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20–255 2017

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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

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 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

DAVID B. MCKINLEY, West Virginia 

Vice Chairman 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

H. MORGAN GRIFFITH, Virginia 

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 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

JOSEPH P. KENNEDY, III, Massachusetts 

GENE GREEN, Texas 

PETER WELCH, Vermont 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(III) 

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. 

(1) 

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 

2 

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 

3 

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 transVerDate Nov 24 2008 13:22 Feb 27, 2017 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 114\114-124 CHRIS
4 

mission 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. 

5 

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 

6 

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.] 

7 

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 

8 

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 

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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 

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cessfully 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 fullblown 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:] 

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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 GuillainBarre 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. 

22 

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:] 

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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 multicomponent 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. 

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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:] 

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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 

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demic 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:] 

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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. 

56 

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 

57 

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 crossactivity. 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 

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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. 

59 

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 shortterm 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 

60 

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. 

61 

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. 

62 

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 

63 

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 tickborne 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 

64 

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 

65 

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. 

66 

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 

67 

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 

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68 

tegrated, 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 

69 

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. 

70 

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 

71 

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 

72 

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. 

73 

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 multiyear 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. 

74 

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. 

75 

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 

76 

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? 

77 

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. 

78 

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 

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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, 

91 

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 mosquitoborne 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 

106 

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 caVerDate Nov 24 2008 13:22 Feb 27, 2017 Jkt 037690 PO 00000 Frm 00110 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 114\114-124 CHRIS
107 

pability 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. 

123 

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 

135 

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. 

136 

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 MaternalFetal 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, 

137 

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. 

138 

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 

139 

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. 

140 

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? 

141 

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 

142 

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. 

143 

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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