[Senate Hearing 114-732]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 114-732
 
        ZIKA VIRUS: ADDRESSING THE GROWING PUBLIC HEALTH THREAT

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                                   ON

  EXAMINING THE ZIKA VIRUS, FOCUSING ON ADDRESSING THE GROWING PUBLIC 
                             HEALTH THREAT

                               __________

                           FEBRUARY 24, 2016

                               __________

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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman

MICHAEL B. ENZI, Wyoming          PATTY MURRAY, Washington
RICHARD BURR, North Carolina      BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia           BERNARD SANDERS (I), Vermont
RAND PAUL, Kentucky               ROBERT P. CASEY, JR., Pennsylvania
SUSAN COLLINS, Maine              AL FRANKEN, Minnesota
LISA MURKOWSKI, Alaska            MICHAEL F. BENNET, Colorado
MARK KIRK, Illinois               SHELDON WHITEHOUSE, Rhode Island
TIM SCOTT, South Carolina         TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah              CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas               ELIZABETH WARREN, Massachusetts
BILL CASSIDY, M.D., Louisiana

                       
                                     
                                       

               David P. Cleary, Republican Staff Director

         Lindsey Ward Seidman, Republican Deputy Staff Director

                  Evan Schatz, Minority Staff Director

              John Righter, Minority Deputy Staff Director

                                  (ii)

  




                            C O N T E N T S

                               __________

                               STATEMENTS

                     TWEDNESDAY, FEBRUARY 24, 2016

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Murray, Hon. Patty, a U.S. Senator from the State of Washington..     3
Collins, Hon. Susan, a U.S. Senator from the State of Maine......    26
Warren, Hon. Elizabeth, a U.S. Senator from the State of 
  Massachusetts..................................................    27
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................    29
Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin..    31
Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana...    32
Murphy, Hon. Christopher, a U.S. Senator from the State of 
  Connecticut....................................................    34
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas.......    36
Bennet, Hon. Michael F., a U.S. Senator from the State of 
  Colorado.......................................................    38
Franken, Hon. Al, a U.S. Senator from the State of Minnesota.....    39
Casey, Hon. Roberts P., a U.S. Senator from the State of 
  Pennsylvania...................................................    41
Scott, Hon. Tim, a U.S. Senator from the State of South Carolina.    43

                               Witnesses

Schuchat, Anne, M.D., RADM, USPHS, Principal Deputy Director, 
  Centers For Disease Control And Prevention, Atlanta, GA........     5
    Prepared statement...........................................     7
Fauci, Anthony, M.D., Director, National Institute of Allergy And 
  Infectious Diseases, Bethesda, MD..............................    12
    Prepared statement...........................................    13
Robinson, Robin, Ph.D., Director, Biomedical Advanced Research 
  And Development Authority, Washington, DC......................    17
    Prepared statement...........................................    19

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Senator Casey, prepared statement............................    49
    Statement from international and domestic groups, submitted 
      by Senator Murray..........................................    50

                                 (iii)

  


        ZIKA VIRUS: ADDRESSING THE GROWING PUBLIC HEALTH THREAT

                              ----------                              


                      WEDNESDAY, FEBRUARY 24, 2016

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10 a.m. in room 
SD-430, Dirksen Senate Office Building, Hon. Lamar Alexander, 
chairman of the committee, presiding.
    Present: Senators Alexander, Murray, Burr, Collins, Scott, 
Roberts, Cassidy, Casey, Franken, Bennet, Baldwin, Murphy, and 
Warren.

                 Opening Statement of Senator Alexander

    The Chairman. The Senate Committee on Health, Education, 
Labor, and Pensions will please come to order.
    For the information of Senators, the vote has been moved to 
noon. So we do not have an 11 a.m. vote, and I appreciate 
Senator McConnell doing that because there is no need to 
interrupt hearings that we have prepared for to have a vote 
unless it is necessary.
    This morning, we are having a hearing about the Zika virus 
to help Congress and the public gain a better understanding of 
the virus, as well as carefully assess what we can do to 
prevent its appeal in South and Central America and how much of 
a concern this will be here in the United States.
    Senator Murray and I each will have an opening statement. 
Then we will introduce our panel of witnesses. After our 
witness testimony, Senators will each have 5 minutes of 
questions.
    Earlier this month, Senator McConnell hosted a briefing on 
the Zika virus with Secretary Burwell.
    Two weeks ago, the Senate Appropriations Labor, Health and 
Human Services, and Education Committee held a hearing with Dr. 
Frieden and Dr. Fauci. I guess that is the committee that 
Senator Murray is the ranking member of.
    This is the third opportunity that some of us have had to 
hear more about the virus. And I thank the witnesses for 
keeping Congress and the public informed.
    I hear a lot about it when I go home, and I am going to be 
asking some questions today which were the questions that were 
asked me by family members and friends. There are a lot of 
questions.
    Let me run through a little of what we know.
    This virus was discovered in 1947. Until recently, it was 
only thought to cause mild symptoms, including fever, rash, 
joint pain, that lasts for about a week. Only one in five 
people infected actually experience any symptoms. This is what 
we have been told.
    Zika is spread mostly by the bite of an infected mosquito 
of the Aedes species. This is the same mosquito that spreads 
dengue fever and chikungunya. The virus can be spread from a 
pregnant woman to her unborn child. It can also be sexually 
transmitted. And I want to ask more about that today because 
there is some new information about that I understand.
    Zika has been showing up in numerous South and Central 
American countries, including Colombia, Mexico, Costa Rica, 
Puerto Rico, and the U.S. Virgin Islands.
    Last year, after an outbreak of Zika, Brazil reported a 
sharp increase in the number of reported cases of a rare birth 
defect called microcephaly in areas affected by the Zika virus 
outbreak. Babies born with microcephaly have smaller heads and 
often have underdeveloped brains. It is a lifetime condition 
that can range from mild to severe, and treatment varies for 
that reason.
    Today there are over 4,000 reported cases of microcephaly 
in Brazil. More than 500 of these have been confirmed. In 2014, 
147 cases of microcephaly were reported in Brazil.
    In conjunction with an outbreak of the Zika virus, an 
additional five countries, French Polynesia, El Salvador, 
Venezuela, Colombia, and Surinam have reported an increase in 
the incidence of cases of microcephaly and/or Guillain-Barre 
syndrome, a syndrome that attacks the nerves and causes 
temporary paralysis.
    Today there are no reported cases of anyone being infected 
by a mosquito with Zika in the United States, or at least that 
is the information we have. There are 82 travel-related cases 
in the United States, including one in Tennessee, in which 
individuals become infected with Zika after traveling to an 
area where Zika is spreading.
    The Centers for Disease Control and Prevention also 
announced yesterday that CDC and State public health 
departments are investigating 14 new reports of possible sexual 
transmission of Zika in the United States.
    Currently there is not a vaccine or an approved treatment 
for Zika. We will want to talk more about that in this hearing. 
There is also no commercially available diagnostic to test for 
Zika, although the CDC and some public health laboratories can 
test to determine if a patient has the Zika virus. We will want 
to talk also about the development of diagnostic tests. CDC is 
working to produce and distribute over 1 million diagnostic 
tests.
    Today I will be asking about the link between the Zika 
virus and microcephaly and also about how the virus affects 
young children. I asked Dr. Frieden at a hearing earlier this 
morning how long a woman who becomes sick with Zika or travels 
to a country where Zika is, should wait before trying to get 
pregnant. I would like to ask that question again today. I will 
be asking if there is any update on what we were told earlier.
    I will also be interested in hearing about the progress on 
vaccines, diagnostic tests. Dr. Fauci said in previous 
testimony it might take 12 to 15 months to develop a vaccine.
    The World Health Organization has turned its attention to 
controlling mosquitoes. More than 200 soldiers in Brazil are 
being deployed to help eliminate standing water. The WHO 
reports that mosquito larvae have been found in plates under 
potted plants, bird baths, and dog bowls. Mosquito control is 
generally a State and local issue. I am interested in hearing 
how CDC is working with these partners to support efforts to 
control mosquito populations in the United States.
    There has also been some discussion about the use of 
genetically modified mosquitoes. I would like to hear how 
realistic that is and what the issues are with that.
    I want to thank the witnesses for being here. This is an 
issue that has the attention of millions of Americans, and 
hopefully in this hearing today, we can provide some accurate 
information so that we take the risk of the Zika virus in the 
United States seriously, but that we do not overreact to it at 
the same time.
    Senator Murray.

                  Opening Statement of Senator Murray

    Senator Murray. Thank you very much, Chairman Alexander. 
Thank you to all of our colleagues who are joining us.
    Dr. Fauci, Dr. Schuchat, and Dr. Robinson, I really 
appreciate all of you being here and sharing your expertise 
with us today.
    Like the chairman, many of us are hearing from families in 
our home States who are deeply concerned about the spread of 
Zika virus, which can have such tragic consequences, especially 
for young families. I am glad we have the opportunity to speak 
with experts who are on the front lines of our response efforts 
and talk about ways Congress can best support this critical 
work.
    There is still a lot we need to learn about this virus, but 
one thing is clear is we cannot wait to act. The scientific 
consensus at this stage is that four out of five of those who 
become infected show no symptoms. For the other 20 percent who 
do, the most common result is a week of mild flu-like symptoms. 
However, in rare instances, there are indications that some 
people infected with the virus have developed Guillain-Barre 
syndrome, which is a potentially life-threatening neurological 
condition. There is growing evidence that Zika can lead to 
microcephaly, a birth defect that usually results in abnormal 
brain development with possible serious long-term consequences.
    The CDC has also reported that in Brazil two women 
miscarried after being infected with Zika and is exploring 
whether there may be other potential consequences for pregnant 
women who become infected.
    The same mosquitoes that carry the virus in South America 
can be found in many parts of the United States. The virus has 
spread to Puerto Rico, putting pregnant women there at risk, 
and many are concerned that it will make its way to the 
mainland when the warm weather returns. And as of this week, 
there are cases being reported as far north as my home State of 
Washington as a result of travel. Speaking for moms and 
grandmothers across the country, this is deeply disconcerting.
    So now is the time to prepare for that possibility and 
develop strategies for controlling the mosquitoes that harbor 
the virus. As we work to fill in the gaps in our knowledge 
about the disease, we also need to expand mosquito control 
efforts, as well as laboratory and diagnostic capabilities, in 
States and cities nationwide. We should work to accelerate 
research and development of effective lab tests, antiviral 
drugs, and critically, a vaccine. And we need to educate health 
care providers and families about this virus and improve health 
care services for low-income pregnant women in areas where Zika 
poses a risk.
    According to the CDC and the Pan-American Health 
Organization, women in many Zika-affected countries face 
barriers to reproductive health care as well as high rates of 
sexual violence.
    I believe it is critical that in Zika-affected countries we 
do everything we can to ensure women have access to the full 
range of reproductive health care, including access to family 
planning services. Democrats are going to continue urging 
bipartisan work to ensure women everywhere have the ability to 
plan their pregnancies, especially in light of this virus.
    The Administration has laid out an aggressive plan to fight 
the Zika virus and has requested supplemental funding to ensure 
all the appropriate resources are being put toward protecting 
families here at home and abroad.
    Some of my Republican colleagues have suggested that 
additional funding is not needed to respond to Zika. They 
believe the Administration should simply shift funding away 
from Ebola response efforts, which are still ongoing. I 
disagree. We need to both finish the job of responding to the 
Ebola crisis and act to address the growing threat of the Zika 
virus. Families' health and safety should not be a zero sum 
game.
    I am very hopeful that here in Congress we can put the 
politics aside and work together to ensure that we do provide 
much needed tools and support. And with the health and well-
being of many families at risk, I hope we can do so quickly.
    Mr. Chairman, I would like to include in the record a 
statement from 29 international and domestic groups supportive 
of women's health. This statement reiterates the need for 
prioritizing women's access to the full range of reproductive 
health care, including family planning, as we respond to this 
Zika virus.
    Thank you again to all of our witnesses who are here today. 
I look forward to hearing from you.
    The Chairman. Thank you, Senator Murray, and it will be 
included.
    [The information referred to can be found in additional 
material.]
    The Chairman. I am delighted to welcome our witnesses. 
Thanks for being here. Your work is integral to the 
government's response to Zika.
    First, we will hear from Dr. Anne Schuchat. She is the 
Principal Deputy Director of the Centers for Disease Control 
and Prevention. She has worked at CDC since 1998. She has been 
director of the CDC's National Center for Immunization and 
Respiratory Diseases and Acting Director of the Center for 
Global Health, among other leadership positions. She has worked 
on vaccine trials for meningitis, pneumonia, and Ebola.
    Next, we will hear from Dr. Anthony Fauci. He is the 
Director of the National Institute of Allergy and Infectious 
Diseases, which is part of the National Institutes of Health. 
He leads research related to preventing, diagnosing, and 
treating infectious diseases. He has held this position since 
1984 during which time he has led the agency's research efforts 
related to HIV/AIDS, influenza, malaria, Ebola, and other 
infectious diseases. In 2014, Dr. Fauci was involved in caring 
for the Ebola patients at NIH and also worked on vaccine trials 
for Ebola.
    Last, we will hear from Dr. Robin Robinson. He is Director 
of the Biomedical Advanced Research and Development Authority. 
This is the agency Senator Burr had such a large role in 
helping to create. And he is the Deputy Assistant Secretary in 
the Office of the Assistant Secretary for Preparedness and 
Response. Dr. Robinson was appointed in 2008 as the first 
Director of BARDA and has led the efforts to build our Nation's 
medical countermeasure pipeline comprised of more than 160 
medical countermeasures for public health threats, including 
pandemic influenza and emerging infectious diseases.
    We look forward to your testimony and ask that you 
summarize it in about 5 minutes. We have a number of Senators 
who would like to ask questions and that would leave time for 
that.
    Dr. Schuchat.

STATEMENT OF ANNE SCHUCHAT, M.D., RADM, USPHS, PRINCIPAL DEPUTY 
DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, 
                               GA

    Dr. Schuchat. Thank you, Chairman Alexander, Senator 
Murray, and members of the committee, for the chance to speak 
with you this morning. I am looking forward to discussing the 
CDC's efforts to prepare and respond to our newest threat, 
which is particularly concerning for pregnant women.
    CDC and partners around the world are working around the 
clock to find out as much as we can and share this quickly so 
that we can get ahead of this problem.
    I want to make three key points about the Zika virus.
    This is a very dynamic situation. We are learning more 
every single day, and what we learn we will share as quickly as 
possible. But there is a lot that we still do not know.
    Second, nature is a difficult adversary. This is a new 
syndrome. It is not a new virus, but it is a new syndrome that 
we are managing and that can be scary. But it is important to 
remember that we can and we should do more to detect, respond, 
and prevent this and other emerging pathogens.
    Third, CDC has unique decades-long experience in dealing 
with this kind of threat. Through our prevention, detection, 
and response activities, our surveillance, our laboratory 
capacities, we work on this kind of thing and are quite 
effective working with State and local public health and with 
countries around the world.
    I want to just briefly go over what we do know, the facts. 
The virus was fist found in 1947, the first outbreak almost 10 
years ago in the small Pacific island of Yap, but what we have 
been seeing this past year is a large outbreak in the Americas 
and then these concerning increases in microcephaly, a serious 
birth defect, and possibly a link with Guillain-Barre syndrome, 
a serious neurologic problem.
    The virus is spread through the mosquito Aedes aegypti 
primarily, and that is a really difficult mosquito to control. 
It is a daytime biter. It feeds on many different people. It 
can be inside and outside the home. And it has been challenging 
to control it in other contexts. So that is going to be 
difficult.
    I want to mention what I think our likely future is and 
preface that by saying we have to be prepared for different 
scenarios. Most of what we think will happen is based on what 
we have seen happening with dengue and chikungunya that are 
also viruses spread by the same mosquito. Those are endemic in 
much of Latin America and they are endemic in Puerto Rico and 
other U.S. territories, but they are not endemic to the 
continental United States. So the trajectory we think we will 
see is based on what we saw with them, that there can be big 
outbreaks of dengue and chikungunya and possibly of----
    The Chairman. Excuse me, Doctor. What do you mean by 
``endemic?''
    Dr. Schuchat. ``Endemic'' is native or natural to the area. 
In Puerto Rico, we have a dengue branch, a laboratory that is 
based in Puerto Rico, because they have that virus causing 
disease year in and year out. We are worried that the Zika 
virus could take hold in Puerto Rico and really be a long-term 
problem there.
    We also know that we have risk in travelers returning from 
areas where the virus is spreading. We saw that with 
chikungunya. We see that with dengue. And we expect to see more 
and more of that with Zika.
    We have had small-scale local spread of dengue and 
chikungunya in the continental United States, in Florida, 
Texas. We think that may happen with Zika, and that is one of 
the reasons we are very keenly interested in supporting State 
and local governments in the southern United States. And we 
need to be ready for things to not play out the way that we 
have seen with those other viruses.
    CDC has had a very aggressive response so far with 
attention to protecting pregnant women with our special travel 
guidance, developing diagnostic tests so that States and locals 
and clinicians could figure out if a person had this virus, 
supporting the States and territories to be ready and to start 
preparing for this, and working with international partners, 
particularly Brazil and Colombia where we have teams on the 
ground trying to answer questions about this syndrome.
    Last week, I was in Brazil and saw the very high-level 
commitment that the government there has to engaging in this 
and was really touched by those same images everybody has been 
seeing of the families who have children severely disabled from 
this virus.
    While we are doing much already, there is so much more we 
need to do, and that is what the supplemental request is about. 
We need to prepare to respond in Puerto Rico. We need the rest 
of the United States to be ready because travelers will be 
returning from these affected areas, and we need to work with 
international partners on the ground to learn as much as we can 
so that we can protect Americans.
    We are learning more every day, but there is much more to 
learn and much more to do. And we will use surveillance 
diagnostics, mosquito control methods, and guidance focused on 
prevention, particularly for pregnant women.
    CDC is the first line of defense for America's health, and 
we are building on our expertise to respond to emerging 
pathogens like Zika, including the essential components of 
disease detection.
    I want to thank you for the chance to answer your questions 
in the future.
    [The prepared statement of Dr. Schuchat follows:]

         Prepared Statement of Anne Schuchat, M.D., RADM, USPHS

                              introduction
    Good morning Chairman Alexander, Ranking Member Murray, and members 
of the committee. Thank you for the opportunity to testify before you 
today on Centers for Disease Control and Prevention's (CDC's) efforts 
to prepare for and respond to the Zika virus outbreak, which threatens 
the United States and the rest of the Americas. The Administration has 
requested approximately $1.9 billion in emergency funding to respond to 
the Zika virus outbreak, including $828 million for CDC, in support of 
both the domestic and international response, with particular attention 
to emergency assistance to the Commonwealth of Puerto Rico and other 
U.S. Territories and States with local transmission of Zika virus.
    CDC is the Nation's health protection agency, working 24-7 to save 
lives and protect people against unpredictable threats such as the Zika 
virus. Nature is a formidable adversary, and Zika is our newest threat, 
particularly to pregnant women. CDC has some of the world's leading 
experts both in diseases spread by mosquitos and in birth defects. We 
must act swiftly to stop the spread of the Zika virus, both 
domestically and globally. While we are learning more about the Zika 
virus every day, there are many things we do not know yet about Zika. 
These include our understanding of the spectrum of effects of Zika 
infection during pregnancy, the risk the virus may play in 
microcephaly, Guillain-Barre syndrome and other possible complications, 
the duration of Zika infectivity in semen, and determining what other 
factors may play a part in the consequences associated with the virus. 
In addition to answering these questions, we are also working to 
accelerate optimal mosquito control strategies, improve testing and 
assure preparedness for rapid detection, control, and prevention within 
the United States and U.S. territories.
    We are making advancements in these areas and will need the 
additional requested funding to do so. We are figuring out more about 
Zika literally every day, and will share information--and adjust our 
guidelines and recommendations--as we learn more. That is the nature of 
a scientific response to an emerging health threat. The doctors, 
scientists, entomologists, and others at CDC are working nonstop to 
protect Americans from this and other health threats. We have already 
made significant progress identifying the Zika virus in brain tissue of 
affected deceased infants, developing new diagnostic tests, issuing 
guidance, conducting epidemiological investigations along with affected 
countries, and improving monitoring and surveillance in the United 
States including in the Commonwealth of Puerto Rico and the other U.S. 
territories. Much of what we know about Zika and similar viruses today 
is based on the work that's been done by CDC scientists. But there are 
still many things we do not yet know. We will continue to use the best 
of modern science to protect the American people. I understand that 
Zika virus and the emergence of serious birth defects cause concern. We 
are committed to providing the American people with the most accurate 
and timely information about Zika virus and the current outbreak.
    CDC is working in collaboration with other components of the 
Department of Health and Human Services (HHS), including the Office of 
the Assistant Secretary for Preparedness and Response (ASPR) and its 
Biomedical Advanced Research and Development Authority (BARDA), the 
National Institutes of Health, and the Food and Drug Administration 
(FDA). We are also working with partners across the U.S. Government to 
communicate with travelers and health care providers, update travel 
alerts and clinical guidance, and develop improved mosquito-control 
methods.
                          zika and its history
    Zika is a flavivirus, which is closely related to dengue, yellow 
fever and West Nile viruses. Zika virus is primarily spread to people 
through the bite of infected Aedes species mosquitos, particularly 
Aedes aegypti. The Aedes aegypti mosquitos, which also transmit dengue 
and chikungunya viruses, are extremely difficult to control. They bite 
during the day, indoors and outdoors, and they preferentially feed on 
humans. And they need only the smallest bit of water to breed--just a 
bottle cap is enough. The mosquitos become infected when they bite a 
person with Zika virus. These infected mosquitos can then spread the 
virus to other people through bites. Case reports of other modes of 
transmission include spread through sexual transmission and blood 
transfusion. Of great concern, Zika virus infection in a pregnant woman 
has been linked to issues in fetal development, and the virus has been 
detected in association with fatal brain malformation in newborns as 
well as in miscarriages.
    While its adverse effects were unforeseen, Zika is not a new virus. 
It was first recognized in 1947 and has caused occasional illness in 
Africa and Asia, but the first outbreak we know of occurred in 2007 in 
the small Pacific island of Yap. Last May, the first local transmission 
of Zika in the Americas was reported in Brazil, and by the end of 2015, 
Brazilian authorities estimated that the outbreak there involved 
perhaps a million suspected cases of Zika virus. In recent months, the 
virus has spread rapidly throughout Latin America and the Caribbean, as 
well as to parts of the Pacific. As of February 18, 2016, 32 countries 
and territories, including the Commonwealth of Puerto Rico, a United 
States Territory, the U.S. Virgin Islands, and American Samoa have 
reported local transmission of the Zika virus.
                     symptoms and adverse outcomes
    Many people exposed to Zika virus will have only mild symptoms--
such as fever, rash, joint pain, and red eyes or conjunctivitis--that 
will last no more than a week. In past outbreaks, about four out of 
five people infected with Zika appear not to have had symptoms at all, 
although we do not know if that is the pattern in this outbreak.
    Increasing evidence suggests that Zika virus infection may be 
associated with more serious health outcomes. In October 2015, 
Brazilian authorities recognized a concerning increase in microcephaly, 
which has occurred in close sequence to Brazil's outbreak of Zika 
virus. Microcephaly is a usually rate, serious condition where a baby's 
head is smaller than expected based on age and sex. Microcephaly is not 
a diagnosis in and of itself, but a sign that the brain did not develop 
as it should in the womb. Babies with microcephaly can have a range of 
problems, including seizures, developmental delay, feeding problems and 
hearing loss. In some cases these problems can be fatal.
    Laboratory tests at CDC strongly suggest a link between Zika virus 
infection during pregnancy and microcephaly. We do not fully understand 
the nature of this relationship, or if there are important cofactors. 
We also do not know what, if any, other outcomes might be associated 
with Zika infection during pregnancy among infants who do not have 
microcephaly. Microcephaly in infants can be devastating to the 
affected families, and this ongoing outbreak is concerning to everyone, 
especially for pregnant women, and their families who may travel to or 
live in the infected areas. The association between Zika virus and 
microcephaly is unexpected. A new infectious cause of fetal 
malformations has not been identified in decades. Zika virus spread in 
the Americas and its effect on pregnancy are developments that we are 
working with partners to better understand.
    Our key priority at this point is to reduce the risk to pregnant 
women of Zika virus infection. Given the potential risks associated 
with maternal Zika infection, prevention is key for this response, with 
a parallel approach of acting based on what we know now and, at the 
same time, discovering more so that we can better prevent adverse 
health outcomes in the future. That's why, during the same week we 
identified Zika in brain tissue specimens from affected infants, we 
issued a warning to advise pregnant women not to travel to affected 
areas. That's why we are working intensively with the Commonwealth of 
Puerto Rico and other areas to get support to women who are or who may 
become pregnant and do what we can to reduce the threat of Zika there. 
And that's why we are also engaging in studies with international 
partners so that we can more fully understand the magnitude of risk and 
the range of outcomes associated with Zika virus infection during 
pregnancy.
    Health authorities in Brazil and elsewhere have also reported an 
increase in suspected cases of Guillain-Barre syndrome, a rare 
neurologic disorder in which a person's own immune system damages nerve 
cells, leading to nerve damage or paralysis that lasts for several 
weeks or several months. Most people fully recover, but it can take a 
few months or even years to do so. Some people with Guillain-Barre 
syndrome have permanent damage and, in rare cases, people have died. It 
is difficult to determine if any particular pathogen ``caused'' or 
``triggered'' Guillain-Barre syndrome. Currently, we do not know if 
Zika virus infection causes Guillain-Barre syndrome. However, the 
development of Guillain-Barre syndrome is a recognized after-effect of 
a variety of different infections. CDC is currently collaborating with 
public health officials in Brazil to investigate whether there is any 
causal link between Zika infection and Guillain-Barre syndrome.
                          domestic activities
    While we are working to better understand these health outcomes, 
transmission, diagnostics, and mosquito control, CDC is moving quickly 
to respond. We have moved our Emergency Operations Center to the 
highest alert level for Zika virus to further enhance our response 
activities in areas with current local transmission and to accelerate 
preparedness efforts in anticipation of local transmission in the 
continental United States.
    For the Commonwealth of Puerto Rico as well as the U.S. Virgin 
Islands and American Samoa, a surge in resources is urgently needed. 
The population of Aedes aegypti mosquitos is widespread on these 
islands, protective environmental factors such as window screens are 
not as prominent, and the density of people puts people there at high 
risk for transmission. All three areas have already reported local Zika 
transmission, with Puerto Rico alone reporting at least 30 cases. 
Furthermore, recent outbreaks of dengue and chikungunya suggest that 
Zika virus may spread extensively and rapidly in these areas. CDC has 
deployed staff to the U.S. Virgin Islands, American Samoa, and Puerto 
Rico to support response activities and provide technical assistance to 
health departments there. CDC and the CDC Foundation are also 
partnering to create Zika prevention kits. Containing educational 
materials, and initial supplies of prevention tools such as insect 
repellant, the purpose of these kits is to help pregnant women in areas 
with local Zika transmission protect themselves and their pregnancies. 
Five thousand of these kits have been dispatched to the Commonwealth of 
Puerto Rico, the U.S. Virgin Islands, and American Samoa; and CDC plans 
to distribute more than 45,000 kits to these areas in the future.
    While we have not yet seen transmission of the Zika virus by 
mosquitos within the continental United States, we expect many 
returning travelers will have Zika infection. As a potential benchmark, 
we received reports of 3,270 travelers from 49 States with laboratory 
confirmed cases of chikungunya infection in 2014 and 2015. There are 
about 40 million people traveling between the continental U.S. and 
Zika-affected areas each year. Therefore, all U.S. jurisdictions must 
be prepared to evaluate, test, and manage patients with potential Zika 
virus infection, particularly pregnant women. Furthermore, Aedes 
aegypti is found in many areas of the United States, raising the risk 
of local transmission. The most recent data available suggest that 
Aedes aegypti are found in 13 States and Aedes albopictus are found in 
31 States and the District of Columbia. Recent chikungunya and dengue 
clusters in the United States suggest that Zika outbreaks in the U.S. 
mainland may be relatively small and localized due to protective 
factors like window screens and less dense living conditions; however, 
any local outbreaks will be of deep concern to the people living there, 
and we must be prepared for different scenarios including more 
extensive transmission risk.
    CDC is working with health departments across the country to ensure 
coordination and to expand capacity for detecting and responding to 
Zika virus. Surveillance is essential to monitor and quickly identify 
areas with local transmission. We conduct multi-faceted surveillance 
for arboviruses, including Zika, through ArboNET, an integrated network 
which funds, through our Epidemiology and Laboratory Capacity 
cooperative agreements, staff in 49 States, the Commonwealth of Puerto 
Rico, and six large municipalities to conduct human case 
investigations, collect and test mosquitos, and perform laboratory 
analysis on arboviruses including Zika. Zika virus is now a nationally 
notifiable disease, meaning States report the virus to CDC, which will 
aid Zika surveillance efforts. CDC is also working with several States 
and the Commonwealth of Puerto Rico to determine a baseline prevalence 
of microcephaly so that any increase, should it occur, can be quickly 
and accurately identified.
    With support from the President's emergency request, CDC will build 
on its current efforts to provide financial and technical resources to 
States and territories through its cooperative agreements to strengthen 
their capacity to prepare for and respond to emerging insect-borne 
threats such as Zika virus. These resources may be used to help health 
departments expand their capability to manage cases of local Zika virus 
transmission in their areas and to implement community education and 
prevention programs to reduce human-mosquito contact and subsequently, 
the risk of Zika transmission. Resources will also be used to implement 
mosquito control strategies, including mosquito surveillance. Current 
mosquito surveillance capacity is uneven across the country, which 
makes our knowledge about the locations of the two mosquito vectors 
that transmit Zika virus potentially incomplete. To effectively track 
the spread of the outbreak, it is critical that States and territories 
receive specimens and test for Zika virus to diagnose and report 
travel-related and locally acquired cases of Zika. Under the emergency 
request CDC will expand its efforts to assist public-health labs 
nationwide to test for Zika and to provide the guidance on how to 
interpret test results. In addition, CDC is available to provide 
testing of any Zika samples upon request. We are working to expand the 
number of health departments that have the ability to perform testing, 
but will need to increase the existing capacity to meet the projected 
demand for Zika testing. Given that, last year, it is estimated that 
approximately 500,000 travelers to areas of current Zika transmission 
were pregnant women and 36,000 pregnant women are currently living in 
the Commonwealth of Puerto Rico, the expansion of testing capacity in 
public health labs nationwide, included in the request, is urgently 
needed in order to ensure that every pregnant woman needing testing for 
Zika virus has access.
    Recognizing the potential for Zika virus transmission through blood 
transfusions, CDC is collaborating with FDA to ensure the safety of the 
blood supply from Zika virus, particularly in regions experiencing 
local outbreaks. CDC has sent experts to the Commonwealth of Puerto 
Rico to assess the steps needed to assure both that Puerto Rico's blood 
supply needs are met and that transfusion-transmitted Zika is 
prevented.
    CDC experts are working intensively to learn more about the 
outbreak and provide people with the information they need to protect 
themselves. We will continue to issue travel alerts for the affected 
areas as confirmation of the virus is reported, and we'll keep the 
American people informed as the situation changes. We recognize people 
are eager for information, and our website has exceeded half a million 
views in recent days.
    CDC has also provided guidance for doctors and other clinicians on 
evaluation, treatment and followup care of pregnant women and infants 
with possible exposure to Zika virus, partnering with organizations 
from around the health care community to help distribute this 
information as widely as possible. Our guidance will continue to be 
updated as our knowledge increases. We have recently updated our 
guidance to provide recommendations for the clinical care and 
management of pregnant women living in areas where Zika transmission is 
widespread, with special consideration to the ongoing risk of maternal 
Zika virus infection throughout pregnancy. These guidance documents 
were prepared in consultation with the American College of 
Obstetricians and Gynecologists, the Society for Maternal Fetal-
Medicine, and the America Academy of Pediatrics.
    CDC also wants to ensure that the general public knows what it can 
do to protect itself. Pregnant women should postpone travel to regions 
with ongoing Zika virus transmission. If they must travel, or if they 
live in affected areas, CDC recommends pregnant women talk to their 
doctors or other healthcare providers first and strictly follow steps 
to prevent mosquito bites. Reducing exposure to mosquitos is important 
for anyone traveling to or residing in areas where the virus is 
circulating. Wearing long sleeves, long pants, using EPA-registered 
repellents such as DEET and permethrin-treated clothing (both of which 
are safe to use in pregnancy), and using other protections such as air-
conditioning will reduce exposure to mosquito bites. Given the 
potential for Zika virus to be spread through sex, pregnant women and 
their male partners living in or who have been to Zika-affected areas 
should abstain from sex or use condoms for the duration of pregnancy. 
This is a rapidly changing situation and our understanding of the risks 
concerning Zika virus infection is incomplete and evolving. As we get 
new information, we will update our advice.
                           global activities
    On February 1, the World Health Organization (WHO) declared the 
recent cluster of microcephaly cases and other neurological disorders 
(such as Guillain-Barre syndrome) and their possible association with 
Zika virus, a public health emergency of international concern, a 
reflection of the seriousness of this unfolding health threat. CDC is 
coordinating its response with the U.S. Agency for International 
Development, as well as the Pan American Health Organization (PAHO), 
the regional arm of the World Health Organization (WHO), and other 
parts of WHO, and is collaborating with many international partners to 
learn more about this outbreak. We are working with the Brazilian 
Ministry of Health on investigation and research partnerships. 
Specifically, one partnership involves studying the link between Zika 
virus infection and microcephaly, while another is examining the 
relationship between Zika virus and Guillain-Barre syndrome. Research 
teams from CDC are also in other countries, including Colombia, to 
explore collaborations that will shed light on the risk of microcephaly 
in relation to Zika virus infection during pregnancy.
    In addition, CDC is offering support to all countries so that they 
can test samples from microcephaly cases for serologic evidence of Zika 
virus infection, and CDC is helping countries throughout the Americas 
establish in-country diagnostic capacity. To that end, we are 
currently, and in conjunction with PAHO, providing training to 
laboratorians in South and Central America on diagnostic tests, 
including two recent workshops in Brazil and Nicaragua.
    CDC's Central American office has also facilitated the verification 
of Zika cases in several countries throughout Latin America, including 
Colombia, Venezuela, and Nicaragua. At the request of the Department of 
State's Bureau of Medical Services, staff from CDC's Global Disease 
Detection Center in Guatemala has been involved in communication 
efforts to ensure that new information regarding Zika virus and its 
possible link to birth defects is communicated to U.S. Mission Health 
Unit staff throughout the Americas.
    The Global Health Security Agenda, with critical support from 
Congress, is collaborating with countries around the world so that we 
can find, stop, and prevent health threats when and where they first 
emerge. Zika has been present in Africa for decades, and it's possible 
that it could become linked to microcephaly there as well. The sooner 
we detect a problem, wherever it occurs, the more rapidly we can 
respond to it and prevent it from spreading. It is in all of our best 
interests to work with others to improve public health capacity around 
the world.
       improving the tools and information for responding to zika
    We need a better understanding of the epidemiology of Zika and 
potential Zika-associated birth defects and other adverse health 
outcomes. We need better diagnostic methods that can quickly and 
clearly differentiate between similar viruses to detect evidence of 
past Zika infection. Testing for current Zika infection is only 
reliable in the first week of illness. A Reverse Transcription-
Polymerase Chain Reaction (RT-PCR) test can provide a definitive 
diagnosis of Zika, but only if it is performed within about 7 days of 
symptom onset. The tests we have available for Zika in persons who are 
no longer ill may have cross-reactivity with similar flaviviruses, 
particularly dengue, which can lead to false-positive or inconclusive 
results and confirmatory testing is required. Diagnosis is particularly 
challenging with Zika virus since most people will not experience 
symptoms. We also need to determine how long a man who has been 
infected with Zika may continue to be able to sexually transmit the 
virus to a partner, and we need better tools to screen the blood 
supply.
    We also need to advance our ability to control the mosquito 
population. Existing methods for mosquito control all have 
shortcomings, especially in areas where the population of Aedes 
mosquitos is rampant. Furthermore, in some areas like the Commonwealth 
of Puerto Rico, mosquitos may have developed resistance to certain 
insecticides, which could reduce the range of substances that can be 
used to effectively decrease mosquito populations. We need to implement 
the best tools we have today, improve current vector control 
strategies, and identify better options. We also need better mosquito 
surveillance to determine the location of mosquitos and areas with 
mosquito resistance to insecticides, which would inform the 
implementation of new mosquito control techniques.
    Finally, a vaccine is needed to protect people at risk of Zika 
virus infections, particularly preventing infection among women of 
childbearing age. At CDC, our scientists developed both a West Nile 
virus vaccine, which is currently in use for animal protection in the 
United States, and a dengue vaccine, which is currently in clinical 
trials. The President's request will increase Zika research, improve 
diagnostics and support advancements in vector control methods. 
Although availability of a licensed Zika vaccine is several years away, 
we do not know how long Zika will be a problem in the Americas nor 
whether the mosquito control efforts that must be implemented will 
yield durable results.
                               conclusion
    Microbes continue to be formidable adversaries. To protect 
Americans, the Zika emergency request invests in the laboratories, 
disease detectives, disease tracking systems, mosquito control, and 
investigations needed to continue to improve these essential tools.
    The emergence and reemergence of health threats, including those 
spread by mosquitos and other vectors is not a unique event but 
something we expect to continue to see in the future. These outbreaks 
cannot be expected to occur in isolation of one another. The 
Commonwealth of Puerto Rico and Hawaii were already responding to 
outbreaks of dengue when Zika virus arose as an urgent health threat. 
We need to address the threat of mosquito-borne diseases 
systematically, rather than episodically. Thank you again for the 
opportunity to appear before you today. I appreciate your attention to 
this concerning outbreak and I look forward to answering your 
questions.

    The Chairman. Thank you, Dr. Schuchat.
    Dr. Fauci.

STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE 
        OF ALLERGY AND INFECTIOUS DISEASES, BETHESDA, MD

    Dr. Fauci. Mr. Chairman, Ranking Member Murray, members of 
the committee, thank you for calling this committee and thank 
you for giving me the opportunity to discuss very briefly with 
you and to answer questions later on on the role of the 
National Institute of Allergy and Infectious Diseases and other 
NIH institutes in the research endeavor to address the Zika 
virus outbreak.
    As shown on this visual, the NIAID has a dual mandate. We 
maintain and grow, as other institutes do, a robust basic and 
clinical research portfolio in the particular discipline for 
which we are responsible. In this case, that is microbiology, 
infectious diseases, and the diseases of the immune system.
    However, in addition and simultaneous with that, we must be 
ready to respond rapidly to new and emerging disease threats as 
they occur, in many cases completely unpredictably. And in 
fact, just last month, I was asked and did write a commentary 
in the New England Journal of Medicine. And as you can see from 
this title, I called it ``Zika Virus in the Americas: Yet 
Another Arbovirus Threat'' because over the last 20-plus years, 
we have seen in the western hemisphere and the Americas 
diseases which we had not seen before, starting with West Nile 
virus back in 1999-2000, chikungunya in 2013, dengue over the 
past 20 years, and now most recently in 2015 the Zika virus. 
This is something that we always need to be prepared for 
because there will always be emerging diseases.
    The NIH and NIAID's response is very complementary to the 
CDC and other components of HHS and in fact the entire Federal 
Government. Our role is the development and research of 
countermeasures to address these outbreaks.
    For example, we do the fundamental basic research, clinical 
research. We provide materials such as reagents not only for 
academia but also for industry, with the ultimate goal of 
developing countermeasures in the form of diagnostics, 
therapeutics, and vaccines.
    I want to spend just a minute or 2 going over some of the 
things--and you have asked those questions yourself, Mr. 
Chairman, in your opening remarks. The questions that remain: 
the difference between symptomatic and asymptomatic disease, 
how long after infection is one vulnerable with regard to 
pregnancy, what are the frequency of sequelae, doing cohort 
studies to determine the incidence of adverse pregnancy in 
Zika-infected individuals and understanding just what the 
underlying pathogenesis of the development of microcephaly is 
in babies born of infected mothers.
    With regard to basic research, it is very similar to what 
we do with many of the other viruses, going all the way back to 
HIV/AIDS, determine the molecular virology, the structure of 
the virus, does it change, and what is the relationship to 
clinical manifestations. What about the immune response to the 
virus? How does the body respond making someone clear the 
virus, and can that be sort of a way for us to be able to get a 
guiding path to develop a vaccine and importantly the 
establishment of animal models?
    As you heard from Dr. Schuchat, the CDC is very heavily 
involved with their diagnostic and reference laboratory to 
develop diagnostics for Zika.
    The NIAID and our grantees are also heavily involved in 
getting approved diagnostics, not only for the virus itself 
with what we call the RT-PCR but sensitive and specific 
antibody tests to determine in fact if someone has been 
infected. And as you well know, that is the question we are all 
being asked by women who have been exposed. Have I been 
infected or not? That is of great importance to them. And those 
kind of diagnostic tests will be critical.
    One of the most important things we have done and are doing 
now with Zika is the development of vaccines. Shown on this 
slide are a number of candidates. The ones with the red bullets 
are those that are essentially what we call ``shovel ready,'' 
in other words, ready to go right into the development in 
clinical trials. The others are not far behind.
    One of the advantages that we have with the development of 
vaccines--let us take the first one on that top bullet called 
``DNA vaccine.'' And I have next to it ``success with West Nile 
virus.'' And what we did, as some of you may remember, is that 
we were able to take this what we call vaccine platform, which 
is a chunk of DNA, in which we inserted the gene for West Nile 
virus. And we made a successful West Nile virus vaccine many 
years ago. It was not used because industry was not 
particularly interested in it.
    But what we were able to do now is very easily pull out 
that West Nile gene and stick in the Zika gene and do exactly 
the same thing. And in fact, we are doing that right now, 
developing product to do preclinical toxes, and we predict that 
we will be in phase 1 study by the end of the summer, and that 
should take about 3 to 4 months. If it is safe and induces the 
kind of response we want, we feel comfortable in being able to 
go to an advanced trial. Whether we will be able to show it is 
effective or not, that is always the big question with 
vaccines, but we are moving very quickly.
    And then finally with the development of therapeutics, 
there are in vitro screening assays and we are looking at any 
of a number of drugs not only for Zika but for other 
flaviviruses.
    Let me close with this slide, which is an article that I 
wrote some time ago, which really says it all about what our 
mandate is. Emerging infectious diseases have been around 
forever, are around now, and will always be around. And it is 
very important for us to address what I call this perpetual 
challenge.
    I want to thank this committee and others for having over 
the years been so very supportive of us in this endeavor. Thank 
you very much.
    [The prepared statement of Dr. Fauci follows:]

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

    Mr. Chairman, Ranking Member Murray, and members of the committee, 
thank you for the opportunity to discuss the National Institutes of 
Health (NIH) research response to Zika virus, an emerging public health 
threat of international concern. I direct the National Institute of 
Allergy and Infectious Diseases (NIAID), the lead NIH institute for 
conducting and supporting research on emerging and re-emerging 
infectious diseases, including those caused by flaviviruses such as 
Zika virus.
    The Administration is taking appropriate action to protect the 
American people and, as you know, it announced a request to Congress 
for approximately $1.9 billion in emergency funding to enhance ongoing 
efforts to prepare for and respond to outbreaks of the Zika virus, both 
domestically and internationally. This includes funding for work on the 
development of vaccines and diagnostics and to improve scientific 
understanding of the disease.
    The overarching mission of NIAID is to conduct and support research 
to better understand, treat, and prevent infectious and immunologic 
diseases. This is accomplished through a spectrum of research, from 
basic studies of the mechanisms of disease to applied research focused 
on developing interventions such as diagnostics, therapeutics, and 
vaccines. As part of this mission, NIAID has a dual mandate 
encompassing both research on ongoing public health issues and the 
capability to respond rapidly to newly emerging and re-emerging 
infections such as Zika virus.
    These emerging and re-emerging disease threats, whether man-made or 
naturally occurring, are perpetual challenges, in part due to the 
capacity of microbial pathogens to evolve rapidly and adapt to new 
ecological niches. To address the challenges posed by emerging 
infectious diseases, NIAID employs both targeted, disease-specific 
research as well as broad-spectrum approaches. NIAID maximizes its 
efforts by prioritizing the development of drugs effective against 
multiple bacteria or viruses, and ``platform'' technologies to 
facilitate rapid development of vaccines and diagnostics applicable to 
multiple infections.
    NIAID is well-positioned to rapidly respond to infectious disease 
threats as they emerge by leveraging fundamental, basic research 
efforts; domestic and international research infrastructure that can be 
quickly mobilized; and productive partnerships with industry. NIAID 
provides preclinical research resources to scientists in academia and 
private industry worldwide to advance translational research against 
emerging and re-emerging infectious diseases. These resources are 
designed to bridge gaps in the product development pipeline and lower 
the scientific, technical, and financial risks incurred by industry in 
order to incentivize them to partner with us in the advanced 
development of effective countermeasures. NIAID also supports our 
Vaccine and Treatment Evaluation Units (VTEUs), a research network that 
conducts clinical trials to quickly investigate promising therapeutic 
and vaccine candidates when public health needs arise. NIAID 
collaborations with other Federal agencies, including those undertaken 
within the Department of Health and Human Services (HHS) Public Health 
Emergency Medical Countermeasures Enterprise (PHEMCE), help advance 
progress against newly emerging public health threats. In addition, 
partnerships with academia, the biotechnology and pharmaceutical 
industries, and international researchers and organizations such as the 
World Health Organization (WHO) and WHO's regional office, the Pan 
American Health Organization (PAHO), are integral to these efforts.
                         overview of zika virus
    Zika virus is a flavivirus. These viruses typically are transmitted 
by mosquitoes and often have the ability to spread quickly to new 
geographic locations because of the widespread prevalence of these 
vectors. Other well-known flaviviruses include dengue virus and yellow 
fever virus; like Zika virus they are transmitted by Aedes mosquitoes. 
Zika virus was discovered in monkeys in Uganda in 1947 and is now 
endemic to Africa and Southeast Asia. During the past decade it has 
emerged in other areas of the world, including Oceania, the Caribbean, 
and Central and South America, where countries, notably Brazil, are 
currently experiencing unprecedented Zika transmission.
    Infections caused by Zika virus are usually asymptomatic. About 20 
percent of infected individuals experience clinical symptoms such as 
fever, rash, joint pain, and conjunctivitis (red eyes). Symptoms of 
Zika virus infection in humans are typically mild and brief, with very 
low hospitalization and fatality rates. The recent outbreak of Zika 
virus disease in Brazil has coincided with a reported increase in the 
number of infants born with microcephaly, a birth defect characterized 
by an abnormally small head resulting from an underdeveloped and/or 
damaged brain. In addition, increases in suspected cases of Guillain-
Barre syndrome (GBS), a rare, acute, immune-mediated peripheral nerve 
disease that leads to weakness, sometimes paralysis, and infrequently, 
respiratory failure and death, have been noted in Brazil and other 
countries in the Americas.
    Further research is needed to better understand the effect of Zika 
virus infection on the body, particularly during pregnancy; to 
investigate the potential relationship between Zika infection and 
congenital abnormalities including microcephaly, as well as to explore 
the potential relationship between Zika infection and GBS; and to 
develop better diagnostics, vaccines and treatments, and new methods of 
vector control. Currently, no vaccines or specific therapeutics are 
available to prevent or treat Zika virus disease. Improved diagnostic 
tests also are needed because Zika virus infection causes non-specific 
symptoms or no symptoms at all and can be difficult to distinguish by 
antibody screening tests from other mosquito-borne infections such as 
dengue, malaria, and chikungunya. Moreover, current antibody screening 
tests can be falsely positive or inconclusive if the individual was 
previously infected with related viruses such as dengue, which is 
prevalent in South America and the Caribbean. Therefore, a positive 
result with the antibody screening test requires an additional test to 
confirm the diagnosis.
                       nih research on zika virus
    NIAID has a longstanding commitment to flavivirus research, 
including extensive efforts to combat diseases such as dengue, West 
Nile virus, and yellow fever. This research has informed our 
understanding of the viral genetics, vector biology, and pathogenesis 
of flaviviruses and provides a strong foundation for our efforts to 
learn more about Zika virus. NIAID has responded to the newly emerging 
Zika virus disease outbreak by expanding our portfolio of basic 
research on Zika virus and other flaviviruses. NIAID also is 
accelerating efforts to develop improved diagnostics and candidate 
therapies for Zika virus as well as prioritizing the development of 
Zika virus vaccines. In addition, screening tests and pathogen 
reduction technologies are critically important to assure safety of the 
U.S. blood supply.
    The emergency funding for NIH would support development of vaccines 
to prevent Zika virus infection, from the discovery phase through 
preclinical and eventually clinical testing. In addition, the funds 
would support basic research to understand the natural history, viral 
biology and pathogenesis, including potential links to microcephaly; 
establishment of animal models to test candidate countermeasures; 
development of rapid, sensitive, and specific diagnostic tests; and 
discovery and preclinical development of new therapeutics to treat 
disease caused by Zika virus. This research is necessary to better 
understand this emerging infection and uncover the best ways to 
diagnose, treat, and prevent Zika virus disease.
    In January 2016, NIAID issued a notice to researchers highlighting 
NIH's interest in supporting research and product development to combat 
Zika virus. Areas of high priority include basic research to understand 
viral replication, pathogenesis, and transmission, as well as the 
biology of the mosquito vectors; potential interactions with co-
infections such as dengue and yellow fever viruses; animal models of 
Zika virus infection; and novel vector control methods. In addition, 
NIH is soliciting Zika virus research to develop sensitive, specific, 
and rapid clinical diagnostic tests; drugs against Zika virus as well 
as broad spectrum therapeutics against multiple flaviviruses; and 
effective vaccines and vaccination strategies.
    NIAID also is partnering with other NIH institutes, the Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development (NICHD), the National Institute of Neurological Disorders 
and Stroke (NINDS), and the National Institute of Dental and 
Craniofacial Research, to accelerate Zika virus research as it relates 
to the mother-infant pair. The Institutes issued a notice that 
indicates NIH's interest in supporting research to understand 
transmission, optimal screening and management in pregnancy, and the 
mechanisms by which Zika virus affects the developing nervous system, 
including potential links to microcephaly and other congenital 
abnormalities.
                 developing tools to combat zika virus
    In response to public health concerns about Zika virus, NIAID has 
accelerated ongoing flavivirus research efforts to speed the 
development of tools that could help control current and future 
outbreaks of Zika virus.
                             vector control
    For many years, NIAID has supported extensive research to 
understand the biology of mosquitoes to help develop tools to limit the 
spread of deadly mosquito-borne diseases such as dengue and malaria. 
This research aids in vector control strategies to reduce mosquito 
bites or limit mosquito populations. In the Americas, Zika virus is 
transmitted primarily by Aedes aegypti mosquitoes, and vector control 
or other methods to prevent exposure to these mosquitoes are currently 
the only ways to prevent Zika infection. NIAID plans to support vector 
competence studies to test various mosquito species for their ability 
to carry and transmit Zika virus and for insecticide resistance. 
Understanding the specific mosquito species involved in Zika outbreaks 
and which insecticides may be effective against them will aid current 
vector control efforts and may inform novel mosquito control strategies 
in the future.
                              diagnostics
    Accurate diagnostic tests for Zika virus infection are needed to 
distinguish it from other flavivirus infections and to identify women 
who have been infected with Zika virus during pregnancy and may be at 
risk for developing fetal complications. Blood, organ, and tissue donor 
screening tests are also needed to assure the safety of transfusion and 
transplantation in areas of active mosquito-borne virus transmission. 
Currently, Zika virus itself can often be detected during the acute 
phase of infection and up to 7 days after the onset of symptoms using 
diagnostic tests for viral RNA (RT-PCR test). While prior infection can 
be detected by testing for the presence of antibodies against Zika 
virus, assays for Zika antibodies may also detect or cross-react with 
antibodies against other flaviviruses, particularly dengue virus. For 
this reason, a positive antibody test does not definitively confirm 
prior Zika virus infection in the setting of possible co-infection or 
prior infection with dengue and other related viruses, and separate 
confirmatory testing is required. This is a particular concern in South 
America where there is a high level of exposure to other flaviviruses, 
particularly dengue virus.
    To facilitate the development of improved Zika virus diagnostic 
tests, NIAID grantees are working to generate antibodies that can 
distinguish between Zika virus and dengue virus. They also are working 
to identify biosignatures unique to Zika infection that could form the 
basis of additional rapid, specific, and sensitive diagnostic tests. In 
addition, NIAID is pursuing the development of a mouse model of Zika 
virus infection that could be used to test new diagnostic and 
therapeutic tools.
                                vaccines
    A safe and effective Zika vaccine would be a very valuable tool to 
help stop the spread of infection and prevent future outbreaks. NIAID 
is investigating multiple Zika virus vaccine candidates, including 
vaccines based on technologies that have shown promise in targeting 
other flaviviruses. The NIAID Vaccine Research Center (VRC) is pursuing 
a DNA-based vaccine for Zika virus that is similar to a West Nile virus 
vaccine previously developed by NIAID. The West Nile vaccine candidate 
was shown in Phase 1 testing to be safe and generated a strong immune 
response in humans, offering a model for Zika vaccine development. 
NIAID scientists also are designing a live, attenuated vaccine, using 
an approach similar to that used for making a vaccine against the 
closely related dengue virus. The dengue vaccine candidate showed an 
excellent safety profile and generated strong immune responses in early 
phase clinical trials. In January, a large Phase 3 trial assessing the 
dengue vaccine candidate was launched in Brazil in collaboration with 
the Butantan Institute. In addition, NIAID grantees are in the early 
stages of developing a Zika virus vaccine based on a recombinant 
vesicular stomatitis virus--the same animal virus used successfully to 
create an investigational Ebola vaccine. Plans are underway to evaluate 
this potential vaccine construct in tissue culture and animal models.
    While these approaches are promising, it is important to realize 
that the development of investigational vaccines and the clinical 
testing to establish whether they are safe and effective takes time. 
Although a safe and effective, fully licensed Zika vaccine will likely 
not be available for a few years, we plan to begin early stage clinical 
testing of one or more NIAID-supported vaccine candidates in 2016.
                              therapeutics
    NIAID has an active program to screen for antiviral drugs active 
against viruses in the flavivirus family, including dengue, West Nile, 
yellow fever, and Japanese encephalitis viruses, as well as the closely 
related hepatitis C virus. NIAID has enhanced these efforts with the 
recent development of an assay to test compounds for antiviral activity 
against Zika virus. NIAID will make this test available to the research 
community and will soon test 10 antiviral compounds with activity 
against other flaviviruses to determine if they are effective against 
Zika virus.
    Promising drug candidates identified by the assay could be further 
tested in a small animal model of Zika virus infection developed with 
NIAID support. The ultimate goal of NIAID-supported flavivirus 
therapeutic research is to develop a broad-spectrum antiviral drug that 
could be used against a variety of flaviviruses, including Zika.
 emergency request for vaccine research and diagnostic development and 
                              procurement
    As I noted in the introduction to my testimony, the Administration 
has announced an emergency-funding request of approximately $1.9 
billion to combat the Zika virus both domestically and internationally. 
Included in the request are resources for Zika-related vaccine 
research, rapid advanced development, and commercialization of new 
vaccines and diagnostic tests for Zika virus. The funding will allow 
NIH to build upon existing resources and work to develop a vaccine for 
Zika virus and the chikungunya virus, which is spread by the same type 
of mosquito. Funding will accelerate this work and improve scientific 
understanding of the disease to inform the development of additional 
tools to combat it. The request also includes resources for FDA to 
support Zika virus medical product development, including the next-
generation diagnostic devices. We look forward to working with the 
Congress to implement this request.
                             collaborations
    Investigation of emerging and re-emerging infectious diseases 
requires expertise from a variety of fields. In the case of Zika virus, 
studies of virology, immunology, natural history, neurology, and 
neonatology will be required to fully understand the pathogenesis of 
this infection. As mentioned previously, NIAID is partnering with other 
NIH institutes including NICHD and NINDS to better understand the 
potential association between Zika virus infection and neonatal 
defects, particularly microcephaly.
    NIAID also is employing partnerships with research institutions in 
South America to advance research on Zika virus infection; additional 
collaborations with academic, industry, and government partners are 
under active exploration. NIAID held a joint meeting in December 2015 
with Brazilian research institute Fiocruz in which Zika was a key area 
of concentration. In addition, NIAID is collaborating with other HHS 
agencies in responding to the Zika epidemic. For example, NIAID, CDC, 
BARDA, ASPR, and FDA are jointly convening a Zika virus workshop on 
March 28-29, 2016, where the latest information on Zika virus will be 
discussed by experts from Federal Agencies, academia, and 
pharmaceutical and biotechnology companies. Topics to be addressed at 
the workshop include virology, epidemiology, possible links to 
microcephaly, and efforts to develop diagnostics, therapeutics, and 
vaccines.
                               conclusion
    NIH is committed to continued collaboration with HHS agencies and 
other partners across the U.S. Government in advancing research to 
address Zika virus infection, and we look forward to working with the 
Congress to implement the President's emergency funding request. As 
part of its mission to respond rapidly to emerging and re-emerging 
infectious diseases throughout the world, NIAID is expanding our 
efforts to elucidate the biology of Zika virus and employ this 
knowledge to develop needed tools to diagnose, treat, and prevent 
disease caused by this virus. In particular, NIAID will pursue the 
development of safe, effective vaccines to prevent disease caused by 
Zika and chikungunya viruses.

    The Chairman. Thanks, Dr. Fauci.
    Dr. Robinson.

    STATEMENT OF ROBIN ROBINSON, PH.D., DIRECTOR BIOMEDICAL 
  ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, WASHINGTON, DC

    Mr. Robinson. Good morning, Chairman Alexander, Ranking 
Member Murray, and members of the committee. I want to thank 
you for the opportunity to testify before you again. As you 
recall, within HHS, I serve as the Director of BARDA and a 
Deputy Assistant Secretary in ASPR.
    Today I will update you on our progress and plans toward 
the current Zika response, while the ASPR is also leading the 
Federal Flint response.
    As we learned through the Ebola and pandemic influenza 
responses, one of our key public health responsibilities in 
infectious disease epidemics is effective communication. One of 
the ASPR's first actions was to coordinate communications 
efforts within HHS and with our private and public stakeholders 
by convening the Disaster Leadership Group to respond to 
emergencies. Through the Disaster Leadership Group and in 
coordination with the Secretary's Operations Center, ASPR is 
collecting and sharing information on Zika across the U.S. 
Government and with health departments in States and 
territories by leveraging our combined capabilities to prepare 
our Nation and formulate an organized response.
    ASPR is also facilitating opportunities for coordination 
among State and local health systems through hospital 
preparedness grants and health care coalitions to provide 
better care of Zika patients.
    Globally, ASPR is playing a key leadership and coordination 
role in Zika affairs by sharing Zika-related information with 
international partners like the WHO and hosting meetings like 
the Global Health Securities Initiatives ministerial meeting 
here in Washington, DC this week and a meeting of the Global 
Research Collaboration for Infectious Disease Preparedness on 
March 14th and 15th Washington, DC.
    With regard to medical countermeasures for Zika, the ASPR 
is leading the coordination of medical countermeasure 
activities in the Zika response using the Public Health 
Emergency Medical Countermeasures Enterprise, or PHEMCE, in 
this governance infrastructure, as we have done in H1N1 
pandemic and the Ebola response. The ASPR has convened a senior 
steering group comprised of senior leaders across the PHEMCE to 
address and coordinate Zika-related medical countermeasure 
policy and operational issues and activities like sample 
sharing.
    BARDA, which transitions medical countermeasure candidates 
from early development at the NIH through the ``valley of 
death'' into advanced development toward FDA approval, is doing 
our part in the U.S. Government Zika response with regard to 
vaccines, diagnostics, and the blood supply. Building on 
existing and new public-private partnerships and lessons 
learned from the H1N1 and Ebola responses, we are supporting 
NIH's lead in the Zika vaccine development that Dr. Fauci is 
head of. In collaboration with the NIH and the Department of 
Defense's Walter Reed Army Institute of Research, we are 
utilizing our centers for innovation in advanced development 
and manufacturing, and our field finished manufacturing network 
to manufacture Zika vaccine candidates for clinical studies.
    We are also providing technical assistance to our industry 
partner in Brazil for Zika vaccine development and commercial 
scale manufacturing as we have done previously for pandemic 
influenza vaccines.
    Also, we are supporting industry partners to utilize their 
new, innovative vaccine platform technologies to develop new 
Zika vaccine candidates today and vaccines for other emerging 
infectious diseases in the future.
    With regard to diagnostics, we are collaborating with CDC, 
NIH, and FDA to facilitate the development of rapid point-of-
care, and laboratory-based serological assays specific for Zika 
to determine who has been infected previously, especially 
pregnant women.
    We are also working with the CDC to prepare and distribute 
reagent validation panels for industry partners to qualify Zika 
diagnostic assays.
    With regard to the blood supply, we are collaborating very 
heavily with FDA to support the development and implementation 
of highly sensitive rapid molecular screening methods and 
pathogen reduction technologies to mitigate the risk of 
potential Zika virus in blood supplies. As we did for the Ebola 
response, we are assisting our Federal partners and medical 
countermeasure developers through our National Medical 
Countermeasure Response Infrastructure, comprised of six core 
service assistance programs that provide animal and human 
clinical testing services, product development and 
manufacturing, and regulatory and modeling capabilities.
    We also continue to encourage inquiries from academic and 
industrial stakeholders for potential Zika and other medical 
countermeasures through our Tech Watch program.
    In closing, our foremost concern is protecting public 
health from known or emerging threats. Zika is our newest 
threat but not our last. Thanks to our combined efforts, 
coupled with lessons learned from previous challenges, we are 
better prepared and more resilient as a nation with the 
flexibility to successfully address a variety of public health 
threats. Congressional approval of the Administration's $1.9 
billion funding request will ensure an effective and rapid 
response and accelerate our ability to prevent, detect, and 
respond to Zika and other emerging infectious disease.
    Thank you for your many years on this. I look forward to 
answering your questions.
    [The prepared statement of Robin Robinson, Ph.D. follows:]

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

    Chairman Alexander, Ranking Member Murray, and members of the 
committee, thank you for the opportunity to testify before you again. 
As you may recall, within the Department of Health and Human Services 
(HHS), I serve as the Director of the Biomedical Advanced Research and 
Development Authority (BARDA) and as a Deputy Assistant Secretary for 
Preparedness and Response (ASPR). Through ASPR and the Public Health 
Emergency Medical Countermeasure Enterprise (PHEMCE), BARDA leads the 
advanced development of medical countermeasures to prepare for and 
respond to emerging infectious diseases, man-made national security 
threats, and other public health emergencies. In ASPR we have been 
working to advance a mission delineated by the Pandemic and All-Hazards 
Preparedness Act (PAHPA) and realize our full leadership capabilities. 
ASPR and BARDA have matured and flourished in many diverse ways over 
the past 9 years. We operate efficiently and from a position of 
strength with the ability to manage numerous lines of effort including 
the water situation in Flint, MI, the recent Ebola epidemic, and the 
current Zika outbreaks. With this testimony I intend to provide a 
progress report on our current efforts and hope to clarify our 
capabilities in the context of Zika.
    The Administration is taking appropriate action to protect the 
American people and, as you know, on February 8, it announced a request 
to Congress for approximately $1.9 billion in emergency funding to 
enhance ongoing efforts to prepare for and respond to outbreaks of the 
Zika virus, both domestically and internationally. This includes 
funding for work on the development of vaccines and diagnostics and to 
improve scientific understanding of the disease. While I will briefly 
describe some of ASPR's activities overall, as the BARDA director, I 
will focus my remarks on the development of vaccines and diagnostics.
    The Zika virus is primarily a mosquito vector-borne viral disease 
threatening the United States and our neighbors in Latin America and 
other parts of the world. Zika is a flavivirus in the same family as 
dengue, West Nile virus, and Yellow Fever, diseases we have been 
monitoring and combating for years. On February 1, the World Health 
Organization (WHO) declared clusters of microcephaly and other 
neurological disorders, and their possible association with Zika virus, 
a public health emergency of international concern. Named after the 
Zika Forest in Uganda, Zika includes common symptoms such as fever, 
skin rash, joint pain, or conjunctivitis. However, eighty-percent of 
people with Zika do not appear to have symptoms at all. Considering 
recent outbreaks in the Pacific Islands, Central America, South 
America, and the Caribbean, we anticipate that the number of Zika cases 
among travelers visiting or returning to the United States is likely to 
increase. We have already seen cases of travelers returning to the 
United States with confirmed Zika virus disease and are particularly 
concerned about the virus becoming endemic in the Commonwealth of 
Puerto Rico, the U.S. Virgin Islands, the American Samoa, with 
potential for local outbreaks in parts of the southern United States. 
Moreover, the Brazilian Ministry of Health estimates that between 
440,000 and 1.3 million suspected cases of Zika occurred in Brazil in 
2015.
    There is still much that we do not know about Zika and its adverse 
health effects on a population. Evidence associating Zika with birth 
defects like microcephaly and other adverse health conditions such as 
Guillain-Barre Syndrome is growing; however, there is still much to 
learn including whether additional factors are involved. HHS is 
actively monitoring the Zika virus, investigating outbreaks, and 
working with domestic and international partners to update health care 
providers and the general public. In addition, HHS is providing 
laboratory and diagnostic tests both domestically and internationally.
    As we learned with Ebola and pandemic influenza, one of our key 
responsibilities in addressing an infectious disease is effective 
communication. This involves delineating a leadership structure and 
updating information as soon as possible using principles of risk 
communication and using multiple avenues, including translated 
materials for non-English speaking communities and enhanced outreach to 
vulnerable populations. Clear, concise, and accurate information can 
reduce the level of concern among the general population and support 
appropriate action by health care providers. With that in mind, HHS and 
our Federal partners are stressing a coordinated response to this 
emerging threat.
    ASPR is fulfilling its leadership roles both through the Disaster 
Leadership Group (DLG) through the PHEMCE to develop and provide 
medical countermeasures. Both were created to effectively improve 
coordination within the Department and with our external stakeholders, 
including nonprofits, other Federal departments, the private sector, 
and the international community. Specifically, the DLG is comprised of 
leadership from across HHS to advise and coordinate policy on critical 
issues related to preparedness and response. Additionally, the 
Secretary's Operations Center serves as the focal point for 
International Health Regulation, and for communication across 
government. The PHEMCE, chaired by the ASPR, serves as the focal point 
for coordinating medical countermeasure development.
    I will focus the remainder of my testimony on BARDA's role. BARDA 
has a mandate from PAHPA to transition medical countermeasure 
candidates from early development across the ``Valley of Death'' into 
advanced research and development toward FDA approval. BARDA has 
established four strategic goals to address medical countermeasure 
needs for the Zika response domestically and globally. These are 
prevention of Zika virus infection through new vaccines; detection of 
acute and previous Zika virus infections through new rapid diagnostics; 
ensuring a safe blood supply from Zika virus through screening and 
virus inactivation; and activation of our National Medical 
Countermeasure Response Infrastructure to aid medical countermeasure 
developers.
    Building on existing and new partnerships and lessons learned from 
the H1N1 and Ebola responses, we are implementing our Zika medical 
countermeasure strategy through the advanced development and 
manufacturing of new Zika-specific vaccine candidates. In collaboration 
with NIH, FDA, and the Walter Reed Army Institute of Research, we are 
working on vaccine development, pre-clinical and clinical testing, and 
commercial scale production, including vaccine manufacturing through 
our Centers for Innovation in Advanced Development and Manufacturing. 
We are also providing technical assistance to our global partners in 
Brazil for Zika vaccine development and commercial scale manufacturing. 
We are supporting industry partners to develop and utilize new and 
innovative vaccine platform technologies to address public health 
emergencies for multiple emerging infectious diseases including new 
Zika vaccine candidates. We are collaborating with CDC, FDA, and NIH to 
facilitate the development of rapid point-of-care and laboratory-based 
serological assays for Zika to determine who has been infected 
previously, especially pregnant women. With regard to the blood supply, 
we are collaborating with FDA to support the development and 
implementation of rapid high-throughput molecular diagnostic screening 
and pathogen reduction technologies. We're particularly concerned about 
blood supplies at risk due to recent Zika virus outbreaks in the 
Commonwealth of Puerto Rico and potentially other parts of the United 
States. As we did for the Ebola response, we are assisting medical 
countermeasure developers through our National Medical Countermeasure 
Response Infrastructure, which is comprised of six core service 
assistance programs that provide animal and human clinical testing, 
product development and manufacturing, and regulatory and modeling 
needs. This infrastructure could potentially be used to develop vector 
protection countermeasures such as mosquito repellants.
    We are also encouraging and receiving numerous inquiries from 
academic and industrial stakeholders for potential medical 
countermeasures through our Tech Watch program. Moreover, contracting 
for ASPR's medical countermeasure programs has been designed to be 
transparent and responsive to industry but also ensure that we have 
appropriate internal controls for the contracting process overall. 
We're able to efficiently move from the idea and proposal stage to 
acquisition. Considering a governmentwide benchmark of 180 days to 
award a contract, ASPR is consistently awarding major acquisition 
contracts within 128 days. During the height of the Ebola response we 
were awarding contracts within 60 days. This success is a demonstration 
of the mature contracting function that ASPR has implemented and one 
that is fulfilling its requirements to support our industry partners 
and the medical countermeasure enterprise.
    Recognizing the domestic impact of global public health 
emergencies, we have strengthened our international partnerships as 
cited above for vaccine development with Brazil. Whether it is pandemic 
influenza, Ebola, or a vector-borne disease like Zika, public health 
emergencies have no borders. We have forged trusted networks and 
relationships with key international partners and continue to receive 
and share information with the WHO, the United Nations, the United 
States Agency for International Development, the U.S. Department of 
State, and countries around the world about best emergency preparedness 
practices and surveillance data on infectious diseases. We maintain 
regular communications and coordination with the G7 countries, Mexico, 
and the European Commission on public health measures, including the 
development and deployment of medical countermeasures. These 
collaborations range from discussing domestic preparedness activities 
of other countries to the medical evaluation and coordination of 
medical countermeasure development. Our weekly Americas' Call 
teleconference involves 18 countries from North America, Central 
America, South America and the Caribbean. Thanks to this mode of 
outreach and coordination, we learned that Panama had Zika samples they 
were willing to share for research, which was a big step forward in 
helping to identify the strain for diagnostic comparisons. The Global 
Health Security Initiative (GHSI) is another success story for 
international coordination. Established shortly after the September 11, 
2001, terrorist attacks, GHSI is an assembly of Ministers, Secretaries, 
Health Commissioners and other senior health officials from the 
European Commission, France, Germany, Italy, Japan, Mexico, the United 
Kingdom, the United States, and the WHO to address global health 
security issues. GHSI played a crucial role in bringing countries 
together for the Ebola response and is already turning its focus to 
Zika. An early focus has been on sample sharing, which is critical to 
the development of vaccines and diagnostics. The next ministers meeting 
is taking place this week in the United States, and Zika will be one of 
the main topics of discussion.
    In closing, our foremost concern is protecting public health from 
known or emerging threats. Zika is our newest threat, but not our last. 
Congressional approval of the Administration's approximately $1.9 
billion funding request will ensure an effective and rapid response to 
outbreaks that threaten the health of the American people and can 
accelerate our ability to prevent, detect, and respond to Zika and 
other emerging infectious diseases. Thanks to our combined efforts and 
with lessons learned from previous challenges, we are a better prepared 
and more resilient Nation with the flexibility to successfully address 
a variety of public health threats. Thank you again and I look forward 
to your questions.

    The Chairman. Thank you very much.
    We have a vote at noon, so there should be ample time for 
all Senators to have a chance to ask their questions. We will 
have a 5-minute round, and I will begin.
    Dr. Fauci, I am going to ask you a series of questions 
which are the questions I get most often asked especially by 
young women in Tennessee and in our family. And if, Dr. 
Schuchat or Dr. Robinson, you want to add to his answers, feel 
free to do it.
    Dr. Fauci, what is the latest information on whether the 
Zika virus actually causes microcephaly?
    Dr. Fauci. The evidence is literally every week, Mr. 
Chairman, accumulating and getting stronger and stronger. 
Definitive proof will come from case control and cohort 
studies, which are ongoing right now. But if you look at work 
that has been done by Brazilians themselves, by the CDC 
together with Brazilians, looking at, for example, stillborn 
miscarriages, individuals who have delivered and amniotic fluid 
examinations, there have now been several instances in which 
whole virus has been actually demonstrated, at autopsy, in the 
brains of these babies, who have died, as well as in placenta 
and amniotic fluid. So while all of us are reluctant to say 
there is definitive evidence, it is really quite strong, and I 
believe that when we finish those cohort and case control 
studies, we will be able to say that it is definitive.
    The Chairman. I have several questions here. How long 
should a woman wait to get pregnant if she has recently 
traveled to an affected area?
    Dr. Fauci. As you know and mentioned in your opening 
statement, about 80 percent of the infections are asymptomatic. 
So a woman may not know that she is infected.
    The Chairman. So how long should she wait?
    Dr. Fauci. In general, we cannot give a definitive answer, 
but we can take a look at what we know about the virus. The 
virus stays in the system anywhere from 7 to 10 days, and then 
it is gone from the blood. It does stay in some organs in men 
for longer. For example, it sequesters in the serum, and there 
has been one case that it has been up to 62 days in the semen. 
And so we cannot say definitively that after, let us say, 30 
days, but we are saying that in general, approximately a month 
is a reasonable time. But we do not want to say that with a 
degree of definitiveness until we actually get more data.
    The Chairman. Thank you.
    You mentioned semen. What about a husband who travels to an 
affected area and comes back? How long should a husband and 
wife wait before--a man and a woman wait before a woman becomes 
pregnant?
    Dr. Fauci. We do not know how long the virus can sequester 
in the serum. So in order to be completely cautious, the 
recommendation is that if a man comes to an area and might have 
been infected, even if they do not know, and comes back and has 
a pregnant wife or a pregnant sexual partner, to essentially 
use correct and consistent use of condoms for the duration of 
the pregnancy or else refrain from sex.
    The Chairman. If a woman has traveled or a man has traveled 
to an affected area and comes back--let us say they come back 
to Nashville and they want to know whether they are infected, 
how do they go about getting a diagnostic test today?
    Who do they call?
    Dr. Fauci. They call their health department.
    The Chairman. Could I ask Dr. Schuchat that question 
perhaps?
    Dr. Fauci. Yes, sure. Go ahead, Anne.
    Dr. Schuchat. We have issued guidance to clinicians on how 
to test for the virus and how to send the specimen----
    The Chairman. So I am in Nashville and I am a 25-year-old 
female and I have just been to Colombia and I come back and I 
want the test. Who do I call?
    Dr. Schuchat. You call your doctor, and your doctor can 
test you and send a specimen to the State or city health 
department. And they will either be able to do the test, 
because CDC has prepared them to do so, or they will forward 
the test on to CDC's labs for the testing.
    The Chairman. But the test should be available today. So if 
you come back to Nashville or wherever you live, you call your 
doctor. I have been to Colombia. I would like to know if I have 
been infected with the Zika virus. The doctor calls the local 
public health?
    Dr. Schuchat. Let me clarify that currently the 
availability of testing is somewhat limited. We have 
recommended that pregnant women who are returning from affected 
areas should be tested between 2 and 12 weeks after they 
return. And yes, they should be able to get that test result.
    For other people who have symptoms, we do recommend 
testing, but for someone who is not pregnant, who is returning 
from an area, we are not yet able to have sufficient testing 
material for them to be tested.
    And it is also important to say that today's tests are not 
perfect. There is a PCR or a molecular test that can tell you 
if you are actively infected within about a week of the 
infection. And there is an antibody test that can tell you if 
you were recently infected. But that antibody test needs a 
second test to make sure it is right, and that second test 
takes a while and is in very limited supply.
    So, unfortunately, we cannot help everyone today with 
perfect diagnostic tests. And that is one of the reasons we 
really need resources to----
    The Chairman. I am running out. So the answer is call your 
doctor.
    Dr. Schuchat. Exactly.
    The Chairman. And your doctor gets in touch with the local 
public health department and you go from there.
    I am going to ask one last question, even though my time is 
up, to whomever knows the answer. If I travel to an affected 
area and become infected, are my young children affected by 
this. If I have a 1-year-old and a 4-year-old, are they 
affected by a mother who might have the Zika virus, or are they 
likely to catch the Zika virus?
    Dr. Schuchat. We do not think so. Right now we think that 
the principal way the virus is spread is through mosquito 
bites. We are concerned now about sexual transmission as a 
possible route, and yesterday we reported on additional 
episodes. But we do not think that a parent returning from an 
area needs to worry about infecting their young child.
    The Chairman. Thank you very much.
    Senator Murray.
    Senator Murray. Thank you very much.
    Dr. Schuchat, pregnant women, as we have been talking 
about, have been told to delay travel to Zika affected areas, 
and in some countries, women are even being told to delay their 
pregnancies until 2018. According to the CDC and Pan-American 
Health Organization, women in many of those countries face high 
rates of sexual violence, lack rights to reproductive health 
care, and have poor access to birth control.
    The U.S. Government has been a global leader on this front 
and needs to continue to be because a strong public health 
demands that women do have access to the full range of 
reproductive health care. And it is really crucial that women 
have the tools to time their own pregnancies.
    I wanted to ask you, does the Zika supplemental request 
that has been sent over address family planning and 
contraception?
    Dr. Schuchat. The Zika request addresses response to the 
outbreak both internationally and domestically. CDC does not 
provide direct services for contraception, but we are working 
with the Office of Population Affairs and with HRSA to make 
sure that the best materials can become available. CDC's role, 
though, is to provide guidance and the best scientific 
information.
    Senator Murray. What steps are being taken to advocate for 
women's reproductive health care in these countries?
    Dr. Schuchat. The best information available is critical 
for women. We know that the decision to become pregnant is a 
personal one, and the issues around the Zika virus are quite 
scary. We are really trying to get the best information out 
there so that women and couples can do their planning. We are 
working across government, though, to make the resources 
available that can help.
    Senator Murray. As you know, the Zika virus was reported in 
my home State of Washington this week. What steps can families 
in my State and nationwide take to protect themselves?
    Dr. Schuchat. The most important thing is if people are 
planning trips to areas where the virus is spreading through 
mosquitoes, that they be aware of that and they protect 
themselves from mosquito bites with repellant, with long 
sleeves, long pants, and so forth. But we also think if women 
are pregnant and considering travel, that they delay.
    In terms of other things to know, we think it is very 
important for people to let their doctors know where they have 
traveled if they are having fever or rash or so forth. That is 
important not just for Zika but for other conditions.
    And we think it is important for people to stay aware 
because things can change. Yesterday we reported new 
information. We will continue to do so.
    We do not expect that Washington State will have large 
outbreaks of the Zika virus based on the way we understand it 
to be spread right now. But we know that about 40 million 
people travel back and forth to the affected areas, and so 
everyone really does need to know about this.
    Senator Murray. In every State, yes.
    What best practices are you recommending for hospitals and 
public health experts?
    Dr. Schuchat. Of course, it is important to take a travel 
history when people are ill. We think it is important for docs 
talking with pregnant women to make sure that they know about 
the travel issues and also about the sexual risk. We were 
surprised that there were additional episodes of sexual 
transmission already evident to us.
    We also think that it is very important for States to be 
able to diagnose this, and so our effort to train and equip the 
laboratories around the country with the diagnostic tests so 
that that information would be available for clinicians----
    Senator Murray. Are you providing those resources to local 
communities?
    Dr. Schuchat. That is what we have been doing so far, but 
we are going to need help to be able to scale the way it is 
necessary.
    Senator Murray. Which is part of the request.
    Dr. Schuchat. Absolutely.
    Senator Murray. Dr. Fauci and Dr. Robinson, as we have been 
talking about, Zika has been linked to some pretty serious 
health outcomes, but there is no treatment that exists today 
for pregnant women who have been infected. Correct?
    Dr. Fauci. Correct.
    Senator Murray. I understand that in my home State of 
Washington, the University of Washington is partnering with the 
University of Texas in Kineta and are in the process of 
developing an antiviral treatment option to use in people who 
are infected. But I know we have got to do more both in 
response to this particular public health crisis and more 
broadly to ensure we know whether treatments are safe and 
effective.
    Are NIH and BARDA working on developing antiviral treatment 
options that could be used with pregnant women who are infected 
with Zika?
    Dr. Fauci. Let me answer first, and then Robin can 
followup.
    The answer is yes. As I mentioned on that next-to-last 
slide, we have screening technologies to looking at compounds 
that already are known to have anti-flavivirus activity and 
determining if in the in vitro or preclinical testing that they 
have activity against Zika. The next step would be going into 
an animal model, which is what we are trying very, very quickly 
to develop because one of the ways to do massive screening is 
to develop a small animal model like a mouse or a guinea pig 
for Zika and to then do that kind of preclinical testing. If 
something looks good there, then we will be funding the same 
sort of early phase 1 trials that we have done.
    The important issue that I think you are aware of, Senator, 
is that we have a double challenge here, not only to develop an 
antiviral against Zika, but to have to test it in pregnant 
women. And whenever you have to test a drug in a pregnant 
woman, there is always the added safety issue that you have to 
be concerned about.
    Senator Murray. Right.
    Dr. Robinson.
    Mr. Robinson. Yes, thank you.
    We are actually looking at a number of drugs that were 
developed for other diseases--say, Ebola--with the NIH and 
being able to repurpose those and to see if they have activity 
against Zika virus and other flaviviruses. And we will move 
forward as the animal models are developed that Dr. Fauci 
talked about.
    Senator Murray. Thank you very much.
    The Chairman. Thank you, Senator Murray.
    Following Senator Collins, I have Senator Warren, Senator 
Cassidy, Senator Baldwin, Senator Burr, Senator Murphy.
    Senator Collins.

                      Statement of Senator Collins

    Senator Collins. Thank you, Mr. Chairman.
    Dr. Schuchat, I heard today Dr. Fauci talk about the 
perpetual challenge that we are always going to be facing from 
these emerging, very troubling, and serious health threats. The 
last time you testified before me, I was chairman of Homeland 
Security, and you testified about the pandemic flu. Last year, 
our Nation was focused like a laser on the Ebola outbreak.
    We seem to have a system where we are constantly scrambling 
to put together plans and emergency funding in order to counter 
these emerging threats. And yet, as Dr. Fauci so correctly 
said, they are perpetual. They are always going to be coming at 
us.
    How can we better plan for emerging health threats so that 
we are not constantly scrambling to put together emergency 
funding packages?
    Dr. Schuchat. Thank you. Nature has been a worthy 
adversary. And influenza, of course, is the most unpredictable 
of all. But CDC is committed to strengthen efforts to detect, 
respond, and prevent emerging infections and pandemics.
    The Global Health Security agenda is all about 
strengthening every countries' ability to do that, to be early, 
to find things early and prevent them spreading. We know with 
the Ebola epidemic, things got extremely out of control in West 
Africa. Had they been able to detect that earlier, it would 
have been a much simpler situation.
    We cannot predict every single pathogen or what nature will 
do, but we can prepare. And the pandemic work is a great 
example of that where, since the mid-2000s, investments were 
able to help us get ready for a pandemic, and when one 
happened, of course, there were extra needs to produce vaccine 
and so forth. But the Nation was much better prepared.
    But no one was expecting a birth defect to be linked to a 
new virus spread by mosquitoes. So we really need to look at 
this systematically for the long haul because we will have more 
threats, and we will have them at the same time. We will not be 
lucky enough to have one at a time.
    Senator Collins. That is, indeed, the challenge that we all 
face.
    Dr. Fauci, as Dr. Schuchat indicated in her testimony, the 
mosquito that carries the Zika virus also is a vector for 
diseases like dengue fever and chikungunya, if I have said it 
correctly. Does NIH's research into mosquito-borne viruses like 
dengue fever have any applicability to our finding a vaccine 
for Zika?
    Dr. Fauci. There are two arms of that approach about 
mosquitoes and vaccine. We do have a program of vector control 
of doing research, of being able to have innovative and novel 
ways to control mosquitoes. You have heard about some of these 
in the press about genetically modified mosquitoes infecting 
mosquitoes with the wolbachia bacteria, which would inhibit 
their ability to develop within them the virus to the point of 
being able to transmit it. So we do that.
    With regard to vaccines, the fact that we have these 
flaviviruses that you have just mentioned--chikungunya is an 
alpha virus, a little bit different than dengue and West Nile 
and Zika. But the fact that we have been studying those for a 
while have really given us very much of a head start in being 
able to use a vaccine platform that we know actually works with 
one which likely--no guarantee, but likely--will work with the 
other, which allowed me, Senator Collins, to say in my opening 
statement that I think we really do have a good head start on a 
vaccine here.
    Senator Collins. Would any of this research translate to 
other vector-borne diseases like Lyme disease, which I realize 
is carried by ticks, not mosquitoes, but is a major problem in 
my State?
    Dr. Fauci. Anytime you study one particular disease, one 
microbe, there almost always are spin-offs of being able to use 
that information for the next type of a disease that you get 
exposed to or that you have an outbreak with. So you are 
absolutely right. What we do now with one vector-borne disease 
gives us insight not only into the transmissibility by that 
vector but also, if it is even slightly related to the previous 
one, it helps us with therapeutics and vaccines. You heard Dr. 
Robinson mention that when we screen for drugs, we screen for 
drugs that may have had activity against other viruses that we 
think might also have activity against Zika. So there is that 
crossover that you are alluding to.
    Senator Collins. Thank you.
    The Chairman. Thank you.
    When you say ``vector,'' that means mosquito.
    Dr. Fauci. Correct.
    The Chairman. Thank you.
    Senator Warren.

                      Statement of Senator Warren

    Senator Warren. Thank you, Mr. Chairman.
    Each time a new disease threat appears, whether it is SARS, 
it is pandemic flu, MERS, Ebola, or Zika, Congress gets very 
interested and it holds hearings like this. But Congress does 
not show the same interest in taking steps before these crises 
occur to make sure that our country is actually prepared when 
disasters strike.
    Dr. Fauci, your agency is the NIH's front line for studying 
infectious diseases. You were here not too long ago at a 
hearing about Ebola, and we talked about the importance of 
basic research.
    What is your agency's budget today compared with a decade 
ago?
    Dr. Fauci. The budget of the NIH in general, or do you want 
to take NIAID?
    Senator Warren. Your agency. What is the difference in your 
budget?
    Dr. Fauci. The NIH budget is really not very different. We 
have had a flat budget over about the past 10 years. In 2016, 
we had the first real increase that we have had in essentially 
a decade. We had an over 6 percent increase. But prior to that, 
from the time the NIH doubling from 1998 to 2003, ended in 
2003, from then until the present time, with the exception of 
2016 when we got a 6 percent increase, our budget was 
essentially flat, which with inflation means it has gone down.
    Senator Warren. It has gone down. And as I understand it, 
if we did an adjustment, kind of back of the envelope, for 
biomedical inflation, it has gone down by about 20 percent over 
that time period.
    Is private industry picking up the slack doing the same 
kind of work that your agency does to help us better understand 
these emerging diseases?
    Dr. Fauci. We synergize very well with private industry, 
but there are things that they do not do, that will not get 
done unless the NIH does it. If you look at the spectrum from 
the development of a concept to the development of a product, 
what we do at NIH is the early development of a concept, early 
development of a product, preclinical testing, phase 1 testing, 
and usually the industry will then come and pick up the 
advanced development with the help of BARDA, which is very much 
that intermediate between the two.
    Senator Warren. OK, but the roles are different. Private 
industry does not pick this up.
    Dr. Fauci. They will never substitute for us.
    Senator Warren. The way I see this, Congress is strangling 
medical research. Even with the small bump in funding last year 
that you referred to, our investment in basic biomedical 
research is billions below where it would be if we just kept up 
with inflation, much less if we decided to increase it.
    So let me ask you, Dr. Robinson. Your agency oversees 
Project BioShield, which was created by Congress in 2004 with 
10 years of guaranteed money to make sure that this country 
stockpiles countermeasures against biological threats in case 
we need them. Do you still have guaranteed funding today?
    Mr. Robinson. We have the annual funding that is provided, 
and we thank you for that very much. And we have been able to 
capitalize----
    Senator Warren. So you are appropriated now.
    Mr. Robinson. Yes.
    Senator Warren. Can you explain to me what the difference 
is between being appropriated and how that affects your ability 
to plan and develop the stockpiles that we need?
    Mr. Robinson. We actually have multiyear budgets that go 5 
years into the future. And last year, you received our 
multiyear budget and our expert opinions as to what we needed 
to actually provide under Project BioShield, under the 
countermeasures that were ready to be bought and to be put into 
the stockpile. And we thank you very much for your fiscal year 
2016 appropriation because that made a lot of those dreams 
actually come true and we acted on those in fact.
    Senator Warren. But let me make sure I understand. The 
consequences of being appropriated now are that you have both 
less money and less certainty than we gave you more than a 
decade ago.
    Mr. Robinson. It is a very different paradigm, and if more 
funding were provided, we certainly would work with you to make 
more of those medical countermeasure dreams come true.
    Senator Warren. Thank you.
    Dr. Schuchat, you are Deputy Director for the Center for 
Disease Control, which is the front line agency responsible for 
tracking outbreaks and keeping us safe when they occur. Has the 
CDC's budget kept up with inflation over the last decade?
    Dr. Schuchat. Our annual appropriations have not. And I 
think the key for the public health agency is that we are as 
strong as the weakest local or State health department and the 
weakest international country. And so much of what we need to 
prepare for emerging threats is a strong front line.
    Senator Warren. Thank you.
    The most effective work for keeping Americans safe does not 
happen when the cameras are rolling and the world is focused on 
the latest outbreak. The real work happens every day, the long, 
hard efforts to lay the scientific groundwork to prepare for 
the next threat. And that work requires real money. It requires 
new mandatory funding for the NIH. It requires more support for 
the development and acquisition of countermeasures by BARDA and 
BioShield, and it requires adequate funding for the CDC.
    Hearings may be good PR, but it is time to step up and fund 
more medical research and more preparedness efforts. Until 
then, our response to the latest crisis will always be too 
little too late.
    Thank you, Mr. Chairman.
    The Chairman. Senator Cassidy has deferred to Senator Burr. 
Thank you for that, Senator Cassidy.
    Senator Burr.

                       Statement of Senator Burr

    Senator Burr. Thank you, Senator Cassidy. Thank you, Mr. 
Chairman.
    I have a number of questions that I am not going to ask the 
witnesses today, but I would ask unanimous consent that I be 
able to submit them and they be made part of the record.
    The Chairman. They will be.
    [The information referred to was not available at time of 
print.]
    Senator Burr. Thank you to all three of you.
    It seems like this is becoming a more regular process where 
we have something unexpected. And it is really at the root of 
why I created BARDA, wrote the legislation, and it was enacted 
in 2006 so that we would be ahead of this. And Senator Warren 
is partially right that over time, the Congress has not funded 
the mechanisms that were embraced so enthusiastically in a 
bipartisan way at the time. And we tried to get by on the cheap 
with a lot of the tools that were needed to supply interest by 
the private sector to be a partner. So I will not ask you what 
failed because I think we all know the answer.
    Dr. Fauci, if this virus, if Zika did not affect unborn 
babies and did not potentially--did not or does not protect 
unborn babies or paralysis, how seriously would we take the 
virus?
    Dr. Fauci. I think it would be honest to say, Senator, that 
if in fact there were no deleterious effects on pregnancy and 
Zika was what it is--namely a disease that is relatively mild, 
that is self-limiting, that has almost no mortality--I do not 
think there would be anywhere near the concern and attention to 
it that we are seeing now. It is the issue of the potential 
catastrophic effects on the fetuses of pregnant women who get 
infected. There would be a big difference in our response.
    Senator Burr. And how long do you anticipate it will take 
to make the epidemiological conclusion that there is a direct 
cause and effect?
    Dr. Fauci. I think we are almost there. I think it will be 
a matter of months not years. I think if you look at the case 
control and cohort studies that are being done, more and more 
information is accumulating, in fact, some that is even already 
accumulated that is not published yet. I think over the next 
couple of months, you are going to be seeing much more 
definitive proof of that association.
    Senator Burr. Let me share with you my disconnect in the 
process to date. Last year, we funded the special reserve fund, 
which is the BioShield component--or this year. Excuse me. 
Fiscal year 2016 at $510 million. But the request from the 
Administration for next year is a $160 million cut in the 
special reserve fund. We are down to $350 million. And at a 
time where we have had H1N1, Ebola, and now Zika--and I might 
put some other things in there that, Dr. Robinson, you and I 
have talked about that have not materialized but we were 
concerned--we have reduced our capacity in funding even from 
the request of the Administration while I read in the 
supplemental request that we have expanded your role of what to 
look at to now include those things that may pose a threat 
where the original legislation said does pose a threat. Am I 
right, Dr. Robinson? And do you see this as an expansion of the 
mission that we are asking BARDA to do?
    Mr. Robinson. I would say we are being asked to act on the 
emerging infectious disease portion of this and the ones that 
actually are known. And we have been able to develop tools that 
actually are able to respond, as I talked about with the 
National Medical Countermeasure Response Infrastructure that 
came directly out of the BARDA funding. We need to have more of 
that, that capacity to be able to respond to threats that we 
know about and new threats that come about. That there are 
threats that we have known about under Project BioShield, again 
as I answered to Senator Warren, if we have more funding there, 
there are medical countermeasures that are going to be ready to 
be procured.
    Senator Burr. Let me just switch quickly to Dr. Fauci 
because I am intrigued with the West Nile platform. I consider 
that to be a platform that you have created, insertion of an 
infectious disease into a DNA. And I think most of us would 
agree that platform technologies are emerging at a rapid pace.
    And here is my question. I think it is refreshing for 
members to understand that there is absolutely a need of a 
public-private partnership, that we cannot develop, as the 
Federal Government, all this, we can take it from basic 
research to commercialization decisions. And BARDA is, in the 
absence of a commercial partner for things that are crucial to 
our future--they are that venture capital over the ``valley of 
death.''
    In the case of where we got to with the West Nile potential 
countermeasure, would we be ahead and by how much had we 
initiated the clinical trials so that maybe we went to approval 
of the West Nile, then confirming the platform technology, and 
now we insert Zika--how would that have shortcut our process?
    Dr. Fauci. I would take it even further. I would have loved 
to have seen a pharmaceutical partner step forward a decade ago 
when we did the DNA platform for West Nile. We know that 
platform works. We did it in a preclinical and then a phase 1 
trial. It has been very, very helpful for us now with Zika.
    The other thing, when you talk about platforms, Senator 
Burr, is that you know the other platform is the vesicular 
stomatitis virus, or the VSV. We actually used that 
successfully with Ebola. That was one of the two vaccines that 
we tested with Ebola, and exactly what we are doing now is the 
same thing. We are taking that same vector, that same platform 
and sticking the Zika virus gene in there. Now we do have a 
pharmaceutical partner for that. We are in pretty good shape 
with that.
    So the answer is it would have been nice if we took it to 
fruition, but I think the platform works. And that is the 
reason why I am pretty confident that we are going to be able 
to push this through.
    The difference now and West Nile is we have several 
pharmaceutical partners that are now calling us up as opposed 
to what we were trying to do hat in hand trying to get them to 
partner with us.
    Senator Burr. Thank you.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Burr.
    Senator Baldwin.

                      Statement of Senator Baldwin

    Senator Baldwin. Thank you.
    I wanted to start by sharing some of the groundbreaking 
research on the Zika virus that scientists are conducting at 
the University of Wisconsin, Madison, which I think highlights 
some of the public health impact of basic research. A UW 
research team, who were initially in South America studying 
drug-resistant strains of HIV, were the first to identify the 
Zika virus circulating in Colombia in October. And as a result, 
now the University of Wisconsin is conducting several NIH-
supported studies to help identify immune responses to the 
virus, as well as the exact impact of the virus on pregnancy.
    But clearly, according to what we have been talking about 
here this morning, there is still a lot that we do not know 
about this virus, even though it was discovered 50 years ago. 
So that continued focus on basic research and information 
sharing is vital. And I wanted to start on that.
    The first question just relates to whether--as we first 
identified the Zika virus predominantly in Africa and Asia, did 
we see evidence there of the same links to microcephaly and 
perhaps also links to Guillain-Barre syndrome there? Or is that 
something that is different about the introduction of the Zika 
virus in South America?
    Dr. Schuchat. What we know about disease in Africa over the 
decade since 1947 when it was first recognized is limited, 
individual cases, what we call sporadic or one-at-a-time cases. 
And then in 2007, this outbreak in Yap happened, which was an 
island-wide--75 percent of people were apparently infected. But 
it is a very small population. So a birth defect like this 
might not have been visible. People now have looked back at 
French Polynesia and their outbreak and realized they did have 
an increase in Guillain-Barre syndrome, so that that was a 
particular issue that had not really been recognized.
    Second, the surveillance in much of Africa and the other 
terrible conditions that occur to babies and the high maternal 
and infant mortality are such that you might have had a pretty 
big problem and not recognized it.
    We are lucky that Brazil had a strong detection system. 
They recognized this outbreak of Zika last spring, which was 
difficult because it was at the same time that they usually 
have dengue virus. But then many months later, they recognized 
this increase in microcephaly.
    I do feel in the next few months we may start to see 
increases in microcephaly in some of these other countries, in 
Colombia where they are having thousands of Zika cases now, and 
women may be in early phases of pregnancy.
    I think the ability to find this in Africa may have been 
limited.
    Senator Baldwin. I do have some further information sort of 
defining where the research agenda needs to be, the basic 
research agenda. But I want to leap ahead to try to get a 
couple of other questions on the record.
    One issue is scientific data sharing. I am encouraged that 
both NIH and CDC have joined the more than 2 dozen government 
organizations worldwide in pledging to share scientific and 
research data related to Zika to speed up our response to the 
virus.
    What have NIH and CDC learned from the Ebola crisis to 
improve that sort of scientific exchange, and what challenges 
do you see remaining to sharing emerging research with other 
research partners related to Zika?
    Dr. Fauci. We are seeing a trend now, Senator, that is in 
my mind a very positive trend of open access to essentially 
everything. In fact, some researchers are actually putting 
their data online even before they submit it for publication. 
The good news about that is that you get it right away. You 
have to be careful because it is not necessarily peer-reviewed. 
But I think the positive aspect of that, if you look now 
compared to, let us say, 10 years ago, the accessibility to 
data is infinitely better than it used to be.
    I see the trend. And the signing of all of those 
organizations that you mentioned correctly I think is a good 
step to formalize and codify that pledge by everyone to have 
open access to data.
    Senator Baldwin. Thank you.
    I see I am out of time. I will submit additional questions 
for the record.
    The Chairman. Thank you, Senator Baldwin.
    Senator Cassidy.

                      Statement of Senator Cassidy

    Senator Cassidy. Thank you, all three, for the good work 
you all are doing.
    A couple things. Dr. Schuchat, the Pan-American Health 
Organization, the World Health Organization were kind of 
speaking about this as if it is a U.S. issue, which Dr. Fauci 
with his great work is always going to be looked to 
internationally. On the other hand, frankly, Pan-American and 
World Health should be point on this. I do not know if you can 
feel honest or not, but are they being point? How has their 
response been?
    Dr. Schuchat. I think the World Health Organization has 
really taken to heart the critiques of the Ebola response and 
is being much more visible and trying to get ahead of this.
    The Pan-American Health Organization is quite strong in 
terms of regional coordination and scientific capacity, and 
they have been working very intensively. We have worked 
together with them on laboratory workshops so that all of the 
countries of the Americas can be trained and ready to diagnose 
this virus. So I think the world is trying to be more prompt 
and coordinated at this point.
    Senator Cassidy. Let me ask. You mentioned in response to 
Senator Collins regarding the influenza, and you mentioned 
models of predicting flow. We all know that it starts over in 
Australia, China, and then sweeps. Dr. Fauci in a publication 
has this kind of hot spot of all these diseases that are 
popping up. What I am unclear about is--we know that people 
move from Africa, Asia, to the Pacific Islands. Anecdotally 
Pacific Islanders were traveling to Brazil. As sure as the sun 
rises in the east and sets in the west, we were going to have 
Zika in Brazil. It seems as if this would have been predictive 
with big data, with cell phone data. Where are cell phones 
being used from one country to the next? I have no doubt that 
there is a Federal agency that tracks this if only for security 
purposes.
    Where are we coupling the kind of new movement of Fauci's 
chart with somebody's understanding of where people are moving 
in order to anticipate these as opposed to finding out about 
them after we start hearing terrible reports?
    Dr. Schuchat. Thank you.
    The prediction capacities are much greater than they had 
been in--for example, chikungunya, another one of these 
mosquito-borne viruses, was not in the Americas till recently. 
But we predicted it was coming, and we prepared for it with 
diagnostic tests and outreach efforts.
    The different thing with Zika is--I think we expected to 
get it in the Americas. We never expected the birth defect 
issue. The good thing, though, about our preparedness is when 
we went to Yap in 2007 to respond to that outbreak, our 
laboratory developed a diagnostic test. So when the problem 
emerged in South America, we already had a diagnostic test 
sitting on the shelf----
    Senator Cassidy. But you mentioned earlier that the 
dengue--I think it is dengue--and Zika actually cross-react.
    Dr. Schuchat. That is right.
    Senator Cassidy. So it is a test but it is a poor test if 
you have a broad background of dengue prevalence. Correct?
    Dr. Schuchat. There are two different kinds of tests. The 
polymerase chain reaction test is specific.
    Senator Cassidy. But more expensive and less accessible.
    Dr. Schuchat. No. The problem is it is only positive when 
you have symptoms during that 1 week.
    We are working on a more specific antibody test that will 
help differentiate, but right now that is a problem.
    Senator Cassidy. Because one of the things that is clearly 
quite likely, since there is a similarity of symptoms between 
these different viruses, that we are overstating the intensity 
of the Zika relative to its actual--if we have a cross-reaction 
of tests, then we have a background of all these other 
illnesses, it is hard to imagine that we are not overstating 
the intensity of Zika because we are aware of it, and our tests 
are less specific. Fair statement?
    Dr. Schuchat. In the Americas, they are actually testing 
for all three. We know that in Colombia, for instance, there 
are a thousand cases of dengue right now--of chikungunya--
excuse me. But then they are also seeing this big emergence of 
Zika. So where they have been looking, they can differentiate 
with the PCR right now.
    Senator Cassidy. Dr. Fauci, the NIH obviously is going to 
be funding this. Has NIH set up a rapid funding mechanism 
where, as opposed to the normal kind of several week/several 
month process of review, boom, the dollars are going up more 
quickly?
    Dr. Fauci. Thank you, Senator. That is a very good 
question. And what we have done is that fortunately we have a 
portfolio of a considerable amount of grantees and resources on 
flaviviruses in general. We had a number of grantees both in 
the United States and in Brazil and other South American 
countries who were grantees for dengue, other types of 
flaviviruses. So we supplemented their grants like that. We 
were able to not go through the months-long review process. We 
were able to do a truncated process to give them a supplement 
to their grants at the same time that we are putting funding 
opportunity announcements out to go through the normal grant 
process. That is the reason why we were able to jump on this 
very quickly.
    The other thing that we did is that it so happened that our 
intramural research program, the Vaccine Research Center who 
developed the Ebola vaccine, are there intramurally. We just 
told them to turn around on a dime and start working on Zika, 
which is what they did. We had two mechanisms going that were 
much, much more quick than the usual grant months and months 
process.
    Senator Cassidy. Thank you. I will yield back.
    The Chairman. Thank you, Senator Cassidy.
    Senator Murphy.

                      Statement of Senator Murphy

    Senator Murphy. Thank you very much, Mr. Chairman.
    Thank you all for your work. We are lucky to have you. I 
think a lot of people in this country take for granted the 
public health infrastructure that exists nationally and at the 
local level. And it is often not until these crises hit and we 
see how other countries have a complete, often, inability to 
respond we understand the importance of the investments that we 
have made and the capabilities that we have. So let me just say 
thank you for your continued work.
    We are coincidentally, having a hearing later today in the 
Appropriations Committee on the proposed foreign aid and 
foreign operations budget. Yesterday Secretary Kerry was before 
the Foreign Relations Committee, on which I sit as well, 
talking about the same subject.
    Senator Warren was making a very persuasive and passionate 
case for the need for robust domestic funding to try to get 
ahead of these crises. But I want to have you help me make the 
case for why we need to have a robust international presence.
    I will put the sort of very broad question to you, Dr. 
Schuchat. Given your experience globally in encountering 
systems that just do not have the capability to get out ahead 
of these epidemics or handle them once they arrive, what is the 
role of the United States and the funding that we provide to a 
variety of different agencies in trying to help some of these 
places, whether it be West Africa, whether it be South America, 
get to the point where we are not chasing our tail on these 
epidemics once they hit?
    Dr. Schuchat. Americans' protection relies on the 
capacities abroad. We know that diseases are an airplane ride 
away. The Ebola outbreak raised awareness, but of course, 
measles comes in. We have so many infections that can threaten 
our population without strong local capacities elsewhere.
    The ability for us to respond to the Ebola outbreak in the 
three affected countries was challenging, a huge, huge 
international effort to get that under control. But it could 
have been so much worse had it been not contained in Nigeria. 
And our investments in Nigeria in polio eradication, in 
strengthening an emergency operations center meant that when 
the virus was imported into Lagos, a quick response tracking 
19,000 home visits of contacts and so forth was able to put 
that----
    Senator Murphy. These were investments that were made 
prior----
    Dr. Schuchat. Prior investments, absolutely. So the issue 
of the weakest country's capacity threatens America and our 
ability to strengthen capacities so these countries can 
prevent, detect, and respond promptly keeps us all safer.
    Senator Murphy. The takeaway from the massive infusion of 
money that we put into Ebola is not that that is a failsafe way 
to attack these epidemics, that you can wait until it hits, put 
in a bunch of money, and you will be guaranteed to have the 
same success we did there, which was remarkable that in a 
relatively short period of time, we were able to contain that 
virus, in part because of a lot of money that we put up at the 
last minute. That is not a guarantee that that is the model 
that will continue to repeat itself.
    Dr. Schuchat. It is much better to detect, prevent, and 
respond early than to come in when you have a multiple-country 
collapse. The economic and other health consequences of Ebola 
were enormous. And so we already know diseases like SARS had 
huge economic hits on Asia. We believe the Zika virus is going 
to be challenging in the Americas.
    Senator Murphy. Dr. Fauci.
    Dr. Fauci. To complement what Dr. Schuchat said, is that we 
had been invested in flavivirus research particularly dengue 
and West Nile and others over a period of decades. So when we 
now, as I mentioned in my opening statement, jump started the 
work on vaccines, we never would have been able to do that had 
we not had what you are referring to, Senator Murphy, the 
decades of investment in research globally and domestically 
that allowed us to move. If we were really starting from 
scratch now, I would never be able to come before this 
committee and say that I think we are going to go into phase 1 
trial by the end of the summer. That would be impossible for us 
to do that. It was that continual support that we had over a 
period of decades.
    Senator Murphy. Contrary to popular opinion, we are 
spending less than 1 percent of our Federal budget on foreign 
aid, including health programs. One of my good friends on the 
Foreign Relations Committee yesterday made an analogy to 
foreign aid to charitable contributions that you may make in 
your town to local organizations. And of course, none of this 
is simply charitable. Right? We are doing it in part because we 
want to help people in far off lands, but we are really doing 
it as part and parcel of our national security strategy, which 
you are an integral part of. And I thank you for it.
    Thank you very much, Mr. Chairman.
    The Chairman. Thank you, Senator Murphy.
    Senator Roberts.

                      Statement of Senator Roberts

    Senator Roberts. Thank you, Mr. Chairman, and thanks to the 
panel.
    Stephen Higgs, who is a doctor out at Kansas State 
University at the Biosecurity Research Institute out there, 
home of the ever-optimistic Wildcats--I was speaking with him 
earlier this week. He is an expert on Japanese encephalitis, 
which is a mosquito-borne virus, very similar to Zika. And he 
really made the point that Senator Burr made about the need for 
more basic research. How we do that with limited funds, I am 
not too sure, but he underscored that.
    One in five people apparently develop symptoms. We cannot 
ignore those that do not have symptoms, however, and can still 
be carriers and possibly transfer the disease to others. That 
was sort of a stunning thing to me that somebody could be a 
carrier and they would not even know it.
    Do we know how long individuals can serve as carriers? One 
study cited by CDC recently said it could be up to a week in 
blood and saliva. I am curious on your thoughts on how we try 
to manage the rather impossible problem of the virus in the 
population that is not exhibiting the symptoms.
    Dr. Schuchat. Thank you.
    The information about one in five people having symptoms 
comes from our investigation in Yap, and it may not hold out. 
We are still looking at that right now.
    What we know right now is that the blood contains the virus 
for about a week and then is cleared. But as Dr. Fauci said, 
some other body sites might have the virus for a longer period, 
and we are actually quite concerned about semen. There is a 
possibility of sexual transmission and we do not know yet how 
long the virus might be present in semen. For most people, the 
infection is all done after a week with or without symptoms, 
but that question of whether sexual transmission might occur 
later is what we are really concerned about right now.
    Senator Roberts. A different subject. I understand that we 
have engaged with the World Health Organization to ensure 
availability of insect repellants, i.e., pesticides, 
insecticides, ET cetera, ET cetera, to address mosquitoes 
carrying the Zika virus. I.e., you get control hopefully first 
before you get into a massive amount of mosquitoes carrying 
this disease.
    How is the CDC working with the EPA and others to ensure--
and I would add in the USDA--that pesticide products are 
registered and available for use as tools in addressing this 
public health situation?
    Dr. Schuchat. We are working really closely with the EPA. I 
can say there was just a joint delegation to Puerto Rico of the 
CDC, HHS, and EPA to look into the issues of mosquito control 
there and to understand about currently registered and 
potential future tools. I think the EPA is quite open to work 
expeditiously to make sure there are products available.
    Senator Roberts. Are we ensuring a variety of tools are 
available to States, towns, and even counties looking at vector 
control, outreach to local public health agencies, and mosquito 
control districts with this kind of registered pesticide----
    Dr. Schuchat. One of the reasons for the emergency request 
is that the mosquito control capacity is so variable, local 
area to local area, State to State. And we know that in many 
areas there are big holes. We do hope to be able to support 
local and State mosquito control groups in the kind of tracking 
that is needed, the evaluation, and the control efforts. It can 
be quite difficult to control Aedes aegypti, and it is even 
possible this virus can be spread through Aedes albopictus, 
which is in even more States than the Aedes aegypti. This is 
going to be a long-term effort, but we think that insect 
control is going to be very important.
    Senator Roberts. The interesting tool that has been 
discussed a lot and tested in Brazil, the genetically 
engineered mosquito--how are we doing on that?
    Dr. Schuchat. There is very interesting information from 
very small-scale studies of the genetically modified mosquito. 
I was just in Brazil and there was active discussion about 
that. I think continued evaluation is important, and I 
understand that FDA is looking at proposals for pilot studies, 
as is the authority in Brazil.
    Senator Roberts. Say a father was just informed by his 
daughter that she is pregnant, 3 months. Say they are from 
South Carolina now, and they enjoy going to the beach. I have 
been in South Carolina quite a bit. You can take the girl out 
of the South, but not the South out of the girl. This is my 
wife. My daughter has just told me she is 3 months pregnant. I 
would just like to ask you what advice I should give her with 
regard to going to the beach this summer.
    Dr. Schuchat. Congratulations to your daughter.
    We would advise her not to travel to South America, 
countries where the virus is circulating and to stay aware of 
where we are reporting concerns. We are not expecting to need 
to issue travel guidance for the continental U.S. right now. If 
we have importation and local circulation, we are not expecting 
it to be large-scale. We do think that sun block is important 
at the beach, and of course, insect repellant at the right 
times of year is important. But we are not expecting to caution 
your daughter about traveling to South Carolina.
    Senator Roberts. Thank you.
    The Chairman. Thank you, Senator Roberts.
    Senator Bennet.

                      Statement of Senator Bennet

    Senator Bennet. Thank you, Mr. Chairman.
    I would like to pick up where Senator Roberts left off, 
which is if you could talk a little bit, Dr. Schuchat or Dr. 
Fauci, whomever, about what people ought to be doing to protect 
themselves, who should be worried, what actions can they take. 
And maybe for Dr. Fauci, in the absence of a vaccine--and I 
heard you say you are optimistic about that, which is good--
what are the range of possibilities of how this disease is 
going to evolve in the United States?
    Dr. Schuchat. For the average person, the key message is to 
protect yourself against mosquitoes, and that involves 
repellant, clothing, screens, air conditioning, and travel 
guidance. Of course, it is the pregnant women that we have 
urged to avoid traveling to Zika-affected areas.
    In terms of what we expect to happen, if the other two 
mosquito-borne viruses, dengue and chikungunya, are a guide, 
then what we would expect is big outbreaks in Latin America 
where this mosquito is quite prevalent, importation through 
travelers but hardly any local spread. Particularly we would be 
focusing on the Southern States where the Aedes aegypti occurs 
and have seen some local spread, but very small scale in the 
past.
    But we would like to get ahead of that with good mosquito 
surveillance and understanding where there are hotspots and 
before there is a big outbreak, making sure we have mosquito 
populations under as good control as possible.
    Senator Bennet. That is very helpful.
    Dr. Fauci.
    Dr. Fauci. Just to add to that because I can almost 
guarantee that the first time that we do have local 
transmission in the continental United States, we will be 
sitting here in front of this committee and we will be talking 
about it. So on the one hand, you do not want to panic when 
that happens. You do not, on the other hand, want to be 
cavalier about it.
    Our experience, as Dr. Schuchat had mentioned, with dengue 
and with other diseases like chikungunya is that you have a lot 
of travel cases because we are so proximal to the Caribbean and 
South America. We are already seeing that. We are going to see 
more of that. There will almost certainly--I would say likely--
be along the Gulf coast, as we have seen with chikungunya and 
with dengue, small, mini local transmission outbreaks of 
clusters of cases. That is a high likelihood that that would 
happen.
    How we respond to that will be very important because 
historically when we saw that with dengue in Texas and Florida, 
there was an accelerated mosquito control effort on the part of 
the local authorities which did not allow that mini, little 
cluster of local transmission to become a nationwide outbreak. 
The same thing happened with chikungunya in Florida. That does 
not mean that we are going to be very complacent and say, well, 
do not worry about it, we have done it before, it is going to 
be OK. But we know that under the proper circumstances, you can 
take a mini, little cluster outbreak and not allow it to expand 
if you jump all over it right away. And that is exactly what 
Anne was talking about that the CDC and the State of Florida 
and the State of Texas are very well aware of what they need to 
do if in fact you wind up with this mini outbreak.
    Senator Bennet. I want to thank you for your leadership.
    My next question was about the CDC. As you know, the CDC's 
Division of Vector-Borne Diseases is in Fort Collins, CO. 
Senator Gardner and I went there last week to see what they are 
doing there. We appreciated very much the opportunity to visit 
with the people there. I wonder, Dr. Schuchat, if you could 
provide details about how the Division of Vector-Borne Diseases 
in Fort Collins is working on this and how you expect to 
involve them going forward.
    Dr. Schuchat. The division has been absolutely central. 
Fort Collins really houses our Zika gurus, and the leader of 
the entire response, Lyle Petersen, is the director of that 
division. They have the laboratory that developed the PCR test. 
They developed the antibody test. They are working on a next 
generation antibody test. And they have the mosquito experts 
who we have deployed to Puerto Rico and elsewhere to help get 
the best advice possible on the ground. We are really fortunate 
that we have people who have spent decades studying these kinds 
of mosquitoes and these kinds of viruses and are able to advise 
the Nation.
    Senator Bennet. Mr. Chairman, when Senator Gardner and I 
were there, we were standing next to each other, and there was 
a mosquito that started to fly next to us. And I said ``Is that 
a mosquito?,'' and the word did not even come out of my mouth 
before the head of the place just went--and that was it for the 
mosquito. So we are proud to have it in Fort Collins.
    [Laughter.]
    Senator Franken. Did he have any blood on his hands?
    [Laughter.]
    Senator Bennet. I do not think so.
    The Chairman. That was a vivid demonstration.
    [Laughter.]
    The Chairman. Thank you, Senator Bennet.
    Senator Franken.

                      Statement of Senator Franken

    Senator Franken. How did the first mosquito that had Zika--
this is a theoretical question for Dr. Fauci. It is an actual 
question that has a theoretical idea behind it, which is how 
did the first mosquito get the Zika virus.
    Dr. Fauci. That is a very good question.
    Senator Franken. Thank you.
    [Laughter.]
    Dr. Fauci. I am validating you, Senator Franken.
    Actually what likely happened is that there is a reservoir, 
probably likely non-human primate that is the low-level animal 
reservoir, and that is how the first mosquito got infected 
because the mosquito has to get infected from some animal. It 
just does not primarily infect the mosquito. The mosquito is a 
vector. Senator Alexander asked what a vector is. The mosquito 
is the vector of the virus. So the virus has to be somewhere 
for that mosquito to carry it.
    Senator Franken. There was an actual purpose to this 
theoretical question. Over three-quarters of the emerging 
diseases we have faced in the last century have come from an 
animal source. Ebola. We believe the pandemic--am I right in 
this--began when a young boy was infected from a bat. Is that 
correct? Is that what we believe?
    Dr. Fauci. We believe that.
    Senator Franken. The reason I was asking about where the 
first mosquito got the Zika virus, you are saying from a 
primate.
    Dr. Fauci. Likely from an animal reservoir, likely a 
primate.
    Senator Franken. While animals can be the source of an 
outbreak, they can also provide us with an early warning that a 
disease is present. Dr. Schuchat, you have experience dealing 
with outbreaks ranging from influenza to Ebola. In what ways 
can we strengthen the collaboration between scientific 
disciplines such as veterinarian medicine, environmental 
health, and human health to improve our ability to predict and 
respond to these infectious diseases?
    Dr. Schuchat. Working across disciplines, the human health 
and animal health, ecology, insect experts, is vital, and that 
is one of the ways that the CDC works, as you were just hearing 
about the Fort Collins group which has virologists, but also 
insect specialists and veterinarians, as well as 
epidemiologists. To respond to something like influenza, you 
really need expertise at that human/animal interface, and one 
of the things we know about our modern world is there are so 
many factors that put humans and animals and our ecosystems in 
closer proximity. So with the Zika virus, we think that humans 
are the principal reservoir for the mosquito bites, but with 
West Nile virus, they were birds and horses. And so we did have 
some early warning in terms of fatalities in birds. Similarly 
with influenza, looking at ill bird populations can be a signal 
that there is a new virus out there.
    I think in public health and merging infectious diseases, 
we really recognize what is called ``one health'' where we try 
to put together the different components and work as a team.
    Senator Franken. That is what I wanted to get to is this 
emphasis on one health. Thank you for that answer.
    The NIH has invested nearly $100 million in research to 
understand viruses similar to Zika. This is good news because 
NIH can leverage existing projects to work on Zika. Yet the 
cost to complete product development and approval is a barrier 
to translating research investment into an approved product. 
This is especially true when the product's profit potential is 
low because a disease affects a small number of patients in 
low-income countries.
    For this reason, I have introduced a bill to add the Zika 
virus to list of diseases eligible to receive a priority review 
voucher to encourage private investment in neglected tropical 
diseases.
    The question is for Dr. Fauci or Dr. Robinson. What are the 
NIH and BARDA doing to engage industry partners in the 
development of a vaccine or treatment for Zika, and what more 
can we as policymakers do to support these efforts?
    Dr. Fauci. Thank you for that question, Senator Franken.
    We are very actively involved in interacting with industry 
right now as we speak in the development of a Zika vaccine. In 
fact, as I mentioned in my opening statement, unlike what we 
have seen with West Nile where we had to push it to phase 1, 
and as it turned out, we could not find anybody to go into the 
next stage of advanced development, we have at least a handful 
of companies already who have come to us and actually asked 
about partnering, companies that we have dealt with in the past 
and some new companies that we have not.
    The bridge between what we are doing and the ultimate 
development of the company is a very important role for BARDA. 
So I would ask Dr. Robinson to maybe give his perspective on 
that because it really is a continuum from us at the concept 
level, the product with the company, and then the intermediate 
with BARDA.
    Mr. Robinson. Thank you, Tony.
    The clinical studies actually show that it is well 
tolerated and it may be immunogenic for these vaccines. You 
still have to be able to make it and you have to be able to 
make it more than just on a laboratory scale. You have to be 
able to make it on a commercial scale. And that is where we 
have really focused our attentions over the past 8 years to 
make sure that domestically companies can be able to do that, 
certainly for big diseases like pandemic influenza, and for 
other diseases in which we are now doing the same thing for 
Zika. And as I mentioned in my statement, we are going to be 
helping a company down in Brazil, which we worked with them on 
pandemic influenza. Those investments actually made that 
facility actually be able to make a commercial scale.
    So then we will have the clinical evidence that it may be 
efficacious. We will have the commercial manufacturing 
capability, and then have a real partner in industry that can 
go forward with it.
    Senator Franken. And that was the platform on the West Nile 
that you spoke of.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Franken. And thanks for 
mentioning your bill that you and Senator Isakson have 
introduced on adding the Zika virus to the FDA priority review 
voucher program. That bill will be taken up by this committee 
on March 9th and hopefully will be approved and a part of the 
Senate's companion legislation to the House's 21st Century 
Cures legislation, which includes the President's precision 
medicine initiative, hopefully support for the cancer moonshot, 
and other funding for NIH. So that is a timely bill.
    Senator Casey.

                       Statement of Senator Casey

    Senator Casey. Mr. Chairman, thank you.
    I would ask consent to submit a statement for the record.
    The Chairman. Yes, it will be accepted.
    [The prepared statement of Senator Casey can be found in 
additional material.]
    Senator Casey. Thank you very much.
    And thank you to our witnesses for your testimony and your 
public service and for taking our questions.
    I guess one thing that I would hope would happen--this 
committee on a whole range of issues but maybe especially on 
health--or I should say preparedness and response to outbreaks 
like the one we are talking about--has always done that in a 
bipartisan way, and I hope that we can support the President's 
supplemental in a bipartisan way.
    I wanted to start with Dr. Schuchat and Dr. Fauci going 
back to the mosquito issue. I am told that there are some 
20,000 pest control companies in the country. Kind of a two-
part question. One is have you engaged with them or is there a 
way to engage them if you have not, in terms of their expertise 
or involvement in these mosquito control efforts? And No. 2, 
what is the public education part of this in terms of just 
informing the public?
    Dr. Schuchat. Yes, we have been working with the mosquito 
control groups out there. There is something called the 
American Mosquito Control Association, and they just had their 
annual meeting and passed through Atlanta on their way home, 
some of the top gurus working together with our response. We 
are really keen for that expertise, the 20,000-some entities 
out there, to be available to local and State health 
departments for the communities that need to get ready. We also 
want to make sure we are sharing the best practices of what is 
actually effective against the Aedes aegypti that carries this 
Zika virus.
    And then we also think that there is a public role because 
individuals can protect themselves with behavioral change, with 
repellant, with screens, and air conditioning, long sleeves and 
so forth and with changing their travel behavior if it is 
necessary.
    Senator Casey. Dr. Fauci, anything on this just in terms of 
either engagement or public education?
    Dr. Fauci. We do not engage directly with the companies. 
That is predominantly what the CDC does. We interact with 
companies through our research on novel ways to do vector 
control.
    Senator Casey. I wanted to ask Dr. Robinson a question 
about children and in particular the challenge of developing 
medical countermeasures and the impact on children. We are told 
that the American Academy of Pediatrics published a statement 
on medical countermeasures for children in which they found 
that despite recent progress by the Federal Government, major 
gaps still remain related to medical countermeasures for 
children. And as you know and as the panel knows, children are 
much more vulnerable to the effects of exposure to some of the 
threats we have been talking about because many of the vaccines 
and pharmaceuticals approved for use by adults for medical 
countermeasures do not have the same--or do not yet, I should 
say, have pediatric formulations or dosing information or 
safety information.
    I guess from the perspective of BARDA, how do you ensure 
that the needs of children are factored into the BARDA 
contracts, for example?
    Mr. Robinson. The Pandemic Preparedness Act charged BARDA 
with actually special populations, including children. So as we 
develop vaccines and therapeutics, those formulations actually 
have to be part of what we do. And there are a number of 
examples. I will give you one of a drug for radiation which we 
have called Prussian blue, and there is a huge blue pill that 
adults would take, but children cannot take that. So we have 
actually supported development of a much more children-friendly 
formulation for that and have been successful in doing that. 
Across the board, with certain vaccines, with pandemic 
influenza and seasonal influenza, we have supported development 
of those vaccines for children and had those tested.
    Senator Casey. I guess as a followup to that, what are the 
standards that you use to determine whether to require 
pediatric testing and labeling for medical countermeasures that 
would be used in children?
    Mr. Robinson. The FDA really is our arbiter there and 
provides the guidance that we need to know what we need to do 
with children, if there are special studies that need to be--
and we certainly work with NIH to make sure that there are 
models there that may simulate what would happen in pediatric 
animals to what you would see in pediatric populations in 
humans.
    Senator Casey. Thank you very much.
    Thanks, Mr. Chairman.
    The Chairman. Thanks, Senator Casey.
    I mentioned that Senator Franken's bill and Senator 
Isakson's will be in our agenda for March 9. Your bill will be 
as well. You have a measure with Senator Burr, the Medical 
Countermeasure Innovation Act, which again we hope the 
committee will consider, approve, and make part of our 21st 
Century Cures legislation, which will become law this year. And 
I thank you for your work on that.
    I apologize to Senator Scott. I got so enthusiastic talking 
about our March 9 markup that I forgot to call on him in order. 
But he will get the last word for the Senators. Senator Scott, 
welcome.

                       Statement of Senator Scott

    Senator Scott. Thank you, Mr. Chairman, and no problems 
there.
    Dr. Schuchat, I certainly am pleased that your answer to 
Senator Roberts about the safety of his daughter hanging out at 
the beaches in South Carolina was an affirmative. There is no 
issue whatsoever. So to the 25 million or so tourists who are 
looking to descend upon the beaches of South Carolina, please 
feel free to call it your home.
    Thank you all for taking the time to be here this morning 
as well.
    One of the things that we know about South Carolina is that 
it is in fact the home to the Aedes mosquito. The real question 
that I have--at least the first one--is what can we expect in 
terms of local transmission in the Southeast, and what is the 
CDC doing to ensure that States and communities are prepared 
for the possibility of a local outbreak. What does that 
coordination look like?
    Dr. Schuchat. Yes. Thirteen States have the Aedes aegypti 
present, and 31 have the Aedes albopictus, and both of those 
mosquitoes can----
    Senator Scott. Who makes these mosquitoes, by the way.
    Dr. Schuchat. Good question.
    Senator Scott. I wish they would stop.
    [Laughter.]
    Dr. Schuchat. One of the aspects of the supplemental 
request is to really reinforce what needs to be done in those 
States to support State and local government to work across the 
spectrum with mosquito control, with surveillance, and lab 
detection, and with communication and outreach, particularly to 
protect pregnant women.
    Senator Scott. One of the questions, as we think about the, 
hopefully, very remote possibility of anything that looks like 
an outbreak in the Southeast and specifically in South Carolina 
is that when I talk to my South Carolina officials, they 
specifically tell me and tell us that the mosquito in question 
is located in one county, whereas looking at the CDC map, it 
appears that perhaps it is in multiple counties. Can you talk 
to me about what I can share with my constituents back at home?
    Dr. Schuchat. Yes. This raises a key point that our maps 
are incomplete. And one of the key ways to control mosquitoes 
is to understand where they are. So part of the resources would 
be to really map out where the particular mosquito vector is 
resident. Even within a community, there can be hotspots. And 
we are particularly interested in--for instance, in Puerto 
Rico, we are interested in hotspots where pregnant women may be 
frequently visiting, not just their homes but the places they 
go.
    Senator Scott. Thank you, ma'am.
    And for anyone on the panel, are you looking into potential 
mitigating factors regarding the severity of the microcephaly? 
In the absence of therapeutics, is there any evidence that 
prenatal care, nutrition, vitamins could have any effect on the 
severity of the microcephaly and babies born to women that 
contract Zika? That is the first question.
    The followup question is, is there any hypothesis as to why 
some babies develop microcephaly and others do not, once 
infected?
    Dr. Schuchat. Those are really important questions, and the 
focus of the study that we are doing right now in Brazil 
looking at women whose babies developed microcephaly and other 
women who were pregnant around the same time from the same 
communities whose babies were OK. We also do not know yet the 
full spectrum. It may be that microcephaly is one of the 
factors that this virus can cause, but that there are other 
parts of the spectrum. There may be milder disease or eye 
disease or other congenital defects. And we do not know about 
cofactors, as you mentioned, nutrition. People wonder about a 
number of things. So we are asking those questions, together 
with our Brazilian counterparts, to try to understand that.
    I think the most critical thing we would like to be able to 
learn is what the risk is, that if you do have Zika virus 
during pregnancy at different stages, what are the chances you 
will have a normal baby, what are the chances your baby will 
have one, two, or three other problems, and whether early 
detection can do anything to improve the health of the child.
    Dr. Fauci. This creates a very good segue into one of the 
questions that we just asked, Senator Scott, about research 
that you do ahead of time as opposed to just in an emergency 
response. The National Institute of Child Health and Human 
Development for years has partnered with Brazilian colleagues 
in prenatal centers doing research on ante-natal issues, not 
necessarily microcephaly because that had not been the target. 
But your question is highly relevant because there are so many 
issues that we still do not understand, as Dr. Schuchat said.
    It would be really unusual for a virus that causes 
congenital abnormalities to have only one specific effect, 
namely microcephaly. We are anticipating that as we study more, 
we are going to see other things that maybe microcephaly is the 
predominant one. We are already seeing a considerable amount of 
eye involvement that has already recently been reported. We 
expect that we will continue to learn as time goes on.
    Senator Scott. Anything to add, Dr. Robinson?
    Mr. Robinson. No. I think they have captured it very well. 
Thank you.
    Senator Scott. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Scott.
    And thanks to the three of you. As I listened to all of 
this--see if this is right. It sounds to me like a vaccine--
that we will be able to create a vaccine for this virus. Is 
that right, Dr. Fauci?
    Dr. Fauci. You never guarantee, but I feel pretty confident 
that we will only on the basis of the fact that we have done it 
for related viruses like dengue.
    The Chairman. So your level of confidence is high.
    Dr. Fauci. It is high, yes.
    The Chairman. It is high that you will be able to create a 
vaccine.
    And it sounds like the level of confidence is high that you 
will be able to create the vaccine sometime in 2017.
    Dr. Fauci. That is going to depend, Senator--and that is a 
very important question because if you look at the standard way 
of dotting all the I's and crossing all the T's, vaccine like 
this would generally take 3 to 5 years.
    The Chairman. Right.
    Dr. Fauci. The reason I said 2017 is if we start the phase 
1 trial in the summer of 2016, it ends at the end of 2016. If 
the epidemic is still raging in South America, we could go into 
an advanced phase 2A/2B trial, and if in fact you have a lot of 
cases, you may be able to prove efficacy in 6 to 8 months, 
which would bring you right through 2017.
    The Chairman. So it depends on there being a lot of cases 
so that you can prove that it is effective.
    Dr. Fauci. Precisely. And that is the reason we were 
stymied somewhat with Ebola in West Africa because we had a 
promising vaccine, and as the trial was getting going, the 
cases, because of good public health activities, started to 
come down. But if in 2017 we are in the middle of a massive 
outbreak, that is unfortunate for the countries, but that would 
be the perfect scenario to be able to prove or not the efficacy 
of a vaccine.
    The Chairman. Well, the same for safety.
    Dr. Fauci. Safety, same thing, the same exact thing.
    The Chairman. The same amount of time.
    But do you not already have an epidemic in Puerto Rico, for 
example? Do you not have a lot of cases in Puerto Rico?
    Dr. Fauci. I know, but we are not ready for phase 2A/2B. 
That is the point.
    The Chairman. If you were. I mean, if we get to January----
    Dr. Fauci. If the situation in the beginning of 2017 is the 
way it is now in South America and in Puerto Rico, we will have 
enough cases to pretty expeditiously prove the safety, efficacy 
or not.
    The Chairman. Then we are talking 6 to 8 months.
    Dr. Fauci. Following the beginning of a phase 2B trial into 
2017.
    The Chairman. Into 2017. And if there is this number of 
cases, you have, I believe you said, manufacturers knocking on 
your door?
    Dr. Fauci. Right.
    The Chairman. There should be a private sector interest to 
produce enough vaccine.
    Dr. Fauci. There will be.
    The Chairman. Under those circumstances, by the end of 
2017, the chances are--and I will use my words--sounds like 
they are good that we may have--that we could have a vaccine if 
those circumstances----
    Dr. Fauci. If those circumstances play out the way we have 
just described them, there is that possibility and likelihood 
that we would.
    The Chairman. Would you also not say that given the 
uncertainty about this disease and the dramatic nature of the 
birth defect associated with it, that if we have such a vaccine 
by the end of 2017, that most young women who may become 
pregnant will want to take the vaccine?
    Dr. Fauci. I believe it depends on where you live. I 
believe that it would be a situation similar to what we saw 
with rubella. In the early 1960s, we averaged about 20,000 
cases of congenital rubella syndrome in women who were infected 
during pregnancy. When we developed the rubella vaccine back in 
the 1960s, although it was for everyone--and it is one of the 
required vaccines--it was fundamentally developed for women of 
child-bearing age. So I would think that if you have an endemic 
or, as you said, essentially baseline level of Zika that indeed 
is causing congenital abnormalities in countries like Brazil, I 
believe that that would be a vaccine that would be highly 
desirable for women of child-bearing age.
    The Chairman. And based upon your continued monitoring of 
sexual transmission, it may be a vaccine that men of those 
women who are partners----
    Dr. Fauci. Quite possibly, yes.
    The Chairman [continuing]. Would want to take. There may be 
women and men in the southern most part of the United States 
who want to take that vaccine as well. I mean, we have areas--
--
    Dr. Fauci. I think that would depend on whether we have 
local outbreak. I would not foresee in the United States, if we 
do not have endemic Zika infection, that this would be 
something for the United States. But I would ask Dr. Schuchat 
to comment.
    The Chairman. Dr. Schuchat, any comment?
    Dr. Schuchat. I think the issue of travelers is important, 
and so we do have many vaccines that are recommended for 
travelers. And this might end up being one of them. If we do 
not end up with a big Zika problem here in the continental 
United States, folks who are planning trips might want to----
    The Chairman. In the way that if we go to Africa, we take a 
malaria----
    Dr. Fauci. Or a yellow fever vaccine. When we all went to 
West Africa during the Ebola outbreak, we all had to show that 
we had been vaccinated for yellow fever.
    The Chairman. So this would fall into a category that we 
are really familiar with, which is that we look for travelers. 
We identify parts of the world where there may be outbreaks of 
certain diseases and you recommend certain vaccines. So that is 
nothing new. We have done that for years.
    Dr. Fauci. Indeed. That is correct.
    The Chairman. And travelers have safely gone to other 
places and come back. I mean, tens of millions of people have 
done that.
    Dr. Fauci. Yes, exactly.
    The Chairman. This has been a very helpful hearing. There 
is a great amount of interest in it. I thank all three of you 
for the contributions that your agencies play to this. And I 
know that the CDC website is probably--Dr. Schuchat, if one has 
questions, the place to go is probably the CDC website. Is that 
right?
    Dr. Schuchat. Yes, CDC.gov.
    The Chairman. CDC.gov.
    Dr. Fauci, would you agree with that or is there another 
place to go?
    Dr. Fauci. I use it every day.
    The Chairman. So if you want to know what to do, if you 
want to find out about diagnostic tests, if you want to know 
where you might travel, if you have other questions, the CDC 
website is the place to go.
    The hearing record will remain open for 10 days. Members 
may submit additional information for the record within that 
time, if they would like.
    The HELP Committee will continue its step-by-step 
innovation process on Wednesday, March 9, when we will consider 
bipartisan legislation, including two bills directly related to 
today's discussion on the Zika virus--I just mentioned it 
earlier--the Adding Zika Virus to the FDA Priority Review 
Voucher Program act, sponsored by Senators Franken and Isakson, 
and the Medical Countermeasures Innovation Act, sponsored by 
Senators Burr and Casey. As I mentioned earlier, these are part 
of what we hope to become the Senate's companion legislation to 
the House-passed 21st Century Cures. We will have a final 
markup for those measures in the first week of April, and 
hopefully they all add up to a substantial package.
    Then we will have to have a discussion about funding, on 
which there is not bipartisan agreement in the committee right 
now. But I think we can get there when we go to the floor. So 
my expectation is that we will have bipartisan agreement on a 
package that may include as many as 45 or 50 measures ready by 
the first week of April, including the two I mentioned that are 
related to Zika, and that we will have a separate bipartisan 
agreement on funding that will be bipartisan. We cannot work 
that out in committee, but we can work it out on the floor. And 
if we take both those pieces of legislation to Senator 
McConnell, say the House has already passed their version, and 
that the President support precision medicine and cancer 
moonshot parts especially, I think we have a very good chance 
of turning that legislation into law.
    Thank you very much for your time today.
    The committee will stand adjourned.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                  Prepared Statement of Senator Casey

    Thank you, Chairman Alexander and Ranking Member Murray, 
for calling this important hearing today. Senator Burr and I 
have worked together on public health preparedness issues for 
several years now, and I am grateful for his work and for the 
committee's tradition of bipartisan work on issues relating to 
public health preparedness.
    As we have seen in the last several years, we face a 
continually evolving public health situation. From novel flu 
strains to Ebola, dengue to chikungunya, MERS and beyond, we 
have seen emerging infectious diseases affect communities 
across the globe. These emerging infections highlight the 
interconnectedness of the global economy in which we live, and 
the fact that many of these infectious diseases are only a 
plane ride away.
    In some respects, we have made great progress in building 
our capacity to respond to these new threats; in other ways, we 
have much further to go to achieve the optimal level of 
preparedness. Ebola was a wake-up call: a disease that we had 
known about for decades suddenly reemerged and began spreading 
rapidly. Thousands of people died, and our partners in West 
Africa are in their (hopefully) final few weeks of monitoring 
to confirm that local transmission of the disease has ceased 
and the outbreak is over. This effort has taken over 2 years.
    With Zika, we face an unusual and disturbing threat that is 
distinct from Ebola. While the Zika virus itself appears to 
cause no illness in the majority of people infected, and only 
moderate illness in the remainder, it has been linked to severe 
complications such as Guillain-Barre Syndrome in some 
individuals. Of greatest concern, however, is the increasing 
evidence that Zika can be devastating to the unborn children of 
pregnant women who are infected, causing microcephaly. Thus, 
while we are still dealing with a global response to the 
threat, the nature of the threat and the necessary response is 
quite different.
    As we continue to learn more about this virus and its 
potential consequences, I will reiterate what I said in the 
early days of the Ebola virus: we should listen to medical 
experts, such as the ones we have here today, and be sure that 
we are making policy decisions based on sound science and the 
best medical evidence available.
    I look forward to hearing from our witnesses here today 
about the current state of our response to the Zika virus, and 
what steps we need to take moving forward, including moving 
forward on the President's emergency supplemental funding 
request, which I believe we should pass so that the Federal 
Government has the resources it needs to respond to the threat 
posed by Zika.
    But looking beyond Zika, we must also think about what the 
next virus will be, and the next, and the one after that. Are 
we prepared? What more do we need to do so that our public 
health workers are prepared for each new threat before it 
emerges?
                  Statement Submited by Senator Murray

                      Open Statement on Zika Virus

    As organizations supportive of a robust and comprehensive public 
health response to the rapid spread of Zika virus in the Latin America 
and Caribbean region, we write to express our support for efforts by 
the U.S. Government to provide resources to aid in the global response 
to this international public health emergency. The spread of Zika 
virus, and the particular health risks it may pose to women who are 
pregnant or may become pregnant, highlights significant gaps in access 
to reproductive health care in the Latin America and Caribbean region.
    We call on the U.S. Government response to Zika virus to include 
comprehensive reproductive, maternal, and child health services through 
bilateral programs as well as through contributions to UNFPA. In order 
to support women in making and carrying out decisions about their 
health, this must specifically include access to family planning 
information, education, services, and contraceptive commodities 
including emergency contraception. It must also provide maternal and 
child health services to support healthy pregnancy outcomes and 
families with children who have microcephaly. In particular, UNFPA, 
with a presence in over 40 countries in the region, is best equipped to 
provide these services immediately to the communities most in need with 
additional support from the U.S. Government and in coordination with 
the World Health Organization and Pan-American Health Organization.
    We know there is still much to learn about Zika virus and the 
response will be complex and require coordination at the global, 
regional, and national levels. While the response to Zika virus may 
evolve, one thing is clear: the U.S. Government must prioritize access 
to comprehensive reproductive and maternal health care services in its 
response to meet the needs of women and families during this health 
emergency and beyond.

    Advocates for Youth; American College of Obstetricians and 
Gynecologists; Better World Campaign; Center for Health and Gender 
Equity (CHANGE); Center for Reproductive Rights; Institute for Science 
and Human Values; International Center for Research on Women; 
International Women's Convocation; International Women's Health 
Coalition; Ipas; NARAL Pro-Choice America; National Abortion 
Federation; National Council of Jewish Women; National Latina Institute 
for Reproductive Health; National Network of Abortion Funds; National 
Organization for Women; National Women's Health Network; PAI; 
Pathfinder International; Physicians for Reproductive Health; Planned 
Parenthood Federation of America; Population Connection Action Fund; 
Population Institute; Religious Institute; Reproductive Health 
Technologies Project; Sexuality Information and Education Council of 
the U.S. (SIECUS); Sierra Club; Universal Access Project; National 
Women's Law Center.

    [Editor's Note: UNFPA--United Nations Population Fund, formerly the 
United Nations Fund for Population Activities.]

    [Whereupon, at 11:56 a.m., the hearing was adjourned.]

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