[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]


      EXAMINING THE U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA VIRUS

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             MARCH 2, 2016

                               __________

                           Serial No. 114-124
                           
                           
                           
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                   COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman
JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Chairman Emeritus                    Ranking Member
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania        ELIOT L. ENGEL, New York
GREG WALDEN, Oregon                  GENE GREEN, Texas
TIM MURPHY, Pennsylvania             DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas            LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee          MICHAEL F. DOYLE, Pennsylvania
  Vice Chairman                      JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington   KATHY CASTOR, Florida
GREGG HARPER, Mississippi            JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky              PETER WELCH, Vermont
PETE OLSON, Texas                    BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia     PAUL TONKO, New York
MIKE POMPEO, Kansas                  JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois             YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia         DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
BILL JOHNSON, Ohio                   JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                     Massachusetts
RENEE L. ELLMERS, North Carolina     TONY CARDENAS, California
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota

              Subcommittee on Oversight and Investigations

                        TIM MURPHY, Pennsylvania
                                 Chairman
DAVID B. McKINLEY, West Virginia     DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
LARRY BUCSHON, Indiana               JOHN A. YARMUTH, Kentucky
BILL FLORES, Texas                   YVETTE D. CLARKE, New York
SUSAN W. BROOKS, Indiana             JOSEPH P. KENNEDY, III, 
MARKWAYNE MULLIN, Oklahoma               Massachusetts
RICHARD HUDSON, North Carolina       GENE GREEN, Texas
CHRIS COLLINS, New York              PETER WELCH, Vermont
KEVIN CRAMER, North Dakota           FRANK PALLONE, Jr., New Jersey (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     3
Hon. Kathy Castor, a Representative in Congress from the State of 
  Florida, opening statement.....................................     5
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     5
Hon. Fred Upton, a Representative in Congress from the state of 
  Michigan, prepared statement...................................   143

                               Witnesses

Nicole Lurie, M.D., Assistant Secretary for Preparedness and 
  Response, U.S. Department of Health and Human Services.........     8
    Prepared statement...........................................    11
    Answers to submitted questions                                  144
Thomas Frieden, M.D., Director, Centers for Disease Control and 
  Prevention.....................................................    21
    Prepared statement...........................................    23
    Answers to submitted questions...............................   148
Anthony Fauci, M.D., Director, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health.............    31
    Prepared statement...........................................    33
    Answers to submitted questions...............................   155
Luciana Borio, M.D., Assistant Commissioner, Counterterrorism 
  Policy, U.S. Food and Drug Administration......................    44
    Prepared statement...........................................    46
    Answers to submitted questions...............................   159
Timothy Persons, Ph.D., Chief Scientist, U.S. Government 
  Accountability Office..........................................    55
    Prepared statement \1\
Peter Hotez, M.D., Ph.D., Dean, National School of Tropical 
  Medicine, Baylor College of Medicine, President, Sabin Vaccine 
  Institute, and Texas Children's Hospital Endowed Chair in 
  Tropical Pediatrics............................................    78
    Prepared statement...........................................    80
    Answers to submitted questions...............................   167
Lawrence O. Gostin, J.D., Linda D. and Timothy J. O'Neill 
  Professor of Global Health Law, Georgetown University Law 
  Center.........................................................    90
    Prepared statement...........................................    92
    Answers to submitted questions...............................   171
Joseph Conlon, M.S., Technical Advisor, American Mosquito Control 
  Association....................................................   105
    Prepared statement...........................................   108
    Answers to submitted questions...............................   181
Jeanne Sheffield, M.D., Director, Division of Maternal-Fetal 
  Medicine, Johns Hopkins School of Medicine.....................   122
    Prepared statement...........................................   124
    Answers to submitted questions...............................   187

----------
\1\ Mr. Person's testimony is available at: http://
  docs.house.gov/meetings/if/if02/20160302/104594/hhrg-114-if02-
  wstate-personst-20160302.pdf.

 
      EXAMINING THE U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA VIRUS

                              ----------                              


                        WEDNESDAY, MARCH 2, 2016

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:15 a.m., in 
room 2322 Rayburn House Office Building, Hon. Tim Murphy 
(chairman of the subcommittee) presiding.
    Members present: Representatives Murphy, Burgess, Griffith, 
Brooks, Mullin, Hudson, Collins, Cramer, Castor, Tonko, Clarke, 
Kennedy, Welch, and Pallone (ex officio).
    Also present: Representative Bilirakis.
    Staff present: Brittany Havens, Oversight Associate, 
Oversight and Investigations; Charles Ingebretson, Chief 
Counsel, Oversight and Investigations; Tim Pataki, Professional 
Staff Member; Chris Santini, Policy Coordinator, Oversight and 
Investigations; Alan Slobodin, Deputy Chief Counsel, Oversight 
and Investigations; Sam Spector, Counsel, Oversight and 
Investigations; Dylan Vorbach, Deputy Press Secretary; 
Christine Brennan, Minority Press Secretary; Jeff Carroll, 
Minority Staff Director; Waverly Gordon, Minority Professional 
Staff Member; Ryan Gottschall, Minority GAO Detailee; Chris 
Knauer, Minority Oversight Staff Director; Una Lee, Minority 
Chief Oversight Counsel; Elizabeth Letter, Minority 
Professional Staff Member; Andrew Souvall, Minority Director of 
Communications, Outreach and Member Services; and Kimberlee 
Trzeciak, Minority Health Policy Advisor.

   OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Murphy. Good morning. We are here for the subcommittee 
on Oversight and Investigations for the Committee on Energy and 
Commerce for a hearing called ``Examining the U.S. Public 
Health Response to the Zika virus.''
    This morning we'll be examining this other public health 
crisis affecting the Western Hemisphere, that Zika virus. This 
virus of mosquito-borne pathogen is currently rampaging through 
South and Central America, and in total has spread to more than 
48 countries and territories.
    While as of late February there have been no known locally-
acquired mosquito-borne cases reported in the Continental U.S., 
over 100 travel-associated Zika virus cases have been 
identified in over 20 states. Outside of the 50 states local 
mosquito-borne transmissions have been reported in Puerto Rico, 
the U.S. Virgin Islands, and American Samoa. Public health 
officials in the U.S. are bracing for the time when Zika passes 
from a traveler with Zika in his or her blood to a local 
mosquito, and then to another person.
    Only about one and five people with Zika infection exhibit 
symptoms, most of which are mild and flu-like. Of greater 
concern is growing evidence of a link between Zika infection 
and microcephaly, a congenital birth defect in infants born to 
infected mothers, as well as Guillain-Barre Syndrome, an immune 
disorder that can result in temporary paralysis. On this basis, 
the World Health Organization recently declared Zika a public 
health emergency of international concern.
    The virus may also be transmitted through blood 
transfusions and sex, leaving the Center for Disease Control to 
issue interim guidelines for prevention of sexual transmission, 
and the Food and Drug Administration to take steps to reduce 
the risk to the U.S. blood supply.
    Thus far, there has been only one reported case in the U.S. 
of a child born with microcephaly to a mother with travel-
associated Zika virus. However, other pregnant American women 
have become infected with Zika. Our understanding of how the 
virus may impact a developing child during pregnancy is nearly 
non-existent. We can, however, reasonably assume that a virus 
affecting development of the brain on a large scale leading to 
microcephaly in the first trimester will also impact 
significant developmental functions for infants, toddlers, and 
children exposed to the Zika virus. These include my concerns 
for developmental disorders of difficulty with learning, 
primary sensory and sensory integration, memory, attention, 
concentration, behavior, mood, language, motor, and others.
    Given all of the unknowns the importance of acting now to 
protect pregnant women and women of reproductive age from 
exposure to Zika virus cannot be overstated. However, we must 
be equally concerned with protecting infants and children with 
developing brains and not wait 5 to 10 years for symptoms to 
appear before we take action to protect, to track, and to 
treat.
    To help prepare for and respond to Zika, the Administration 
recently requested Congress provide over $1.8 billion in 
emergency funding. The request includes support to states, U.S. 
territories, the International Community for Mosquito Control, 
virus testing, and expanding surveillance and response 
activities. It also supports efforts to build upon existing 
resources to develop a vaccine for Zika.
    While the Administration's request has worthy aims, it's 
one-off emergency funding approach like the $6 billion for 
Ebola emergency funding demonstrates a reactionary posture 
towards public health preparedness rather than a strategic one. 
We want a strategic posture.
    On February 12th, this subcommittee held a hearing 
examining the federal government's preparedness for biological 
threats focused on the finding of the Blue Ribbon Study Panel 
on Biodefense. The panel concluded that the federal government 
is ill prepared to handle future biological threats, an 
alarming conclusion because since 2002 infectious disease 
outbreaks, epidemics, and pandemics have emerged with 
increasing frequency, and Zika is just the latest example of 
this trend.
    The Administration's response to Zika raises very serious 
questions. There are no commercially available diagnostic tests 
for Zika, nor has a vaccine been developed. In the absence of 
these measures, mosquito control is the nation's critical 
defense. However, mosquito control in the U.S. is a patchwork 
of 700 mosquito abatement districts depending on the state, 
county, and city funding and personnel with varying 
capabilities. This unorganized hodgepodge could leave the U.S. 
vulnerable to a rapid outbreak of Zika. The Administration has 
not explained how its emergency request will address issues 
with vector control. We want to work with the Administration to 
solve that problem.
    Public Health Departments and the CDC are using two Zika 
diagnostic tests only available for U.S. labs. As the 
Government Accountability Office testimony makes clear, these 
tests have serious limitations, including the ability to either 
detect Zika or to be able to distinguish Zika from other 
viruses.
    In addition, the confirmatory testing for Zika detection is 
used only by CDC and a few labs, is cumbersome and not suitable 
for screening a large number of individuals. This very limited 
capacity for confirmatory testing is very troubling when we 
consider the expected surge and the demand for Zika testing as 
we reach the warmer months. Again, the Administration must 
explain its plan to address this testing capacity issue.
    Once again as with Ebola, we are assured that Zika will not 
be a significant problem in the U.S., and while Dr. Anthony 
Fauci of NIH has stated that it is unlikely the U.S. will have 
a major Zika outbreak, other experts differ. In his written 
testimony to this committee, Dr. Peter Hotez of Baylor School 
of Medicine notes the experience of Texas showed a Dengue 
outbreak occurred in the poorest areas of Houston and other 
Gulf Coast cities vulnerable to Zika.
    This morning we'll be taking testimony from a panel of 
federal witnesses and experts, including the Assistant 
Secretary for Preparedness and Response at HHS, the Director of 
CDC, the Director of the National Institute of Allergy and 
Infectious Diseases at NIH, the Acting Chief Scientists of FDA, 
as well as the Chief Scientist of the GAO. Welcome. We will 
then hear from a second panel featuring specialists in tropical 
and maternal fetal medicine, mosquito control, and global 
health law.
    I want to thank all our witnesses for joining us this 
morning and look forward to hearing your testimonies.
    I now recognize, since Ms. DeGette is not here, we're 
promoting her to the Ranking Member Pro Tempe of the 
subcommittee, Ms. Castor of Florida, for 5 minutes.
    [The statement of Mr. Murphy follows:]

                 Prepared statement of Hon. Tim Murphy

    This morning, we will be examining a public health crisis 
afflicting the Western Hemisphere. The Zika virus, a mosquito-
borne pathogen rampaging through South and Central America, 
advances menacingly toward the U.S. The Zika virus has spread 
to more than 48 countries and territories. While as of late 
February there had been no known locally acquired mosquito-
borne cases reported in the continental U.S. states, over 100 
travel-associated Zika virus disease cases have been identified 
in over 20 states. Outside of the 50 states, local mosquito-
borne transmission has been reported in Puerto Rico, the U.S. 
Virgin Islands, and American Samoa. Public health officials in 
the U.S. are bracing for the time when Zika passes from a 
traveler with Zika in his or her blood to a local mosquito, and 
then to another person.
    Only about one in five people with Zika infection exhibit 
symptoms, most of which are mild and flu-like. Of greater 
concern is growing evidence of a link between Zika infection 
and microcephaly, a congenital birth defect in infants born to 
infected mothers, as well as Guillain-Barre AE1 Syndrome, an 
immune disorder that can result in temporary paralysis. On this 
basis, the World Health Organization recently declared Zika a 
``public health emergency of international concern.''
    The virus may also be transmitted through blood 
transfusions and sex, leading the Centers for Disease Control 
(CDC) to issue interim guidelines for prevention of sexual 
transmission and the Food and Drug Administration (FDA) to take 
steps to reduce the risk to the U.S. blood supply. Thus far, 
there has been only one reported case in the U.S. of a child 
born with microcephaly to a mother with travel-associated Zika 
virus; however, other pregnant American women have become 
infected with Zika. Our understanding of how the virus may 
impact a developing child during pregnancy is nearly non-
existent. Given all of the unknowns, the importance of acting 
now to protect pregnant women and women of reproductive age 
from exposure to Zika virus cannot be overstated.
    To help prepare for and respond to Zika, the Administration 
recently requested Congress to provide over $1.8 billion in 
emergency funding. The request includes support to states, U.S. 
territories, and the international community for mosquito 
control, virus testing, and expanding surveillance and response 
activities. It also supports efforts to build upon existing 
resources to develop a vaccine for Zika.
    While the Administration's request has worthy aims, its 
one-off emergency funding approach, like the $6 billion for 
Ebola emergency funding, demonstrates a reactionary posture 
towards public health preparedness rather than a strategic one. 
On February 12th, this Subcommittee held a hearing examining 
the federal government's preparedness for biological threats, 
focused on the findings of the Blue Ribbon Study Panel on 
Biodefense. The panel concluded that the federal government is 
ill-prepared to handle future biological threats--an alarming 
conclusion because, since 2002, infectious disease outbreaks, 
epidemics, and pandemics have emerged with increasing 
frequency. Zika is just the latest example of this trend.
    The Administration's response to Zika raises very serious 
questions. There are no commercially available diagnostic tests 
for Zika, nor has a vaccine been developed. In the absence of 
these measures, mosquito control is the nation's critical 
defense. However, mosquito control in the U.S. is a patchwork 
of 700 mosquito-abatement districts dependent on state, county, 
or city funding and personnel, with varying capabilities. This 
unorganized hodgepodge could leave the U.S. vulnerable to a 
rapid outbreak of Zika. The Administration has not explained 
how its emergency request will address issues with vector 
control.
    Public health departments and the CDC are using two Zika 
diagnostic tests only available for U.S. labs. As the 
Government Accountability Office's testimony (GAO) makes clear, 
these tests have serious limitations, including the ability to 
either detect Zika or to be able to distinguish Zika from other 
viruses. In addition, the confirmatory testing for Zika 
detection is used only by CDC and a few labs, is cumbersome, 
and not suitable for screening a large number of individuals. 
This very limited capacity for confirmatory testing is very 
troubling when we consider the expected surge in the demand for 
Zika testing as we reach the warmer months. Again, the 
Administration must explain its plan is to address the testing 
capacity issue.
    Once again, as with Ebola, we are assured that Zika will 
not be a significant problem in the U.S. While Dr. Anthony 
Fauci of the NIH has stated that it is unlikely that the U.S. 
will have a major Zika outbreak, another expert differs. In his 
written testimony to the committee, Dr. Peter Hotez, of Baylor 
School of Medicine, notes that the experiences of Texas showed 
dengue outbreaks occurred in the poorest areas of Houston and 
other Gulf Coast cities vulnerable to Zika.
    This morning we will be taking testimony from a panel of 
federal witnesses, including the Assistant Secretary for 
Preparedness and Response at HHS, the Director of CDC, the 
Director of the National Institute of Allergy and Infectious 
Diseases at NIH, the Acting Chief Scientist of FDA, as well as 
the Chief Scientist of the GAO.
    We will then hear from a second panel featuring specialists 
in tropical and maternal-fetal medicine, mosquito control, and 
global health law. I would like to thank all of our witnesses 
for joining us this morning.
    I now recognize the Ranking Member of the Subcommittee, Ms. 
DeGette, for her opening statement.

  OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF FLORIDA

    Ms. Castor. Well, thank you, Mr. Chairman, for calling this 
important hearing, and I want to thank all of our expert 
witnesses who are here today for everything that you do to keep 
American families healthy and safe.
    So many of my neighbors across the State of Florida, and 
the Gulf Coast, and Puerto Rico are very concerned with the 
impacts of the Zika virus. We want our states and our 
communities to be well prepared and we want to better 
understand the impacts of the virus.
    In Florida, CDC has confirmed the Zika case count is now up 
to 44 cases. All of these cases are travel-related, so there 
are no locally-acquired cases in Florida. Overwhelmingly, 
people who have traveled to Brazil and Latin America to visit 
family and friends, or travel on business or for pleasure have 
contracted the virus and have brought it back. Fortunately, the 
Zika symptoms are not severe but there is a great concern for 
emerging evidence to support the association between Zika and 
microcephaly in infants born to mothers who contracted the Zika 
virus during pregnancy.
    I'm also especially concerned with the American citizens in 
Puerto Rico because we now have 117 confirmed cases. It is the 
most affected area in the United States, and the CDC predicts a 
sharp rise. Again, family and friends who travel back and forth 
from Puerto Rico to the U.S. want to know what the impacts are 
and how they can be better prepared, especially as spring and 
summer approach. That's going to bring larger and more active 
mosquito populations. The U.S. must be prepared to quickly 
address local transmission within Puerto Rico, the Gulf Coast, 
and the entire United States.
    I'm also particularly concerned with the weakening of our 
public health infrastructure across the country. After the 
Great Recession, I saw very significant cuts in the State of 
Florida, but Florida is not alone. We have those cuts and 
weakenings to public health departments and public health 
infrastructure. And I think Ebola was something of a wake-up 
call, but the Zika virus and other viruses, diseases, we've got 
to be better prepared. I agree with Chairman Murphy, a much 
more robust prevention strategy would be in our best interest.
    For the Zika virus, addressing the crisis requires a 
multidimensional response, including accelerating the research, 
development, and procurement of vaccines and diagnostics, 
providing emergency assistance to states. Thank you, CDC, for 
what you've done in responding quickly to the State of 
Florida's request, and we've got to enhance our surveillance 
capacity.
    Thank you, again. I look forward to your testimony. I yield 
back.
    Mr. Murphy. Thank you. Now we'll take Mr. Upton's 
testimony, and for the record recognize Dr. Burgess for 5 
minutes.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. Thank you, Chairman, thank you for the 
recognition, thank you for having this hearing this morning, 
thanks to our witnesses. We always learn so much when we have a 
panel like this in front of us, and today I'm sure will be no 
exception.
    This virus continues to spread through the Americas and it 
really has become clear that this is a direct threat to our 
public health and our public safety. So I'm in contact with 
people back in my state, and my county health officials, and 
one of the things that they've expressed to me is concern over 
the flexibility and the scalability of federal aid at the state 
level, so I'm actually interested in hearing from our panel 
about that this morning. Obviously, I share that concern. It is 
important that state and local agencies, as well as the local 
docs on the ground have the ability to fight what they need to 
fight and not have barriers from us at the federal level.
    You know, Ebola happened in our backyard in north Texas, 
and many ways we thought we were prepared, but in some ways we 
turned out not to be prepared. So I guess I'm interested this 
morning; yes, I want the reassurances that we're prepared, but 
I really also want to hear what were the Lessons Learned when 
we went through the Ebola crisis in September and October of 
2014, and what is the applicability of those lessons to what's 
going on on the ground today. A variety of other questions 
concerning the testing and the development of tests for this 
illness. And, obviously, I'm terribly interested, Dr. Fauci, in 
the pathogenesis of the illness as it affects pregnancies, both 
miscarriages and infants who are born affected, and very 
interested in learning the status of the vaccine development.
    Thank you, Mr. Chairman. I will yield back my time.
    Mr. Murphy. Anybody else on our side wish to take any time? 
If not, Mr. Pallone on his way but what we'll do is we will 
begin our testimony, or begin that process. When he comes in, 
we may interrupt after one of you speak.
    Let me introduce the panel, start off with this. We have 
Dr. Nicole Lurie, Assistant Secretary for Preparedness and 
Response with the Department of Health and Human Services; Dr. 
Thomas Frieden, Director of the Centers for Disease Control and 
Prevention; Dr. Anthony Fauci, Director of the National 
Institute of Allergies and Infectious Diseases at NIH; Doctor, 
is it Luciano or Luciana?
    Dr. Borio. Luciana.
    Mr. Murphy. Luciana Borio, Acting Chief Scientist at FDA; 
and Dr. Timothy Persons, Chief Scientist at the U.S. Government 
Accountability Office. Welcome everyone for being here.
    You're aware that the committee is holding an investigative 
hearing and when so doing has the practice of taking testimony 
under oath. Do any of you have any objections to taking 
testimony under oath? Seeing no objections, the Chair then 
advises you that under the rules of the House and the rules of 
the committee you're entitled to be advised by counsel. Do any 
of you desire to be advised by counsel during your testimony 
today?
    Dr. Borio. No.
    Mr. Murphy. No one wants that, so in that case would you 
all please rise, raise your right hand. I'll swear you in.
    [Witnesses sworn.]
    Mr. Murphy. Thank you. You are now all under oath and 
subject to the penalties set forth in Title 18, Section 1001 of 
the United States Code. We'll have you give a 5-minute opening 
statement. Mr. Pallone, do you want to give yours now or do you 
want to wait until we do some of the panel? We can go right to 
your opening statement.
    Mr. Pallone. It's up to you.
    Mr. Murphy. Well, let's make a smooth transition. If you're 
ready, we'll do that now, and then I'll call on Dr. Lurie. We 
just did the swearing in so you're aware of what we did. So Mr. 
Pallone is recognized for 5 minutes.
    Mr. Pallone. Thank you, Mr. Chairman, and the witnesses 
today for joining us to discuss the Zika virus and what the 
federal government is doing to respond to the threat.
    Zika represents a serious threat to global health and 
security and we must address that threat decisively both at 
home and abroad. It's suspected of causing a multitude of 
devastating birth defects, most notably microcephaly, a 
condition which babies are born with severe brain defects. In 
adults, the virus has been associated with Guillain-Barre AE1 
Syndrome which can result in paralysis and even death. Although 
scientists are not able to say definitively that Zika is the 
cause, evidence is mounting each day to support a causal 
relationship between the virus and these serious health 
conditions.
    The Zika virus is spreading explosively through the 
Americas with active local transmission in 31 countries and 
territories. The Pan American Health Organization predicts that 
the virus will eventually spread to every country in the 
Americas except perhaps Canada and Chile.
    The crisis in Puerto Rico could become particularly severe 
as Zika is expected to infect one in five Puerto Ricans, and 
given the territory's debt crisis and inability to fund even 
the most basic health services robust assistance from the 
federal government will be absolutely crucial to contain the 
virus and protect as many pregnant women as possible.
    As spring and summer approaches we must also be prepared to 
address local transmission of Zika within the Continental 
United States, particularly in southern states where the 
mosquitoes that carry the disease are common.
    As Dr. Hotez on our second panel has previously noted, 
``Local transmission of Zika in the U.S. will likely 
disproportionately affect poor neighborhoods in the southern 
states where inadequate window screening, standing water, and 
imperfect waste disposal provide ideal mosquito breeding 
grounds, and addressing Zika will require a multidimensional 
public health response. It must include accelerating research, 
development, and procurement of vaccines and diagnostics, 
providing emergency assistance to states and the U.S. 
territories, and enhancing our surveillance capacity to track 
the Zika virus in people and in mosquitoes.''
    The Administration has requested emergency funding to 
address each of these components, and I look forward to hearing 
more about the details of this request today. Unfortunately, 
the Republican chairs of the House Appropriations Committee 
have declined to fund the Administration's request and have, 
instead, called upon the agencies to divert unobligated Ebola 
funds. I believe this decision is shortsighted and would 
increase health risks both at home and abroad.
    As our witnesses will make clear today, Ebola remains and 
will continue to remain a threat to human health for the 
foreseeable future. It could reemerge at any point, and as 
we've seen it can cause outbreaks that decimate economies, 
trigger widespread panic, and result in a tragic loss of human 
life.
    NIH is using its Ebola funds to conduct essential ongoing 
research including the development of an Ebola vaccine, and CDC 
is continuing to conduct its global efforts to combat the Ebola 
Virus on the ground. Shortchanging these efforts would damage 
our ability to effectively respond to both Zika and Ebola, as 
well as to any future threats. The remaining Ebola funds are 
largely committed to the global health security agenda, a 
multi-year effort to keep Americans safe by strengthening the 
capacity of developing countries to prevent, detect, and 
respond to emerging epidemics.
    Let's not forget how Ebola managed to spiral out of 
control. To build an effective global system for containing 
infectious disease we must make sure that the poorest and most 
vulnerable countries have the surveillance capacity to identify 
outbreaks and respond quickly, and fighting Zika will not be 
easy. Like Ebola, it thrives in impoverished communities and 
its heaviest burden falls on vulnerable populations least able 
to respond. The disease is difficult to track as most people 
infected with Zika experience no symptoms, and the research 
agenda is extensive given how little we know about the disease. 
But I'm confident that our federal agencies are up to the task 
as long as Congress does its part and provides the necessary 
resources. And I hope that all my colleagues on both sides of 
the aisle recognize the importance of these investments and 
that we'll be able to work together in a bipartisan manner to 
address the Zika threat in the coming weeks.
    Thank you, Mr. Chairman. I yield back.
    Mr. Murphy. Thank you. Now we'll go and proceed with the 
testimony. We'll start with you, Dr. Lurie. You know how this 
works; watch your lights and try and keep it at 5 minutes.
    Thank you very much. You may proceed.

   STATEMENT OF NICOLE LURIE, M.D., ASSISTANT SECRETARY FOR 
PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN 
 SERVICES; THOMAS FRIEDEN, M.D., DIRECTOR, CENTERS FOR DISEASE 
CONTROL AND PREVENTION; ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL 
    INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL 
     INSTITUTES OF HEALTH; LUCIANA BORIO, M.D., ASSISTANT 
   COMMISSIONER, COUNTERTERRORISM POLICY, U.S. FOOD AND DRUG 
 ADMINISTRATION; TIMOTHY PERSONS, Ph.D., CHIEF SCIENTIST, U.S. 
                GOVERNMENT ACCOUNTABILITY OFFICE

                   STATEMENT OF NICOLE LURIE

    Dr. Lurie. Thanks. Good morning, Chairman Murphy, Ms. 
Castor, and distinguished members of the subcommittee. I'm Dr. 
Nicole Lurie, the Assistant Secretary for Preparedness and 
Response, and thank you for the opportunity to talk to you 
today about yet another emerging threat, the Zika virus.
    While we don't yet know everything we need to know about 
Zika, as a primary care physician and as a mom, I know how 
deeply concerning what we're all learning is. As you know, ASPR 
was established almost a decade ago by the Pandemic and All 
Hazards Preparedness Act in part to overhaul the government's 
approach to emergencies that threatens the public's health, 
whether naturally occurring or manmade. Since that time and 
with the support of Congress including many of you, ASPR has 
done just that, developing a flexible set of capabilities to 
quickly adapt to challenging threats, including Ebola, MURS, 
and now Zika virus.
    Since early reports of the potential link between Zika 
virus and microcephaly, HHS has taken proactive and as 
scientific evidence has mounted increasingly targeted actions 
to protect the American people. Today I'll highlight three 
areas in which ASPR's work is critical.
    First, our central role is to coordinate across HHS and 
beyond ensuring that all components have the latest information 
and best scientific evidence to inform key decision making, and 
that all are driving toward the same goals.
    Second, ASPR has a mandate to develop the most promising 
medical countermeasures through the Biomedical Advanced 
Research and Development Authority or BARDA. I know this 
committee is aware of how successful BARDA has been producing 
22 licensed products and support nearly 200 countermeasure 
candidates over the years.
    Third, ASPR is clearing longstanding obstacles to progress 
in this area, such as agreements on virus sample sharing and 
close collaboration with regional and international partners. 
You should know that well before the first case of Zika in the 
U.S. in early January, I convened the HHS Disaster Leadership 
Group to coordinate our preparedness efforts. This group is 
made up of leaders from across HHS including CDC, NIH, and FDA, 
and it ensures that the department's senior leaders have shared 
awareness and the ability to make timely, informed, and 
coordinated decisions during emergencies. We've convened this 
group for every emergency and it will continue to meet 
throughout this crisis.
    Similarly, on December 2nd of last year I directed the 
Public Health and Medical Countermeasure Enterprise or PHEMCE 
to conduct a comprehensive review of its portfolio to identify 
candidate products with the potential to stop transmission of 
Zika.
    This committee is well aware that the best ideas for 
medical countermeasures won't translate into the drugs, 
vaccines, diagnostics we need without investment. The BARDA 
component of ASPR is tasked with transitioning promising 
medical countermeasures through advanced development and across 
the so called valley of death toward FDA approval. In the case 
of Zika we've established three countermeasure priorities, 
vaccines, diagnostics that can detect both acute and previous 
infections, and insuring a blood supply that's safe by 
developing blood screening tests for Zika, and techniques for 
virus inactivation in blood.
    Because access to virus samples is critical for developing 
diagnostics and vaccines, we've worked across government to 
successfully establish sample sharing and vaccine development 
agreements, including with Panama and Brazil, respectively. 
We've also established a mechanism to address international 
requests for assistance because we recognize that health 
security knows no borders.
    While we move forward aggressively to prepare for the 
threat of Zika, many of our efforts will depend on new 
resources. The Emergency Supplemental Request includes funds 
for CDC, which is responsible for the bulk of the public health 
response, for medical countermeasure development, and for 
contingencies that may arise over the course of the response.
    For countermeasures we've been successful in moving from a 
reactive model of preparedness to a proactive one, building on 
strong day to day systems and a flexible set of capabilities to 
do this. The same goes for state and local health departments 
which is why preparedness for all hazards is so important.
    A lesson from both H1N1 and Ebola was the need for flexible 
funding to insure that we can move quickly as other departments 
can so that something that starts as a crisis does not become a 
full-blown emergency. The contingency fund included in the 
President's supplemental request addresses this overarching 
need; enabling us, if needed, to make emergency procurements or 
quickly take other actions that become necessary but that we 
cannot currently anticipate.
    In sum, HHS has mounted a proactive and coordinated 
response to the Zika virus, building on Lessons Learned from 
previous challenges, and the domestic preparedness 
infrastructure we've worked so hard to establish. Congressional 
approval of the Administration's funding request will provide 
critical resources to improve our ability to prevent, detect, 
respond, and rapidly adjust to Zika and other emerging vector-
borne infectious diseases.
    Thank you again for inviting me here. I look forward to 
your questions.
    [The statement of Dr. Lurie follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Murphy. Thank you, Dr. Lurie.
    Now, Dr. Frieden, you're recognized for 5 minutes.

                    STATEMENT OF TOM FRIEDEN

    Dr. Frieden. Thank you very much, Chairman Murphy, 
Representative Castor, and members of the subcommittee.
    At the outset, I want to make a few key points. First, 
we're literally still discovering new things every day about 
Zika. CDC has about 600 staff currently working on this 
response. We're activated at Level 1, the highest level of our 
emergency operations center. We have staff in Brazil, Colombia, 
Puerto Rico, and other parts of the world looking at and 
learning from a developing situation.
    Zika is new, and new diseases can be scary particularly 
when they affect the most vulnerable among us. And it's also 
particularly scary because in Puerto Rico today cases are 
doubling every week. By April we're likely to see widespread 
transmission in Puerto Rico, and by June, mosquito season is 
likely to start in parts of the U.S. where the mosquito that 
can spread Zika is present. There's a limited window of 
opportunity to take action. When we look at chikungunya which 
affected Puerto Rico, started in 2014, within 2 months it was 
all over the island, within 8 months one out of four adults 
were infected. If that pattern is followed with Zika we could 
see hundreds of thousands of infections by the end of the year.
    CDC is working 24/7 to respond to this, learning more about 
the link with microcephaly, Guillain-Barre AE1 Syndrome, 
improving diagnostics, looking at ways to optimize vector 
control with current tools. This is the latest in a series of 
unpredicted and unpredictable health threats. What is 
predictable is that there will be more health threats, and 
that's why it's so important that we continue to improve the 
ability of countries around the world to find, stop, and 
prevent health threats.
    Now, first, what do we know about Zika? You've outlined, 
Mr. Chairman, other members some of the key facts here. It's 
been around since 1947. We didn't know it could cause outbreaks 
until 2007. It was thought to cause mostly mild disease. It 
spread primarily by the Aedes aegypti mosquito. This is the 
cockroach of mosquitoes. It lives indoors, it lives in the 
shade, it is hard to kill, and it's very effective at spreading 
diseases. That's why Dengue and Chikungunya and other diseases 
spread by it can spread so explosively.
    What is really new and unprecedented is the link to 
microcephaly. It's been more than 50 years since a pathogen 
causing microcephaly or other severe birth defects was 
identified that would do so on such a broad level. And as far 
as we know, never before has there been a mosquito-borne cause 
of a severe fetal malformation.
    The link to Guillain-Barre AE1 Syndrome looks increasingly 
certain. Studies published this week, if replicated would 
basically prove that link, and it wouldn't be surprising. We've 
seen Guillain-Barre AE1 Syndrome after a wide variety of 
infections. But microcephaly, the complication of microcephaly 
is truly unanticipated, potentially catastrophic, and 
permanent, the very definition of the need for an emergency 
supplemental response.
    Fundamentally, there are four different patterns of spread. 
First, among travelers, some of them pregnant. And we have 40 
million people going to and from Zika-affected areas each year. 
Second, sexual partners. This is why we issued guidance to 
reduce the risk of sexual transmission. Third, possible cases 
and clusters in parts of the U.S. that have the mosquito 
vectors present. That's why we need to scale up our support for 
those entities. Fourth, areas likely to have widespread 
transmission around the world, and especially in parts of the 
U.S., including Puerto Rico, that have had large outbreaks of 
Dengue.
    The supplemental is critically important for CDC to respond 
as part of a whole of government response. The request of CDC 
is for $828 million in three categories: urgent support for 
Puerto Rico, a response in the Continental U.S., and 
international support, as well.
    There are many very concerning diseases out there whether 
it's Ebola, SARS, MURS, or the next HIV. We can't let down our 
guard. Supplemental funding is essential for us to do several 
things, including reducing the risk to pregnant women by 
finding out more and doing more especially in Puerto Rico and 
other areas where it may spread widely, by finding where 
mosquitoes are spreading in the U.S., and better controlling 
them, by establishing a registry for birth defects and 
improving the monitoring of pregnant women, by supporting 
states and territories directly to improve prevention and 
management of cases, diagnosis of patients, increased 
laboratory capacity, and implement key interventions. This is a 
critically important and urgent need, and I look forward to 
answering your questions. And thank you for the invitation to 
appear before you today.
    [The statement of Dr. Frieden follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Murphy. Thank you, Dr. Frieden.
    Dr. Fauci, you're recognized for five minutes.

                   STATEMENT OF ANTHONY FAUCI

    Dr. Fauci. Mr. Chairman, Ms. Castor, members of the 
committee, first I want to thank you for giving me the 
opportunity to discuss with you today the role of the National 
Institute of Allergy and Infectious Diseases and the NIH in 
general in the research endeavor to address this. As you know, 
the NIH is part of a multi-component aspect of the Department 
of Health and Human Services, and we're responsible primarily 
for the research for the development of countermeasures.
    As I have told this committee in past hearings, the dual 
mandate of the Institute is somewhat unique among NIH 
institutes because although we, like others, have the 
responsibility of developing a robust basic and clinical 
protocol and agenda in all of the areas for which we're 
responsible, for us it happens to be infectious diseases, 
microbiology, and immunology. However, we also have the unique 
dual mandate of being able to respond very rapidly to emerging 
threats. And as a matter of fact, that's exactly what we're 
doing right now.
    I had the opportunity and the privilege to write this 
perspective in the New England Journal of Medicine in January 
in which I said exactly what Mr. Chairman said in his opening 
statements, that this is yet again another threat, another 
arbovirus threat. If you historically over the last couple of 
decades we had West Nile, we have chikungunya, we have dengue, 
and now we have Zika. And as Tom said just a few moments ago, 
we're going to have others, so it's very important for us to 
have as part of the overall effort a research component to be 
able to develop the response. And as shown on this slide it's 
multifaceted. We do everything from basic research to 
fundamental clinical research and clinical trials. We do 
provide, not very well appreciated, the research resources for 
pharmaceutical companies, as well as for academics who want to 
get into the field of studying this disease, and we're already 
negotiating with a number of them.
    The bottom line of it all, and the end game is to develop 
diagnostics, therapeutics, and vaccines. I just want to spend a 
minute or so going through some of the things that we are now 
addressing.
    First, natural history. We were discussing just a couple of 
moments ago, it's very important to understand the true natural 
history, not only of the disease, symptomatic versus 
asymptomatic. Can an asymptomatic person who's infected and 
pregnant actually have a baby who is a microcephalic baby, or a 
baby that has a congenital defect? We need to study that. we 
also need to have cohort studies to understand how this has 
evolved. What we call pathogenesis of disease is trying to 
understand how this disease evolves. We did this with Ebola, we 
did this with HIV, and we're planning to do that with Zika.
    Another is the fundamental basic research. We know an awful 
lot about viruses like HIV, like chikungunya, like dengue. We 
need to know a lot more about Zika. Luckily, it's related to 
some of those diseases.
    Also, the immune response. We don't understand a lot about 
the immune response. The immune response is generally helpful. 
We know with dengue that immune response can actually enhance 
disease. We need to know the protection against Zika, and 
whether or not there are any deleterious effects. And also, we 
need to establish animal models.
    You mentioned vector control. We do have basic research 
collaborations with pharmaceutical companies and individual 
investigators looking at novel ways to have vector control. 
You've heard of several of these such as Wolbachia infection of 
mosquitoes or genetic modification of mosquitoes.
    Also in diagnostics, the CDC has taken the role in 
developing and now distributing widely some of the diagnostics 
that are available, but we still need high specific, easy to 
perform diagnostics that can tell an important question. To 
tell if someone is infected is relatively easy. We do a PCR, 
it's highly specific. The question that is really on everyone's 
mind is, have I been infected and if so, how long ago? And that 
is something that needs specificity because the current 
available antibody tests tend to cross-react with diseases that 
are prevalent in these societies, particularly dengue.
    Now the issue that we're really concentrating much of our 
effort on is the issue of vaccines, and we now do have a couple 
of candidates that we're looking at putting into a Phase 1 
trial, hopefully by the end of this summer and early fall, 
which will take a couple of months to determine if, in fact, 
they're safe and do they induce an immune response that will 
allow us to go to the next phase of the response, which is an 
efficacy phase. And we have a number of candidates that I'll be 
happy to talk to the group about during the question period.
    One I want to bring up in particular, and that is why we 
have what we call vaccine platforms, things that we have 
experience with. An example is, we developed a vaccine for West 
Nile virus several years ago. It was safe, and it induced a 
good immune response. Unfortunately, there was no company that 
was particularly interested in partnering with us. I don't 
think we're going to have that problem now because we have a 
number of companies that are interested. But what we've done is 
we've taken that DNA platform and done a very simple thing; 
we've pulled out the gene of West Nile and we stuck in the gene 
of Zika, and we're going to be starting a Phase 1 trial, as I 
mentioned, hopefully. And then finally, we have our screening 
assays for the development of therapeutics we're going to be 
looking at because, obviously, therapeutics are a very 
important part.
    So I'll close with this last slide, reiterating what Dr. 
Frieden, and Dr. Lurie, and I said, that these threats will 
continue to confront us. And I want to thank the committee for 
your interest and support of us during these periods. Thank 
you.
    [The statement of Dr. Fauci follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Murphy. Thank you, Dr. Fauci.
    Dr. Borio, you're recognized for 5 minutes.

                   STATEMENT OF LUCIANA BORIO

    Dr. Borio. Good morning, Chairman Murphy, Representative 
Castor, and members of the subcommittee. Thank you for the 
opportunity to discuss the FDA's actions to respond to the Zika 
virus outbreak.
    FDA is working closely with our partners to help minimize 
the impact of yet another tragic outbreak. Last month I had the 
privilege of traveling to Brazil, my country of birth, with a 
small HHS delegation to meet with the Brazilian Minister of 
Health and several of his senior officials. The engagement was 
extremely productive. In particular, FDA and ANVISA, 
Brazilian's National Regulatory Agency, committed to working 
very closely and reach convergence in the areas of vaccine 
development and diagnostic tests.
    FDA is working to help protect the safety of our nation's 
blood supply, to facilitate the development and availability of 
blood donor screening and clinical diagnostic tests, to support 
the development and investigation of vaccines and therapies, to 
review a proposal for the use of innovative strategy involving 
genetically engineered mosquitoes to enhance vector control, 
and to protect the public from fraudulent products. To help 
mitigate the risk of Zika transmission from blood transfusions, 
FDA issued guidance recommending important measures to keep our 
nation's blood supply safe. And just yesterday, FDA issued new 
guidance with recommendations to reduce a risk of transmission 
of Zika by human cellular and tissue-based products are used in 
medical procedures.
    I'm happy to report that last week we issued the first 
emergency use authorization for a test developed by the CDC. We 
continue to work very interactively with the CDC and several 
diagnostic companies, several diagnostic companies to support 
development of additional tests.
    The association between Zika, microcephaly, and other pro-
pregnancy outcomes results in a very serious and challenging 
situation for pregnant women who test positive for Zika virus 
infection. Just last week, CDC reported that among nine 
pregnant travelers with laboratory confirmed Zika virus 
infection there were two early pregnancy losses, two elective 
terminations, and one infant with severe microcephaly at birth. 
It is not difficult to imagine the fear, uncertainty, and 
anguish these women and their families likely experienced; 
therefore, it is essential that diagnostic tests for Zika virus 
provide accurate results.
    In recent weeks we have seen an increased interest by 
clinical laboratories to develop their own tests for Zika. We 
share the goal of expanding the availability of good tests, and 
to support these efforts FDA developed simple templates that 
developers can use to submit data to the FDA for expedited 
review, but FDA is urging developers to work with us to insure 
that their tests meet the standards for accuracy and precision. 
And I need to make clear that FDA will not hesitate to take 
appropriate action to prevent the use of tests that did not 
meet our standards.
    FDA is actively engaged with NIH and BARDA to help 
accelerate the development of vaccines, and as we did during 
the Ebola epidemic we will do all we can to facilitate access 
to investigation of vaccines through appropriate clinical 
trials as quickly and safely as possible.
    Finally, we are reviewing a proposal for a field trial to 
determine whether the release of a genetically engineered line 
of Aedes aegypti mosquitoes will suppress the local Aedes 
aegypti mosquito population in the release area of Key Haven, 
Florida. We are preparing to very soon release for public 
comment a Draft Environmental Assessment regarding the 
potential impacts of this proposed field trial.
    In closing, FDA is deeply engaged and fully committed to 
sustaining our aggressive response activities to mitigate the 
impact of Zika. Thank you.
    [The statement of Dr. Borio follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Murphy. Thank you, Dr. Borio.
    Now, Dr. Persons is recognized for 5 minutes.

                  STATEMENT OF TIMOTHY PERSONS

    Mr. Persons. Thank you, Mr. Chairman, Ms. Castor, and 
members of the subcommittee. I'm pleased to be here today to 
discuss GAO's preliminary observations on Zika virus disease. 
I'll summarize our findings of the four topics you asked us to 
examine; specifically, one, the epidemiology and transmission 
of Zika including what's known about its link to microcephaly 
and neurological diseases. Two, the current diagnostic and 
testing methods for Zika. Three, the methods for mosquito 
control. And, four, the proposed federal research agenda as it 
relates to Zika virus and disease.
    With regard to epidemiology and transmission, while several 
countries noted over here on this graphic have reported 
outbreaks of Zika virus disease, unanswered questions remain 
regarding the epidemiology and transmission of the disease. 
Accurate information on the incidents of Zika is lacking. Five 
primary reasons for this are first, about 80 percent of persons 
who are infected do not show clinical symptoms resulting in 
potentially significant underestimation of the true incidence 
of infection. Second, since many of the remaining 20 percent of 
those who manifest clinical symptoms may not go to a physician 
because the symptoms are mild, the true incidence of disease is 
potentially significantly under-reported. Third, an accurate 
count of the number of cases of Zika virus disease requires a 
consistent standardized international case definition; however, 
at the moment different countries have different definitions, 
thus complicating epidemiological analysis and research. 
Fourth, on February 1st of this year the World Health 
Organization acknowledged that there was no international 
standard surveillance case definition for microcephaly. 
Problems with changing case definitions, lack of sufficient 
information on underlying causes of brain pathology, and lack 
of baseline data make it difficult to accurately determine the 
increase of microcephaly in Brazil, and how much stems from the 
Zika virus. And fifth, the lack of approved diagnostic tests 
complicates our understanding of the virus and may hinder our 
response to the current outbreak.
    With regard to detection and testing, currently no 
commercially available test exists for Zika, as the Chairman 
pointed out. The FDA recently issued an emergency use 
authorization for an antibody-based test for the Zika virus; 
however, the main limitation is the inability to differentiate 
between infection with Zika and infection with other closely 
related flaviviruses such as dengue. Since closely related 
flaviviruses such as dengue may also be present in regions 
where Zika has broken out, the use of this test could 
incorrectly identify non-Zika virus associated infections, thus 
risking extra burden on laboratory and health care systems, and 
distorting epidemiological analyses.
    With regard to mosquito control, because Zika virus disease 
cannot yet be prevented by drugs or vaccines, controlling the 
vector remains a critical factor in mitigating the spread of 
the virus, and hence disease. GAO identified three categories 
of mosquito control. First, standing water treatment. Second, 
insecticides. And third, emerging technologies.
    The WHO determined that maintaining vector control after a 
disease subsides is complicated by dwindling resources. In the 
United States, vector control methods are under state and local 
jurisdictions which determine the method to use by local needs 
and factors. Emerging control technologies include the use of 
biologicals, genetically modified mosquitoes, and auto 
dissemination traps. According to the scientific literature 
these technologies show some promise in studies and field 
trials but would need to be part of an overarching integrated 
mosquito control strategy.
    With regard to the federal research agenda, the NIH and CDC 
have identified several high priority areas for research; for 
example, linkages between Zika and microcephaly, improving 
diagnostic tests and vaccine development. Efforts in these 
areas are necessarily ambitious but agencies may face 
challenges in implementing this agenda. For example, given the 
number of known cases in the U.S. is so few, NIH and CDC may 
have to rely on the cooperation of other countries to account 
for a sufficient number of cases to carry on the proposed 
research. However, data from other countries may differ because 
of differing definitions of Zika virus disease and 
microcephaly.
    Turning to vaccine development, NIH officials told us that 
given their experience with the development of a vaccine for 
dengue fever, a vaccine for Zika could be ready in 3 to 4 
years. Zika virus disease poses new challenge to vaccine 
development testing especially on pregnant women for whom 
several barriers to developing and testing vaccines exist. 
Overcoming these barriers may extend the time for vaccine 
testing and approval, and the information we have from NIH in 
our prior work suggests that developing a Zika virus vaccine 
may take longer than currently anticipated.
    In conclusion, GAO's past work including, for example, our 
recent analysis on Swine Enteric Coronavirus Disease outbreaks 
in pigs has shown some similarities such as a lack of validated 
diagnostic tests, immature mechanisms for reporting the disease 
and no approved vaccine. These preliminary observations on the 
Zika virus point to a persistent and urgent need for a 
proactive, agile, integrated, and coordinated set of programs 
in research and development including epidemiological studies, 
mosquito control, testing capabilities, modeling and 
simulation, and vaccine development, especially in light of 
other emerging diseases such as chikungunya and dengue which 
spread via the same mosquito vectors as Zika, and which also 
pose a risk to human health.
    Mr. Chairman, Ms. Castor, members of the subcommittee, this 
concludes my prepared remarks. I'd be happy to respond to any 
questions that you or other members may have at this time. 
Thank you.
    [Mr. Person's written statement has been retained in 
committee files and can be found at: http://docs.house.gov/
meetings/if/if02/20160302/104594/hhrg-114-if02-wstate-personst-
20160302.pdf.]
    Mr. Murphy. Thank you. I thank all the panel for your 
information. Now we'll begin questioning. I'll begin with 5 
minutes myself.
    Dr. Lurie, under the Pandemics and All Hazards Preparedness 
Act and its reauthorization, the Assistant Secretary for 
Preparedness response was create a lead federal official for 
coordinating these health emergencies. My understanding, 
Secretary Burwell designated you as Lead Federal Official for 
coordinating the response with Flint and Ebola. Am I correct?
    [No response.]
    Mr. Murphy. Has she named you the Lead Federal Official for 
the Zika response?
    Dr. Lurie. So in terms of the Zika response, ASPR's role as 
it usually is, is to coordinate for her and on her behalf 
policy issues and other issues related to the Zika response. 
ASPR is very actively fulfilling that role, as you heard in my 
testimony. As part of that role, the CDC has primary 
responsibility for the operational public health response, and 
Dr. Frieden has the lead for that.
    Mr. Murphy. So is that how it's going to break down, the 
Lead Federal Official will be Dr. Frieden, and not you, or do 
we----
    Dr. Lurie. ASPR has coordinating responsibility on behalf 
of the Secretary for this. The primary response is an 
operational public health response and that's what CDC does day 
in and day out.
    Mr. Murphy. We just want to make sure we have some sense of 
how this is working out.
    Dr. Lurie. Yes, absolutely.
    Mr. Murphy. Dr. Persons, what are the concerns associated 
with the assay recently authorized by the FDA for emergency 
use?
    Mr. Persons. Yes, thanks, Mr. Chairman. The test is called 
the MAC-ELISA test. Its main concern is just its cross-
reactivity with other flaviviruses, as other witnesses have 
pointed out. So you can tell that you have a related flavivirus 
but you cannot have the specificity to say you have Zika with 
assurance, unless or until you have the RT PCR basis to back 
you up and do that.
    Mr. Murphy. But is all this going to put an extra burden on 
the labs and health care systems, and will that distort some of 
our analysis then if we can't fully do that?
    Mr. Persons. That is, indeed, a risk to the system.
    Mr. Murphy. Dr. Frieden, do you want to comment on that, 
too?
    Dr. Frieden. Just to clarify, the IGM that was FBUA 
approved by FDA in wonderful excellent time with good 
collaboration, that test we believe is accurate, particularly 
in people less likely to have been exposed to dengue. There is 
a second test that we do which is a neutralization assay, a 
PRNT on the IGM positive, so we would in some cases, depending 
on the combination of the IGM and the PRNT be able to say we 
believe it is definitively Zika. In other cases we can say only 
that it's a flavivirus that may or may not----
    Mr. Murphy. So we can get a false positive if they've been 
exposed to dengue. Is that what happens, Dr. Borio?
    Dr. Borio. Well, just for clarity, is that the emergency 
authorization is not just for the ELISA test, the one that 
causes the cross-activity. The authorization is for the ELISA 
test and a confirmatory test done at CDC. We will have very 
high standards for the UA.
    Mr. Murphy. I'm aware of that, and you had elaborated this 
point, too. I just want to find out if we have enough capacity 
in our public health labs and health care system to handle what 
the GAO is concerned about with this emergency response. If we 
don't, we need to know that as Congress.
    Dr. Frieden. So we are concerned about the capacity in 
terms of the number of tests. Our laboratories have been 
working around the clock for the PCR. We've produced more than 
370,000 of them. We think that's ample for the MAC-ELISA. We're 
up around 100,000 level. It could be that in some places, in 
some areas individuals who want to be tested will not be able 
to be tested until we further scale up production and roll out 
validation of the state labs.
    Mr. Murphy. Let me make sure I understand this. So if we're 
also currently trying to develop a vaccine and some people who 
have been exposed to Zika virus will be immune to it. And is 
that the avenue? I guess, Dr. Fauci, this is your area. Is that 
the avenue by which will help us determine a vaccine, if some 
people have developed their own immunity? Does that give us 
some other ideas of where to go with this? Am I down the right 
road there?
    Dr. Fauci. Yes. I think in a vaccine trial it depends on 
what stage of the trial. When you're in a Phase 1 trial those 
are people who are completely normal. That's the thing I was 
mentioning that would start at the end of the summer. When you 
get into a trial in the field in Brazil, obviously you're going 
to want to know people who were pre-exposed, as well as people 
who were not exposed as a subgroup of the study. The 
fundamental study will be to determine the extended safety and 
some degree of efficacy in a Phase 2A2B. As a subset of that 
group, you'd want to know what the response would be in those 
who were previously exposed, perhaps asymptomatically, versus 
those who were never exposed.
    Mr. Murphy. And so where we are now, we don't have the 
capacity and you're asking Congress for help because we just 
don't have the capacity to handle this. Right, Dr. Frieden?
    Dr. Frieden. There are many things that we will not be able 
to do or do at scale without the emergency supplemental.
    Mr. Murphy. And this will delay our responsiveness and 
detection in developing a vaccine until we get this level 
higher? We all agree with that?
    Dr. Fauci. Agreed.
    Mr. Murphy. Thank you. Ms. Castor, recognize you for 5 
minutes.
    Ms. Castor. Thank you. The Zika outbreak began in Brazil 
nearly a year ago, and it's rapidly spread across the Americas. 
I'm very concerned by the virus' recent arrival in Puerto Rico 
and its rapid spread there. News reports earlier this week said 
there are well over 100 confirmed cases of Zika in Puerto Rico, 
and that the number is almost sure to rise over the next few 
weeks.
    Dr. Frieden, can you give us an update on the situation in 
Puerto Rico? What should we expect to see there in the coming 
weeks? And then could you go into greater detail on the current 
diagnostic tools in Puerto Rico, and whether or not they differ 
in Brazil and across the Americas?
    Dr. Frieden. Thank you very much. In Puerto Rico we have 
basically the 1-2 punch of Zika and similar viruses. We have 
the mosquito that can spread the virus, and we have a human 
environment without screens and air conditioning widely 
available that lead to explosive spread of viruses spread by 
this mosquito. So as I mentioned earlier, we have chikungunya 
which spreads by the same mosquito. One out of four adults 
became infected with it within 8 months of the introduction of 
that virus to the island.
    In terms of the diagnostic tests, the tests are the same 
but they perform differently in different places depending on 
what the individuals there have been exposed to. So first off, 
as Dr. Fauci mentioned, the test for active infection, that's 
straightforward and accurate, so if someone is sick, they have 
fever, then between the onset of symptoms or maybe a day or two 
before until about four to seven days after symptom onset, that 
test will be positive and it's definitive. But past that period 
it's much more challenging to determine whether someone was 
previously infected with Zika. That requires looking at 
antibodies, and the EUA that the FDA approved on Friday allows 
us to do that in a way that looks at the IGM or short-term 
antibody response which may become positive within the first 
week, and stay positive for some as yet undetermined period of 
time, it could be months. And then to confirm that with a test 
that actually grows the virus and sees if it is inhibited by 
the patient's own serum, the neutralization assay. So it's an 
algorithm-based testing. CDC has a dengue branch in Puerto 
Rico. We currently have all 50 of our people from that branch 
plus another 25 from the rest of CDC on the island now working 
hard on every aspect of the response.
    Ms. Castor. Dr. Fauci, Dr. Borio, do you want to add 
anything on the diagnostics?
    Dr. Fauci. No, but we will do better. As Dr. Frieden said, 
this is what we have right now, but we are all of us trying 
very hard to develop a much more specific test that would 
answer the question directly that everyone is concerned with. 
But for what we have now, that's what we're talking about.
    Dr. Lurie. I would only add that we've been really 
approached by a whole array of companies who are now actively 
working to develop their own diagnostic tests. We're in a 
position to provide them support and to work closely in 
collaboration with FDA to make a smooth, easy path if those 
diagnostics are effective.
    Ms. Castor. Thank you. And, Dr. Frieden, Puerto Rico has 
seen recent outbreaks of other related infectious diseases in 
Puerto Rico. What have those outbreaks taught us about Puerto 
Rico's public health infrastructure and its capacity to 
respond?
    Dr. Frieden. Well, I think it's fair to say that mosquito 
control, the capacity is very limited. In addition, the 
challenges of controlling this mosquito are very great so even 
though there have been efforts to reduce spread of dengue and 
chikungunya, they have had very little, if any, impact on the 
actual disease spread.
    Ms. Castor. I understand that the FDA has issued guidance 
on blood donation calling on blood banks in areas where Zika is 
locally transmitted to import blood from regions without an 
outbreak, instead of using local donations. Dr. Borio, what 
does that mean for Puerto Rico? Does it affect their ability to 
provide medical care to their residents?
    Dr. Borio. So FDA's guidance meets an important public 
health need, which is to keep the nation's blood supply safe. 
In areas with active transmission, the guidance does require 
whole blood and blood components to be imported from areas 
without active virus transmission until a diagnostic test that 
can be used to screen the blood supply is available. So there 
is a potential that our guidance could impact in theory the 
supply of blood to areas of active transmission.
    That being said, that should not be the case in Puerto Rico 
because we have been working very closely with our partners, 
Puerto Rico health officials, CDC, and Dr. Lurie's office to 
mitigate the impact of our guidance. And Dr. Lurie may have 
more to add on that.
    Ms. Castor. Well, I note that the President's emergency 
budget request includes $225 million for grants in technical 
assistance for Puerto Rico and other U.S. territories facing 
Zika outbreaks. Is that going to get to the heart of the 
matter?
    Dr. Frieden. That is crucially important for us to be able 
to mount a robust response, and the sooner the better.
    Ms. Castor. Thank you very much. Thank you, Mr. Chairman.
    Mr. Murphy. Yes, just a follow-up. Would you say that 
Florida and Texas are probably some of our highest risk states?
    Dr. Frieden. Yes, we've seen clusters of dengue and 
chikungunya in Florida or Texas, and because of the presence of 
the vector we anticipate that these could be areas where we 
might see clusters of local transmission.
    Mr. Murphy. OK.
    Ms. Castor. In fact, Mr. Chairman, there was recently a map 
published in the national newspaper and it had Florida in 
bright red, so it's definitely gotten everyone's attention, so 
this is very timely. Thank you.
    Mr. Murphy. I will then recognize the doctor from Texas to 
follow up there. Dr. Burgess, you're recognized for 5 minutes.
    Mr. Burgess. Thank you. And again, thanks to our panel for 
being here today, and we always do learn so much when you come 
in to talk with us.
    So, Dr. Frieden, let me just ask you, after talking to my 
folks on the ground back in Denton County yesterday, what 
constraints has the CDC placed on states when it comes to the 
expenditure of preparedness Ebola dollars to combat Zika?
    Dr. Frieden. We have several different funding streams 
available that includes the Public Health Emergency 
Preparedness dollars. Those I believe but would have to 
confirm, we have indicated to states that they can use for the 
Zika response.
    Mr. Burgess. Those dollars should be able to travel freely 
between missions?
    Dr. Frieden. That's the PHEP, the Public Health Emergency 
Preparedness grants. For the Ebola dollars, I would have to get 
back to you.
    Mr. Burgess. And please do, because that is important. And 
we're hearing stuff about funding. I get that. It always come 
up in this subcommittee, and I'm not immune to that. But, Dr. 
Frieden, let me just ask you, the travel restrictions, Tier 2 
travel advisory right now for countries in the Caribbean and 
Central America, and South America. Is that correct?
    Dr. Frieden. Yes.
    Mr. Burgess. What is the reluctance to go to Tier 3 
restrictions?
    Dr. Frieden. There's not really a reluctance. It's a 
question of what's appropriate to the circumstances. We're not 
saying that nobody should go; we're saying that women who are 
pregnant should consider not going. And similarly in other 
situations.
    Mr. Burgess. You're asking us for more money. OK, I get 
that, and you're saying it's an emergency. I might believe you 
more that it's an emergency if you would be willing to say and 
we really don't want you to go down there. The State 
Department, when I talk to them they say oh, we rely entirely 
on the CDC, but they're also not assigning women of 
reproductive age to those outposts. So there's kind of a 
disconnect there.
    Dr. Frieden. What we feel is we need to give people 
information and allow them to make the choices. We've heard of 
situations where someone is going back for a funeral or a very 
important personal event, and so we say you shouldn't go, but 
we also say we understand there are some circumstances in which 
women will go. And in those circumstances we provide the 
information on how they can best protect themselves with 
mosquito repellant and other means.
    Mr. Burgess. Again, it just seems logical that nonessential 
travel really should be circumspect right now.
     Dr. Fauci, let me just ask you a question, because going 
back several years to what was called the Swine Flu outbreak, 
and we talked on several occasions during that. I remember the 
conference call that occurred during March Madness of 2009, and 
I remember talking to you during the August recess about the 
availability for the vaccine was a few weeks away. It wasn't 
quite going to be there for the start of school, but it would 
be a week or two after, so the middle of September. So that's a 
6-month time frame if I'm doing my math correctly that you were 
able to identify the genetic sequence of the virus, reverse 
engineer a vaccine, test it, assure its safety and efficacy, 
and get it to school teachers on the second week of school. 
That's pretty impressive.
    Dr. Fauci. Right.
    Mr. Burgess. And why are we different with this? Is this 
just because it's a different virus?
    Dr. Fauci. Yes. Well, what you have with influenza was a 
strain change and a production to have over 150 million doses 
available over that period of time. What we're talking about 
right now, as I mentioned, and if I may, let me just clarify--
--
    Mr. Burgess. Sure.
    Dr. Fauci [continuing]. What is a feasible time frame 
within the context of there are always vicissitudes when you're 
dealing. So we have this couple of candidates, two or three 
that are likely going to go into a Phase 1 trial in 2016. The 
one I mentioned as a prototype because it seems to be 
temporally ahead of the others, is one that we think by the end 
of the summer we'll have enough, and we have our own pilot 
plant where we're making doses. We're working very closely with 
the FDA colleagues on trying to make sure we get that same 
smooth transition that they helped us with when we went into 
the Phase 1 trial with Ebola. So let's say we start at the end 
of the summer/the beginning of the fall, it's likely it will 
take a few months, similar to the Ebola Phase 1 where you know 
if it's safe and it can induce an immune response.
    In 2017, likely in the first couple of months, if the 
epidemic is still raging in South America, that's very 
important for a vaccine trial.
    Mr. Burgess. Sure.
    Dr. Fauci. Because we're now in a trial, not a 
distribution. We'll likely get an answer of its efficacy very 
quickly. When I say quickly, I say 8 to 10 months, at which 
point then you make a decision, you look at the data and you 
decide what kind of regulatory decision or not you're going to 
make.
    Remember with Ebola, by the time we were ready to go with 
the vaccine the cases due to the CDC and other efforts had gone 
all the way down, and there were very few cases to be able to 
prove efficacy. I don't think we're going to see that because 
nobody anticipates that this outbreak is going to just 
disappear in Brazil.
    Mr. Burgess. Correct.
    Mr. Murphy. Thank you.
    Mr. Burgess. Well, I do appreciate that, and I've got a 
number of questions. And certainly after communicating with my 
folks back home, this is going to be an ongoing evolving 
difficulty, and I really would appreciate the ability to 
interact with all of you as things develop. Thank you, Mr. 
Chairman.
    Mr. Murphy. Thank you. The gentleman's time has expired. 
Recognize Mr. Pallone for 5 minutes.
    Mr. Pallone. Thank you, Mr. Chairman.
    I'm going to talk about the money, too. The President 
submitted the $1.9 billion request for Zika that directs funds 
to areas that the agencies have identified as priorities. But, 
of course, the House Republicans have thus far declined to fund 
the Administration's request; instead, calling upon the 
agencies to divert unobligated Ebola funds to finance the Zika 
response. And I believe this decision is ill-advised, and it 
will force federal agencies to either compromise the critical 
work that they're doing in other areas, or shortchange the 
federal response to Zika and Ebola. So let me ask questions in 
this regard.
    Dr. Frieden, can you explain to us what you plan to do with 
the agency's remaining Ebola funds?
    Dr. Frieden. Ebola is not over. As of today, 84 CDC top 
staff are in West Africa responding to the Ebola outbreak. Last 
month labs in West Africa tested approximately 10,000 samples 
for Ebola. It was only in January that we had the most recent 
Ebola case in Sierra Leone, so we're still actively responding 
and tracking. And as you noted in your remarks, the Ebola 
supplemental funds also directed CDC to work over a 5-year 
period to strengthen the systems around the world that could 
find, stop, and prevent other health threats such as Zika 
before they spread widely so that we can learn more rapidly 
about them and protect Americans more effectively.
    Mr. Pallone. All right. Let me go to Dr. Fauci, same 
questions. What do you expect to do with the Agency's remaining 
Ebola funds, and why is it important that the Agency complete 
this work?
    Dr. Fauci. Well, the NIH was given $238 million from the 
Ebola supplement. We only have less than $10 million left. We 
have about $9 million left, and we have ongoing studies, both 
the survivor study, as well as the next phase of the vaccine 
study, so quite frankly, Mr. Pallone, we don't have any Ebola 
money to switch over. Right now what I'm doing in anticipation 
of hopefully the approval of the supplement, is I'm moving 
money from other areas right now to get a start on the things 
that I just mentioned to Dr. Burgess; namely, the vaccine and 
other components. So we're using money that we have to shift 
around from other places. We don't have any really substantial 
money that's left on Ebola.
    Mr. Pallone. So let me ask both of you, Dr. Frieden or Dr. 
Fauci, if Congress does not move quickly to fund the Zika 
supplemental the way the President has requested, how will the 
agencies meet the demands of fighting the Zika epidemic? How 
will this affect the other work that you do?
    Dr. Frieden. Well, first off we're already drastically 
scaling back the work we're doing on other diseases, such as 
dengue and tick-borne disease because we're devoting those 
staff to the Zika response, even the area of birth defects 
which usually considered to be an area that would respond to an 
emergency. We've been pulling staff to work on this who would 
otherwise be working on a series of other challenges in that 
field.
    And without the supplemental we won't be able to most 
effectively reduce the threat against pregnant women by 
learning more and doing more to protect them. We won't be able 
to rapidly improve our awareness of where the mosquito 
populations are in the U.S., and to control them before 
mosquito season. We won't be able to establish a robust birth 
defects registry to further understand this, or initiate and 
follow-up on critical studies to understand key unknowns, such 
as for babies born to mothers with infection who don't have 
microcephaly, do they have other severe problems? That's going 
to be a many month and many year undertaking that has to be 
started now or we'll lose the opportunity to do it most 
effectively. And we won't be able to support states and 
territories in their ability to rapidly increase their 
effectiveness here to the extent that we would like to.
    Mr. Pallone. Dr. Fauci, do you want to add to that?
    Dr. Fauci. Yes, Mr. Pallone. Ditto what Dr. Frieden said 
about not being able to do several of the things that I showed 
on the slide of our research agenda. But one of the additional 
things that also worries me about not getting the supplement is 
that we are now starting to forge partnerships with the 
pharmaceutical companies that are getting quite interested in, 
and they're linked to BARDA, and we're all working together to 
try and push to develop products.
    If it turns out we don't get the supplement, we will be 
viewed as an unreliable partner, and we don't want that because 
we had that, you might remember, when we were doing the 
biodefense issues years and years ago where we would start 
partnering with the pharmaceutical companies, and when it 
looked like we weren't going to get a particular amount of 
partnership money, they pulled back. And that would be the 
worst thing in the world for us, is to have the pharmaceutical 
companies think we're not a reliable partner.
    Mr. Pallone. Thank you, gentlemen.
    Mr. Murphy. Thank you. Now recognize Mr. Griffith for 5 
minutes.
    Mr. Griffith. Thank you, Mr. Chairman.
    Dr. Borio, as you mentioned in your opening the FDA is 
currently considering an application for a field trial with 
genetically engineered mosquitoes that would take place in the 
Florida Keys. Can you update us on where it stands today with 
your agency, and when you expect the Florida field trial to 
start? And I'm going to leap forward in an attempt to save a 
little bit of time because you know we're limited. Does the FDA 
have sufficient legal authority to expedite the review process 
for this product given the current Zika emergency? And if not, 
what additional authorities are needed?
    Dr. Borio. We do have the authorities, and we are 
expediting the review of this. And like I said, very soon we 
hope to release for public comment the Environmental Assessment 
and associated findings.
    Mr. Griffith. Do you have the ability since there's an 
emergency to truncate or eliminate the public comment before 
you do the field trials, particularly in light of the fact that 
the particular modification of the mosquito has been tested in 
a number of countries in tropical environments?
    Dr. Borio. Mr. Griffith, it's very important for us to go 
through the process and include the period of public comment. 
We need to give the public an opportunity to comment on the 
Environmental Assessment given the significant attention that 
this novel technology has generated, especially in the 
communities for the proposed sites. So it is true that there 
have been many field releases done, especially in Brazil. I 
learned more about them when I was there last week. The data 
seems to be promising in terms of reducing the mosquito 
populations in those small field trials, but we need to go 
through our process. And we are greatly expediting the process.
    Mr. Griffith. In light of the concerns in the Commonwealth 
of Puerto Rico, is it possible to expand, do you have the 
authority to expand and maybe look at a field site not only in 
Florida, but also in Puerto Rico? And since you have not yet 
opened the public comment you're going to go through that 
process, have public comment there, as well?
    Dr. Borio. So if the company and public health authorities 
in Puerto Rico are interested in that, we would be very 
supportive of the process. So the geography might be a little 
bit different from the field trial that is being proposed, so 
the company would have to submit the assessment for that--
anything that may be different for the new field trial. But we 
will look to create efficiencies as much as possible.
    Mr. Griffith. As I understand it, it's been a multiple 
year, I want to say 4 but don't hold me to that, years in 
getting to this point. Would they have to go through that same 
process in Puerto Rico, or is there some way that we could 
shorten that time period up extensively so the tests could be 
going simultaneously?
    Dr. Borio. I understand that's the case, and what I can 
tell you is that this is being greatly expedited now. And I 
believe that where we are today in the process, that it would 
not be a protracted process to be able to rapidly assess the 
request for a field trial elsewhere.
    Mr. Griffith. All right, I do appreciate that.
    Dr. Fauci and Dr. Frieden, you all have been involved 
somewhat in this with the genetically engineered mosquito. How 
is your agency assisting the company that's developed this 
novel technology? It looks like it's trials of 5,000 people, 
lots of mosquitoes. Looks like it's been about 90 percent 
effective in some of the areas it's been tried in.
    Dr. Frieden. We have a number of vector control experts who 
have consulted with the company and others, listened to them as 
well as provided our input. I think one of the challenges is 
the issue of scalability. These particular mosquitoes don't fly 
very far, so you may have to release millions upon millions of 
them every short distance in order to get the knockdown.
    The other thing that's very important to understand is, 
this mosquito is so tricky that even when we've seen very large 
knockdowns in mosquito populations, we haven't necessarily seen 
commensurate reductions in human infections, so it'll be 
important to look at both of those factors.
    Mr. Griffith. And while it could just be other factors. I 
do know in one situation some of the disease that they carry 
was knocked down substantially, but there may have been some 
other factor involved. It's hard to eliminate all the other 
factors, as well. I do appreciate that, as well.
    I do think it's something we ought to look at. It's pretty 
exciting stuff, and it's got to be a whole lot easier to 
release millions of mosquitoes than it is to go door to door 
with pesticides. Did you have something you want to say, 
doctor?
    Dr. Fauci. Yes. Actually, we've been negotiating and 
discussing with Oxytech, the company that involved with that.
    Mr. Griffith. Yes.
    Dr. Fauci. And looking at trying to make sure we correlate 
what Dr. Frieden was saying, the decrease in mosquitoes with 
actually a decrease in disease because it may be that that we 
don't really have that exact correlate. You really want to 
prove that before you start doing a massive thing, because 
scalability is really going to be a major problem. And you 
don't want to scale up unless you know it works.
    Mr. Griffith. And I have a follow-up question for you 
that's off subject, but U.S. Pharmacopeia is looking at allergy 
injections for folks and trying to change some of those rules, 
and they may have some right. But have they consulted with you 
about that?
    Dr. Fauci. Nothing to do with Zika.
    Mr. Griffith. Nothing to do with Zika. But since you're 
involved with the Institute of Allergy and Infectious Diseases, 
I thought I'd ask.
    Dr. Fauci. I'm sorry. I was taken by surprise with that.
    Mr. Griffith. But they have not consulted----
    Dr. Fauci. Not to my knowledge. They may have consulted 
with my staff, but not directly with me.
    Mr. Murphy. If you need to think about that, you can get 
back to him on a time. Thank you. Now recognize Ms. Clarke for 
5 minutes.
    Ms. Clarke. Thank you very much, Mr. Chairman. I thank our 
panelists today. It's good to see you again, Dr. Frieden.
    This question is for Dr. Frieden, Dr. Lurie, and Dr. Fauci. 
Just as a bit of background, it's my understanding that the 
majority of people infected with the Zika virus will remain 
asymptomatic. However, 20 percent of those infected will 
experience symptoms which range from fever to GBS, which can 
leave persons paralyzed.
    Though so far there have been no local transmission of the 
virus in the Continental U.S., does CDC expect to see local 
transmission in the U.S. as the mosquito population increases 
this summer? While the mosquitoes that carry Zika are common in 
southern states, they can range as far north as my home 
district of Brooklyn, New York. Your location, as well as lack 
of access to air conditioning increases one's chance of coming 
in contact with the virus, as was pointed out by Dr. Frieden in 
discussing the situation in Puerto Rico.
    Many of my constituents living in the Brownsville section 
of my district in Brooklyn are very low income, and likewise 
the low income communities of the south has some of the highest 
concentrations of poverty in the United States, and tend to 
lack access to air conditioning. In the south not only do these 
communities lack access to air conditioning, but they also lack 
access to health insurance as many southern governors have 
chosen not to expand Medicaid coverage under the ACA. If they 
do get sick with the Zika virus, having access to care may 
become problematic. The bottom line is that economically 
distressed Americans will likely be the ones most impacted by 
the spread of Zika were that to manifest.
    With that in mind here's my question. What are we going to 
do to assist low income and disadvantaged communities to 
prevent being infected in the first place, as well as spread 
the word of the virus in their communities especially since 
Zika can be sexually transmitted?
    Dr. Frieden. Thank you very much. Our primary concern or 
most urgent concern is places like Puerto Rico which are likely 
to see widespread transmission. In addition, we're advising 
pregnant women and their sexual partners to use condoms if the 
sexual partner has come from an area where there has been Zika 
transmission.
    Furthermore, there are parts of the U.S. that have a 
secondary vector, the albopictus mosquito, the tiger mosquito 
is much more widely distributed, but it appears to be much less 
effective at spreading Zika. So unlike aegypti, which bites 
multiple people, bites only humans, lives indoors, albopictus 
is less of a threat. It appears that it can spread Zika, and 
dengue, and other viruses but much less efficiently than the 
other virus. So our goal with the supplemental funding would be 
to provide resources for states and local communities to both 
reduce the risk of mosquito-borne transmission where that is at 
higher risk, and also to respond to cases so that people who 
come back with Zika minimize their chances of being bitten by a 
mosquito, and thereby initiating a chain of transmission.
    Ms. Clarke. And my hope is that there will be a lot of 
public information, education, particularly as the summer hits, 
especially in a place like New York where you have that 
international mix and blend of individuals.
    Dr. Fauci and Dr. Frieden, the CDC expects to see local 
transmissions of the Zika virus at some point in the 
Continental U.S. Currently, the south has the highest number of 
people living with HIV in the United States, over 40 percent of 
those living in the south are HIV positive. I'd like to know 
how the Zika virus impacts with those living with HIV? Do we 
expect to see some more serious symptoms in HIV positive 
individuals who are infected with Zika? Do we have a sense of 
that yet?
    Dr. Frieden. I'll let Dr. Fauci continue, but I would say 
the primary issue we see at this point is to pregnant women 
regardless of HIV status with the risk of birth defects.
    Dr. Fauci. Yes. If you look at the historical analogies 
with other flaviviruses, we have not seen a serious difference 
at all in an HIV infected versus non-HIV infected person with 
that kind of--however, I'm glad you brought that point up, Ms. 
Clarke, because that's part of natural history studies. When 
you do natural history studies of cohorts you will be able to 
get subgroups of that who are HIV positive or not, and actually 
definitively answer your question, as opposed to saying our 
impression is that there really is not. But just to reiterate 
what Dr. Frieden said, we really focus on the pregnant women. 
That's the real target issue here.
    Ms. Clarke. Very well. Mr. Chairman, I yield back.
    Mr. Murphy. The gentlewoman yields back. Now recognize Mr. 
Hudson for 5 minutes.
    Mr. Hudson. Thank you, Mr. Chairman, and thank you to the 
panel for this very informative discussion.
    It was mentioned that there are clusters of dengue in 
Florida and Texas. It got me thinking, just in terms of folks 
coming across our southern border. There's been a lot of 
discussion about different diseases and other public health 
concerns.
    Dr. Frieden, is this also a concern that folks coming 
across the border could be bringing Zika with them? Is that 
something we're looking at?
    Dr. Frieden. Well, on the one hand we know that Zika and 
other diseases do spread largely because of human migration. 
But, in fact, there are 40 million Americans or 40 million 
people from the U.S. who travel to Zika-affected areas each 
year and then travel back, and so the number on the border 
crossing will be a very minute proportion of that.
    What we have seen is in some communities that are 
essentially across the border, for example, Brownsville and 
Matamoros in Texas, when dengue spread it spread in both parts, 
but it spread eight times more in Matamoros because it was more 
crowded and had less access to air conditioning.
    Mr. Hudson. I understand. Dr. Lurie, what role will 
mosquito or vector control play in our response to Zika?
    Dr. Lurie. Well a we talk about this paradigm of prevent, 
detect, respond, prevention is key, so mosquito vector control 
has got to underpin our efforts for the foreseeable future for 
Zika, and also for other vector-borne diseases.
    Mr. Hudson. Well, there are currently 700 mosquito control 
districts across the United States at the state and local 
level. What role should the federal government play in mosquito 
control?
    Dr. Frieden. One of the areas that we would like to enhance 
and for which we need supplemental funding is to better 
understand the capacity of mosquito control districts, and to 
support improvement of that capacity, and better linkage of the 
mosquito control districts with the health departments and 
environmental departments, whatever is most effective within 
that state or county. They often bridge multiple counties and 
they may not always be well integrated, but in effective vector 
control programs for vector-borne disease you may need an 
integration of the public health staff and the mosquito control 
staff to identify the places or even the houses to target. And 
that's really important, and one of the areas that we want to 
urgently improve.
    Mr. Hudson. When you talk about houses to target are you 
talking about spraying insecticide?
    Dr. Frieden. Yes.
    Mr. Hudson. Is that the effective way to----
    Dr. Frieden. Both insecticide and what's called larvicide 
that kills the developing mosquito.
    Mr. Hudson. OK. Well, because the mosquito that carries 
Zika breeds in small pools of water often indoors near houses, 
aggressive trash cleanup and removal is something that's been 
talked about as one of the most effective ways. Do you envision 
a federal role in terms of trash cleanup and those sort of 
things, or is it more information----
    Dr. Frieden. No. I mean, we really want to support state 
and local entities with technical guidance. We also recognize 
that reduction in breeding sites, cleanups is important, it's 
high profile, but it's very difficult, as you pointed out with 
mosquitoes that can breed in the amount of water of a bottle 
cap. It can be extremely difficult to be effective, so it is a 
component of integrated vector control strategies. We do think 
that is a state and local responsibility, but we have, I 
believe, a responsibility to provide technical guidance, best 
practices, and catalytic funding to try to improve that, 
especially when something as unanticipated and potentially 
devastating as Zika is upon us.
    Mr. Hudson. So the funding request doesn't cover any of 
those type activities. It's more just the coordination and 
information?
    Dr. Frieden. We would have some support for local vector 
control, mostly along the lines of rapidly surging in if 
there's an area that's not able to do it, and for a particular 
cluster by establishing rapid response teams, sharing best 
practices, identifying resources that can be shared among 
jurisdictions.
    At CDC more than 60 percent of our funding or thereabouts 
goes out to state and local entities. We exist to support the 
front lines at the state and local government, but what we do 
at CDC is to develop the tools, the science, the things like 
the test kits for Zika that we then distribute to and support 
local entities to use.
    Mr. Hudson. Makes sense. Is it possible to predict or 
anticipate using surveillance or other means what the next 
emerging infectious disease would be?
    Dr. Frieden. There are many people who would tell you yes. 
My own belief is probably not, because there are so many 
possibilities. Just to give you a sense, I just returned from a 
trip to Africa looking at some of our programs there. I've 
recently spoken with our teams in India. They've identified two 
tick-borne viral hemorrhagic fevers, this is Congo Crimean 
Hemorrhagic Fever and Kyasanur Forest Disease that are much 
more widely distributed than anyone knew before. So whether 
we're going to have now a tick that could bite you and you 
could have a bleeding disease that kills you, I don't know if 
that's going to come next. But no one, I think, would have 
predicted that H1N1 would have come from Mexico, or MURS from 
the Middle East, or Ebola widely distributed in West Africa, or 
Zika causing birth defects.
    Mr. Hudson. Thank you. Mr. Chairman, I'm out of time. I 
yield back.
    Mr. Murphy. Thank you. Now recognize Mr. Tonko for 5 
minutes.
    Mr. Tonko. Thank you, Mr. Chairman. Thank you to our 
witnesses for providing very valuable information.
    I'm encouraged by our government's rapid response to the 
Zika virus, and the assistance we have provided and are 
continuing to provide in the areas most affected by the 
outbreak. This in my opinion underscores one of the most 
important messages we hear every time we have a hearing on 
disease outbreak, and that is that we have to be prepared for 
what we can't predict.
    So with that in mind, Dr. Frieden, how is our response on 
Zika, and our continued response on Ebola preparing us for the 
next emerging threats?
    Dr. Frieden. We use the framework of prevention, detection, 
response. Those are three core areas of what we need to do both 
in this country and around the world. Prevention may be things 
like better vaccines or reduced risk of spread of Ebola and 
other diseases in hospitals. Detection is about laboratory 
networks, as well as disease detectives or epidemiologists, and 
tracking systems so we know how common certain conditions are 
and can quickly detect an increase, whether it's in 
microcephaly or other conditions. And response, the ability to 
have rapid response teams that can be on the ground within 
hours or days and have the tools needed to assess the situation 
and mitigate to the greatest extent science allows.
    Mr. Tonko. Thank you. And how are we assisting our state 
and local health departments in their preparedness, and 
certainly their response efforts? What can we do to coordinate 
the response across all levels of government?
    Dr. Frieden. There are many aspects of the response which 
are critically important to be coordinated. For example, we 
provide diagnostic tests, we work with health care providers, 
we inform of the latest scientific evidence about it. And with 
the supplemental request we would be able to be much more 
robust and involving many parts of state government around the 
U.S., and within states strengthening the hands of state and 
local health departments in their ability to provide services, 
education, information, and interventions to address the spread 
of Zika, and to reduce the risk.
    Dr. Lurie. If I might----
    Mr. Tonko. Sure, Dr. Lurie.
    Dr. Lurie [continuing]. Add that one of the most important 
components of this is being sure that our day-to-day public 
health system is strong so that it can do this detection. If 
you start from a low level each time and we build and then let 
it decay it doesn't really make any sense. Our country has a 
pretty good history of national attention deficit disorder when 
it comes to preparedness and maintaining a strong public health 
infrastructure, and a strong preparedness system is going to be 
key both for this outbreak and for all the questions about how 
we are going to deal with the next outbreak. Those day to day 
systems are critical.
    Mr. Tonko. Thank you. And it seems as though keeping each 
one of those independent bodies strong and functioning then 
provides for a better sense of coordination. And infectious 
diseases that are threats out there need to be addressed in a 
way that addresses individual states and individual nations. No 
one can escape some of those impacts, so I think coordination 
is important. And the key to containing those infectious 
diseases is to contain them at their source, I would think. So 
the coordination here, I agree, is very important.
    Dr. Lurie. Yes. No, thank you for that, and that's the job 
of my office, to do that coordination.
    One of the things that we also do is think about Lessons 
Learned from other outbreaks. And as I said earlier, one of the 
things that has characterized challenges in our response 
whether it was to H1 or to Ebola is that Congress was very 
generous in providing supplemental funds, but we can't move out 
quickly and prevent a crisis before it becomes an emergency 
unless we have some kind of a contingency fund to be able to 
get going at the beginning.
    We've shortened the time dramatically between when Congress 
is able to approve funding and when we can get it out the door, 
but each one of those things still creates a lag. I work with 
FEMA all the time, and you know that when a Presidential 
emergency is declared and the Stafford Act is activated, money 
moves right away. At HHS, we don't have that kind of a response 
fund to respond to public health emergencies, and that's 
something that I think we're very focused on.
    Mr. Tonko. OK. That's good information to have. And 
finally, Dr. Frieden, how does our assistance in Latin American 
countries as they grapple with Zika help keep America safer, 
Americans safer?
    Dr. Frieden. The more quickly we can understand Zika from 
our work in Latin America and the Caribbean the better for 
those countries and the better for Americans. This is where 
it's spreading now, this is where the evidence is. That's why 
we have teams on the ground in Brazil and Colombia, and we're 
working side by side in partnership with those countries and 
others. We disseminated our diagnostic test to countries around 
the world, and we learn together so we're safer together.
    Mr. Tonko. Thank you very much. Mr. Chair, I yield back.
    Mr. Murphy. Thank you. Now recognize Mr. Collins for 5 
minutes.
    Mr. Collins. Thank you, Mr. Chairman. I want to thank the 
panel.
    I've just got a couple of questions. Certainly, in the 
past, whether it was dengue fever or West Nile, the threat was 
there, but nothing like what we potentially have here with Zika 
and the link to the microcephaly. So if a woman is tested and 
she tests positive, I'm trying to--is there a treatment today? 
There isn't, so for a pregnant woman to be diagnosed with Zika 
is a very bad, stunningly bad day for her, her family, and the 
potential of which----
    Dr. Frieden. That's why we've worked very closely with the 
American College of Obstetricians and Gynecologists. We've 
provided detailed guidance in conjunction with ACOG. They've 
sent that out to their members as well, and we provided 
information so that as soon as we know more information we 
provide that to clinicians, as well as women.
    Mr. Collins. So here's a question. We do know, there's been 
some studies done that there's some women that have a history 
of breast cancer in their families, and some women will decide 
to forego the test for fear of what the test will show, 
especially if there may not be a treatment. So if you're a 
pregnant woman and there is no treatment if you test positive, 
there are women who just for their own sanity would opt to not 
be tested.
    Dr. Frieden. We leave that up to the pregnant woman and 
her----
    Mr. Collins. Well, I know, but----
    Dr. Frieden [continuing]. Clinician, but we do find that 
there's a great desire on the part of pregnant women to be 
tested. And it's not that there's nothing that can be done. For 
example, we would want to insure that that infant were 
delivered in a facility that has advanced care capacity to 
provide the intensive support that it might need. Dr. Fauci?
    Dr. Fauci. Actually, just to confirm that what we're 
seeing, the anxiety associated with people who are traveling 
there, there is a great need to know. We're not seeing denial. 
There are people who really want to know as much information as 
we can give them. And as Dr. Frieden said, we leave the 
individual response to that information up to the individual 
and their physician, but they are really very much in desire of 
information, which is what we're trying to get them. This 
relates to the answer to the question about ultimately getting 
a highly specific and sensitive test to tell you if, in fact, 
you were infected.
    Mr. Collins. So to lead to that, now I'm assuming the rapid 
tests that people are looking at are all antibody tests pretty 
much.
    Dr. Fauci. Well, as we said you have to ask are you 
infected now? That's not an antibody test, that's a molecular 
PCR test. The test that people are more in desire of, they go 
and come back and say I know that 80 percent are likely 
asymptomatic, so I don't know if I were infected or not.
    Mr. Collins. What was your----
    Dr. Fauci. They want to know an antibody test. Right?
    Mr. Collins. That's correct. So I'm assuming the industry 
is looking at the rapid tests, are in fact antibody tests. 
They're not going to pick it up pre-antibody but----
    Dr. Fauci. Right.
    Mr. Collins. I'm assuming that's what's being done.
    Dr. Fauci. A lot of activity is trying to develop an 
antibody test that's highly specific for Zika and doesn't 
cross-react with other similar viruses.
    Mr. Collins. All right. So like in HIV where you've got 
some false positives, there's the Western Blot that will look 
for P24 protein or something like that.
    Dr. Fauci. Right.
    Mr. Collins. Is there such a protein in Zika?
    Dr. Fauci. You could actually--in fact, Dr. Frieden will 
just explain it, so why don't you go ahead about the----
    Dr. Frieden. There are several proteins in Zika that are 
specific to Zika. However, they're not that dissimilar from 
similar proteins with dengue and Yellow Fever, so there can be 
cross-reactivity. But we can give as of today a definitive 
diagnostic result to a person with prior infection in some 
circumstances. In other circumstances where there's more cross-
reactivity in the serum it's more difficult.
    Mr. Collins. But I was hearing from GAO or others that some 
of these confirmatory tests, they are not widely available.
    Dr. Frieden. Right.
    Dr. Fauci. What you can do to make it specific is that you 
can actually--and this is what our grantees are working on 
right now, is that if you look at the molecule for dengue, 
which is the most likely bad actor of cross-reactivity, and you 
look at the molecule of Zika, you could mutate out of Zika 
those components that are common between Zika and dengue and 
still have a protein that's left that the only thing it has is 
things that are highly specific to Zika. That's what we're 
working on right now. We don't have that, but that's----
    Mr. Collins. So now one last question in the last few 
seconds. If somebody has antibody, they progress to that state, 
they do a PCR test. Wouldn't the PCR test still identify the--
--
    Dr. Lurie. No.
    Dr. Fauci. No. The virus is gone within days of infection, 
within 7 to 10 days it's gone. So once the virus is cleared you 
could do PCR all you want, you won't get anything.
    Mr. Collins. Interesting. All right. Well, thank you for 
that update, especially on what we ultimately need is--I mean, 
if there's possibly some treatment if someone tests positive. 
Appreciate the information.
    Mr. Murphy. Thank you. The gentleman's time has expired. 
Now recognize Mrs. Brooks of Indiana for 5 minutes.
    Mrs. Brooks. Thank you, Mr. Chairman, and thank you so much 
for holding this important hearing.
    I think what you were just talking about, Dr. Fauci and Dr. 
Lurie, I'm curious about what is BARDA, and HHS, and NIH doing 
to support and facilitate these platform-based technologies 
that you're referring to against the known and emerging 
threats? You've kind of talked about it a little bit, but what 
are you actually doing to support platform technologies? Dr. 
Lurie, you want to start?
    Dr. Lurie. Sure, great question. So, back in 2010 when we 
took a look at the countermeasure industry and decided to 
pivot, we decided to move away from one bug/one drug to these 
platform technologies, so we are actually now engaged with a 
host of vaccine development companies, we have open 
solicitations to work with them. We are providing technical 
assistance on the use of platforms specifically. The same thing 
with diagnostics and tests in that regard. We built these 
Centers for Advanced Development and Manufacturing. One of them 
is in your home state, and they also are positioned to use 
various platform technologies to make vaccines so that when a 
candidate is ready they would be the kind of place that you 
could actually do the scale up, development, the pilot lot 
manufacturing, and potentially even with technology transfer be 
able to, when they're ready, manufacture large volumes of 
vaccines. So Dr. Fauci's group and mine are working extremely 
actively, talk every day to be sure these hand-offs are ready 
and the platforms are ready.
    Mrs. Brooks. Thank you. Dr. Fauci, anything else you want 
to add to that?
    Dr. Fauci. Yes. Actually some examples, just for your 
information. You have the DNA platform which we've worked with 
BARDA on. We have the vector platform, the VSV vector where you 
insert the gene of a particular virus. We did it with Ebola, 
we're doing it right now with Zika. You have nanoparticles, 
ferrite nanoparticles so there are all things that can be 
transferred across all infections, and that's what we mean by a 
platform, something that you could say this is the way we're 
going to go, and we're going to stick in the appropriate 
infection. Once you have those and you have a good solid group 
of platforms you're going to cut down very, very significantly 
the amount of time it takes to go after a particular infection.
    Mrs. Brooks. And is there anything we need to be doing to 
encourage this so it does go faster?
    Dr. Fauci. Yes. I think that we need some money.
    Mrs. Brooks. Let me ask Dr. Lurie about money. Speaking of 
money.
    Dr. Lurie. Yes.
    Mrs. Brooks. I'm confused because the President requested 
just $350 million for the special reserve fund for FY 2017, and 
the language that was included in the President's request would 
expand the allowable use for the SRF. This was a reduction in 
funds, if I'm not mistaken. It was a reduction in funds for the 
SRF, and so how is it that the President can put that in his 
budget, reduce those funds, and yet we're still needing to do 
all of these things we need to do with respect to other threats 
like anthrax or smallpox?
    Dr. Lurie. So there's no question at all that the funding 
is critically important. You know, BARDA gets----
    Mrs. Brooks. But, Dr. Lurie, why did the President request 
a reduced amount of funding?
    Dr. Lurie. Because it provided additional flexibility for 
advanced research and development funds so that we could move 
forward with those platforms. Right now the Special Reserve 
Funds are limited to being able to purchase things that are 
material threats on the material threat determination, and our 
pretty profound need right now is in the advanced research and 
development area.
    Mrs. Brooks. And so you're not concerned about the level of 
funding with respect to material threats.
    Dr. Lurie. Oh, we----
    Mrs. Brooks. You believe it's sufficient?
    Dr. Lurie. No, we are always concerned that we can do the 
job we need to do for the American people and having enough 
money to be able to procure for bio threats. As you know, in 
the multi-year budget we've got a 5-year projection of what it 
is that we need. We believe that for Fiscal Year '16 or '17, 
sorry, that we have sufficient funds to procure the 
countermeasures that will be ready.
    Mrs. Brooks. Thank you. Dr. Frieden, I'm very concerned 
about the stockpiling, the strategic national stockpile, and 
could you talk to me about things that BARDA, CDC can do to 
improve the effectiveness, the coordination of the strategic 
national stockpile because I don't think we're ready.
    Dr. Frieden. Well, we've been optimizing the stockpile for 
some time. We're able to deliver----
    Mrs. Brooks. What does that mean?
    Dr. Frieden. We're able to now deliver products to more 
places more quickly. We're also looking at how to get as much 
protection for our dollar as possible in terms of the mix of 
products in the stockpile. And we're also looking at the 
different threats that we may face to make sure that we have a 
balanced portfolio to be able to address those that might be 
the greatest risk to Americans.
    Mrs. Brooks. Based on the hospitals and the folks I talked 
to back home we seem to lurch from crisis to crisis and I'm 
very concerned that we are still not ready. Thank you, I yield 
back.
    Mr. Murphy. Gentlewoman yields back. Now recognize Mr. 
Bilirakis of Florida for five minutes.
    Mr. Bilirakis. Thank you very much, Mr. Chairman. Thanks 
for allowing me to participate in this subcommittee. Appreciate 
it and thanks for holding the hearing.
    The Zika outbreak like global issues especially pressing in 
Florida and other Gulf States given that these locations are 
vulnerable to the spread of Zika. In Florida we already have 
two cases in Hillsborough County, one of the counties that I 
represent.
    A question for Dr. Borio. You mentioned innovation 
strategies being proposed to help suppress virus-carrying 
mosquitoes. It is my understanding that FDA is currently 
considering an application for a field trial with genetically 
engineered mosquitoes in Florida. The question is, could you 
update us on where the field trial application stands today, 
and when the earliest starting date could be?
    Dr. Borio. Thank you. So we are working to soon release for 
public comment the Draft Environmental Assessment that the 
company developed. We work closely with EPA and CDC in 
reviewing the materials, so hopefully very soon it will be 
released. Once we have an opportunity to review the comments we 
receive from the public, then we'll make a final decision 
regarding the application. We're expediting the process. It's 
part of our Emerging Infectious Disease Task Force in response 
to Zika, so our--the reviewers involved in this technology are 
part of our Emergency Response Task Force, so we're doing 
everything we can to move this as expeditiously as we can.
    Mr. Bilirakis. Well, give me an estimate.
    Dr. Borio. Yes. I'm unable to give an estimate at this time 
because it really will depend a little bit on the volume and 
interest from the public. We are working those----
    Mr. Bilirakis. Well, I'm sure there's a great deal of 
interest based on what my constituents tell me.
    Dr. Borio. Yes, it has been an area of tremendous interest, 
and including some opposition. I think, you know, what we don't 
right now is where the public stands in the setting of Zika and 
the new developments associated with Zika. So we're doing 
everything we can to move this very quickly. We're 
collaborating across government with CDC and EPA. We'll learn a 
great deal about this technology also during my visit to Brazil 
last week, last month, so what I can tell you right now is that 
we are prepared to move very quickly on this.
    Mr. Bilirakis. Thank you. Next question. You mention FDA's 
emergency use of authorization referencing diagnostic tests. 
Would FDA be able to use an emergency use authorization to 
advance the use of this technology should the Secretary declare 
a public health emergency? So if you can answer that question.
    Dr. Borio. Our EUA authority is currently limited to human 
products, not to animal products. And this technology is 
regulated under our animal drug regulations, so it's separate, 
so we do not have currently authorities on emergency 
authorization for animal drugs.
    Mr. Bilirakis. OK, next question. Are there other 
innovative products or strategies being proposed that you're 
aware of, and able to discuss at this time?
    Dr. Borio. I would like to defer those answers to my 
colleagues from CDC.
    Mr. Bilirakis. Please, please, please.
    Dr. Frieden. There are a variety of other mosquito control 
approaches that are being considered. One is simply to optimize 
our currently available products. And we think there's 
considerable progress that we could make by doing that, 
different ways of applying different combinations of products, 
different ways of assessing mosquito populations after the 
application of these products. That's very important and needs 
to be done.
    In addition, there are new tools that are exciting. One of 
them is the genetically modified mosquitoes that you mentioned. 
Another is Wolbachia, a bacteria that infects mosquitoes and 
then can reduce their life expectancy and their ability to 
spread disease. This has been done on a pilot basis. But, 
again, the question about all of them are are they scalable, 
will they reduce human disease, are they practically 
implemented? And NIH is doing work in this area, as well.
    Mr. Bilirakis. Anyone else wish to comment on this? Thank 
you.
    Right now there are three tests I understand for detecting 
Zika during different stages of infection. It is my 
understanding that Florida and a few other jurisdictions are 
able to utilize the RT PCR test to detect infection. However, 
given that those who are infected often don't show symptoms, it 
seems crucial that we are able to disseminate diagnostic 
capabilities such as the antibody testing to state and local 
authorities. So what hurdles do we face in increasing access to 
these diagnostic tests nationwide?
    Dr. Frieden. We're working around the clock to do that.
    Mr. Bilirakis. Yes, go ahead.
    Dr. Frieden. Excuse me. We've already produced 375,000 of 
the realtime PCR. We've got roughly 15 to 20 states already 
approved for use of that. Now with the IGM EUA just last 
Friday, we expect to have another 15 or 20 states approved for 
that. That's where most of the returning travelers live and 
we'll continue to produce them. We've been able to accelerate 
our production capacity at CDC so that we can increase the 
proportion of the need that's met, but we recognize that there 
may be a period of weeks or a month or two where people who 
want the test can't get it. We're in active discussions as is 
BARDA and other parts to encourage the private sector to do 
more in this area. But right now, the CDC developed a test 
which scientists at CDC spent years working on, is the best 
thing out there in terms of what's available. And we're working 
around the clock to make it more widely available.
    Mr. Bilirakis. All right. Well, thank you very much, Mr. 
Chairman. I appreciate it. I yield back.
    Mr. Murphy. I know we're done with this. I know Ms. Clarke 
has 1 minute. She'd like to ask one more question for 1 minute.
    Ms. Clarke. Thank you, Mr. Chairman. Thank you for your 
indulgence.
    Clearly, there's still a lot more to learn about the Zika 
virus. No doubt the public health response to Zika virus will 
be complex and require coordination at the global, regional, 
and national level. While the response to Zika may evolve, one 
thing is clear; governments and international organizations 
must commit to funding and providing access to comprehensive 
reproductive health services to meet the needs of communities 
during this public health emergency and far beyond.
    Preventing pregnancy and the spread of the disease is 
desired by women in their childbearing age as has been 
suggested already in Brazil during this outbreak. As a follow-
up to Congressman Collins' line of questioning, what more can 
the CDC be doing, or what else can Congress do to support the 
CDC to help women prevent unintended pregnancies, if so 
desired, and prevent continued spread of this disease through 
possible sexual transmission?
    Dr. Frieden. Thank you. As you noted, about half of the 
pregnancies in the U.S., and about two-thirds of pregnancies in 
Puerto Rico are unintended. We do not issue advice to women on 
whether or not to get pregnant. We don't think that's our role. 
We do provide information so that women, their families, and 
their providers can make a decision about whether to use 
effective contraception. We provide guidelines for which 
methods of contraception are most effective, and how those 
might be used. This is basically the approach that we're 
taking, is providing information.
    Mr. Murphy. Thank you. Dr. Burgess would like 1 minute.
    Mr. Burgess. And, Dr. Frieden, if we can just talk one 
second about the spraying issue. You and I have talked about 
this a lot in the past, straight spraying, aerial spraying. 
Obviously for this mosquito it is a little bit different, and 
as I understand it, it's backpacks and going into yards and 
gardens. So is the CDC developing any guidance for our local 
public health offices as to what they can and cannot do, or can 
and cannot expect? As far as local spraying, is it always going 
to require consent to go on property? Do people need to 
identify when they have an ill person at home so that those 
areas can be perhaps on heightened surveillance?
    Dr. Frieden. We've looked at all of these issues and 
compared experiences across jurisdictions. We have a public 
health law project which provides information and advice to 
jurisdictions on models and what's possible in different 
places. I do think that there are ways to optimize current 
mosquito control practices, and that's one of the things that 
we need to rapidly accelerate, and for which the supplemental 
request would be used.
    Mr. Burgess. Do people have the ability to actually get the 
insecticide themselves and use it in their homes if they don't 
want the CDC coming in with backpacks?
    Dr. Frieden. The CDC wouldn't go in with backpacks, but 
this a thing that we're looking at quite actively. It depends 
on mosquito resistance. We're currently doing studies in Puerto 
Rico to see which products the mosquitos are resistant to, and 
we found that for some there's 100 percent resistance, for 
others they're largely susceptible. And it'll depend on what 
those results are for whether that could be done in exactly 
what you mentioned, showing people here's where you need to 
spray. Here are the products that work, is one approach that 
we're considering.
    Mr. Burgess. Thank you. Thank you, Chairman.
    Mr. Murphy. I want to thank this panel for your work. We 
have a second panel coming up here. As you know, other members 
may have questions for you, so I ask members to submit the 
questions and then please respond in a prompt manner. I'm sure 
we'll be following up with all of you by phone, by visits, by 
other hearings. This is critically important for our nation's 
health, so thank you so much for attending today.
    And while this panel is stepping away and we're preparing 
the next panel to come to the table, I'll begin the 
introductions of Panel Two.
    We have with us today Dr. Peter Hotez, the Dean of the 
National School of Tropical Medicine at Baylor. He's also 
President of the Sabin Vaccine Institute and Endowed Chair in 
Tropical Pediatrics at Texas Children's Hospital. Second, we 
have Lawrence Gostin, Linda D. and Timothy J. O'Neill Professor 
of Global Health Law at Georgetown University Law Center. Next 
we have Joseph Conlon, Technical Advisor to the American 
Mosquito Control Association, and Dr. Jeanne Sheffield, 
Director of the Division of Maternal-Fetal Medicine at the 
Johns Hopkins School of Medicine. And as soon as we have our 
panel seated; again, it'll be Dr. Hotez, Lawrence Gostin, 
Joseph Conlon, and Dr. Jeanne Sheffield, I'll begin with some 
of the parts here.
    Let me just say to the panelists, you are aware that the 
committee is holding an investigative hearing. When doing so it 
has the practice of taking testimony under oath, so if you 
could all please be seated, I'll swear you in. Do any of you 
have any objections to testifying under oath? Seeing no 
objections, the Chair then advises you that under the rules of 
the House and the rules of the committee you are entitled to be 
advised by counsel. Do any of you desire to be advised by 
counsel during testimony today? No, say no then.
    In that case if you would please rise and raise your right 
hand, I'll swear you in.[Panel sworn.]
    Mr. Murphy. Thank you. All the panelists have affirmed 
that, so now you're under oath and subject to the penalties set 
forth in Title 18, Section 1001 of the United States Code.
    We will now ask each of you to give a 5-minute summary of 
your opening statement. Dr. Hotez, you are recognized first. 
Please make sure you're turned on, bring the mic close to you, 
and watch for the red light. Thank you.

STATEMENT OF PETER HOTEZ, M.D., Ph.D., DEAN, NATIONAL SCHOOL OF 
TROPICAL MEDICINE, BAYLOR COLLEGE OF MEDICINE, PRESIDENT, SABIN 
VACCINE INSTITUTE, AND TEXAS CHILDREN'S HOSPITAL ENDOWED CHAIR 
IN TROPICAL PEDIATRICS; LAWRENCE O. GOSTIN, J.D., LINDA D. AND 
 TIMOTHY J. O'NEILL PROFESSOR OF GLOBAL HEALTH LAW, GEORGETOWN 
UNIVERSITY LAW CENTER; JOSEPH CONLON, M.S., TECHNICAL ADVISOR, 
AMERICAN MOSQUITO CONTROL ASSOCIATION; JEANNE SHEFFIELD, M.D., 
 DIRECTOR, DIVISION OF MATERNAL-FETAL MEDICINE, JOHNS HOPKINS 
                       SCHOOL OF MEDICINE

                    STATEMENT OF PETER HOTEZ

    Dr. Hotez. Mr. Chairman, Representative Castor, and members 
of the subcommittee, I thank you for giving me the opportunity 
to speak today. I'm Dean of the National School of Tropical 
Medicine at Baylor College of Medicine. I also head a product 
development partnership that makes neglected tropical disease 
vaccines that the big pharmaceutical companies won't make 
because they're vaccines for the diseases of the poorest 
people.
    For my remarks about Zika today, I want to focus on my 
perspective living and working in the Gulf Coast of the United 
States, and our unique vulnerability to Zika epidemics, and why 
I believe that this spring or summer Zika could begin affecting 
pregnant women living in economically distressed areas of 
Texas, Louisiana, Mississippi, Alabama, and Florida. And why I 
worry that by the end of this year we could see microcephaly 
cases appearing on the Gulf Coast. I also want to talk a little 
bit about some of the hurdles in vaccine development if there's 
time.
    The reason I'm concerned particularly about the Gulf Coast 
is because the Gulf Coast is unique in that it's the only part 
of the United States with the possible exception of Tucson, 
Arizona that has the Aedes aegypti mosquito. That's the 
mosquito that's now mostly responsible for transmission all 
over Latin America and the Caribbean, so it's Aedes aegypti 
that we mostly have to be concerned about. But my other reason 
I'm concerned about the Gulf Coast, and one not really being 
talked about enough is extreme poverty. I mean, the reason why 
we're seeing Zika in Pernambuco State and Recife in Brazil is 
because that's the poorest area, one of the poorest areas of 
Brazil. It is the epicenter, not just of Zika, but all of 
Brazil's neglected tropical diseases. It's where we see 
lymphatic filariasis, that's where we see schistosomiasis. And 
the reason there's so much Zika there is when you--and it 
doesn't take much to understand it. You an just view one of the 
poor communities, you see no window screens, holes in the 
window screens, but it's also the environmental degradation 
around the area. You see discarded tires, you see plastic 
containers filled with water, and all of those factors combine 
to make the perfect storm, and why Pernambuco is such a deadly 
place in terms of microcephaly cases and Zika.
    It's the same reason why I'm very worried about Haiti. I 
know we're mostly focusing on the United States, but I'd just 
like to make the point that I think Haiti is going to be 
decimated by Zika. UNICEF estimates there's 264,000 pregnant 
women every year in Haiti, so we could be looking at more than 
100,000, maybe 200,000 pregnant women with Zika in their first 
or second trimester. We could be looking at tens of thousands 
of cases of microcephaly in Haiti, in a country that basically 
has no health system. So this is a humanitarian catastrophe 
that's unfolding in front of our eyes, and I really don't see 
any significant global action right now happening in Haiti.
    And the reason I'm particularly worried about the U.S. Gulf 
Coast, dengue actually caused outbreaks in Houston in 2003, 
2004, and 2005. That was worked on by our National School of 
Tropical Medicine. The reasons are clear, we have Aedes 
aegypti, but where this is most happening are in the poor areas 
of Houston, so the historic African American wards like the 
Fifth Ward in Houston where I can take you there just a minute 
off the highway. This is not hard to find, and what I'll show 
you are dilapidated housings with no window screens, holes in 
the window screens. You'll see discarded tires all along the 
side of the road filled with organic debris and water, and the 
Aedes aegypti mosquito likes nothing more than discarded tires 
along the side of the road.
    Right now our Harris County Mosquito Control Division is 
finding Aedes aegypti mosquitoes. Those numbers are going to 
start to climb beginning April and into May, and I'm quite 
worried that we won't learn that there's going to be a Zika 
outbreak until we start seeing microcephaly cases towards the 
end of the year. So what do we need to do about this?
    First of all, I think the U.S. Government needs a more 
active role in coordinating what's going on in Haiti, or what's 
not going on in Haiti, working with the Organization of 
American States and WHO. Remember this is a disease we can 
fight. Between 1947 and 1962 we eradicated the Aedes aegypti 
mosquito from the Western Hemisphere for most of Latin America. 
We did it by old-fashioned mosquito control programs and being 
aggressive by draining water sources. The Aedes aegypti 
mosquito was eradicated in 18 Latin American countries and 
resulted in dramatic reductions in dengue and yellow fever.
    Equally important, we need a coordinated response to combat 
the threat of Zika on the Gulf Coast. This means surveillance 
of mosquitos and Zika detection. Beyond mosquito control we 
need to collect the garbage, we need to get rid of the 
discarded tires and standing water in poor neighborhoods, 
provide pregnant women living in poverty with adequate screens 
for their homes. This approach goes beyond the health sector 
and beyond the remits of the CDC. It could require involvement 
of Housing and Urban Development, EPA, even Homeland Security. 
Remember, even if a few babies are born with microcephaly on 
the Gulf Coast it will be talked about in the same context as 
Katrina, it will be talked about in the same context as the BP 
Oil spills; so, therefore, I urge this committee to 
aggressively pursue policies to protect that region. Thank you.
    [The statement of Dr. Hotez follows:]
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    Mr. Murphy. Thank you, doctor. Your time has expired. We'll 
come back to you.
    Professor Gostin, you're recognized next for five minutes.

                  STATEMENT OF LAWRENCE GOSTIN

    Mr. Gostin. Thank you, Mr. Chairman Murphy, Representative 
Castor, and the House subcommittee. I'm going to discuss four 
is very briefly. First is the President's supplemental 
appropriation. Secondly, how we continually under-invest and 
the financing of these kinds of ongoing threats. Third, our 
public health measures like travel isolation, quarantine. And 
fourth is child, maternal, and reproductive services.
    First in terms of the President's appropriation which I 
strongly support. So why act now? Well first, as you've heard 
from the first panel, there's a clear and present danger to the 
United States and our hemisphere. The United States is the 
global health leader, humanitarian leader, and we are the major 
leader in our own hemisphere in the Americas and the Caribbean. 
We also have our own domestic homeland to protect.
    We remember when Ebola arose here in Dallas and other 
places, how ill-prepared we were, and the public would not 
accept that. Ebola taught us a vital lesson to act quickly, act 
decisively, mobilize funding, and attack the hazard as its 
source. There have been four global commissions since Ebola. I 
was a member of two of them, and they have strongly urged us to 
act and act now.
    I remember during the Ebola appropriations and when the 
President sent military forces and the Department of Defense 
into West Africa. I was on PBS News Hour and they asked me what 
I thought, and I said I was very proud of America, and I think 
we need to be proud of America now in our response to Zika.
    Should we take Ebola funding for Zika? I think we should 
not. We would be robbing Peter to pay Paul. This is still a 
major threat in West Africa. We promised to rebuild and 
strengthen the decimated health system in West Africa, and 
America's word is its bond, and its leadership should never be 
placed in doubt. And that should be on a bipartisan basis, in 
my opinion.
    Zika, moreover, has a deep moral as well as a health 
dimension. I'm a public health ethicist, and if you had a 
hearing, for example, nine months from now and there was a 
mother with a microcephalic child here and we failed to act 
decisively now, I think the American public would find that 
unacceptable.
    From financing, we have continually underestimated our 
financing needs. I was a member of the National Academy of 
Science's Global Health Risk Framework Commission. They said 
that an Ebola epidemic, a SARS epidemic, an influenza epidemic, 
and now Zika could affect up to 10 percent of global GDP in the 
affected areas, and the commission suggested that there was an 
estimated $60 billion loss to GDP every year expected with $6 
trillion in the 20th century, in the 21st century. With that, 
the President's $1.8 billion supplemental appropriation to me 
looks modest and would reap great benefits. I would also 
support a contingency fund so that we don't have to mobilize 
funds in the midst of an epidemic.
    Third are public health measures. I believe that the CDC 
was absolutely right in its travel advisory for pregnant women. 
In fact, the CDC went further than the World Health 
Organization. I think it was right to do that. I think any of 
us if we had a daughter who asked us if she were pregnant 
should she go to a Zika-affected country, we would tell her 
what the CDC is telling her, that she should consider 
postponing that travel. But I would not go further and have 
travel restrictions or bars, isolations, quarantines, or border 
controls, some of which were used during Ebola, some 
successfully, but many not. I think there would also be 
Constitutional challenges appropriately to many of those 
measures.
    And then, finally, I believe that we need to be very 
attentive to child, maternal, and reproductive services. Pope 
Francis supported the use of contraception particularly in 
relation to Zika. We have women in the United States and in 
Puerto Rico that need reproductive services and health care 
services for them and their children, and we shouldn't let them 
down if they're under-insured or uninsured.
    So I thank you, Mr. Chairman and the committee for your 
clear recognition of this health threat facing the United 
States and the Americas, and for your leadership in this 
regard.
    [The statement of Mr. Gostin follows:]
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    Mr. Murphy. Thank you, Professor.
    Now we're going to turn to Mr. Conlon, who I also 
understand was an entomologist in the United States Navy for a 
couple of decades.
    Mr. Conlon. Indeed.
    Mr. Murphy. So thank you.

                   STATEMENT OF JOSEPH CONLON

    Mr. Conlon. Thank you. Good morning, Mr. Chairman and 
members of the subcommittee, Representative Castor. My name is 
Joseph Conlon. I'm a retired U.S. Navy Medical Entomologist and 
I serve as the Technical Advisor for the American Mosquito 
Control Association, and I welcome this opportunity to provide 
a mosquito control perspective to the deliberations of this 
committee.
    The recent introduction and spread of Zika virus in the 
Western Hemisphere has reawakened in the United States an 
appreciation of mosquitoes as not just nuisances, but 
transmitters of devastating diseases. And I use the term 
``reawakened'' advisedly for mosquito-borne diseases such as 
malaria, dengue, yellow fever were once quite common in the 
United States and, indeed, played a major part in shaping our 
nation's destiny. These diseases no longer claim victims in the 
United States as a matter of course largely due to the 
exemplary efforts of organized mosquito control agencies in 
conjunction with an enlightened and effective public health 
infrastructure. But even more mosquito-borne diseases are a 
mere 7-hour flight from our shores, and our public health 
agencies must be prepared to meet these challenges that they 
will eventually present.
    Zika virus is thought to be primarily transmitted from 
human to human by the bite of an infected Aedes aegypti and 
possibly Aedes albopictus species of mosquitoes. Of these, 
Aedes aegypti has been primarily responsible for transmitting 
the disease due, in part, to its preference by humans both day 
and night and its predilection for biting the lower extremities 
out of sight. Moreover, females frequently take multiple 
partial blood meals often from different individual humans, not 
only increasing the likelihood of feeding on an infectious 
human, but also leading to single infectious females 
potentially feeding on and infecting multiple humans within a 
relatively short time period. This is unique.
    Both Aedes aegypti and Aedes albopictus, the Asian Tiger 
mosquito are notoriously difficult to kill and/or prevent. They 
live inside our houses under furniture, beds, in closets. Their 
eggs can withstand months of drying and their young can develop 
in water containers as small as a discarded soda bottle cap. 
Virtually any collection of stagnant water in containers, tree 
holes, leaf axles, et cetera can serve as an egg-laying habitat 
for these species. Thus, draining wet areas does not prevent 
their development around our homes and yards.
    Aedes aegypti has been found in isolated areas of 
California and along the southern tier of states up into 
Georgia and South Carolina. Aedes albopictus is a bit more 
cold-hardy and its range includes those states but extends 
northward to Illinois and New York. States within this range 
have excellent integrated mosquito control programs in some 
areas, but mosquito control outside of their jurisdictions is 
spotty. Indeed, many potential ports of entry throughout the 
United States have limited or no mosquito control available and 
there is a pressing need for funding to establish sustainable 
mosquito control programs in these areas if outbreaks are to be 
contained.
    Successful mosquito control is based first and foremost on 
a comprehensive knowledge of the vector in order to exploit its 
vulnerabilities. All prevention and control strategies are 
based on this knowledge; however, the cryptic nature of Aedes 
aegypti makes normal surveillance and control strategies 
problematic. This demands that mosquito control in the 734 
established districts and over 1,100 municipal programs be 
improved in the following seven areas: improved mosquito 
surveillance tools for adult Aedes aegypti; availability of 
pesticide resistance testing kits and accurate rapid diagnostic 
tests for arboviral agents and trapped mosquitoes; faster 
communications about protocols between public health 
laboratories and mosquito control programs; funding to 
underwrite new data call-ins that might influence a pesticide 
registrant's decision to keep proven products on the market; 
funding for field validation of new control modalities such as 
lethal overtraps; intracellular controls using Wolbachia; 
genetically modified mosquitoes; new active ingredients such as 
dopamine receptor agonists to name a few. We also need a 
national strategy to elicit sustained public participation in 
removing and draining containers used by Aedes aegypti as 
position sites. Also identifying areas at risk of Zika 
transmission, assisting to the extent possible any federal 
programs, underwriting the startup of new vector control 
programs in impoverished areas at risk.
    The federal government has several mechanisms available to 
help these needs if funds already authorized were to be 
appropriated. Three in particular come to mind. First, the 
expanded laboratory capacity program of CDC for funding 
increases in arboviral testing capacities. Second, the Mosquito 
Abatement for Safety and Health Act by which local governments 
could receive matching federal funds up to $100,000 for the 
establishment and/or enhancement of mosquito abatement 
programs, and $100 million total for building sustainable 
programs where they do not exist. The funding for this was 
authorized but never appropriated. Third, the Food Quality 
Protection Act which authorizes the use of federal funds when 
the cost of new data for public health pesticides was more than 
their producers could afford putting their registration at 
risk.
    The national capacity to control mosquito-borne disease at 
present and in the future will largely depend on the extent to 
which these support programs or their functional equivalent in 
the President's February 22nd Emergency Supplemental Fund 
Request are implemented. Increased tourism, travel, and trade 
make continual introductions of exotic diseases carried by 
mosquitoes virtually inevitable. Resources for prevention and 
control programs must be made available and employed so that 
future cases of exotic diseases can be contained and eliminated 
before their establishment and spread.
    The President's recent request for emergency supplemental 
funding for Zika prevention and control tangibly addresses our 
acknowledgment of current shortfalls in mosquito-borne disease 
control capability and seeks avenues to remedy them towards our 
shared goal of protecting the American people from exotic 
diseases. The American Mosquito Control Association agrees. Our 
citizenry deserves no less. Thank you.
    [The statement of Mr. Conlon follows:]
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    Mr. Murphy. Thank you, Mr. Conlon.
    Dr. Sheffield, you're recognized for 5 minutes.

                 STATEMENT OF JEANNE SHEFFIELD

    Dr. Sheffield. Thank you. Chairman Murphy, Ms. Castor and 
representatives, I'd like to thank you for the opportunity 
today to testify before you on the effects of Zika virus in 
pregnant women and how clinicians are responding to this virus 
threatening the United States and the rest of the Americas.
    The Zika virus epidemic is a unique situation. It is a mild 
disease in adults in most cases, of little consequence to date 
other than the uncommon but potentially devastating 
complication of Guillain-Barre AE1 Syndrome. However, maternal 
Zika infection during pregnancy can have enormous consequences 
to the developing fetus. Zika has received international 
attention predominantly because of its effect on the developing 
fetus, specifically the association with microcephaly, 
significant effects on brain growth and development, and ocular 
abnormalities. Thus, much of the focus so far of current 
efforts has been on the management of the at-risk patients.
    You've heard extensive testimony about the origin of this 
virus and its spread over the last six decades, so I won't 
repeat myself or repeat that information for the sake of time. 
While the Continental United States has not identified a case 
of local transmission of Zika, there is a growing number of 
confirmed travel-related cases, several of these in pregnant 
women as we've heard about. While transmission of Zika virus is 
primarily through the infected mosquito, transmission may also 
rarely occur through infected blood in laboratory accidents, 
vertical transmission from a pregnant mother to the fetus has 
been confirmed, and finally cases of sexual transmission of 
Zika from an infected person to an uninfected sexual partner is 
increasingly being documented.
    Data regarding Zika virus infection in pregnancy are 
limited, and it is imperative that resources are directed to 
elucidating the pathophysiology of the infection on pregnancy, 
rate of fetal transmission, influence of timing in infection 
and relation to pregnancy on fetal manifestations of the 
disease, and long-term consequences of fetal infection. While 
it is unknown at this time if pregnant women are more 
susceptible to Zika virus, the disease itself does not appear 
any worse in pregnant women compared to non-pregnant women. 
Zika infects pregnant women in any trimester, and the virus has 
been found in multiple different tissues from fetal losses, 
amniotic fluid, the placenta, and the brain of infected 
neonates.
    The Brazilian outbreak of virus was associated with a 
significant rise in microcephaly. Microcephaly itself is 
diagnosed when the head is significantly smaller than what 
would be expected for the sex and gestational age of the 
infant. There are many causes of microcephaly, average rate is 
about 2 to 12 per 10,000 live births in the United States. 
There are multiple etiologies or multiple causes, chromosomal 
abnormalities, genetic abnormalities, toxin exposures such as 
mercury, alcohol exposure during pregnancy, and in the case of 
Zika, also other infections such as cytomegalovirus and 
rubella.
    The reason microcephaly develops in association with Zika 
is currently under investigation. Infants with microcephaly can 
have multiple long-term complications depending on the severity 
of the microcephaly and the associated abnormalities: seizures, 
developmental delay, including speech and motor abnormalities 
are just a few of these complications. There is no known cure, 
and treatments are very limited depending on what the etiology 
is of the microcephaly. Significant resources are going to have 
to be focused on the long-term care of these affected infants.
    Since the microcephaly association was first noted several 
months ago, we now know that there's multiple other 
abnormalities, and I've detailed these in my written testimony. 
Soon after the association of Zika virus infection and fetal 
microcephaly was identified, the Centers for Disease Control 
and Prevention set up a health alert and brought together 
subject matter experts including arbovirus virologists, public 
health personnel, and obstetrics and gynecologists with 
expertise in infectious disease and pregnancy. While data were 
very limited at that time, interim guidelines were rapidly 
developed to inform physicians caring for pregnant women, 
management strategies were disseminated, and educational 
materials describing preventative measures were made widely 
available not just to physicians but to the general public. 
These guidelines have been updated several times as new 
information has been elucidated. As was mentioned, the American 
College of OBGYN and also the Society for Maternal-Fetal 
Medicine have played a very integral part in the development 
and dissemination of this information, and I will be glad to 
answer any questions related to the management of these 
patients.
    Zika virus infection is now a notifiable disease allowing 
for better surveillance of disease burden. The CDC has 
developed a pregnancy registry with confirmed Zika infection in 
the United States. They actually released a report on Friday 
that was briefly mentioned earlier detailing the initial 
results of 257 Zika tests performed for pregnant women in the 
report, 3 percent were positive. The nine women that were 
positive, two electively terminated, two had a miscarriage or 
first trimester loss, one delivered an infant with severe 
microcephaly, and two pregnancies are ongoing, two pregnancies 
have delivered and so far there are no known effects to the 
infant. One woman was infected in a third trimester and 
delivered a healthy infant. So while this initial report is an 
important first step, much more is needed for the physician to 
be able to effectively counsel pregnant women at risk for 
infection. Support for both national and international research 
targeting key populations such as pregnant women is imperative. 
Until effective treatments and/or a vaccine are developed, 
prevention of maternal infection is necessary to prevent the 
devastating consequences of fetal infection. Thank you.
    [The statement of Dr. Sheffield follows:]
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    Mr. Murphy. Thank you, doctor. I'll now recognize myself 
for 5 minutes of questions.
    First, Dr. Sheffield, has any of the medical academies or 
the AMA come out with any recommendations with regard to asking 
mothers and keep ing the record if they have traveled to any 
areas where Zika virus is known?
    Dr. Sheffield. I think that's actually a superb question, 
and we talked about it quite extensively. My hospital, Johns 
Hopkins, we have developed a very comprehensive screening tool 
with a list of the countries and territories that are currently 
affected, and we are trying to spread this information out to 
multiple other centers. When I talk to other colleagues from 
around the country they are doing the same thing. So very 
similar to Ebola, we're working on a screening questionnaire.
    Mr. Murphy. So would you say at this point, should it be a 
standard that OBGYNs and pediatricians ask that question of 
mothers, if they have traveled to during pregnancy?
    Dr. Sheffield. Absolutely.
    Mr. Murphy. And with regard to that, and this is whether or 
not they had symptoms, just if they traveled there or nearby.
    Dr. Sheffield. Whether they traveled. The pregnant women 
regardless of symptoms require testing.
    Mr. Murphy. Even if in second or third trimester, of 
travel.
    Dr. Sheffield. Yes, sir.
    Mr. Murphy. I mean, I know myself as a psychologist, worked 
for many years with developmentally delayed children that 
there's a lot of long-term intellectual motor and sensory 
complications. I must admit, I'm also concerned that 
regardless, because we don't know yet all the route of what 
happened to this virus with the developing brain, that I wonder 
even if an infant or a young child is also infected with the 
Zika virus, the outcome on the brain, we simply don't know 
that. Am I correct?
    Dr. Sheffield. I think that is actually one of the big 
concerns, is that even if you're infected in the third 
trimester, have no evidence at delivery of microcephaly or 
neurologic abnormalities, the long-term follow-up of these 
babies is imperative because we don't know what the long-term 
consequences are going to be.
    Mr. Murphy. That's correct. I agree with you there.
    Dr. Hotez, you've been critical what you call the 
narrative. We've been mostly hearing from the U.S. Government 
that the Continental U.S. is a wealthy place with few of the 
risk factors contributing to the rapid spread of the arbovirus 
infection such as Zika, dengue, and chikungunya in Latin 
America and the Caribbean. But as a specialist in tropical 
disease based in a major Gulf Coast urban center, why do you 
disagree with that narrative that we shouldn't worry as much?
    Dr. Hotez. Thank you for that question. The reason is we 
have poor people in this country, we have 20 million Americans 
that live at half the U.S. poverty level. We now have 1.65 
million families that live on less than $2 a day according to 
the University of Michigan Center for Poverty. And what we're 
finding is something very interesting about the world's 
neglected diseases, that currently most of the world's 
neglected diseases, which include Zika, are actually found in 
wealthy G20 countries, but it's the poor living among the 
wealthy that account to it for this. So the G20 countries 
account for most of the world's worm infections, and dengue, 
and chagas disease, and leishmaniasis. We have 12 million 
Americans now living with a neglected tropical disease in the 
United States, most of them in the American south, most living 
along the Gulf Coast. For all the reasons that I mentioned in 
my previous testimony that we know that poor areas are 
particularly vulnerable. I have pictures.
    Mr. Murphy. But even with that, I only have a minute, 50 
seconds. I want to ask, and then we can look at those later. 
But even so, I don't know how far these mosquitoes may travel 
in their lifetime, get a wind. Do we have any idea? Mr. Conlon, 
is it miles?
    Mr. Conlon. Not in the case of Aedes aegypti and Aedes 
albopictus. Their ranges are about 100 to 200 meters from where 
they actually breed.
    Mr. Murphy. I see. And along these lines, too, does anyone 
know if the virus can live in the water in which they breed, 
and can the virus be transmitted for an adult to offspring? 
Just to help the American public understand this. Does anybody 
know?
    Mr. Conlon. To my knowledge, it can't reside in water. 
However, it is vertically transmitted from the mosquito, the 
adult mosquito to their offspring, so they're born with it.
    Mr. Murphy. That's disturbing, too. In your testimony, Mr. 
Conlon, you also observed that malaria and yellow fever, both 
mosquito-borne diseases were once quite prevalent, but that 
today they no longer claim victims due to the efforts of the 
Organized Mosquito Control Agencies. How is this accomplished? 
And the infrastructure given is pretty disjointed. How can we 
improve that?
    Mr. Conlon. Well, as Dr. Hotez mentioned, there are many 
places in the United States that do have socioeconomic 
conditions that are conducive to the spread of these types of 
diseases. Those conditions were quite evident back in the past 
in places like Norfolk, places like Louisiana, all throughout 
Louisiana. There were a number of different areas that these 
got transmitted. Dengue fever was first discovered in 
Philadelphia, Pennsylvania, so we should not rely upon the 
south to be the potential breeding ground for these things, but 
anywhere that poverty occurs where you've got difficulties in 
trash removal, you've got certain socioeconomic conditions 
conducive to keeping water containers inside. Those can really 
hurt.
    I want to emphasize, though, that mosquito control is 
conducted on an integrated basis and we should not think that 
there is any silver bullet for this. We've got to utilize all 
the tools that are at our disposal in order to keep these 
diseases from establishing. We need a number of different 
modalities.
    Mr. Murphy. Thank you. I'm out of time. Now turn to Ms. 
Castor for 5 minutes.
    Ms. Castor. Thank you. Well, thank you all very much. In 
addition to the previous panel, you all have really given 
everyone a wake-up call about what has to be done. And I'm more 
convinced than ever that we've got to move this supplemental 
appropriation, and it can't get bogged down in the typical 
congressional budget battles. We need to move it as quickly as 
possible.
    And, Dr. Gostin, I wanted to thank you for emphasizing the 
moral imperative for the Congress to act quickly. And Dr. 
Hotez, I think you're absolutely right to raise the issue of 
Haiti right now and the consequences because there hasn't been 
much discussion about Haiti. And I think they are particularly 
at risk. I think we can do better in mobilizing the 
international aid community and religious community that have 
so many initiatives there.
    I want to focus back on pregnant women because it appears 
that the impact and the connection to microcephaly came as 
something of an unwelcomed surprise. Dr. Sheffield, you've been 
very involved in drafting the guidelines for the CDC, the 
Society of Maternal-Fetal Medicine, and ACOG. Can you go into 
greater detail on the science and what we know?
    Dr. Sheffield. So when the guidelines were first drafted--
very soon after the reports initially came out about the 
microcephaly, they called a group of people together, and we 
freely admitted--I was not a Zika expert at the time. I knew 
very little actually about the Zika virus infection. However, 
the group of us had done a lot of work over the years with 
other infections and how it affects pregnancy, such as 
cytomegalovirus, and so the group of us that came together at 
the request of the CDC kind of looked at what data was 
available to us with the understanding of what happens with 
other viruses, and drafted just the original, the initial 
guidelines, which have subsequently been updated every time new 
data comes out. But the guidelines initially, if you look back 
a couple of months ago when they first came out, they were 
essentially screen everybody that traveled, and we talked a 
little bit about how to screen, the diagnostic tools that we've 
already talked about earlier today, and then ultrasound looking 
for actual fetal abnormalities, particularly in the head.
    Ms. Castor. What's going on here? With other infectious 
diseases in maternal health, what--are there any other diseases 
where we've seen similar impacts to the fetus or child that 
would develop microcephaly?
    Dr. Sheffield. This virus is fascinating because this virus 
is very neurotropic. It likes the brain, it likes the fetal 
brain and nervous tissue obviously in adults since we're 
talking about Guillain-Barre AE1 Syndrome, but it is very 
neurotropic. There aren't a lot of other viruses that affect 
the developing fetus that is so specific to the nervous system, 
or to the brain. There are other viruses such as rubella, one 
of the most devastating viruses out there that cause multiple 
fetal abnormalities, but it causes abnormalities in multiple 
different systems. Same with some of the other viruses and 
parasites that will affect a pregnant woman. This one so far 
has been very, very focused on brain and neurologic 
abnormalities.
    Ms. Castor. OK. So we're going to need extensive research 
on all that, and that is just starting. Is that right?
    Dr. Sheffield. Absolutely.
    Ms. Castor. Is that how you would characterize it? So let's 
drill down on the recommendations for maternal health. Because 
in the Western Hemisphere, as Dr. Hotez says, we are so 
interconnected, Florida to Brazil, and Latin America and 
Colombia, and Puerto Rico, to Mexico, to Haiti. It's just 
millions and millions of families, travelers where you're just 
not going to be able to talk about travel bans of things like 
that, so you've got to give folks the most constructive 
recommendations. So talk about citizens of the U.S. and Puerto 
Rico, what you're advising them right now if they are of 
childbearing age and intend to get pregnant?
    Dr. Sheffield. So right now myself as I'm sitting across 
the table from one of my pregnant women that is considering 
traveling and my colleagues across the country are all pretty 
much following the ACOG, SMFM, and CDC guidelines, which is if 
you have a pregnant woman that is interested in traveling to a 
Zika affected area currently we, one, recommend against it. If 
they do have to travel there is excellent education out there 
about prevention of mosquito bites because if they do travel, 
it all becomes prevention because, again, there is no 
treatment, and there's no vaccine currently available. So for 
right now it is prevention. So we spend a lot of time if they 
do have to travel talking about preventative measures, and 
there again is a lot of information on the CDC Web site for 
that.
    We also, if they come back from travel, and this is where a 
lot of my patients are coming in, as two months ago they never 
heard of Zika virus. They've all traveled down to an affected 
area and they're coming back suddenly in a panic after seeing 
everything that's happened. And those are the ones where we 
have testing available. Again, not perfect as we've heard, but 
it's what we have available, and then ultrasound or evaluation.
    Ms. Castor. Could you name those specific areas so that we 
have that?
    Dr. Sheffield. The specific areas for the evaluation?
    Ms. Castor. The travel to.
    Dr. Sheffield. Oh, travel to. So the CDC has a linked Web 
site of travel notice, and they keep updating it. Every time a 
new country or a new territory comes up, they update that list. 
Last I saw it was about 30 or so countries and territories, and 
it's online. It's very easily accessible, and actually we 
update it for our clinicians. We have the link right there in 
clinic. They click on it, they pull it up, and they're able to 
say OK, where did you travel? All right, you're on the list.
    Ms. Castor. But Brazil.
    Dr. Sheffield. Brazil, Colombia, Puerto Rico, though Cuba 
is not on it, we actually have tested one patient that's 
traveled from Cuba, so we're talking about the Caribbean.
    Ms. Castor. And it's not going to be a static list. That 
list is going to change.
    Dr. Sheffield. No, it is frequently. It's actually 
frequently updated as new countries are reporting.
    Ms. Castor. Thank you.
    Mr. Murphy. Thank you. Yes, that list is available on CDC's 
Web site. It's quite extensive, throughout the Caribbean, 
Central America, South America, Mexico. Other issues coming up, 
too, for the summer Olympics, as well.
    Mr. Collins, you're recognized for 5 minutes.
    Mr. Collins. Thank you, Mr. Chairman. I want to thank the 
panel as well. Maybe following up on Ms. Castor's comments.
    I think what a lot of us are worried about is there is no 
vaccine, and if somebody does test positive there's no 
treatment, and it's somewhat disturbing but Dr. Sheffield, that 
some women would even choose to terminate the pregnancy. But 
picking up on that, education to me, because we're not going to 
have a vaccine tomorrow or next week, and we'll have better 
diagnostics before we're going to have vaccines and treatments. 
So I'm thinking education, guidelines, pamphlet, with a sense 
of urgency into the physicians' offices. I don't know how many 
typical doctors right now have this information in their 
waiting room, but a lot of times we think we're invincible, 
from what I'm hearing. So a couple of questions: do we have 
even an idea, a 25-year old woman who--she's got 15 years or 
longer to be in her childbearing years. How long if she's 
infected, so she gets the Zika virus, she's not pregnant. She 
waits X period of time. Is that 1 year, 2 years, 10 years, 
never? Do we have any idea?
    Dr. Sheffield. So right now the guidance is if you travel 
to an area you're not pregnant, we're recommending people wait 
at least 4 weeks. The reason for that is the incubation period 
is about up to 2 weeks. The viremic time period where the virus 
can cross to the placenta and then to the fetus is somewhere 
around 7 to 10 days.
    Mr. Collins. Yes, but what I'm getting at is, OK, she's 
tested positive. She's not pregnant. How long would a woman who 
knows she's had the Zika virus, she was infected. Should she 
wait to consider having children? Is it never, or is it 1 or 2 
years? Do we have any guidelines in that area?
    Dr. Sheffield. We don't. Right now we're saying about four 
weeks, but that is based on, again, very, very limited data. 
That's where we desperately need information coming out of 
Brazil, and Colombia, and some of the U.S. studies that are---
    Dr. Hotez. It'll be important to determine if Zika is going 
by the same play book as something like dengue where the virus 
is in your system for a couple of weeks, and then it's gone. 
And that's probably the likely scenario. There is evidence 
that, for instance, West Nile virus can sometimes persist in 
the kidneys for periods of months or years, but that appears to 
be an exception----
    Mr. Collins. So even though someone may be antibody 
positive, the virus, like you're saying with dengue, has 
cleared the bloodstream. You're saying then at that point it's 
to the best of your knowledge they would no longer be infecting 
a fetus?
    Dr. Sheffield. To the best of our knowledge, yes.
    Dr. Hotez. Right.
    Mr. Collins. That's very good news, actually, if there's 
such a thing as good news here.
    Dr. Hotez. It's about the only good news about this virus.
    Mr. Collins. Yes. But if it clears, which is the difference 
in HIV and some others, because it doesn't clear. Yes, sir?
    Mr. Gostin. The other thing to consider is for women who 
are considering getting pregnant but are not pregnant now, what 
we tell them, because they won't necessarily go to their 
physician's office. That's why, in addition to education in the 
doctor's office, I think we need to do public health 
information campaigns to advise young women about what their 
risks are so that they can make well-informed decisions. And 
this is particularly important with the Rio Olympics that are 
looming, because although it will be the Southern Hemisphere's 
winter, there still will be active transmission. And they'll be 
coming then to the northern height of the summer where we could 
then see local transmissions here. So those are all kinds of 
things to consider in addition to the fact that, as you've all 
said, you have so much interchange between Puerto Rico, other 
U.S. territories.
    Mr. Collins. So if there is one absolute, I'm assuming the 
one absolute is a pregnant woman should not travel to those 
areas, because you're saying they could be third trimester and 
we don't know. So would that at least be a fair absolute; 
you're pregnant. You just stay away?
    Dr. Sheffield. I'm a physician. We never deal in absolute--
--
    Mr. Collins. Well, sometimes you need absolutes.
    Dr. Sheffield. But we do strongly recommend they not 
travel.
    Dr. Hotez. The problem will come and what happens in the 
summer when the Gulf Coast of Texas or Florida becomes an area 
included in the travel ban zone, and then we're going to----
    Mr. Collins. That would be a nightmare.
    Dr. Hotez. That would be a nightmare.
    Mr. Collins. Total nightmare.
    Dr. Hotez. That's a real----
    Mr. Collins. But thank you for your testimony. This 
education is absolutely critical for us, as well as the public. 
And I want to thank the Chairman for holding this hearing, and 
thank the witnesses for your testimony. I yield back.
    Mr. Murphy. Thank you. Ms. Castor, going to recognize you 
for an additional couple of minutes here, 5 minutes.
    Ms. Castor. Thank you very much.
    In some of the countries experiencing outbreaks many do not 
have access to primary health services; that means limited 
access to family planning, as well. Dr. Hotez, it's fairly 
plain but would you explain to everyone why it is in the best 
interest of Americans and American families that we tackle the 
disease in Brazil, and in Puerto Rico, and other places in the 
Western Hemisphere?
    Dr. Hotez. Well, thank you for that question. I think 
what's becoming clear is the Gulf Coast of the United States is 
part of the same eco-zone that the Caribbean and Central 
America is. There's a homogeneity there, especially in our 
impoverished areas. I can take you through parts of the Fifth 
Ward of Houston and you might think you're in Port Au Prince or 
Tegucigalpa, and so we have to realize that what is happening 
in Haiti and in Central America is the same vulnerability as 
the Gulf Coast, and take that accordingly.
    Ms. Castor. Dr. Gostin.
    Mr. Gostin. Yes. It's a very good, actually, because one of 
the things we've learned with SARS, with Ebola, with so many 
novel infectious diseases, and it's more true, or at least as 
much true with Zika is that we can't just be defensive in the 
United States. You actually have to go to the source of the 
infection; that, in other words, to protect ourselves we also 
need to protect the people and the ecosystem, and the mosquito 
population.
    Ms. Castor. So what should we be doing, what should the 
U.S. be doing to insure that women in these countries have 
access to family planning services during this crisis?
    Mr. Gostin. Well, I believe that for health reasons and for 
moral reasons we should encourage it. There are particular 
countries that have told women not to become pregnant for a 
year, 2 years, and more. And as Pope Francis said, we need to 
give them the tools to be able to achieve that goal. And, of 
course, if they do have infants, then we need to give the 
mother maternal health care, we need to give the child 
services. I think it's very important. And, of course, it's 
important in Puerto Rico because Puerto Rico is going through a 
major financial crisis, bankruptcies. It's Medicaid system is 
in shambles. And part of the President's appropriation request 
is to support that and it seems to me that as a territory of 
the United States it's very important. But also because of the 
interchange of travel between people in Puerto Rico and the 
United States.
    Ms. Castor. Dr. Sheffield, give us the practical advice of 
doctor to patient you would give on family planning in the 
impacted areas.
    Dr. Sheffield. So practically speaking, I am an advocate of 
providing effective contraception in order to, as you 
mentioned, provide a tool to prevent pregnancy if the woman so 
desires, if she does have to travel to Zika-affected areas. So 
if I have a woman that is not pregnant and is not interested in 
becoming pregnant in the near future, we do talk contraception, 
particularly if she is traveling down to Zika-affected areas.
    Ms. Castor. And then there's also been the discovery that 
Zika also poses a risk through sexual transmission, so it's not 
just women. We must also target communications and resources to 
men who may carry and spread the Zika virus. Dr. Sheffield, 
what guidance would you offer to men traveling to areas with 
active Zika transmission?
    Dr. Sheffield. So this has kind of thrown a wrench in it in 
our discussions over the last month or so. Now that sexual 
transmission has been confirmed and we are discovering more and 
more cases of sexual transmission, again all of them so far 
have been male to female transmission as was mentioned earlier. 
Our counseling right now is if you are a male who has a 
pregnant female partner, when you come back from travel from a 
Zika-affected area use condoms or actually abstain from sexual 
practice; however, if you don't abstain, use condoms. And we're 
using the word, consistently and correctly use the condoms, and 
trying to prevent transmission. It may not be 100 percent 
unless it's true abstinence, but it at least provides some 
protection.
    Ms. Castor. It's a very important message for the millions, 
and millions, and millions of our neighbors who travel across 
the Americas and in the Western Hemisphere, so thank you all 
very much for your testimony today.
    Mr. Murphy. Thank you. I want to follow up with a couple of 
questions, as well. First of all, with regard to this you're 
recommending, obviously, abstain from travel, abstain from 
other contact here. Does anyone know if airlines, and cruise 
ships, and travel agents are spreading that word, as well? 
Professor Gostin?
    Mr. Gostin. They have not yet, but what we saw with Ebola 
was that even before governments were implementing policies, 
the airline industry was doing that. This is a major financial 
issue for the industry, as well, particularly again because of 
the large travel to the Olympics and others, people canceling 
their flights, so I think it's very important for the United 
States Government and other governments to work with the 
airline industry to make sure that they follow the best public 
health advice.
    Mr. Murphy. Certainly advise that. Mr. Conlon, with regard 
to this, many times people travel to areas and then go to a 
resort area. One would assume that there would be some 
different sort of vector control there versus another part of 
the community. Do you have any advice on that?
    Mr. Conlon. In places in the Caribbean that do have vector 
control capabilities in the resort areas, it tends to be rather 
problematic, even more so than in the United States. I would 
recommend that people, and particularly males that are going 
into this area, utilize EPA registered repellants. They do work 
against all these mosquitoes, and they just need to follow 
label recommendations. But I would caution everyone to make 
sure they're EPA registered. There's a lot of mosquito 
repellant products out there that have rather iffy data sets 
supporting them, so EPA has taken into consideration that 
they're safe to use and they're effective at least four hours 
when utilized properly. What you do is you reduce human 
mosquito contact, no problem with the disease.
    Mr. Murphy. So it isn't just the matter of looking at what 
islands and countries to avoid, but it doesn't necessarily give 
me confidence that even if it is a four or five star resort 
that they necessarily have full vector control. And if you 
still go there, to use some sort of mosquito repellant, so 
there's multiple levels.
    Mr. Conlon. Absolutely. And I would also say that if you're 
going to a resort that's got an 18-story hotel you can find 
Aedes aegypti at 18 stories. They go up through the elevator 
shafts.
    Mr. Murphy. OK. In your testimony you also noted the 
American Mosquito Control Association is currently developing 
guidelines specifically geared towards aegypti and albopictus. 
What will these guidelines focus on, and when will they be 
ready, and how do you see them being put to use?
    Mr. Conlon. Well, hopefully, we're going to get them ready 
by about April, but one can never know when you're talking 
about dealing with volunteers. We're specifically going to try 
to shift our control paradigms and our recommendations from 
reactive, which is oftentimes larvicide. Larvicide are not 
going to be the answer with this mosquito, primarily because we 
generally use larvicide because the larvae are contained in a 
small area, they're easy to get at, they're easy to kill, and 
then they spread out as adults, and make it difficult for us to 
deal with them with regard to adulticides. In the case of this 
mosquito, though, larvicide are not going to be the answer 
because they're occurring in the same area where the adults 
are, so you might as well kill the adults in addition to. So 
we're going to focus more on the adulticide issues, we're going 
to focus more on trying to get community support, elicit 
community support to get rid of the habitat. This is a human 
problem. This not necessarily an Aedes aegypti problem. We're 
creating the problem, and we need to be conversant in creating 
the solution, as well.
    Mr. Murphy. All right, thank you. Dr. Sheffield, what do we 
know currently about the risk of a Zika infection passing from 
an asymptomatic mother to a child during pregnancy? It can 
still happen?
    Dr. Sheffield. We think it can. There haven't been 
excellent documented cases yet of an asymptomatic mother 
passing to an infant, or passing to her fetus. That being said, 
we are assuming that it could happen, and so the 
recommendations are the same whether you're symptomatic or 
asymptomatic.
    Mr. Murphy. And, again, that's something the OB and the 
pediatricians should always in screening questions, where have 
you been? So how frequently should pregnant women who could 
have had an asymptomatic Zika infection be tested for the 
virus?
    Dr. Sheffield. So right now when a pregnant woman comes 
back from a Zika-affected area, we're doing the initial test. 
We're doing the PCR, RT-PCR if she is symptomatic. If she is 
asymptomatic, we are doing the IGM and the plaque-reducing 
neutralizing antibody test. If that is negative, we still are 
following up the fetus with serial ultrasounds. If the 
ultrasound becomes abnormal, we will retest a mother that 
initially tested negative, and we will offer amniocentesis to 
test the fetus, also.
    Mr. Murphy. And do we have the capacity to handle all those 
tests?
    Dr. Sheffield. Right now we have not been turned down on a 
test. Maryland actually is able to do the test. It's the one of 
the states that's able to do the test. However, when we start 
rolling this out to all 50 states, I think that is a large 
question, is if every pregnant woman who travels needs to be 
tested at least once, do we have the capacity? And then you 
start looking at the asymptomatic, or the symptomatic men and 
testing. I think that is a concern.
    Mr. Murphy. Is it possible also for the Zika virus to be 
transmitted through a breast-feeding mother to her infant?
    Dr. Sheffield. So that's an excellent question. For breast-
feeding mothers, so far they have found Zika RNA in the breast 
milk, so we know that at some point the virus has made it to 
the breast milk. That being said, there have been no cases of 
transmission from breast milk. There also have not been active 
virus identified from the breast milk, so we know that there's 
parts of virus there. That's why the PCR comes back positive. 
But as of right now we haven't found active virus in breast 
milk.
    Mr. Murphy. Well, I want to thank this panel and the 
previous panel. This is very sobering and, quite frankly, very 
frightening stories we have heard today about a very real 
nightmare of the spread of Zika virus. And we don't have the 
answers yet, we don't have the tests yet, we don't have the 
solutions, and I don't even think we know all the consequences 
yet of what this does to adults, to infants, and what we'll see 
in the future with children, whether it is those who have been 
affected in utero with the virus, or those who may have been 
affected during early childhood, because we don't know what 
that could do to the developing brain, as well. So we'll 
monitor this very closely.
    We thank you and the other panelists for your information 
on this. So I'd like to thank the witnesses and the members who 
have attended today. Thank you, Ms. Castor, for stepping in 
here.
    I remind all members they have 10 business days to submit 
questions for the record. I ask that the witnesses all agree to 
respond promptly to the questions. And with that, this hearing 
is adjourned. Thank you.
    [Whereupon, at 12:56 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                 Prepared statement of Hon. Fred Upton

    Mr. Chairman, thank you for holding this hearing on the 
U.S. public health response to the Zika virus.
    Since January, bipartisan committee staff has been 
examining our public health preparedness for Zika through 
meetings with federal agencies, state health departments, 
public laboratories, international organizations, experts in 
tropical diseases and mosquito control, as well as other key 
stakeholders.
    While there has yet to be a confirmed case of mosquito-to-
human Zika transmission across the 50 states, this may only be 
a matter of time. Meanwhile, we must confront the tragic 
incidence of microcephaly in babies born to women that acquired 
the infection from travel abroad. We must work diligently to 
reduce the chance of sexual transmission as well as 
contamination of the national blood supply.
    Our understanding of the virus is growing by the day. 
However, there are still many questions that remain to be 
answered before we can be assured that we are doing our utmost 
to protect the American people from this and future pandemics. 
Of particular concern is the disorganization of mosquito 
control systems and the limited capacity for lab testing to 
diagnose Zika.
    Zika is another example demonstrating the need for greater 
preparedness. Zika is one of the emerging biological threats 
that formed an important part of the inquiry of the Blue Ribbon 
Study Panel on Biodefense, discussed at a hearing before this 
Committee several weeks ago. The panel's findings should serve 
as an urgent reminder of the need to build capacity--and 
improve coordination--at all levels of government to address 
present and future public health crises, whether of manmade or 
natural origin.
    The federal witnesses testifying before us this morning are 
uniquely positioned to discuss how the federal response to Zika 
has been formulated, expand upon the $1.9 billion requested of 
Congress on February 22 under the emergency supplemental 
appropriation, and address how it builds upon the lessons 
learned from responses to past outbreaks, such as Ebola. Our 
GAO witness will add his preliminary observations on the 
contours of a successful domestic, regional, and global 
response, and our second panel will feature non-government 
perspectives that will assist us in identifying crucial 
questions for further study.
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