closely with the World 
Health Organization (WHO), the United Nations, the Ministries of Health 
in affected countries, and other international partners to respond to 
the current Ebola outbreak in West Africa. CDC receives regular updates 
of morbidity and mortality to evaluate the spread of the disease and 
combines this information with reports from CDC's staff deployed to the 
area. Hundreds of CDC staff members have provided logistics, staffing, 
communication, analytics, management, and other support functions for 
the response. CDC continues to commit significant staffing and 
financial resources to the international Ebola response both on the 
ground in West Africa and through its domestic EOC.
    CDC is working closely with U.S. Agency for International 
Development (USAID) and its Office of Foreign Disaster Assistance 
(OFDA) to support the deployment to Liberia of a DART, which is 
overseeing the U.S. Government's Ebola response in West Africa.
    CDC, in partnership with WHO's Global Outbreak Alert and Response 
Network and the U.S. National Institutes of Health (NIH), provided a 
field laboratory to Liberia to increase the number of specimens being 
tested for Ebola. The lab is currently operating at full capacity and 
is only the second site in Liberia capable of testing specimens from 
patients with suspected Ebola. CDC has also deployed a second 
laboratory in Sierra Leone.
    CDC has activated its EOC to help coordinate technical assistance 
and control activities with partners. On August 6, 14, CDC elevated the 
EOC to a Level 1 activation, its highest level, because of the 
significance of the outbreak. CDC supports countries in establishing 
their own national and sub-national EOCs. Each of the three West 
African countries at the center of the epidemic now has an Incident 
Manager, reporting to the President of the country, to lead response 
efforts.
    Hundreds of CDC staff members have provided logistics, staffing, 
communication, analytics, management, and other support functions for 
the response. CDC has deployed several teams of public health experts 
to the West Africa region. CDC staff are deployed to Guinea, Liberia, 
Nigeria, Senegal, and Sierra Leone to assist with response efforts, 
including surveillance, contact tracing, data management, laboratory 
testing, and health education. CDC continues to send additional public 
health experts to the affected and neighboring countries. CDC experts 
have been deployed to non-affected border countries, including Cote 
d'Ivoire, to conduct assessments of Ebola preparedness in those 
countries.
Risk to Americans
    Question 4. Dr. Bell, what is the risk of Ebola spreading from West 
Africa to the United States?
    Answer 4. In response to the case of Ebola in the United States, 
teams from CDC are deployed to Dallas to assist with the investigation. 
They are supported 24/7 by CDC's EOC and Ebola experts at CDC's Atlanta 
headquarters. Teams work closely with State and local health 
departments in finding, assessing, and assisting everyone who came into 
contact with the Ebola patient. Although the risk spread of Ebola in 
the United States is very low, CDC and partners are taking precautions 
to isolate any cases of Ebola and prevent the spread of the disease. 
CDC recognizes that even a single case of Ebola diagnosed in the United 
States raises concerns and that when a case is imported into the United 
States, secondary cases resulting from transmission from that case may 
occur. CDC and partners are taking precautions to contain any cases of 
Ebola and prevent the spread of the disease.
    Every day, CDC works closely with partners at U.S. international 
airports and other ports of entry to look for sick travelers with 
possible contagious diseases. CDC has enhanced its outreach with DHS 
and other partners at ports of entry (primarily international airports) 
to use routine procedures for identifying and reporting travelers who 
show signs of infectious disease. CDC and DHS are conducting enhanced 
entry screening at five U.S. airports (New York's JFK International, 
Washington-Dulles, Newark, Chicago-O'Hare, and Atlanta) for all U.S.-
bound air travelers who have been in Guinea, Liberia, or Sierra Leone. 
CDC provides interim guidance for monitoring people potentially exposed 
to Ebola and for evaluating their intended travel, including the 
application of movement restrictions when indicated.
    The virus is not transmitted easily, does not spread from people 
who are asymptomatic, and the United States has effective infection 
control measures in place to prevent the spread of the disease in the 
United States. Medical and public health professionals across the 
country have been preparing to respond, and any U.S. hospital should be 
prepared to identify, assess and isolate a patient with Ebola.
                            senator cochran
Border Security and Ebola
    Question 1. Dr. Bell, it is my understanding that the Centers for 
Disease Control and Prevention is working closely with U.S. Customs and 
Border Protection and other partners at our ports of entry, 
particularly international airports, to identify travelers who show 
signs of infectious disease. While this is an important step, I am 
hopeful that we are also paying close attention to our land border as a 
potential entry location. Can you specifically speak to the 
contingencies that are being deployed in the event Ebola arrives from 
our Nation's Southwest border?
    Answer 1. We defer to the DHS with regard to contingencies at U.S. 
borders. We do note that CDC and partners are taking precautions to 
prevent the spread of Ebola to other countries. The U.S. Southwest 
border is not a major route of entry for people coming from the 
affected countries in West Africa. CDC has issued a Warning Level 3 
(the highest level) travel notice for the three countries where the 
Ebola outbreak is severe. U.S. citizens should avoid all nonessential 
travel to Guinea, Liberia, and Sierra Leone. CDC is assisting with exit 
screening and communication efforts in West Africa to prevent sick 
travelers from boarding commercial planes, buses, trains, or ships. CDC 
also has issued interim guidance about Ebola virus infection for 
airline flight crews, cleaning personnel, and cargo personnel. This is 
part of a layered approach that includes exit screening and standard 
public health practices such as patient isolation and contact tracing 
in countries with Ebola outbreaks. Successful containment of the recent 
Ebola outbreaks in Nigeria and the Democratic Republic of Congo 
demonstrate the effectiveness of this approach. Increasing awareness 
and preparedness here in the United States to rapidly identify and 
isolate potential Ebola patients and ensuring ready access to 
diagnostic testing through the Laboratory Response Network are 
additional components of this approach. Ultimately, the best way to 
protect Americans from Ebola is to stop the outbreak in West Africa.
Response from International Community
    Question 2. Thank you for coming in today to describe efforts by 
the U.S. Government to respond to the Ebola outbreak in West Africa. I 
am hopeful that the United States can play a leadership role in 
addressing this humanitarian crisis, but I am also curious about the 
contributions of international organizations and our partner nations. 
Will you please describe efforts by the international community to stop 
the Ebola epidemic?
    Answer 2. Generating increased international support for the 
response is a top priority for the U.S. Government. As the United 
States expanded our response (scaling from 20 to over 100 personnel 
from CDC, deploying the largest DART in USAID's history and then 
establishing the Joint Force Command), agencies and departments have 
been engaged in a steady campaign to mobilize contributions of 
resources and personnel from other countries, including direct outreach 
to international counterparts by principals.
    Pressing other countries to increase their responses to the Ebola 
epidemic has been a feature of nearly all bilateral engagements, and we 
have also used the announcement of the Joint Task Force deployment on 
September 16, 2014, the U.N. Security Council session hosted by the 
United States on September 18, 2014, and the U.N. Secretary General's 
High-Level Meeting on September 25, 2014, to mobilize increased 
engagement and investment from other governments. The U.N. Secretary 
General initiated the United Nations Mission for Ebola Emergency 
Response (UNMEER), and the Mission was approved unanimously by the U.N. 
General Assembly on September 18, 2014.
    The Mission's overall aim is to reinforce government leadership and 
for a rapid and coherent response focused on five strategic 
priorities--stop the spread of the disease; treat the infected; ensure 
essential services; preserve stability in affected communities; and 
prevent the spread to neighboring countries and beyond. The immediate 
focus is on getting treatment units built, staffing them, and tracing 
contacts of those infected with Ebola to isolate and treat them if they 
come down with the disease.
    To date, more than 35 donor countries have contributed and pledged 
upwards of $690 million to the response. Highlights include:

     Following the announcement of the Joint Force Command, the 
United Kingdom, which had previously committed to establish a hospital 
in Sierra Leone to care for infected health workers, announced that it 
will stand up 700 Ebola treatment beds in Sierra Leone and establish a 
military command center there.
     France has announced additional resources, and that it 
will provide a hospital facility in Guinea.
     Germany has pledged to build additional Ebola treatment 
units, will provide C-160 transport aircraft to support the air bridge 
in West Africa, and is mobilizing volunteers to support the response.
     The World Bank has committed $400 million, and the African 
Development Bank has committed $150 million.
     The European Union has committed to providing $180 million 
and to expanding its response effort.
     The IMF Executive Board approved $130 million expansion of 
zero-interest loans for the three affected West African nations.
     South Africa has committed to build and staff an Ebola 
treatment unit as well.
     Others, including China, Cuba, India, Japan, Canada, 
Sweden, Australia, Norway, Switzerland, South Korea, Thailand, Ghana, 
Malaysia, Denmark, Spain, Ireland and the African Union, are providing 
significant financial and in-kind support.
Ebola Protection and Control
    Question 3. Do you believe the additional $88 million that has been 
requested by the President to respond to this Ebola crisis will provide 
you with the resources required to protect against the potential spread 
of Ebola in the United States and to address needs abroad?
    Answer 3. The Congress appropriated $30 million for CDC through the 
continuing resolution. These resources will support CDC for period of 
the continuing resolution, allowing us to ramp up efforts to contain 
the spread of this virus. More than half of the funds are expected to 
directly support staff, travel, security and related expenses. A 
portion of the funds will be provided to the affected area to assist 
with basic public health infrastructure, such as laboratory and 
surveillance capacity, and improvements in outbreak management and 
infection control. Should outbreaks recur in this region, they will 
have the experience and capacity to respond without massive external 
influx of aid, due to this investment.
    The remaining funds will be used for other aspects of strengthening 
the public health response such as laboratory supplies/equipment, and 
other urgent needs to enable a rapid and flexible response to an 
unprecedented global epidemic. CDC is working to identify our potential 
resource needs for the rest of the fiscal year, and possibly further, 
as we deal with this evolving public health emergency.
Capacity for Drugs or Vaccines
     Question 4. Do you believe the capacity we have to approve, 
produce, and distribute drugs and vaccines here in the United States is 
sufficient to contain an infectious disease such as Ebola should it 
make its way here to the United States?
    Answer 4. The United States has the capacity to approve, produce, 
and distribute drugs and vaccines in the United States for many 
infectious diseases for which there are commercial products (e.g., 
pandemic influenza) to prevent or treat these diseases or there are 
late-stage product candidates in the pipeline (e.g., H7N9 avian 
influenza). However, we, like other industrialized countries, must 
depend initially on a high quality healthcare system to provide 
supportive care for infectious diseases where the drug and vaccine 
development pipeline is comprised of very early stage product 
candidates like Ebola or there are no candidates at all in the pipeline 
like MERS-CoV; the domestic development and manufacturing 
infrastructure established over the past 5 years (e.g., CIADMs) is 
engaged and rapidly responding with the advanced development and 
manufacturing of new experimental drugs and vaccines. This 
infrastructure is being utilized today in the Ebola response by 
transitioning early stage drug and vaccine candidates into advanced 
development by conducting clinical trials and scaling up manufacturing 
to commercial scale, leading to an accelerated availability of these 
product candidates from several years to less than 1 year.
                             senator shelby
Auburn Canine Program
    Question 1. Dr. Bell, today, canines are trained to detect 
explosives, drugs, chemical changes in people with diabetes and 
epilepsy, and even certain cancers quicker and more effectively than 
any mechanism available to us. Researchers at Auburn University are 
currently using decades of research and development in canine detection 
to train dogs to instantly detect viruses like Ebola in the field. 
While this research area is new, its foundation is based on decades of 
research that has proven the canine nose to be one of the greatest 
detection devices in the world. This would provide first responders and 
medical professionals in the field a much more effective method to 
detect a virus in a person or on materials and surfaces that could 
spread the deadly virus. The possibilities are limitless in diagnoses, 
triage, and containment. It would also establish a baseline capability 
that would have applications across the spectrum of disease prevention. 
Are you familiar with this concept and would this type of effort fit 
within your purview and capability to support and fund?
    Answer 1. Efforts of this kind are outside of CDC's scope of 
responsibility and expertise; however, CDC is open to exploring 
rigorously evaluated and proven innovations as they emerge from private 
or public partners.
Components to a Response
    Question 2. Dr. Bell, you have stated that there are 4 necessary 
components to the Ebola response:

     Case identification and prompt isolation and treatment of 
patients;
     Identify contacts, monitor them for 21 days, isolate if 
they become sick, and identify and monitor their contacts;
     Infection control in health care facilities; and
     Safe burial practices.

    How much of this has been occurring in the affected countries?
    Answer 2. CDC is employing a variety of strategies in the affected 
countries. The success of multiple approaches to halting an outbreak 
has been borne out by Nigeria. Multiple partners are working in each of 
the three affected countries to implement each component of the 
response. Progress is being made, but significant challenges remain on 
all fronts.

    Question 3. In particular, how important and difficult is it to 
perform adequate contact tracing in this region when many of the 
citizens do not have regular access to phone and Internet?
    Answer 3. Contact tracing is a challenge in the affected countries. 
In some settings where the number of cases is very large or there are 
security concerns, contact tracing is incomplete, but CDC teams and 
partners continue to support contact tracing in most settings. CDC 
teams in the affected countries report that cell phones are generally 
not being used to reach people. Home visits are the most common method 
of contact tracing.
Training American Health Workers for Ebola Care in West Africa
    Question 4. Dr. Bell, the U.S. Government does not provide direct 
care to Ebola patients in West Africa. With a significant deficit of 
trained health workers to provide care in these countries, how is the 
United States contributing to help address this issue?
    Answer 4. CDC has taken several steps to provide training and 
guidance to health care workers to respond to cases of Ebola. CDC has a 
lead role in infection control training for health care workers and 
safe patient triage throughout the health care system, communities, and 
households in Liberia, Sierra Leone and Guinea. In addition, CDC 
created a Safety Training Course for Healthcare Workers Going to West 
Africa in Response to the 2014 Ebola Outbreak. The primary purpose of 
the course is to ensure that clinicians intending to provide medical 
care to patients with Ebola have sufficient knowledge of the disease 
and its transmission routes to work safely and efficiently in a well-
designed Ebola Treatment Unit.
    The U.S. Agency for International Development (USAID) is managing 
the recruitment of health care workers interested in volunteering in 
West Africa. More information about their efforts can be found on the 
USAID website.
                              senator burr
    Question 1. What are the current mortality rates associated with 
the Ebola outbreak for each country in Africa with an Ebola outbreak? 
How have these mortality rates changed since the outset of the outbreak 
in each country? Have these countries experienced a change in the 
mortality rates since additional support has been provided by the 
international community? If so, how have these mortality rates changed 
over the course of the outbreak?
    Answer 1. CDC's ability to calculate case fatality rates is limited 
by the available data. While CDC can calculate crude case fatality 
rates from the data provided in the situation reports shared by Guinea, 
Liberia, and Sierra Leone, these likely do not reflect the true case 
fatality rates in each country because of limitations in reported data. 
These limitations include unknown clinical outcomes as well as under-
reporting of both cases and deaths. Reporting differs across country, 
resulting in differences in crude case fatality rates that are unlikely 
to reflect true differences.
    In Guinea, as of October_ 14, there are a reported 1,243 cases and 
748 deaths, corresponding to a crude case fatality rate of 60.2 
percent. In Liberia, as of October 4, 2014, there are a reported 3,929 
cases and 2,210 deaths, corresponding to a crude case fatality rate of 
56.2 percent. In Sierra Leone, as of October 6, 2014, there are a 
reported 2,823 cases and 880 deaths, corresponding to a crude case 
fatality rate of 31.1 percent.
    In a report in the New England Journal of Medicine, the World 
Health Organization authors reported a case fatality rate based on only 
a subset of cases with a known clinical outcome. They report, ``This 
analysis shows that by September 14, 2014, a total of 70.8 percent (95 
percent confidence interval [CI], 68.6 to 72.8) of case patients with 
definitive outcomes have died, and this rate was consistent among 
Guinea, Liberia, and Sierra Leone.'' \4\ Because of the limitations of 
the data, we are unable to report on the change in case fatality rates 
over time. Observed changes over time in the crude case fatality 
rates--like the reported differences between countries--are likely 
artifacts of reporting.
---------------------------------------------------------------------------
    \4\ WHO Ebola Response Team. Ebola Virus Disease in West Africa--
The First 9 Months of the Epidemic and Forward Projections. N Engl J 
Med. 2014 Sep 22. [Epub ahead of print] PubMed PMID: 25244186.

    Question 2. Will the United States' response to the current 
outbreak, including the CDC, change if Ebola becomes endemic to West 
Africa? If so, how will the current strategies to reduce the rate of 
transmission, and ultimately break the chains of Ebola transmission, 
change in the event the Ebola virus becomes endemic to West Africa?
    Answer 2. Strategies to control Ebola and break transmission chains 
will not change if Ebola transmission becomes more widespread in 
Africa. However, the magnitude and complexity of the effort to reverse 
the trend will be much greater, further stretching the limited 
capacities of countries and the international community and making 
success that much harder to achieve. Further, the risk of multiple 
exportations of cases from affected countries will increase. It is for 
these reasons that it is so critical to stop the outbreak in the three 
currently affected countries.

    Question 3. How would point of care rapid diagnostics change the 
current trajectory of the Ebola outbreak? How would identifying an 
infected individual before the onset of symptoms change the current 
response strategy being deployed overseas in Africa? How quickly could 
CDC deploy point of care rapid diagnostics in the field clinics in West 
Africa should such diagnostic tools become available? Could this length 
of time be further reduced, and if so, what steps need to be taken to 
ensure that the time it would take to deploy and utilize such 
diagnostics is as short as possible, including as part of either a 
domestic or international response?
    Answer 3. There is not currently an approved test that can 
determine if a person is ill with Ebola before symptoms appear although 
there are products under investigation. CDC is not aware of any that 
have been approved by recognized governmental bodies comparable to FDA. 
Rapid diagnostics allow for testing for Ebola in a non-laboratory 
environment, such as in a health care facility. In health care 
facilities, patients suspected to be ill with Ebola wait, often for 
days, for symptoms to present; inevitably there are individuals that 
are ill with Ebola as well as many individuals who have other diseases 
with Ebola-like symptoms (e.g., malaria). While waiting in these areas, 
the latter often become infected with Ebola from those that are 
actually ill with the disease. Rapid tests would allow for a quicker 
discernment of those very ill with Ebola in these waiting areas, thus 
reducing the spread of Ebola to those who are not ill with the disease. 
However, the current rapid tests in development require a high amount 
of virus to be present in a person's blood, far more than the longer, 
standard polymerase chain reaction tests require.
    CDC is partnering with companies to review and assess experimental 
new tests so that these technologies can be refined and produced 
quickly in the United States, thereby streamlining the procurement 
process and speeding deployment of new products to West Africa. The 
deployment process from the United States to the outbreak region can be 
undertaken as quickly as three to 5 days. However, transportation and 
distribution in the affected countries remains a significant challenge.

    Question 4. How will the distribution of Ebola medical 
countermeasures, both vaccines and therapeutics, be prioritized when 
they become available?
    Answer 4. CDC would not be making a determination of prioritizing 
investigational therapeutics; however, the Department of Health and 
Human Services is in ongoing discussions with global partners such as 
WHO on this issue.
    No specific therapeutics for patients with EVD are approved. 
Furthermore, CDC cannot influence the requests made by clinicians for 
investigational new drugs or therapies for emergency or compassionate 
use. To ensure efficacy and safety, controlled clinical trials need to 
be implemented.
    Several investigational Ebola vaccine candidates have been 
developed. NIH has begun initial clinical studies to assess the safety 
and immune response of a candidate vaccine to prevent EVD. The 
Department of Defense (DoD) has also begun clinical studies for a 
different candidate vaccine. In addition, two companies, Tekmira and 
BioCryst Pharmaceuticals, received funding from the DoD to develop 
potential drugs to treat Ebola. BioCryst, with NIH support, is working 
to develop an antiviral drug to treat Ebola; the first phase of (human) 
safety testing is expected to begin later this year.

    Question 5. Please outline in detail how CDC is partnering with 
USAID and DoD in the training and deployment of medical personnel for 
the countries impacted by the current Ebola outbreak?
    Answer 5. In response to this unprecedented humanitarian crisis, 
CDC created a first-ever domestic Ebola Treatment Unit Safety Training 
Course. This course provides both didactic as well as extensive hands-
on education regarding the multiple complex issues faced by care 
providers when working in Ebola Treatment Units (ETUs). The course was 
designed specifically for U.S. personnel deploying to provide care in 
ETUs within West Africa. We have worked closely with the Department of 
Defense to ensure that their personnel who require this training are 
enrolled in this course. We have offered technical advice regarding the 
Department of Defense's mission to establish an ETU safety training 
course in-country and have shared CDC's ETU Safety Training course 
curriculum materials. We have also hosted several discussions with DoD 
regarding additional training coordination in Liberia. USAID has 
established a website where persons interested in deploying to provide 
care in ETU's may register. Links are provided on this website to the 
registration page for the CDC ETU Safety Training Course.

    Question 6. There have been media reports that U.S. health care 
facilities that have provided treatment to patients infected with Ebola 
in the United States have had difficulty in disposing of the medical 
waste associated with this treatment. Please outline in detail how CDC 
is working with individual health care facilities, and other Federal 
and State partners, to resolve the issue of proper disposal of medical 
waste associated with the treatment of Ebola patients in the United 
States.
    Answer 6. CDC, in collaboration with the U.S. Department of 
Transportation (USDOT) and the Occupational Safety and Health 
Administration (OSHA), have issued guidance on the disposal of medical 
waste from patients with Ebola to help States and hospitals coordinate 
for safe management of waste. Ebola-associated waste disposal is 
subject to State and local regulations. Notably, Ebola-associated waste 
that has been appropriately inactivated or incinerated is no longer 
infectious.
    Medical waste generated in the care of patients with known or 
suspected EVD is subject to procedures set forth by local, State and 
Federal regulations. Basic principles for spills of blood and other 
potentially infectious materials are outlined in the OSHA Bloodborne 
Pathogen standard, 29 CFR 1910.1030. Medical waste contaminated with 
Ebola virus is a Category A infectious substance regulated as a 
hazardous material under USDOT's Hazardous Materials Regulations (HMR; 
49 CFR, Parts 171-180). The HMR apply to any material USDOT determines 
is capable of posing an unreasonable risk to health, safety, and 
property when transported in commerce. For offsite commercial transport 
of Ebola-associated medical waste, strict compliance with the HMR is 
required.
    The inactivation or incineration of Ebola-associated medical waste 
within a hospital system may be subject to State, local and OSHA 
regulations.

     Onsite inactivation
         Ebola-associated medical waste can be inactivated 
        through the use of appropriate autoclaves. Other methods of 
        inactivation (e.g., chemical inactivation) have not been 
        standardized and would need to consider worker safety issues, 
        as well as the potential for triggering other Federal safety 
        regulations.
     Onsite incineration
         Ebola-associated medical waste can be incinerated. The 
        products of incineration are not infectious and can be 
        transported and disposed of in accordance with standard 
        protocols for hospital waste disposal.

    Question 7. Who at the National Security Council is responsible for 
coordinating the inter-agency response to the Ebola outbreak in West 
Africa? Is this individual responsible for coordinating the inter-
agency response for domestic Ebola efforts as well? If not, who is?
    Answer 7. The U.S. Government response to the Ebola epidemic in 
West Africa is a whole-of-government effort that draws on the 
capabilities and expertise of numerous government departments and 
agencies. Similar to other crisis response and humanitarian emergencies 
around the world, USAID leads and coordinates the U.S. response in the 
field. Many agencies are working closely on domestic Ebola preparedness 
and response, including HHS, CDC, and DHS, in coordination with the 
Assistant to the President for Homeland Security and Counterterrorism.
                              senator kirk
    Question 1. The CDC has determined that $30 million was needed for 
additional response efforts. It is estimated that this outbreak could 
last another 12-18 months. Will more assistance be needed or do you 
anticipate the $30 million covering the next year and a half?
    Answer 1. Congress appropriated $30 million for CDC through the 
continuing resolution. These resources will support CDC for period of 
the continuing resolution, allowing us to ramp up efforts to contain 
the spread of this virus. More than half of the funds are expected to 
directly support staff, travel, security and related expenses. A 
portion of the funds will be provided to the affected area to assist 
with basic public health infrastructure, such as laboratory and 
surveillance capacity, and improvements in outbreak management and 
infection control. The remaining funds will be used for other aspects 
of strengthening the public health response such as laboratory 
supplies/equipment and other urgent needs to enable a rapid and 
flexible response to an unprecedented global epidemic. CDC is working 
to identify our potential resource needs for the rest of the fiscal 
year, and possibly further, as we deal with this evolving public health 
emergency.

    Question 2. With all the different agencies involved, which one is 
leading the efforts against Ebola? What coordinated efforts are 
happening between the agencies? What are other nations doing to 
contribute? 
    Answer 2. Within the West Africa region affected by the Ebola 
outbreak, USAID continues to lead the United States' overseas response, 
while CDC, the Department of Defense, Department of State, and other 
Federal Departments and Agencies are supporting the whole-of-government 
approach to this national security priority. USAID has deployed a DART 
to coordinate planning, operations, logistics and other components of 
the interagency effort. CDC staff is working with Ministries of Health 
to improve surveillance, contact tracing, laboratory capacity, 
emergency operations planning and other critical capabilities.
    HHS, and in particular CDC, is working closely with the World 
Health Organization (WHO), the United Nations, the Ministries of Health 
in affected countries, and other international partners to respond to 
the current Ebola outbreak in West Africa. The Ebola epidemic reminds 
us that our global efforts to build the capacity to prevent, detect, 
and rapidly respond to infectious disease threats like EVD have never 
been more vital. In February 2014, CDC came together with nations 
around the world to launch the GHSA as a 5-year effort to accelerate 
action. On September 26, 2014, President Obama met with leaders of 40 
nations as well as top Administration officials to advance progress in 
the GHSA.
    CDC receives regular updates of morbidity and mortality to evaluate 
the spread of the disease and combines this information with reports 
from CDC's staff deployed to the area. Hundreds of CDC staff members 
have provided logistics, staffing, communication, analytics, 
management, and other support functions for the response. CDC continues 
to commit significant staffing and financial resources to the 
international Ebola response both on the ground in West Africa and 
through its domestic EOC.
    CDC has activated its EOC to help coordinate technical assistance 
and control activities with partners. CDC supports countries in 
establishing their own national and sub-national EOCs. Each of the 
three West African countries at the center of the epidemic now has an 
Incident Manager, reporting to the President of the country, to lead 
efforts.
    To date, more than 35 donor countries have contributed and pledged 
upwards of $690 million to the response. Highlights include:

     Following the announcement of the Joint Force Command, the 
United Kingdom, which had previously committed to establish a hospital 
in Sierra Leone to care for infected health workers, announced that it 
will stand up 700 Ebola treatment beds in Sierra Leone and establish a 
military command center there.
     France has announced additional resources and that it will 
provide a hospital facility in Guinea.
     Germany has pledged to build additional Ebola treatment 
units, will provide C-160 transport aircraft to support the air bridge 
in West Africa, and is mobilizing volunteers to support the response.
     The World Bank has committed $400 million and the African 
Development Bank has committed $150 million.
     The European Union has committed to providing $180 million 
and to expanding its response effort.
     The IMF Executive Board approved $130 million expansion of 
zero-interest loans for the three affected West African nations.
     South Africa has committed to build and staff an Ebola 
Treatment Unit as well.
     Others, including China, Cuba, India, Japan, Canada, 
Sweden, Australia, Norway, Switzerland, South Korea, Thailand, Ghana, 
Malaysia, Denmark, Spain, Ireland and the African Union, are providing 
significant financial and in-kind support.
                              senator enzi
    Question 1. In previous communications with CDC, it was indicated 
that there are only a few facilities specially equipped to deal with 
highly contagious diseases, such as Emory University Hospital in 
Atlanta. What will be the policy for treatment of patients diagnosed 
within the United States? Will they be transported to these facilities 
or cared for onsite or in other designated facilities?
    Answer 1. CDC is working with additional hospitals to ready their 
facilities for additional patients with Ebola. Any U.S. hospital should 
be prepared to identify, assess and isolate a patient with Ebola. CDC 
developed guidance documents and checklists to help U.S. hospitals 
prepare for, test, and treat patients with Ebola, and works to keep the 
health care system informed of new developments. CDC uses its Health 
Alert Network (HAN) to provide information and guidance to U.S. 
healthcare workers and hospitals regarding Ebola. CDC distributed a HAN 
notice August 1, 2014, and five updates have followed. The most recent 
HAN notice about Ebola was distributed on October 2, 2014.
    CDC created plans outlining its course of action for when a 
laboratory-confirmed Ebola diagnosis occurs in the United States. The 
operational plans include assistance to State, tribal, territorial and 
local officials and the domestic health care community, and leverage 
CDC's expertise and resources in epidemiology, surveillance, 
coordination of laboratory testing, health promotion and communication, 
healthcare and infection control, traveler health and screening.
    CDC's response to a diagnosed case follows three key public health 
tenants--prevention, detection and response. The concept of prevention 
focuses on actions which can affect the spread of the disease. 
Detection centers on activities to find the disease through 
surveillance and contact tracing. CDC's response efforts include its 
agency-wide incident management and response capabilities in support of 
domestic requirements.
    CDC has redoubled its efforts to educate American health care 
workers about how to isolate patients and how to protect themselves 
from infection, including developing and disseminating resources, 
hosting informational calls, and creating trainings. CDC has:

     Hosted Clinician Outreach and Community Activity calls for 
clinical professionals to provide information about what U.S. hospitals 
need to know to prepare for Ebola.
     Created guidance about Ebola for clinicians in U.S. health 
care settings.
     Posted a Medscape Expert Commentary for healthcare 
providers whose patients are travelers with concerns about Ebola. The 
commentary includes information about the Ebola outbreak in West 
Africa, the transmission Ebola virus, and how to talk to travelers 
about their risk.
     Created guidance for U.S. healthcare workers on 
``Infection Prevention and Control Recommendations for Hospitalized 
Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S. 
Hospitals.''
     Developed a checklist for hospitals to aid in Ebola 
preparedness, which can be found on the CDC website.
     Built a Safety Training Course for Healthcare Workers 
Going to West Africa in Response to the 2014 Ebola Outbreak. The 
primary purpose of the course is to ensure that clinicians intending to 
provide medical care to patients with Ebola have sufficient knowledge 
of the disease and its transmission routes to work safely and 
efficiently in a well-designed Ebola Treatment Unit (ETU).
     Collated the Top 10 Ebola Response Planning Tips: Ebola 
Readiness Self-Assessment for State and Local Public Health Officials 
to help guide planning and readiness for Ebola response at State and 
local levels and assist health officials in assessing their 
jurisdictions' level of readiness for a potential Ebola response.

    Question 2. What steps are being taken by CDC to ensure adequate 
coordination across agencies to, identify any new cases of Ebola 
quickly, facilitate treatment, and to contain any spread of the 
disease? Please identify all of the agencies involved, the departments 
that are working on them, the steps taken to ensure coordination, and 
the plans for updating Congress on the activities.

    Question 3. Since the beginning of the Ebola outbreak in West 
Africa, the CDC continually indicated a low probability of a case 
occurring in the United States. What are the CDC screening and 
monitoring processes for travelers who are likely to come into contact 
with the Ebola virus? Please identify the specific steps involved, 
coordinating agencies, and the data used to make claims of the low 
probability of occurrence in the United States.
    Answer 2 and 3. Although the risk of an Ebola outbreak in the 
United States is very low, HHS and its sister Departments are taking 
steps to protect Americans from the Ebola virus. To ensure the United 
States is prepared to respond to an Ebola epidemic, the CDC has 
detailed response plans in place for once an Ebola case is confirmed to 
respond to Ebola cases in the United States. The plans include: 
instructions to rapidly disseminate information about the Ebola case(s) 
to key public health, health care system, and emergency management 
partner organizations; providing current information to State, local, 
and territorial public health departments; and coordinating critical 
issues management regarding State and local needs for the CDC EOC 
incident manager and other response task force teams. CDC has also 
developed a web-based document, for use in State and local planning 
that identifies rapidly emerging CDC guidelines for public health 
preparedness national standards regarding Ebola.
    Additional CDC efforts include:

     Preparing providers, hospitals, State and local health 
departments and others involved in public health preparedness and 
response for the possibility of an Ebola case in the United States, 
including guidance documents on the identification and treatment of an 
Ebola patient, infection control guidelines, laboratory testing and 
other recommendations necessary to protect U.S. health care workers and 
the general public. Over the coming days and weeks, CDC will be working 
with other Federal, State, and local governments and private 
organizations to strengthen U.S. readiness for detecting and preventing 
additional cases of Ebola in this country. These efforts include the 
entry screening at U.S. ports of entry and enhanced outreach to 
healthcare workers and hospitals to improve their infection control 
practices and policies.
     Providing funding and assistance to State and local health 
departments for all-hazards preparedness, including an infectious 
disease outbreak. This funding and assistance helps public health 
departments develop capabilities that are applicable to responding to 
many public health threats.
     Developing guidance for laboratory technicians and other 
health care personnel who collect or handle specimens in the United 
States.
     Working closely with DHS's CBP and other partners at U.S. 
ports of entry to conduct enhanced entry screening to identify 
travelers who show signs of infectious disease. CBP is conducting entry 
screening at five U.S. airports (New York-JFK, Washington-Dulles, 
Newark, Chicago-O'Hare, and Atlanta), that receive 94 percent of 
travelers from the Ebola-affected nations of Guinea, Liberia, and 
Sierra Leone, as of October 11, 2014. If a potentially sick traveler is 
identified during or after a flight, the traveler will be immediately 
isolated, and CDC will conduct an investigation and work with the 
airline, Federal partners, and State and local health departments to 
notify them and take any necessary public health action. Entry 
screening is part of a layered process that includes exit screening and 
standard public health practices, such as patient isolation and contact 
tracing in countries with Ebola outbreaks. Successful containment of 
the recent Ebola outbreaks in Nigeria and the Democratic Republic of 
Congo demonstrate the effectiveness of this approach.
     Assisting with exit screening and communication efforts in 
West Africa to prevent sick travelers from boarding commercial planes, 
buses, trains, or ships. CDC also has issued interim guidance about 
Ebola virus infection for airline flight crews, cleaning personnel, and 
cargo personnel.

    In addition to CDC's efforts relating to prevention, detection, and 
response, FDA is investigating what types of medical products could be 
used to address the Ebola epidemic in West Africa and in the United 
States. Currently, there are no treatments or vaccines that have been 
shown to be safe or effective against the Ebola virus, and products 
currently under development are in the very early stages of 
investigation. FDA is using its regulatory mechanisms to enable access 
to investigational medical products to facilitate appropriate access to 
investigational Ebola medical products under an appropriate regulatory 
mechanism to support preparedness and response efforts to help protect 
people of the United States from the Ebola virus.
    Additionally, under the FDA's Emergency Use Authorization (EUA) 
authority, FDA can allow the use of an unapproved medical product--or 
an unapproved use of an approved medical product--for a larger 
population during certain types of emergencies, when, in addition to 
other factors, there is no adequate, approved, and available 
alternative. FDA has authorized the use of an Ebola diagnostic test, 
developed by DoD, under an EUA to detect the Ebola virus in 
laboratories designated by DoD. This test has been made available to 14 
laboratories within the United States to support the rapid diagnosis of 
any suspected cases of Ebola infection and to monitor patients already 
infected with the Ebola virus. These sites are located close to ports-
of-entry where travelers from West Africa frequently arrive in the 
United States or in locations where infected U.S. patients are 
currently being treated. In addition, FDA has issued EUAs authorizing 
the use of Ebola diagnostic tests developed by CDC and is working with 
U.S. and non-U.S. commercial diagnostic test developers to clarify EUA 
regulatory requirements and provide support in order to increase the 
supply of available diagnostic tests for Ebola infection in the United 
States and West Africa.
    NIH and Biomedical Advanced Research and Development Authority 
(BARDA), along with DoD, are supporting the development and 
manufacturing of early stage Ebola vaccine and therapeutic candidates. 
Key animal challenge efficacy studies and human safety and 
immunogenicity studies are or will be underway in the United States and 
other countries for several of these candidates. The results of these 
initial human safety studies will inform expanded clinical studies in 
affected African countries early next year. Scaled up manufacturing of 
several of these product candidates has started as well to achieve 
commercial scale manufacturing capacity next year.

  Response by Anthony S. Fauci, M.D. and Robin A. Robinson, Ph.D. to 
Questions of Senator Casey, Senator Bennet, Senator Whitehouse, Senator 
  Baldwin, Senator Warren, Senator Alexander, Senator Moran, Senator 
      Shelby, Senator Cochran, Senator Burr, and Senator Kirk \1\
---------------------------------------------------------------------------

    \1\ Note: Content accurate as of October 15, 2014. Responses do not 
reflect enactment of the $238 million for NIH in emergency funding to 
support clinical trials in response to the Ebola Epidemic.
---------------------------------------------------------------------------
                             senator casey
    Question. In addition to vaccines and treatments that are specific 
to Ebola, are there any broad antiviral products being considered for 
development, that could be used against either Ebola or other known 
novel viruses?
    Answer. Guided by our Strategic Plan and priorities, the National 
Institute of Allergy and Infectious Diseases (NIAID) supports the 
fundamental research needed to better understand infectious agents in 
order to develop broad-spectrum antibiotics and antivirals--drugs that 
can prevent or treat diseases caused by multiple types of bacteria or 
viruses. In addition, NIAID has intensified its efforts to develop new 
technologies that can be broadly applied to more efficiently develop 
diagnostics and vaccines against a wide variety of infectious agents, 
including pandemic influenza viruses, methicillin-resistant 
Staphylococcus aureus (MRSA), 
extensively drug-resistant Mycobacterium tuberculosis, dengue, 
chikungunya, and filoviruses such as Ebola.
    NIAID is funding BioCryst Pharmaceuticals to develop and test 
BCX4430, a novel drug with broad-spectrum antiviral activity including 
against Ebola viruses. To date, BCX4430 has shown some activity in 
animal infection models for Ebola and Marburg viruses. A Phase I trial 
is expected to begin in late 2014 or early 2015. NIAID is also funding 
in vivo studies of brincidofovir, a broad-spectrum antiviral developed 
by Chimerix, Inc., for use against other viral diseases, including 
smallpox. In addition, NIAID offers in vitro testing as part of its 
suite of preclinical research services available to the scientific 
community and private industry to test products for antiviral activity 
against Ebola viruses. NIAID is using this screening program to assist 
investigators who have antiviral candidates that may be effective 
against Ebola viruses.
    Intramural scientists at NIAID's Rocky Mountain Laboratories (RML) 
in Hamilton, MT, are working on therapeutics that might be effective 
against all hemorrhagic fever viruses including the filoviruses Ebola 
and Marburg and the arenavirus Lassa. Ribavirin, a drug currently used 
to treat hemorrhagic fever viruses such as Lassa virus, is being 
examined for its potential use in combination therapy to treat Ebola 
virus infection. NIAID intramural scientists are investigating broad 
antiviral therapies that target host cell proteins essential to viral 
replication. One such antiviral currently being evaluated for hepatitis 
C treatment has shown activity against Ebola virus in vitro and will be 
further assessed. NIAID scientists also have screened a small 
collection of broad-spectrum antivirals that are in development against 
influenza and other RNA viruses; this screening has generated two 
potential lead compounds for further evaluation.
    NIAID's pursuit of broad-spectrum therapies effective against 
entire classes of pathogens aims to maximize the investment in research 
on emerging and re-emerging infectious diseases. NIAID will continue to 
pursue broad-spectrum antiviral drugs for use against a variety of 
viruses including Ebola virus.

                             Senator Bennet

    Question 1. There are many charities and volunteers here that want 
to help end this outbreak and care deeply about the outcome. For 
example, in my home State, the Centennial-based Project CURE has been 
working with local volunteers and high schools, like Valor Christian 
High School in Highlands Ranch, to send medical supplies to West 
Africa. They have already sent 4 large containers of supplies for 
medical workers there. They want to know that their government is 
showing a coordinated response to this effort, and that their work will 
not be in vain. Can you give them and other volunteers across the 
country some peace of mind that their work is helping and you all are 
doing everything you can to coordinate an effective response to this 
outbreak?
    Answer 1. NIAID defers to other witnesses.

    Question 2. Given the emergence of Ebola as a significant public 
health threat--and the level of funds understandably being allocated in 
response--I am concerned about our ability to respond to other 
emergencies, such as pandemic influenza, which are far more common 
threats. In particular, I'm concerned that we are jumping from crisis 
to crisis and failing to adequately budget for rapid response 
capabilities to public health pandemics, like Ebola, pandemic 
influenza, and MERS. Just earlier this month, for instance, a DHS OIG 
report highlighted that our pandemic influenza stockpiles have not been 
effectively managed, and I'm concerned that we may be falling behind on 
these other types of preparedness issues. How are you assuring that we 
are adequately prepared and not compromising our ability to rapidly 
respond to address other public health crises, like pandemic influenza, 
in addition to emerging threats like Ebola?
    Answer 2. NIAID has a dual mandate that balances research on 
current biomedical challenges with the capacity to respond quickly to 
emerging and re-emerging infectious threats. Since the 2001 anthrax 
attacks, with the support of the Congress, NIAID has vastly expanded 
its research portfolio in biodefense and naturally emerging and re-
emerging infectious diseases, focusing its efforts on pathogens that 
pose high risks to public health and national security, including 
pandemic influenza, MRSA, Mycobacterium tuberculosis, dengue, 
chikungunya, and filoviruses such as Ebola.
    To improve our preparedness for numerous infectious threats, 
whether naturally occurring or deliberately introduced, NIAID has 
adopted a flexible strategy to encourage the development of broad 
spectrum therapeutics effective against whole classes of pathogens. To 
encourage this process, NIAID ``de-risks'' the development of new and 
improved therapeutics by providing early stage research resources to 
academia, biotechnology firms, and industry. For example, NIAID offers 
in vitro and in vivo screening and evaluation of candidate 
countermeasures against a broad array of infectious pathogens including 
bacteria, fungi, viruses, and parasites. These preclinical research 
services, coupled with NIAID's strong support for basic and applied 
research, have enhanced our ability to ultimately address a variety of 
global infectious disease threats.
    NIAID research includes the development of new and improved 
vaccines against a variety of infectious disease threats to global 
public health. As part of this effort, the NIAID Vaccine Research 
Center (VRC) is pursuing design strategies to facilitate the 
development of vaccines for emerging public health threats such as 
Middle East Respiratory Syndrome (MERS), chikungunya, pandemic 
influenza, and Ebola viruses. The VRC is currently applying the results 
of its longstanding preclinical vaccine research program to accelerate 
clinical studies of a chimpanzee adenovirus-based Ebola vaccine 
candidate developed in collaboration with GlaxoSmithKline. Phase I 
clinical studies of this vaccine are ongoing at the National Institutes 
of Health Clinical Center, and additional studies are planned for sites 
around the world.
    In response to the public health threats posed by seasonal and 
pandemic influenza, NIAID VRC and extramural researchers are engaged in 
a broad range of basic and applied research on influenza virus. NIAID 
is supporting research and development of new therapies, diagnostics, 
and vaccines for both seasonal and pandemic influenza strains. For 
example, during the 2009 H1N1 influenza pandemic, VRC researchers 
utilized advanced genetic sequencing and gene-based vaccine technology 
platforms to develop and test an experimental 2009 pandemic H1N1 
influenza vaccine within 4 months. In addition, NIAID-supported 
clinical research units quickly determined the safe and effective doses 
of the 2009 H1N1 influenza vaccine for the elderly, children with 
asthma, and individuals with compromised immune systems.
    The development of a ``universal'' influenza vaccine is a key goal 
of the NIAID infectious diseases research program. A ``universal'' 
influenza vaccine would induce a potent immune response to the common 
elements of the influenza virus that undergo few changes from season to 
season and from strain to strain. Such a vaccine could protect against 
multiple strains of the virus over several years and help provide 
protection in the event of an influenza pandemic. NIAID VRC and 
extramural researchers are working with the conserved stem region of 
influenza proteins to stimulate broader, more universal protection 
against multiple influenza strains and to develop nanoparticle vaccine 
platforms to improve the potency and breadth of influenza protection.
    NIAID remains committed to fulfilling its dual mandate to balance 
research on infectious and immune-related diseases with the capability 
to mobilize a rapid response to newly emerging and re-emerging 
infectious diseases.
                           senator whitehouse
    Question. The severity of the current Ebola outbreak has led to the 
use of still-experimental treatments, such as ZMapp--which Dr. Brantly 
received. How can we encourage the development of treatments and 
vaccines that treat incredibly deadly, but rare diseases, like Ebola? 
How have our Federal health care agencies, including NIH, CDC, and FDA, 
coordinated to help expand access to experimental treatments in a safe 
and ethical way?
    Answer. The 2001 anthrax attacks underscored the importance of a 
national strategy for the development of medical countermeasures to 
combat deadly infectious disease threats, whether man-made or naturally 
occurring. Since that time, NIAID has greatly accelerated its 
biodefense research program to rapidly respond to known and possible 
future threats. NIAID supports basic research, identification of drug 
and vaccine targets, preclinical testing, and clinical trials in order 
to move candidate medical countermeasures along the product development 
pipeline. Critical to this effort are NIAID's public-private 
partnerships with organizations including non-profits, academic 
institutions, and biotechnology and pharmaceutical companies.
    Equally important to the development of medical countermeasures for 
deadly diseases such as anthrax, smallpox, and Ebola virus disease, is 
NIAID's collaboration with Federal agencies such as the Centers for 
Disease Control and Prevention, the Food and Drug Administration (FDA), 
the Biomedical Advanced Research and Development Authority (BARDA), and 
the Department of Defense (DoD). For example, NIAID coordinates with 
its partners through the Public Health Emergency Medical 
Countermeasures Enterprise to ensure that the results of NIAID-
supported research can be translated rapidly into safe and effective 
medical countermeasures. In particular, NIAID transitions the advanced 
research and development of high-priority medical countermeasures to 
BARDA, with the goal of FDA approval, licensure, clearance, or 
emergency use authorization and, if appropriate, possible inclusion in 
the Strategic National Stockpile.
    Efforts to date have included early stage development of a smallpox 
vaccine candidate and two smallpox drug candidates to complement the 
vaccines that currently exist, as well as anthrax vaccine and 
therapeutic candidates.
    In response to the current Ebola outbreak in West Africa, the NIAID 
Vaccine Research Center (VRC) worked closely with FDA colleagues to 
expeditiously move CAd3, an Ebola candidate vaccine developed by the 
NIAID VRC and GlaxoSmithKline, into clinical studies while still 
maintaining rigorous safety, ethical, and regulatory standards. 
Proactive communication and partnership enabled FDA to review VRC's 
Investigational New Drug (IND) application in less than 1 week, leading 
to acceleration of the clinical study start date. Ongoing discussions 
among NIAID VRC, BARDA, and industry partner GlaxoSmithKline will 
accelerate development of CAd3 through additional vaccine manufacturing 
and clinical trials to further determine safety and immune response. In 
addition, the NIAID VRC is collaborating with the DoD Walter Reed Army 
Institute of Research on plans to evaluate safety and immunogenicity of 
the candidate vaccine in healthy adults in Uganda.
    NIAID will continue its longstanding investment in research to 
develop tools to prevent, diagnose, treat, and control deadly diseases 
such as Ebola. To effectively bring a concept from the earliest stages 
of basic research to a finished product requires that we rigorously 
evaluate safety and efficacy along the product development pipeline and 
leverage public-private partnerships between academia, non-profit 
organizations, private industry, and government agencies around the 
world.
                            senator baldwin
    Question 1. Dr. Fauci, one of your NIH colleagues and an Ebola 
expert recently argued that scientists must share data, like diagnosis 
and detection data, with their colleagues in real-time to improve the 
public health response to the Ebola outbreak. Can you please explain 
why this is so critical, what is NIH's role in this data exchange, and 
how similar information sharing has helped address prior outbreaks like 
influenza and SARS?
    Answer 1. The National Institutes of Health (NIH) has a 
longstanding commitment to make scientific data publicly available in a 
timely manner. This was exemplified by the Human Genome Project, an 
international research project that required rapid and comprehensive 
data release during its mapping and sequencing of the full human 
genome. Recently, NIH has expanded this commitment to sharing important 
genomic data by implementing a policy requiring NIH-funded large scale 
genome projects to include data sharing plans. For the past 10 years, 
NIAID has endorsed this commitment, and contributes to several publicly 
accessible and searchable international data bases, such as NIH's 
GenBank, a collection of all publicly available DNA sequences.
    Publicly released data, including datasets generated and released 
by NIAID, serve as critical resources for scientists around the world, 
and are essential to enable the advancement of research and 
surveillance of infectious diseases. For example, in early April 2009, 
a novel influenza virus was isolated from a patient in California; by 
the end of April 2009, the genome of the H1N1 influenza virus was 
sequenced and the data released into the public domain. The genetic 
characterization of this virus revealed that it was a novel strain, 
gave clues to its drug sensitivity and resistance, and was instrumental 
in production of effective diagnostics and vaccines used in the 
subsequent 2009 H1N1 influenza pandemic. Ongoing NIAID sequencing 
efforts and resources seek to provide additional information about the 
Ebola virus strain currently circulating in West Africa. This 
information, shared in real-time, can help researchers to understand 
how the virus is transmitted and causes disease, as well as guide 
strategies for developing new therapeutics, vaccines, and diagnostics.
    Although there is no rapid, point-of-care diagnostic test for Ebola 
virus currently available, real-time data sharing is an increasingly 
important aspect of collaborative research and could critically 
influence both patient care and epidemic management of the current 
Ebola virus outbreak. The ability to rapidly and accurately detect and 
report the presence of Ebola virus in blood samples would allow 
healthcare providers to more quickly isolate and care for patients with 
Ebola virus disease. Importantly, rapid diagnosis and reporting would 
also help to identify patients who have symptoms consistent with Ebola 
virus disease but actually have a disease caused by another pathogen. 
Upon testing negative for Ebola, these patients could minimize their 
contact with Ebola patients and be given appropriate treatment for 
their disease. In addition, real-time data sharing is critical to 
guiding the public health response because it allows for a more 
accurate understanding of sources of infection, new outbreak locations, 
and the scope and rate of transmission. Rapid data sharing is also 
important for assessing the utility of diagnostic tests and the 
significance of viral gene mutations. Established diagnostic assays 
that detect specific gene sequences of a virus may not be as effective 
in detecting viruses with genetic variants. Real-time generation and 
sharing of genetic sequence data, including mutations, is crucial to 
ensuring these molecular diagnostic tests remain valid.

    Question 2. Dr. Fauci, in the absence of an approved therapeutic 
treatment for Ebola, can you please discuss the importance of highly 
effective and efficient diagnostics in controlling this outbreak, and 
what steps we are taking to develop and implement such tools? In 
August, the FDA authorized the emergency use of a diagnostic test 
developed by the Department of Defense in the affected region. Can you 
provide an update on how this test is working and being used on the 
ground?
    Answer 2. Accurate and accessible diagnostics for Ebola virus 
infection are needed for the rapid identification and treatment of 
patients in the current Ebola outbreak because the symptoms of Ebola 
can be easily mistaken for other common causes of fever in West Africa, 
such as malaria. Point-of-care, or onsite, Ebola virus diagnostics are 
particularly valuable as they allow caregivers to quickly identify 
infected patients in order to isolate them and minimize additional 
exposures to the virus.
    NIAID provides resources for investigators developing Ebola 
diagnostics. With NIAID support, Corgenix Medical Corporation is 
developing rapid immunodiagnostics for Ebola virus using genomic 
technology to produce recombinant viral proteins. NIAID is advancing 
development of additional diagnostics, including those using novel 
technologies such as microfluidics, optofluidics and nanophotonics, 
which are capable of detecting multiple viruses including Ebola. Such 
innovative approaches can provide information critical to the creation 
of point-of-care diagnostics that could be distributed and used in 
areas where Ebola virus outbreaks occur. In addition, intramural 
scientists from NIAID's Rocky Mountain Laboratories in Hamilton, MT, 
and NIAID's Integrated Research Facility in Frederick, MD, have 
responded to the ongoing epidemic in West Africa by providing technical 
diagnostic support on the ground in Liberia.
    NIAID defers to CDC regarding the emergency use of diagnostics in 
West Africa.

    Question 3. The President recently outlined a comprehensive 
response to combat this epidemic that includes the efforts of an 
estimated 3,000 U.S. forces and a strong partnership with the United 
Nations and our other international partners. The first cases of Ebola 
were reported in March; it is now October and the Ebola crisis is only 
worsening. Why did we not initiate this response in March? In 
hindsight, what should have been the United States' first action item 
when cases were first reported, and what can we learn from this to 
prevent the world from seeing such tragedy again?
    Answer 3. NIAID defers to other witnesses.
                             senator warren
    Question 1. Fighting epidemics in developing countries presents 
unique challenges. Despite all the attention that's being paid to the 
Ebola outbreak, serious health problems have gripped these countries 
for years. In Liberia, for example, 17 percent of deaths are due to 
Malaria, and Sierra Leone has one of highest rates of infant and 
maternal mortality in the world. Countries currently dealing with Ebola 
have a poor healthcare infrastructure and very few healthcare workers--
and are barely able to provide basic care, much less handle an 
epidemic.
    How would long-term investments to improve the basic healthcare 
infrastructure of developing nations help to improve our ability to 
respond to new outbreaks and epidemics?
    How are the United States and international aid organizations 
helping to take care of health care needs besides Ebola in the epidemic 
regions?
    Answer 1. NIAID defers to other witnesses regarding investments to 
improve basic healthcare infrastructure of developing nations, and 
regarding how United States and international organizations are helping 
to take care of health care needs besides Ebola in the epidemic 
regions.

    Question 2. Each time a new disease or disease threat appears, we 
see a spike in public attention and an avalanche of government support 
to address the immediate crisis. Congress has no problem spending 
billions of dollars combating SARS, pandemic flus, MERS, and now Ebola, 
one outbreak at a time. When there is a crisis, of course we should 
act. But over the same time period, Congress has slashed the purchasing 
power of America's flagship research agencies--the agencies that do the 
work to make sure that we are ready for these crises before they occur.
    The National Institutes of Health has nearly 25 percent less 
purchasing power today than it did a decade ago. When asked last week 
about Ebola vaccine development, Francis Collins said, ``If we had just 
been able to have basically equivalent purchasing power over these 10 
years, we would have been at least a year ahead of where we are now.'' 
After years of stable reserve fund support, the budget for BARDA is now 
subject to the tumultuous appropriations process. A company in 
Cambridge, MA, received a Department of Defense grant in 2010 to 
develop an Ebola treatment, and the company developed a drug with 
promising trials. We still don't know if that treatment might be 
effective because the funding was cut in 2012 because of shrinking 
Federal support.
    How can investments in basic research and in development help to 
prepare our Nation to deal with known and unknown contagious disease 
threats?
    Answer 2. NIAID is the lead institute at NIH for conducting and 
supporting basic research on biodefense, including chemical, 
biological, radiological, and nuclear threats as well as emerging and 
re-emerging infectious diseases. Basic research supported by NIAID 
contributes to a comprehensive understanding of the scientific and 
medical aspects of these potential threat agents and informs the 
development of medical countermeasures.
    The NIAID research portfolio includes basic research to understand 
the biology, immune response, and pathogenesis of potential bioterror 
agents and emerging and re-emerging infectious diseases, including 
plague, smallpox, Ebola virus disease, and influenza. This research 
provides insight into how these agents cause disease and reveals 
potential targets for the development of medical countermeasures to 
diagnose, treat, and prevent disease. NIAID also supports 
translational-research and product-development efforts to capitalize on 
basic research discoveries and to advance candidate medical 
countermeasures through the product development pipeline. These efforts 
help to ensure our Nation's preparedness to respond to public health 
threats posed by emerging and re-emerging diseases.
    NIAID's basic research investment helps inform development of 
products that can gain Food and Drug Administration (FDA) approval, 
licensure, clearance, or emergency use authorization and, if 
appropriate, be considered for inclusion in the Strategic National 
Stockpile. If candidate countermeasures show promise in proof-of-
concept animal studies or early human testing, NIAID transitions these 
candidates to the Biomedical Advanced Research and Development 
Authority (BARDA) for advanced development. Examples of recent 
successful transitions from NIAID to BARDA include vaccines and 
therapies for anthrax and pandemic influenza--a next-generation 
treatment for chemical exposure; two smallpox antiviral drugs; and, in 
partnership with DoD, the candidate Ebola therapeutic ZMapp. NIAID also 
supported clinical trials, advanced development, and manufacturing 
services leading up to the BARDA's procurement of Bavarian Nordic's 
smallpox vaccine, IMVAMUNE, which has been accepted into the Strategic 
National Stockpile. Results from recent NIAID studies have supported 
the procurement of NEUPOGEN and Leukine for the Strategic National 
Stockpile to treat Acute Radiation Syndrome. The progress of these 
successful products into advanced development and procurement to ensure 
the Nation's preparedness would not have been possible without NIH/
NIAID's important investments in basic and applied research on 
biodefense and emerging and re-emerging diseases.
                           senator alexander
    Question 1. You mentioned that you have an arrangement with the 
Broad Institute in Boston, MA to track the genetic changes of the 
virus. Please describe this arrangement and how it allows you to track 
the genetic changes of the virus as the outbreak continues, including 
changes that could result in increased transmissibility or other 
changes with respect to the virus. Are there plans for additional 
arrangements to facilitate further study of the Ebola virus circulating 
in the current outbreak in West Africa in order to inform research on 
vaccines, treatments, diagnostics, including point-of-care, as well as 
any characteristics of the virus that could improve our public health 
response?
    Answer 1. For the last 10 years, NIAID has supported the Genomic 
Center for Infectious Diseases at the Broad Institute to genetically 
characterize viruses that cause infectious diseases such as dengue 
fever and Lassa fever. Their work has expanded to include the genomic 
sequencing and analysis of Ebola viruses isolated from patients in West 
Africa. One project, the results of which were recently published in 
Science magazine, characterized nearly 100 Ebola virus genomes from 
patients in Sierra Leone, allowing researchers a clearer view of how 
the virus can change over the course of an epidemic. The researchers at 
the Broad Institute currently are leveraging existing partnerships in 
Sierra Leone and Nigeria to obtain additional samples for genomic 
sequencing and analysis.
    Findings from these studies will inform investigations into the 
species of Ebola virus causing the current outbreak. The goal of these 
investigations is to identify and track genetic variations over time 
and at multiple locations and to monitor potential genetic signals of 
transmissibility or other changes in the biology of the virus. The 
research team at the Broad Institute also has allowed the scientific 
community immediate access to its findings by releasing the full-length 
genome sequences on the National Institute of Health's National Center 
for Biotechnology Information (NCBI) genome sequence data bank. This 
data sharing encourages collaboration among the global scientific and 
public health communities to accelerate discoveries about Ebola virus 
transmissibility and adaptation. NIAID will continue to support the 
efforts of the Broad Institute in enhancing and guiding strategies for 
Ebola therapeutics, vaccines, and diagnostics.

    Question 2. NIAID and BARDA are funding studies and clinical trials 
for several candidates for Ebola therapies and vaccines. How are you 
coordinating together to ensure the smooth transition of promising 
candidates from the earlier phase research supported by NIH to some of 
the later advanced research and development supported by BARDA? How are 
you coordinating with the Department of Defense on the research 
supported by them? Please also describe your coordination with the Food 
and Drug Administration with respect to these drug and vaccine 
candidates.
    Answer 2. A core component of NIAID's mission is to conduct and 
support basic and applied research on potential biothreat agents, 
including newly emerging and re-emerging infectious agents such as 
Ebola virus. NIAID aims for our basic research investment to inform 
development of products that can gain Food and Drug Administration 
(FDA) approval, licensure, clearance, or emergency use authorization 
and, if appropriate, be considered for inclusion in the Strategic 
National Stockpile. If candidate medical countermeasures against 
biothreats show promise in proof-of-concept animal studies or early 
human testing, NIAID transitions these candidates to BARDA for advanced 
development. NIAID's longstanding and successful collaborations with 
BARDA, FDA, CDC, and the Department of Defense (DoD) are critical to 
accelerating efforts to develop treatments and vaccines for Ebola virus 
disease.
    In partnership with BARDA, DoD, and FDA, and others, NIAID is 
working to accelerate the development of medical countermeasures for 
Ebola virus. NIAID has worked closely with FDA to advance testing of 
the CAd3 Ebola vaccine candidate developed by NIAID in partnership with 
GlaxoSmithKline. This candidate uses a chimpanzee virus as a carrier to 
introduce Ebola virus genes into the body in order to stimulate an 
immune response. NIAID is currently conducting Phase I clinical trials 
of the CAd3 candidate vaccine at the National Institutes of Health 
Clinical Center in Bethesda, MD and additional testing at the 
University of Maryland and Emory University. Proactive communication 
and partnership enabled FDA to review NIAID's Vaccine Research Center's 
Investigational New Drug (IND) application in less than 1 week, leading 
to acceleration of the clinical study start date. CAd3 will also be 
evaluated in the United Kingdom and the West African country of Mali, 
and further clinical trials are under consideration should the vaccine 
prove safe and indicate an ability to generate an immune response.
    NIAID and DoD are currently coordinating efforts to accelerate the 
production of two Ebola vaccine candidates. NIAID and DoD are 
collaborating with NewLink Genetics on an investigational recombinant 
vesicular stomatitis virus (VSV)-based vaccine candidate developed and 
licensed by the Public Health Agency of Canada. NIAID has worked with 
FDA to enable this candidate to begin Phase I safety studies in the 
fall of 2014 at Walter Reed Army Institute of Research in Silver 
Spring, MD, and at the NIH Clinical Center in Bethesda, MD. Another 
project aims to produce a vaccine candidate based on an existing rabies 
vaccine that could protect against Ebola and rabies, important diseases 
in certain regions in Africa. NIAID and DoD are partnering with 
researchers at Thomas Jefferson University to produce sufficient 
quantities of this candidate to begin clinical testing in early 2015.
    In addition, NIAID is partnering with DoD and BARDA to advance the 
development and testing of the Ebola therapeutic candidate ZMapp. 
ZMapp, developed by Mapp Biopharmaceutical, Inc., with support from 
NIAID and DoD, is a combination of three monoclonal antibodies that can 
protect monkeys from death due to Ebola virus when administered up to 5 
days after infection. NIAID is working closely with partners at DoD, 
BARDA, and FDA to help determine whether ZMapp is safe and effective. 
BARDA currently is working with Mapp Biopharmaceuticals to accelerate 
the manufacturing of more ZMapp for additional testing.
    NIAID is an active participant in the Public Health Emergency 
Medical Countermeasure Enterprise (PHEMCE), an interagency effort led 
by the Department of Health and Human Service's Office of the Assistant 
Secretary for Preparedness and Response that coordinates Federal 
activities to increase preparedness against chemical, biological, 
radiological, and nuclear threats, including Ebola viruses. As an 
active member of the PHEMCE, NIAID participates in multiple teams and 
committees to ensure coordination of scientific activity with PHEMCE 
partners, including BARDA, FDA, and DoD. In addition, NIAID 
participates in the Ebola Medical Countermeasures Senior Steering 
Group, coordinated by the White House Office of Science and Technology 
Policy. Senior staff from all agencies participating in the Ebola 
response meet twice weekly to discuss medical countermeasures for Ebola 
virus in the context of the U.S. response to the Ebola epidemic.
    NIAID will continue to play an active role in the PHEMCE and work 
with BARDA, DoD, FDA, and other partners to advance the development of 
diagnostics, therapeutics, and vaccines for Ebola virus.
                             senator moran
Blood Transfusions
    Question 1. Dr. Fauci, the World Health Organization has endorsed 
the use of blood transfusions from recovered Ebola patients into sick 
patients; however there doesn't appear to be much scientific 
information showing that this works. What is your professional judgment 
on this form of treatment?
    Answer 1. The ability to safely and effectively prevent and treat 
Ebola virus infection is a longstanding priority of the National 
Institute of Allergy and Infectious Diseases (NIAID). However, it is 
important to balance the urgency to deploy investigational medical 
countermeasures in an emergency such as the current Ebola outbreak with 
the need to ensure the safety, determine the efficacy of candidate 
therapeutics, and avoid inadvertent harm. NIAID will do this with 
careful attention to safety, established scientific principles, ethical 
considerations, and the urgent, pressing needs of the affected 
populations.
    Some patients infected with Ebola and hospitalized in facilities 
across the United States and affected countries in West Africa received 
so-called ``convalescent serum'' in addition to other medical care. The 
rationale behind use of convalescent serum is that it contains 
antibodies generated by the immune system of an Ebola survivor during 
the course of infection. These antibodies may help newly infected 
patients to fight Ebola virus. However, more must be known about the 
safety and effectiveness of plasma (``convalescent serum'') 
transfusions from those who have recovered from Ebola virus infection.
    Blood and plasma transfusions have been used as treatment against 
many infectious diseases, and the scientific rationale behind 
``convalescent serum'' therapy suggests that it could be a potential 
treatment for Ebola virus infection. However, there are limited data 
from patients who have undergone this procedure, and further research 
is required before a determination is made that this therapy is a safe 
and effective treatment for Ebola virus infection.
    Note that an alternative mechanism to deliver antibodies that may 
help to treat the Ebola virus would be to artificially manufacture 
these antibodies and deliver them as a drug. This is the principle on 
which the therapeutic candidate ZMapp, a combination of three 
monoclonal antibodies, is based. A drug like ZMapp contains only the 
most potent neutralizing antibodies and its manufacture is standardized 
and regulated. The Department of Health and Human Services is 
vigorously supporting manufacturing and further evaluation of ZMapp.

    Question 2. Is there the necessary infrastructure in-country to 
make sure this technique is done safely? I am particularly concerned 
that Liberia, Guinea, and Sierra Leone do not have the proper blood 
screening procedures in place to ensure that they will not be spreading 
other diseases, like HIV.
    Answer 2. Proper blood screening from donors and blood typing of 
donors and recipients are essential for safe transfusions and to avoid 
dangerous transfusion reactions. In order to safely implement blood 
transfusions to treat Ebola in West Africa, there must be an 
infrastructure capable of identifying survivors, collecting their 
blood, identifying blood type of donor and recipient, and processing 
the blood to screen it for other infectious agents common to the 
region, such as malaria and hepatitis C. The limited health care 
infrastructures in the nations seriously affected by Ebola would make 
it challenging to ensure that blood transfusions were consistently 
administered safely and to collect data appropriate for clinical 
research on this intervention.
Trial Infrastructure
    Question 3. Dr. Fauci, the World Health Organization announced that 
it would accelerate the use of experimental therapies and vaccines to 
contain the expanding Ebola epidemic. In addition, it has endorsed the 
controversial treatment of blood transfusions. As these treatments are 
deployed, how do we tell whether they are effective? Is there 
infrastructure in place to track effectiveness?
    Answer 3. NIAID is committed to working with partners to evaluate 
candidate drugs and vaccines for safety and efficacy. The U.S. 
Government, working in partnership with industry, has an established 
mechanism for testing and reviewing the safety and efficacy of 
potential medical interventions. Randomized controlled clinical trials 
remain the ``gold standard'' for the evaluation of candidate drugs and 
vaccines because they represent the most efficient way to prove 
efficacy and lack of an unexpected harmful effect.
    It is important to balance the urgency to deploy investigational 
medical countermeasures in an emergency such as the current Ebola 
outbreak with the need to ensure the maximal safety and to determine 
the efficacy of candidate Ebola therapeutics. Blood transfusions, other 
Ebola-specific, blood-related products such as plasma from convalescent 
patients or processed serum from either convalescent patients or 
hyperimmune serum from vaccinated individuals, and other candidate 
interventions will be considered as potential experimental Ebola 
therapeutics. These potential therapies will undergo the same rigorous 
testing and evaluation with regards to safety and efficacy as other 
candidate Ebola treatments. As these treatments are deployed for 
emergency use and clinical evaluation, NIAID will continue to work with 
its partners, including non-profit organizations, biotechnology and 
pharmaceutical companies, Federal agencies such as the Centers for 
Disease Control and Prevention, the Biomedical Advanced Research and 
Development Authority, and the Food and Drug Administration, to support 
the clinical trials infrastructure necessary to determine the safety 
and effectiveness of medical countermeasures for Ebola.
                             senator shelby
Ebola Drug Candidate
    Question 1. A university in my State is pioneering a drug, with 
your support at NIAID, that would reactivate the body's immune system 
after Ebola or other viruses deactivate it. What promise do you see in 
this line of drug discovery?
    Answer 1. NIAID supports a broad portfolio of basic research to 
better understand Ebola viruses and applied research to develop 
diagnostics, therapeutics, and vaccines against Ebola viruses. This 
research includes efforts to design and develop drugs to treat Ebola 
virus disease that would inhibit viral replication and its deleterious 
effects on the human immune system. One promising approach is the 
development of nucleoside derivative drugs. These drugs interfere with 
the reproductive process of the virus and may have activity against a 
broad spectrum of viruses. NIAID currently is supporting preclinical 
studies on promising drugs for the treatment of Ebola, and nucleoside 
derivatives are among the candidates that may enter clinical testing to 
evaluate their safety and markers of efficacy in the near future.
    In complement to NIAID's ongoing development of drugs that directly 
target Ebola viruses, NIAID is supporting research that may provide 
significant insights into the mechanisms that govern the immune 
response to viruses. These insights could be used to design highly 
effective and long-lasting vaccines and inform studies on the 
development of novel therapeutic interventions that would enhance human 
responses to viral infections. NIAID will continue to support promising 
approaches to the development of drugs to treat Ebola virus disease and 
enhance the immune response to combat Ebola virus infection.
NIH Research on Ebola
    Question 2. Dr. Fauci, NIH has several Ebola vaccines and therapies 
in development. Could you talk about the prospects for these treatments 
and give your professional judgment on which is the most promising 
approach?
    Answer 2. NIAID supports and conducts basic, translational, and 
clinical research on novel therapeutics and vaccines targeting emerging 
and re-emerging infectious diseases, including Ebola viruses. The 
ongoing NIAID response to the current Ebola outbreak focuses on working 
with non-profit, private industry, and government partners around the 
world to advance the development of medical countermeasures against the 
disease, including evaluating the use of drugs licensed or approved to 
treat non-Ebola diseases as a potential treatment for patients infected 
with Ebola. This approach has led to the generation of multiple 
therapeutic and vaccine candidates across the different stages of the 
product development pipeline.
    While NIAID is an active participant in the global effort to 
address the public health emergency in West Africa, it is important to 
recognize that we are still in the early stages of understanding how 
infection with the Ebola virus can be treated and prevented. The most 
promising therapeutic and vaccine approaches will be identified through 
further research, including evaluation of candidates at the preclinical 
and clinical stages.
    Some of the candidate vaccines and therapeutics currently in 
development with NIAID support are described below.
    Vaccines. The NIAID Vaccine Research Center collaborated with the 
pharmaceutical company GlaxoSmithKline to develop an experimental 
vaccine based on Chimpanzee Adenovirus 3. The vaccine candidate has 
shown promising results in animal models against two Ebola virus 
species, including the Zaire Ebola species responsible for the current 
outbreak. A small Phase I study to examine the safety and ability of 
this candidate vaccine to induce an immune response in humans began on 
September 2, 2014, at the NIH Clinical Center in Bethesda, MD, with 
results anticipated by the end of the calendar year. Additionally, NIH 
is collaborating with DoD and NewLink Genetics on Phase I safety 
studies of another vaccine candidate based on a recombinant vesicular 
stomatitis virus.
    An additional vaccine candidate being developed by a team of NIAID 
intramural scientists and Thomas Jefferson University investigators is 
based on an existing licensed rabies vaccine and aims to protect 
against Ebola and rabies viruses. The vaccine is currently undergoing 
preclinical testing and NIAID is partnering with DoD to produce 
sufficient quantities of the vaccine candidate to begin clinical 
testing in 2015.
    Therapeutics. A combination of three antibodies known as ZMapp has 
been shown to protect monkeys from death due to Ebola virus when 
administered up to 5 days after infection. ZMapp was developed by Mapp 
Biopharmaceutical, Inc., with support from NIAID and DoD. NIAID's 
preclinical services are now being used to provide preliminary safety 
data to support the use of ZMapp for clinical trials in humans.
    NIAID also has funded BioCryst Pharmaceuticals to develop and test 
BCX4430, a novel drug that interferes with the reproductive process of 
the virus. BCX4430 has activity against a broad spectrum of viruses and 
has shown some activity in animals against infection by Ebola virus and 
the related Marburg virus. Additionally, NIAID scientists are working 
on therapeutics that may be effective against multiple hemorrhagic 
fever viruses including Ebola and Marburg filoviruses and the 
arenavirus Lassa. Ribavirin, a drug currently used to treat viral 
hemorrhagic fevers such as Lassa fever, is being examined for its 
potential use in combination therapy to treat Ebola virus infection.
    Candidate therapeutics are being considered for future clinical 
trials to evaluate their safety and efficacy. NIAID will continue to 
work with biopharmaceutical companies and public health agencies around 
the world to advance development of promising candidates and increase 
access to safe and effective medical countermeasures for Ebola virus 
disease as quickly as possible.
                            senator cochran
Response from International Community
    Question 1. Thank you for coming in today to describe efforts by 
the U.S. Government to respond to the Ebola outbreak in West Africa. I 
am hopeful that the United States can play a leadership role in 
addressing this humanitarian crisis, but I am also curious about the 
contributions of international organizations and our partner nations. 
Will you please describe efforts by the international community to stop 
the Ebola epidemic?
    Answer 1. NIAID defers to colleagues coordinating the Ebola 
outbreak response.
Ebola Protection and Control
    Question 2. Do you believe the additional $88 million that has been 
requested by the President to respond to this Ebola crisis will provide 
you with the resources required to protect against the potential spread 
of Ebola in the United States and to address needs abroad?
    Answer 2. NIAID defers to recipients of supplemental funding.
Capacity for Drugs or Vaccines
    Question 3. Do you believe the capacity we have to approve, 
produce, and distribute drugs and vaccines here in the United States is 
sufficient to contain an infectious disease such as Ebola should it 
make its way here to the United States?
    Answer 3. NIAID defers to other witnesses.
Prioritization of Funding
    Question 4. Dr. Robinson and Dr. Fauci, NIH receives approximately 
$1.7 billion per year for biodefense and emerging infectious diseases 
and BARDA receives $415 million. How does HHS prioritize the 
utilization of this funding to address known and emerging threats?
    Answer 4. NIAID is the lead institute at NIH for conducting and 
supporting basic and applied research on biodefense, including 
chemical, biological, and radiological/nuclear threats, and emerging 
and re-emerging infectious diseases. This research provides the 
foundation for developing medical products and strategies to diagnose, 
treat, and prevent a wide range of biodefense threats and infectious 
diseases, whether those diseases emerge naturally or are deliberately 
introduced as an act of bioterrorism.
    Since the 2001 anthrax attacks, with the support of the U.S. 
Congress, NIAID has vastly expanded its research portfolio in 
biodefense and emerging and re-emerging infectious diseases. NIAID's 
biodefense research is guided by its Strategic Plan for Biodefense 
Research, which has been developed and updated in consultation with 
biodefense research experts. NIAID's research also aligns with the 
priorities of the interagency Public Health Emergency Medical 
Countermeasures Enterprise (PHEMCE). NIAID's pathogen priority list is 
periodically reviewed and is subject to revision in conjunction with 
our Federal partners, including the Department of Homeland Security, 
which determines threat assessments, the Centers for Disease Control 
and Prevention, which prepares for and responds to emerging pathogen 
threats in the United States, and the Biomedical Advanced Research and 
Development Authority, with which we collaborate to transition 
promising medical countermeasures for advanced development.
    Guided by our Strategic Plan and priorities, NIAID supports the 
fundamental research needed to better understand infectious agents in 
order to develop broad-spectrum antibiotics and antivirals--drugs that 
can prevent or treat diseases caused by multiple types of bacteria or 
viruses. In addition, NIAID has intensified its efforts to develop new 
technologies that can be broadly applied to more efficiently develop 
diagnostics and vaccines against a wide variety of infectious agents, 
including pandemic influenza viruses, MRSA, extensively drug-resistant 
Mycobacterium tuberculosis, dengue, chikungunya, and filoviruses such 
as Ebola.
    NIAID's biodefense research portfolio includes investigator-
initiated research as well as targeted research initiatives to 
capitalize on new scientific opportunities, provide critical research 
resources, and stimulate research in high-priority areas. All NIAID 
research, whether investigator-initiated or solicited, undergoes peer 
review. Scientific experts evaluate the scientific and technical merit 
of proposed research, and funding decisions are based on scientific and 
technical merit of proposed projects, availability of funds, and 
relevance to program priorities. NIAID's research funding process 
provides the flexibility needed to respond rapidly to address known and 
emerging disease threats.
                              senator burr
    Question 1. How is NIAID structuring the clinical trials with 
respect to both Ebola vaccine and therapeutic candidates, including 
with respect to enrolling clinical trial participants in West Africa? 
Are there aspects of the current Ebola clinical trials that are unique 
given the state of the outbreak overseas?
    Answer 1. NIAID is consulting with experts around the world to plan 
clinical trials of Ebola medical countermeasures that will enroll 
participants in West Africa. An important part of these ongoing 
discussions is an evaluation of whether candidate vaccines and 
therapeutics are available in sufficient quantities for testing and 
whether early clinical testing has indicated they are safe and can 
generate the desired response.
    With respect to vaccines, the NIAID Vaccine Research Center (VRC) 
plays a leading role in the evaluation of safety and immunogenicity of 
candidate Ebola vaccines. Currently, the VRC is conducting and 
supporting Phase I clinical trials of CAd3, an experimental vaccine 
developed by NIAID and GlaxoSmithKline which has shown promising 
results in animal models against two Ebola virus species, including the 
Zaire Ebola species responsible for the current outbreak in West 
Africa. NIAID and GlaxoSmithKline plan to share doses of the vaccine 
candidate with an international consortium comprising Oxford 
University, the Wellcome Trust, and the World Health Organization in 
order to enable other planned clinical trials. With respect to 
therapeutics, only limited clinical use of Ebola therapeutic candidates 
under expanded access mechanisms has occurred so far. Plans for 
systematic clinical testing are under active discussion at this time.
    Aspects of the planned Ebola clinical trials unique to this 
outbreak include the rapid establishment of complex technology transfer 
arrangements, the facilitation of expedited regulatory reviews, and the 
extraordinary deployment of NIAID resources and infrastructure to 
safely provide clinical materials to international partners. NIAID is 
committed to advancing candidate Ebola vaccines and therapeutics while 
ensuring the maximal safety of clinical trial participants.

    Question 2. Are there vaccine and therapeutic candidates that we 
should be pursuing that are not already in the pipeline?
    Answer 2. There are a number of promising vaccine and therapeutic 
candidates for Ebola virus currently in the development pipeline, and 
additional approaches are constantly being investigated and considered 
for further development. NIAID employs multiple approaches to identify 
and develop potential Ebola virus medical countermeasures. NIAID 
supports a strong foundation of basic research to better understand 
Ebola virus and to identify biological targets to inform the 
development of diagnostics, therapeutics, and vaccines. NIAID is 
actively examining these targets to assess scientific concepts and to 
advance promising approaches along the development pipeline.
    NIAID employs a multifaceted and interdisciplinary approach to 
ensure a robust pipeline of candidate medical countermeasures for Ebola 
virus. In collaboration with our partners in government and industry, 
we will continue to evaluate novel ideas and pursue promising 
candidates. Currently NIAID is actively engaging scientists around the 
world who have come forward to discuss their candidate Ebola 
diagnostics, therapeutics, and vaccines. NIAID also makes resources 
available to academic and industry researchers, such as in vitro and in 
vivo screening, to help evaluate potential medical countermeasures and 
advance promising candidates. For example, since 2011, over 30 
different vaccines, formulations, or dosing schedules against 
filoviruses, the virus family that includes Ebola viruses, have been 
evaluated using NIAID's preclinical services. Seven qualified for 
further testing and five are currently in the product development 
pipeline. NIAID is fully committed to engaging its resources to 
identify and evaluate promising vaccines and therapeutics.
                              senator kirk
    Question 1. Dr. Fauci and Dr. Robinson, are there medical 
countermeasures in development to support the current Ebola outbreaks? 
I believe that Ebola was identified as ``threat sufficient'' to affect 
national security in 2006. How does HHS prioritize investments to 
address known and emerging threats?
    Answer 1. NIAID defers to other witnesses on HHS prioritization of 
investments.
    NIAID supports a broad portfolio of intramural and extramural basic 
research to better understand Ebola viruses and applied research to 
develop diagnostics, therapeutics, and vaccines against Ebola viruses. 
NIAID has supported a number of medical countermeasures currently in 
development. As described below, medical countermeasures for Ebola 
virus disease currently in advanced development include therapeutic 
candidates ZMapp, CMX001 (brincidofovir), BCX4430, T-705 (favipiravir), 
TKM-Ebola, and vaccine candidates CAd3 and VSV-EBOV. It is important to 
note that these products are still in development and have not been 
shown to be safe and effective in Ebola patients. So far, only limited 
clinical use of these products under expanded access mechanisms has 
occurred in patients with documented or suspected Ebola virus 
infection.
Vaccines
    CAd3. The NIAID Vaccine Research Center and pharmaceutical company 
GlaxoSmithKline have developed an experimental vaccine that uses the 
chimpanzee adenovirus 3 (CAd3) as a vector to introduce Ebola virus 
genes into the body, stimulating an immune response. This vaccine 
candidate has shown promising results in animal models against two 
Ebola virus species, including the Zaire Ebola species responsible for 
the current outbreak in West Africa. A small Phase I study to examine 
the safety and ability of this candidate to generate an immune response 
began on September 2, 2014, at the National Institutes of Health (NIH) 
Clinical Center in Bethesda, MD. Results from the study are anticipated 
by the end of 2014, and will help inform future development of the 
vaccine.
    VSV-EBOV. The Public Health Agency of Canada has developed VSV-
EBOV, an investigational recombinant vesicular stomatitis virus Ebola 
vaccine subsequently licensed to NewLink Genetics. NIAID is 
collaborating with DoD in support of efforts by NewLink Genetics to 
conduct Phase I safety studies for VSV-EBOV. These studies are planned 
for the fall of 2014 at Walter Reed Army Institute of Research in 
Silver Spring, MD, and the NIH Clinical Center in Bethesda, MD.
Therapeutics
    ZMapp. NIAID supported Mapp Biopharmaceutical, Inc., to develop MB-
003, a combination of three antibodies that provides some protection 
from Ebola virus disease in monkeys when administered within 48 hours 
of exposure. An optimized product derived from MB-003, known as ZMapp, 
has protected monkeys from death due to Ebola virus up to 5 days after 
infection. NIAID's preclinical services are now being used to gather 
safety data for the use of ZMapp in clinical trials. ZMapp was recently 
administered to several patients with Ebola virus disease as an 
experimental treatment, although it is not possible at this time to 
determine whether ZMapp benefited these patients. BARDA is implementing 
plans to optimize and accelerate the manufacturing of ZMapp so that 
clinical safety and efficacy testing can proceed as soon as possible. 
NIAID will continue to work closely with partners at BARDA, DoD, and 
FDA to advance development and testing of this therapeutic candidate.
    CMX001 (brincidofovir). NIAID is evaluating therapeutics in 
development or licensed for the treatment of other diseases for 
activity against Ebola virus. One of these investigational agents is 
brincidofovir, an antiviral originally targeting smallpox that has had 
NIAID support for parts of the development program conducted by 
Chimerix, Inc. Currently, brincidofovir is in advanced clinical testing 
for use against cytomegalovirus and adenovirus infections. In vitro 
screening suggested some activity against Ebola virus and the candidate 
is now undergoing NIAID-funded in vivo testing against Ebola virus 
disease.
    BCX4430. NIAID has funded BioCryst Pharmaceuticals to develop and 
test BCX4430, a novel drug that interferes with the reproductive 
process of the virus and has activity against a broad spectrum of 
viruses. In preclinical testing, BCX4430 has shown some activity in 
animals against infection by Ebola virus and the related Marburg virus. 
A Phase I clinical trial of this drug is expected to begin in late 2014 
or early 2015.
    T-705 (favipiravir). NIAID funded early screening of T-705, or 
favipiravir, a broad-spectrum antiviral against RNA viruses. T-705 is 
owned by Toyama Chemical of Japan and licensed by MediVector for 
development in the United States. This drug is licensed in Japan for 
pandemic influenza; in the United States, it is undergoing DoD-
supported Phase III clinical trials for use against influenza. Pilot 
studies funded by DoD are underway to test the effectiveness of 
favipiravir against Ebola virus in nonhuman primates.
    TKM-Ebola. DoD has supported development of TKM-Ebola by Tekmira 
Pharmaceuticals. TKM-Ebola is a small, inhibitory RNA molecule that 
interferes with Ebola virus replication. Tekmira Pharmaceuticals began 
Phase I trials of TKM-Ebola in January 2014. The trial in healthy 
uninfected volunteers is currently on a partial clinical hold; however, 
the FDA has allowed use of TKM-Ebola under an expanded access mechanism 
in individuals with suspected or confirmed Ebola virus infection.

    Question 2. Dr. Bell and Dr. Fauci, with all the different agencies 
involved, which one is leading the efforts against Ebola? What 
coordinated efforts are happening between the agencies? What are other 
nations doing to contribute?
    Answer 2. NIH supports foundational research and facilitates 
interagency partnerships that lead to the development of new and 
improved medical countermeasures for biodefense and emerging and re-
emerging infectious diseases. NIAID is the lead component of the NIH 
for research and development of medical countermeasures against Ebola 
virus. Basic and applied research supported by NIAID contributes to a 
comprehensive understanding of the scientific and medical aspects of 
Ebola virus and aims to advance development of diagnostics, 
therapeutics, and vaccines against this deadly disease. Critical to 
these efforts are NIAID's collaborations with other Federal entities, 
particularly CDC, FDA, BARDA, and DoD.
    NIAID has responded to the current Ebola virus outbreak in West 
Africa by leveraging longstanding and productive partnerships to 
accelerate ongoing research efforts. For example, NIAID is working 
closely with partners at DoD, BARDA, and FDA, along with the product 
developer, Mapp Biopharmaceutical, Inc., to advance development and 
testing of this Ebola therapeutic candidate ZMapp to determine whether 
it is safe and effective. ZMapp is a combination of three antibodies 
developed with support from NIAID and DoD. ZMapp has shown promising 
results in studies with monkeys, and NIAID is partnering with BARDA and 
FDA to accelerate manufacturing and additional testing of ZMapp. NIAID 
will continue to work closely with BARDA to transition additional 
therapeutic candidates for advanced development as appropriate. NIAID's 
ongoing coordination with FDA will help to advance promising 
therapeutics into clinical testing to determine their safety and 
efficacy.
    In addition, NIAID and DoD are coordinating efforts to accelerate 
the production of Ebola vaccine candidates. One project aims to 
generate immunity to Ebola and rabies viruses using a vaccine candidate 
based on an existing rabies vaccine. NIAID and DoD are currently 
partnering with researchers at Thomas Jefferson University to produce 
sufficient quantities of the candidate to begin clinical testing in 
early 2015. NIAID and DoD also are collaborating with NewLink Genetics 
on an investigational recombinant vesicular stomatitis virus (VSV)-
based vaccine candidate developed by the Public Health Agency of Canada 
and licensed to NewLink Genetics. This candidate has begun Phase I 
safety studies in fall 2014 at Walter Reed Army Institute of Research 
in Silver Spring, MD, and at the NIH Clinical Center in Bethesda, MD.
    NIAID will work closely with FDA to evaluate the safety and 
immunogenicity data from this trial as well as from NIAID's ongoing 
Phase I clinical trial of the chimpanzee adenovirus-based Ebola vaccine 
(CAd3), developed in collaboration with GlaxoSmithKline.
    NIH also participates in the Ebola Medical Countermeasures Senior 
Steering Group, led by the White House Office of Science and Technology 
Policy and comprising senior staff from all Federal agencies 
participating in Ebola response activities. Through this and other 
mechanisms, NIAID will continue its efforts to accelerate the 
development of safe and effective countermeasures against Ebola virus 
by leveraging existing partnerships with industry and other Federal 
agencies including CDC, FDA, BARDA, and DoD.
    NIAID defers to other witnesses regarding which Agency is leading 
efforts against Ebola and other nations' contributions against Ebola.

     Response to Questions of Senator Casey and Senator Warren by 
                         Ishmael Alfred Charles

                             senator casey
    Question 1. You stated that stigma surrounding Ebola is a problem 
for combating the current outbreak. What message do you think needs to 
be articulated to help fight that stigma?
    Answer 1. Well over the period with the current outbreak we have 
practically seen how stigmas and discrimination have torn apart more 
people almost as much as the outbreak. At community level, it is 
important to use our religious leaders and community volunteers to 
preach about acceptance and the fact that those who have survived Ebola 
cannot transfer the virus or cannot get anyone sick. Also at the 
regional and international level people need to get more education on 
how Ebola spreads, for example in the United States, institutions like 
CDC and NIH need to engage the wider society that Ebola is not an 
African outbreak. It can take place anywhere. It is more serious in 
Africa because of the bad leadership and poor health infrastructures 
and system. Also that Ebola does not spread by merely seeing someone 
but only through bodily contact, as the lack of sufficient information 
is also creating more confusion.
    Stigma is degrading attitude of the society that brings not only 
shame and disgrace, but also discredits a person or a group because of 
an attribute to an outbreak like Ebola.
    Stigma leads to people not being treated with dignity and respect 
and promotes hate and disunity which is socially unacceptable.

    Question 1a. Which people in local communities do you feel would be 
best able to communicate that message?
    Answer 1a. There are community stakeholders who also are the 
opinion leaders of the community.
    The following are examples: Religious leader (e.g., Imam, Pastors 
and Rev. Fr.), Traditional Heads, popular sports/soccer players, 
musicians/comedians and influential personalities.

    Question 2. In your testimony, you stated that schools in Sierra 
Leone are closed indefinitely, while the illiteracy rate is 70 percent. 
How can the international community help affected countries fill in 
this education gap for their children and improve literacy?
    Answer 2. Prior to the Ebola outbreak, the basic survival of the 
ordinary citizen was difficult. The outbreak has undoubtedly compounded 
the already worse situations.
    The cost of the basic school or learning materials increased just 
before the outbreak and the outbreak has stopped all economic 
activities such as trading and movement. Schools are closed to avoid 
contact among pupils and students.
    The following interventions may help:

    (1) Take care of the education of the orphans of Ebola victims.
    (2) Help the government to provide affordable education at all 
levels for the citizens (e.g., Free tuition for secondary schools and 
reduction in college and university fees.)
    (3) Reintroduce school feeding programs in primary schools to 
augment the post Ebola recovery.
    (4) Support the universities directly with their needs including 
subsidies.

    Clearly we realized that in a post conflict country only recovering 
from the aftermath of the war has not helped the situation at all. 
Schooling was badly disrupted and it has only further damaged the 
educational development of the country, a country with 70 percent 
illiteracy. Schools have closed indefinitely, and this is exposing many 
young girls to teenage pregnancy and further increasing the burden. My 
suggestion is for us to ensure that these children who will be pregnant 
after Ebola will need to be enrolled in a special school to ensure that 
they don't become drop outs.
    Also there is a need for a recap type of school. Post war era, we 
had a schooling program called Remedial term, which was an accelerated 
learning and teaching program. We will need a similar program in the 
post Ebola era, so that the school pupils will be able to recap and 
catch up with what they have lost.

                             senator warren
    Question 1. Fighting epidemics in developing countries presents 
unique challenges. Despite all the attention that's being paid to the 
Ebola outbreak, serious health problems have gripped these countries 
for years. In Liberia, for example, 17 percent of deaths are due to 
Malaria, and Sierra Leone has one of highest rates of infant and 
maternal mortality in the world. Countries currently dealing with Ebola 
have a poor healthcare infrastructure and very few healthcare workers--
and are barely able to provide basic care, much less handle an 
epidemic.
    How would long term investments to improve the basic healthcare 
infrastructure of developing nations help to improve our ability to 
respond to new outbreaks and epidemics?
    Answer 1. Any attempt to address the health care problems in 
developing countries, like Sierra Leone should focus on sustainable 
infrastructure and a strong system that is in rhythm with international 
best practice(s).
    Our current health care facilities including the Infrastructure do 
not address the needs/demands of most of the recent outbreaks and 
epidemics.
    In addition to the substandard provisions, there are no improving 
systems that will implement and monitor the effective and efficient use 
of the health care facilities.
    The following are recommended:

    1. Establishment of a Centre for Diseases Control (CDC) in every 
country, especially those that were badly affected by Ebola.
    2. Strengthening of health care systems.
    3. Ensure a vibrant disease surveillance network within West 
Africa.

    Question 2. How are the United States and international aid 
organizations helping to take care of health care needs besides Ebola 
in the epidemic regions?
    Answer 2. The international aid organizations and U.S. 
organizations are helping in diverse ways which include provision of 
food and nonfood items to people as hunger and starvation is on the 
increase. This support is not enough, hence there is a huge need for 
more support to the community people across the country, especially in 
the badly hit areas of the country.

    [Whereupon, at 5:45 p.m., the hearing was adjourned.]

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