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U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA 

VIRUS: CONTINUING CHALLENGES 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

FIRST SESSION 

MAY 23, 2017 

Serial No. 115–34 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

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 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

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 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

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 

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 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

H. MORGAN GRIFFITH, Virginia 

Vice Chairman 

JOE BARTON, Texas 

MICHAEL C. BURGESS, Texas 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(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. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 4 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 7 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 8 

Prepared statement .......................................................................................... 9 

WITNESSES

Timothy M. Persons, Ph.D., Chief Scientist, Government Accountability Office ......................................................................................................................... 12 

Prepared statement .......................................................................................... 15 

Answers to submitted questions ...................................................................... 149 

Lyle R. Peterson, M.D., Director, Division of Vector-Borne Diseases, National 

Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease 

Control and Prevention ........................................................................................ 30 

Prepared statement .......................................................................................... 32 

Answers to submitted questions ...................................................................... 154 

Luciana Borio, M.D., Acting Chief Scientist, Food and Drug Administration ... 41 

Prepared statement .......................................................................................... 43 

Answers to submitted questions ...................................................................... 163 

Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious 

Diseases, National Institutes of Health ............................................................. 54 

Prepared statement and slide presentation ................................................... 56 

Answers to submitted questions ...................................................................... 167 

Rick A. Bright, Ph.D., Director, Biomedical Advanced Research and Development Authority, and Deputy Assistant Secretary, Office of the Assistant 

Secretary for Preparedness and Response, Department of Health and 

Human Services ................................................................................................... 77 

Prepared statement .......................................................................................... 79 

Answers to submitted questions ...................................................................... 172 

SUBMITTED MATERIAL

Subcommittee memorandum .................................................................................. 121 

Letter of February 15, 2017, from Ms. Schakowsky, et al., to Robert M. 

Speer, Acting Secretary of the Army, submitted by Ms. Schakowsky ............. 133 

Letter of May 10. 2017, from John Bel Edwards, Governor, State of Louisiana, 

to Robert M. Speer, Acting Secretary of the Army, submitted by Ms. Schakowsky .................................................................................................................. 136 

Letter of May 22, 2017, from Adam Gluck, Vice President and Head, U.S. 

Government Relations, Sanofi, to Mr. Murphy and Ms. DeGette, submitted 

by Ms. DeGette ..................................................................................................... 138 

Article of May 2017, ‘‘Emerging Infectious Diseases in Pregnancy,’’ by Richard 

H. Beigi, Obstetrics & Gynecology, Vol. 129, No. 5, submitted by Mr. 

Burgess ................................................................................................................. 140 

(1) 

U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA 

VIRUS: CONTINUING CHALLENGES 

TUESDAY, MAY 23, 2017 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:04 a.m., in Room 

2123, Rayburn House Office Building, Hon. Tim Murphy (chairman 

of the subcommittee) presiding. 

Members present: Representatives Murphy, Griffith, Burgess, 

Brooks, Collins, Barton, Walberg, Walters, Costello, Carter, Walden 

(ex officio), DeGette, Schakowsky, Castor, Tonko, Clarke, Ruiz, and 

Pallone (ex officio). 

Also present: Mr. Bilirakis. 

Staff present: Jennifer Barblan, Chief Counsel, Oversight and Investigations; Ray Baum, Staff Director; Elena Brennan, Legislative 

Clerk, Oversight and Investigations; Adam Fromm, Director of 

Outreach and Coalitions; Brittany Havens, Professional Staff Member, Oversight and Investigations; Katie McKeough, Press Assistant; David Schaub, Detailee, Oversight and Investigations; Jennifer 

Sherman, Press Secretary; Alan Slobodin, Chief Investigative 

Counsel, Oversight and Investigations; Sam Spector, Policy Coordinator, Oversight and Investigations; Evan Viau, Staff Assistant; 

Hamlin Wade, Special Advisor for External Affairs; Jeff Carroll, 

Minority Staff Director; Waverly Gordon, Minority Counsel, Health; 

Chris Knauer, Minority Oversight Staff Director; Miles Lichtman, 

Minority Policy Analyst; Kevin McAloon, Minority Professional 

Staff Member; Dino Papanastasiou, Minority GAO Detailee; Olivia 

Pham, Minority Health Fellow; and C.J. Young, Minority Press 

Secretary. 

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

Mr. MURPHY. Good morning, and welcome to our Oversight and 

Investigations Subcommittee hearing on ‘‘U.S. Public Health Response to the Zika Virus: Continuing Challenges.’’ 

Today, the subcommittee continues its examination of the Zika 

virus, and the subcommittee first examined the virus last year during the early stages of the outbreak across Central and South 

America. 

As this year’s mosquito season is about to begin, the time has 

come to review what has been done and what we have learned 

2 

since then and to examine the challenges that our Federal health 

agencies continue to face. To date, every State in the continental 

United States, minus Alaska, has reported cases of the Zika virus, 

and two States, Florida and Texas, have reported cases of locally 

acquired mosquito-borne transmission. 

As of March 2017, there were 84 countries, territories, or subnational areas with evidence of vector-borne Zika virus, and 13 

countries have reported evidence of person-to-person transmission 

of the virus. 

A recent report released by the Centers for Disease Control and 

Prevention, or the CDC, found that 1 in 10 women in the United 

States with a confirmed Zika virus infection during pregnancy had 

a baby with a virus-related birth defect. 

Emerging infectious diseases present unique challenges to public 

health systems here and around the world. When the committee 

held its hearing on Zika last March, much was unknown about the 

virus and its impact on public health. I want to commend our public health agencies for the work that they have all done. Diagnostic 

tools were quickly developed and approved under Emergency Use 

Authority, and more are in the pipeline now. Multiple vaccine candidates are in development, and much research into the virus and 

its effects have taken place. When instances of local transmission 

occurred in Florida and Texas, the CDC acted quickly in tandem 

with State and local partners to contain the spread. 

But despite these efforts, the unknowns of this disease still outnumber the knowns. We don’t know the actual number of infections 

in the United States. We don’t know the long-term impact of Zika 

infection during pregnancy on children born to infected mothers. 

We don’t know about the long-term impacts of infection on men or 

on people who exhibit no symptoms of Zika. There are difficulties 

with the diagnostic tests we have in use today, and we don’t have 

good information or modeling on how the virus will spread this 

year, let alone beyond that. 

The GAO is here today reporting on its evaluation of the U.S. 

public response to Zika, work commissioned by this committee. 

This is not the first time GAO has done such an analysis and response to emerging infectious diseases, and each time, GAO has 

found that HHS was reactive in its response to outbreak prevention, preparedness, detection, and response. Once again, GAO has 

shown that we are not fully prepared at the outset of the outbreak. 

The GAO evaluated the U.S. public health response to Zika in 

three key areas: one, case definition and an understanding of how 

the disease spreads into community and the factors that affect this 

distribution; two, the development and use of diagnostic tools; and, 

three, methods of mosquito control. 

The GAO findings are sobering. While there have been many advances, actions are needed to address major challenges. According 

to the GAO, the lack of standardized Zika case definition at the beginning of the outbreak complicated the collection of consistent and 

timely data. The diagnostic tests varied in their ability to detect 

the virus and provide accurate results. Manufacturers of diagnostic 

tests faced multiple challenges, including gaining access to FDAauthorized tests for comparison use, and the users of the tests 

3 

could not even determine the most accurate diagnostic tests based 

on the information provided. 

And of great concern, the GAO report raises questions about 

CDC’s and FDA’s disclosure of test information and the treatment 

of CDC’s own subject-matter expert, who was removed and then reinstated to his position after dissenting over concerns about the 

CDC Zika diagnostic tests provided to labs. 

With regard to State and local mosquito control efforts, CDC developed technical guidance and provided funding and technical assistance. GAO identified challenges here as well for Federal agencies, including the need to effectively communicate information 

about the geographical distribution of the mosquito that primarily 

transmits the Zika virus. Much of the money appropriated by Congress last year to respond to Zika went to States and localities in 

the form of grants, and effective communication is critical to ensure 

that our Federal tax dollars are spent wising. 

It is clear that we have much to discuss today. We will hear from 

a panel of distinguished Federal witnesses, including the Centers 

for Disease Control and Prevention, the National Institutes of 

Health, the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, as well as the Government Accountability Office. 

I want to thank all of our witnesses for joining us this morning. 

[The prepared statement of Mr. Murphy follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

Today the subcommittee continues its examination of the U.S. public health response to the Zika virus. The subcommittee first examined the Zika virus last year 

during the early stages of the outbreak across Central and South America. As this 

year’s mosquito season is about to begin, the time has come to review what has been 

done-and what we have learned-since then, and to examine the challenges that our 

Federal health agencies continue to face. 

To date, every State in the continental United States, minus Alaska, has reported 

cases of the Zika virus, and two States—Florida and Texas—have reported cases of 

locally acquired mosquito-borne transmission. As of March 2017, there were 84 

countries, territories, or subnational areas with evidence of vector-borne Zika virus 

and 13 countries have reported evidence of person-to-person transmission of the 

virus. A recent report released by the Centers for Disease Control and Prevention 

(CDC) found that one in ten women in the United States with a confirmed Zika 

virus infection during a pregnancy had a baby with a virus-related birth defect. 

Emerging infectious diseases present unique challenges to public health systems 

here and around the world. When the committee held its hearing on Zika in March 

of last year, much was unknown about the virus and its impact on public health. 

I want to commend our public health agencies for the work they have done. Diagnostic tools were quickly developed and approved under Emergency Use Authority, 

and more are in the pipeline now. Multiple vaccine candidates are in development, 

and much research into the virus and its effects have taken place. When instances 

of local transmission occurred in Florida and Texas, the CDC acted quickly in tandem with State and local partners to contain the spread. 

But despite these efforts, the unknowns of this disease still outnumber the 

knowns. We don’t know the actual number of infections in the United States. We 

don’t know the long-term impact of Zika infection during pregnancy on children 

born to infected mothers. We don’t know about the long-term impacts of infection 

on men, or on people who exhibit no symptoms of Zika. There are difficulties with 

the diagnostic tests we have in use today. And we don’t have good information or 

modeling on how the virus will spread this year, let alone beyond that. 

The GAO is here today reporting on its evaluation of the U.S. public health response to Zika-work commissioned by this committee. This is not the first time GAO 

has done such an analysis in response to emerging infectious diseases. And each 

time, GAO has found that HHS was reactive in its response to outbreak prevention, 

4 

preparedness, detection, and response. Once again, GAO has shown that we were 

not fully prepared at the outset of the outbreak. 

The GAO evaluated the U.S. public health response to Zika in three key areas: 

(1) case-definition and an understanding of how the disease spreads into community 

and the factors that affect this distribution; (2) the development and use of diagnostic tools; and (3) methods of mosquito control. The GAO findings are sobering: 

while there have been many advances, actions are needed to address major challenges. 

According to the GAO, the lack of a standardized Zika case definition at the beginning of the outbreak complicated the collection of consistent and timely data. The 

diagnostic tests varied in their ability to detect the virus and provide accurate test 

results. Manufacturers of diagnostic tests faced multiple challenges including gaining access to FDA-authorized tests for comparison use, and users of the tests could 

not even determine the most accurate diagnostic test based on the information provided. 

And, of great concern, the GAO report raises questions about CDC’s and FDA’s 

disclosure of test information and the treatment of CDC’s own subject matter expert 

who was removed and then reinstated to his position after dissenting over concerns 

about the CDC Zika diagnostic test being provided to labs. 

With regard to State and local mosquito control efforts, CDC developed technical 

guidance and provided funding and technical assistance. GAO identified challenges 

here as well for Federal agencies, including the need to effectively communicate information about the geographical distribution of the mosquito that primarily transmits the Zika virus. Much of the money appropriated by Congress last year to respond to Zika went to States and localities in the form of grants, and effective communication is critical to ensure that our Federal tax dollars are spent wisely. 

It is clear that we have much to discuss today. We will hear from a panel of distinguished Federal witnesses, including the Centers of Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, as well as the Government 

Accountability Office. 

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 a 5-minute opening 

statement. 

Mr. MURPHY. I now recognize the ranking member of this subcommittee, Ms. DeGette, for a 5-minute opening statement. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

This committee has been examining issues related to disease preparedness for more than a decade. We have looked recently at preparedness and response capabilities related to Ebola, seasonal flu, 

and pandemic flu, and, of course, now the Zika virus. 

As you mentioned, last year, the Zika epidemic spread across 

Brazil, Latin America, and into the U.S. There were more than 

5,000 Zika cases in the U.S. and over 36,000 in the U.S. territories. 

Now, as we continue to face challenges with these epidemics and 

global pandemics, we can’t be satisfied with simply reacting to each 

new emergency. Instead, we have to devote efforts and resources to 

ensuring that we’re prepared before the next threat occurs. Oftentimes, we don’t even know where those will come from. 

We need to do more at the Federal and State levels to combat 

emerging infectious diseases. As I pointed out over a year ago, the 

bipartisan Blue Ribbon Study Panel on Biodefense concluded that 

the U.S. is underprepared for bioincidents, whether they’re deliberate attacks or naturally occurring events. This is still a problem, 

despite our assiduous attention to it. For example, just this month, 

members of this subcommittee released a comprehensive GAO reVerDate Mar 15 2010 11:18 Dec 13, 2017 Jkt 037690 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X34ZIKAASKOK121117\115X34ZIKAPENDING WAYNE
5 

port on avian flu. That audit uncovered shortcomings in our preparedness and raised key questions about our ability to rapidly respond to future outbreaks. GAO found that, while we can impose 

biosecurity measures after an emergency hits, our preparation is 

limited to voluntary actions, which are too often ineffective. 

Today, we’re going to hear again from the GAO, but this time on 

how our disease-fighting agencies are addressing the ongoing Zika 

threat and the remaining challenges. So, even though we’re working on getting there, we’re still not where we need to be when it 

comes to disease preparedness and emerging infectious threats. 

I’m looking forward to hearing from all of the witnesses today 

about how we can improve processes in response to the GAO’s recommendation. 

I want to talk about another area, which is funding, and I know 

with the release of the President’s budget today, everybody is concerned about funding. I’m really concerned about whether agencies 

have adequate funding to prepare and respond to a potential outbreak. We’re fortunate to have premier public health agencies overseeing these efforts, but if their hands are tied with funding, those 

agencies can’t do their work. Last year, Congress made available $1.1 billion to fight Zika, but 

key agencies received far less money than they requested. In the 

end, agencies like the CDC had to reprogram funds to respond to 

this unfolding threat, diverting the funding from other top priorities. 

This year, as I said, President Trump has proposed slashing 

HHS’ budget and making deep cuts to public health agencies like 

the CDC or the NIH. This is so counterproductive. Now is not the 

time to make draconian threats—cuts to the agencies charged with 

stopping Zika or any other health crisis. Although we don’t know 

what funds the administration will need to address the Zika threat 

for 2017, I don’t have any reason to believe that they’re going to 

need less than last year. 

So I intend to ask the panelists whether they think that we’re 

adequately resourced to go into the 2017 mosquito season. We don’t 

want to find ourselves in the middle of this summer scrambling to 

cobble together another emergency supplemental. 

And, finally, I want to welcome Dr. Petersen from Fort Collins 

here today. Dr. Petersen is the Director of the Division of Vectorborne Diseases, and that agency is in Fort Collins, Colorado. I went 

up and visited the facilities, Mr. Chairman, last year, and thanks 

to the efforts of former Congressman Bob Schaffer and myself, we 

were able to get new state-of-the-art facilities up there a few years 

ago. They’re doing remarkable research, and I just want to thank 

you for adding your intelligence and your perspective today. And I 

also want to welcome all of our witnesses, of course. 

And, with that, Mr. Chairman, I will yield back. 

Mr. MURPHY. Thank you. 

The gentlelady yields back, and I will recognize the chairman of 

the full committee for a 5-minute opening statement. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Mr. WALDEN. I thank the chairman. 

6 

Thank you for holding this timely hearing on U.S. public health 

response to the Zika virus. I want thank all of our witnesses for 

being here today and for providing us with your testimony. 

For well over a year, our bipartisan committee staff have been 

working diligently to examine our public health preparedness for 

Zika and other emerging infectious diseases. This is our second 

hearing since the outbreak of this virus. 

First, I want to commend the agencies that are appearing before 

us today. Each agency has undertaken a huge effort to increase our 

knowledge of the virus, to develop diagnostic tests and vaccine candidates quickly, and to educate our communities about how to respond to this virus and the mosquito that carries it. 

I also want to commend the State and local entities that are 

working hard to treat those impacted by Zika and to reduce the 

population of Zika-carrying mosquitoes. While much progress has 

been made over the past year, the GAO released a report today 

showing our understanding and preparedness to combat this virus 

and other biological threats still face significant challenges. Particularly as we head into the summer months, we must do better. 

Though the FDA has authorized two different types of diagnostic 

tests under the Emergency Use Authorizations, there’s still no commercially available diagnostic tests on the market for the detection 

of the Zika virus. Currently, there are no specific therapies or vaccines approved by the FDA to prevent or treat the virus. Perhaps 

most concerning is we still don’t know the full spectrum of health 

consequences associated with mother-to-child transmission, nor do 

we know what the short-term and long-term outcomes are for those 

who contract the virus with or without clinical symptoms. 

We also continue to face significant issues in supporting mosquito control efforts and our ability to accurately model and predict 

the spread of viruses geographically. The number and implication 

of unknowns is frankly a bit alarming. It begs the question, how 

prepared are we for the next outbreak? Zika is not the only biological threat that we face today. As our society becomes increasingly 

global and world travel becomes easier, more efficient, and more 

frequent, the risk of spreading disease through human contact will 

increase rapidly. 

Sadly, emerging infectious diseases, including Zika, Ebola, yellow 

fever, dengue, pandemic influenza, and others, perhaps many more 

that have yet to even be discovered threaten our human and bioterrorism defenses every day. The slides made famous on national television by our witness, Dr. Anthony Fauci, dramatizes the change 

from 30 years ago with just HIV as a global example of emerging 

infectious disease to a recent slide showing more than 40 examples. 

Last year, the subcommittee held a hearing on the report of the 

Blue Ribbon Study Panel on Biodefense. It presented several concerns and expert recommendations to improve U.S. biodefense. The 

experts on the panel made it quite clear we need to stop thinking 

of disease preparedness and response as occasional episodic events, 

a reactive approach that’s left us constantly lagging in our response 

efforts. Instead, we must shift our mindsets and strategies toward 

a broader, more comprehensive, and proactive approach, one that 

considers the larger context of our preparedness for future infectious diseases and outbreaks. 

7 

Federal witnesses testifying before us this morning are uniquely 

positioned to help aid in our efforts, and I thank you all for appearing before the subcommittee. 

[The prepared statement of Mr. Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

Mr. Chairman, thank you for holding this very timely hearing on the U.S. public 

health response to the Zika virus. 

For well over a year our bipartisan committee staff has been working diligently 

to examine our public health preparedness for Zika and other emerging infectious 

diseases. This is our second hearing since the outbreak of the virus. 

First, I want to commend the agencies that are appearing before us today. Each 

agency has undertaken a huge effort to increase our knowledge of the virus, to develop diagnostic tests and vaccine candidates quickly, and to educate our communities about how to respond to this virus and the mosquito that carries it. I also 

want to commend the State and local entities that are working hard to treat those 

impacted by Zika, and to reduce the population of Zika-carrying mosquitoes. 

While much progress has been made over the past year, the GAO report released 

today shows our understanding and preparedness to combat this virus—and other 

biological threats—still faces significant challenges. Particularly as we head into the 

summer months, we must do better. 

Though the FDA has authorized two different types of diagnostic tests under 

Emergency Use Authorizations, there are still no commercially available diagnostic 

tests on the market for the detection of the Zika virus. Currently, there are no specific therapies or vaccines approved by the FDA to prevent or treat the virus. 

Perhaps most concerning is that we still don’t know the full spectrum of health 

consequences associated with mother-to-child transmission. Nor do we know what 

the short-term and long-term outcomes are for those who contract the virus, with 

or without clinical symptoms. We also continue to face significant issues in supporting mosquito control efforts and our ability to accurately model and predict the 

spread of viruses geographically. 

The number and implication of unknowns is alarming. It begs the question: How 

prepared are we for the next outbreak? 

Zika isn’t the only biological threat that we face today. As our society becomes 

increasingly global and world travel becomes easier, more efficient, and more frequent, the risk of spreading disease through human contact will increase rapidly. 

Sadly, emerging infectious diseases including Zika, Ebola, yellow fever, Dengue, 

Chikungunya, pandemic influenza—and perhaps many more that have yet to be discovered—threaten our human and bioterrorism defenses every day. The slides made 

famous on national television by one of our witnesses, Dr. Anthony Fauci, dramatizes the change from 30 years ago with just HIV as the global example of emerging 

infectious disease to a recent slide showing more than 40 examples. 

Last year, this subcommittee held a hearing on the report of the Blue Ribbon 

Study Panel on Biodefense, which presented several concerns and expert recommendations to improve U.S. biodefense. The experts on the panel made it quite 

clear that we need to stop thinking of disease preparedness and response as occasional, episodic events—a reactive approach that has left us constantly lagging in 

our response efforts. Instead, we must shift our mindsets and strategies towards a 

broader, more comprehensive, and proactive approach—one that considers the larger 

context of our preparedness for future infectious diseases and outbreaks. 

The Federal witnesses testifying before us this morning are uniquely positioned 

to help aide us in these efforts, and I thank them for appearing before the subcommittee this morning. 

Mr. WALDEN. And I yield the balance of my time to the chairman 

of the Health Subcommittee, Dr. Burgess. 

Mr. BURGESS. Thank you, Mr. Chairman. Thank you for yielding. 

So, to paraphrase the Rolling Stones, summer is here, and the 

time is right for fighting vectors in the street. I want to thank our 

panelists for being here today. Some new faces, and that will be 

good to get to know you a little bit better, and some people that 

we have talked with many times before. 

8 

And, Dr. Fauci, just thinking back to the 108th Congress, we 

talked about SARS, we talked about avian flu, we talked about 

swine flu, we talked about Ebola, and we talked about Zika. And 

every one of those illnesses, of course, has a particular impact upon 

women and pregnancy, and that has certainly been—and I appreciate the focus that you have put on that during the times that we 

have had the privilege of having you before our subcommittee. 

So I want to welcome our witnesses. Look forward to what your 

testimony is going to be today. 

And, Mr. Chairman, I yield back. 

Mr. MURPHY. With that then—— 

Ms. DEGETTE. Will the gentleman yield? It is not the Rolling 

Stones. It is Bruce Springsteen. 

Mr. MURPHY. The record will stand corrected. 

Mr. BURGESS. No, no, no correction of the record. I will put my 

iTunes against yours. 

Mr. MURPHY. Thank you. Well, we reached a new level for this 

hearing. The gentleman yields back. 

I recognize Mr. Pallone for 5 minutes. 

Mr. PALLONE. I won’t comment because I don’t know. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Thank you, Mr. Chairman, and thank you to all our witnesses 

for joining us this morning to discuss the Federal Government’s 

preparations for the 2017 Zika season. I look forward to hearing 

from our panelists today about how they believe the Zika virus will 

spread in 2017, what they anticipate the upcoming mosquito season will look like, what challenges remain, and what additional resources they need to do their job. 

In March of 2016, the committee held a hearing to examine the 

Federal Government’s response to the spreading Zika threat. Since 

then, we have learned a great deal more about this virus. For example, scientific consensus now indicates that Zika infections in 

mothers during pregnancy can cause microcephaly in newborns, a 

severe birth defect of the brain. 

As we’ll hear from GAO today, although CDC and FDA took 

steps to respond to the unique challenges posed by the Zika outbreak last year, there remains room for improvement. This is particularly true regarding our ability to predict the spread of Zika, to 

better coordinate and control mosquito populations at the local 

level, and to more rapidly develop diagnostic tests for detecting 

Zika infection. 

These steps to improve preparedness should also go hand-inhand with strengthening our healthcare programs. We must ensure 

that individuals affected by Zika, particularly pregnant women and 

children born with microcephaly, have access to ongoing screening 

and health services. 

An integral part of that effort is the Medicaid program. Medicaid 

provides contraceptive services that help prevent Zika infection and 

diagnostic services to detect infection. Medicaid is also a vital 

source of care for children born with special healthcare needs like 

microcephaly. 

9 

Today, Medicaid covers one in three children in the United 

States. The President’s budget is expected within the hour, and 

there are reports that he plans to propose slashing Medicaid by 

over $800 billion, and this would decimate the Medicaid program 

and endanger our ability to manage public health emergencies like 

Zika. 

I also remain concerned about the status of Medicaid funding in 

Puerto Rico. As everyone in this room understands, Zika has 

wreaked havoc upon Puerto Rico, yet as we head into the 2017 

mosquito season, funding for Puerto Rico’s Medicaid program 

through the Affordable Care Act is on track to be exhausted as 

early as this October. And despite the $295 million allocated for 

Medicaid funding in Puerto Rico as part of the recent continuing 

resolution, up to 900,000 people remain at risk of losing their 

health coverage at the end of this year. 

So, in short, a strong public health infrastructure is also one of 

the best tools to fight epidemics, and Medicaid is an essential component in protecting us from threats such as Zika. Fighting Zika 

will not be easy, but the first step should be to maintain critical 

health services for those who may be affected and provide agencies 

with the resources they will need to respond to an outbreak. 

Now I’m concerned about recent reports that nearly 700 positions 

at CDC are vacant because of the ongoing hiring freeze and that 

Federal support to States for Zika response may be discontinued. 

That’s why Democratic members of this committee sent a letter to 

CDC last week asking whether the agency has sufficient funding 

to prepare and respond to Zika this year. It is critical that we give 

these agencies the tools they need to bolster our preparedness. 

So let me conclude by saying thank you to the agencies before 

us today who work on a daily basis to fight this disease. I don’t 

think anybody else wants to—you would like to? I yield the balance 

of my time to the gentlewoman from Florida. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Thank you, Mr. Chairman, and thank you to all our witnesses for joining us this 

morning to discuss the Federal Government’s preparations for the 2017 Zika season. 

I look forward to hearing from our panelists today about how they believe the 

Zika virus will spread in 2017, what they anticipate the upcoming mosquito season 

will look like, what challenges remain, and what additional resources they need to 

do their job. 

In March of 2016, this committee held a hearing to examine the Federal Government’s response to the spreading Zika threat. Since then, we have learned a great 

deal more about this virus. For example, scientific consensus now indicates that 

Zika infection in mothers during pregnancy can cause microcephaly in newborns, a 

severe birth defect of the brain. 

As we will hear from GAO today, although CDC and FDA took steps to respond 

to the unique challenges posed by the Zika outbreak last year, there remains room 

for improvement. This is particularly true regarding our ability to predict the spread 

of Zika, to better coordinate and control mosquito populations at the local level, and 

to more rapidly develop diagnostic tests for detecting Zika infection. 

These steps to improve preparedness should also go hand-in-hand with strengthening our health care programs. We must ensure that individuals affected by Zika, 

particularly pregnant women and children born with microcephaly, have access to 

ongoing screening and health services. 

An integral part of that effort is the Medicaid program. Medicaid provides contraceptive services to help prevent Zika infection, and diagnostic services to detect infection. Medicaid is also a vital source of care for children born with special health 

10 

care needs, like microcephaly. Today, Medicaid covers 1 in 3 children in the United 

States. 

The President’s budget is expected within the hour, and there are reports that he plans to propose slashing Medicaid by over $800 billion. This would decimate the 

Medicaid program and endanger our ability to manage public health emergencies 

like Zika. 

I also remain concerned about the status of Medicaid funding in Puerto Rico. As 

everyone in this room understands, Zika has wreaked havoc upon Puerto Rico. Yet, 

as we head into the 2017 mosquito season, funding for Puerto Rico’s Medicaid program through the Affordable Care Act is on track to be exhausted as early as this 

October. 

And despite the $295 million allocated for Medicaid funding in Puerto Rico as part 

of the recent Continuing Resolution, up to 900,000 people remain at risk of losing 

their health coverage at the end of this year. 

In short, a strong public health infrastructure is often one of the best tools to fight 

epidemics, and Medicaid is an essential component in protecting us from threats 

such as Zika. Fighting Zika will not be easy, but the first step should be to maintain 

critical health services for those who may be affected and provide agencies with the 

resources they will need to respond to an outbreak. 

I’m concerned about recent reports that nearly 700 positions at CDC are vacant 

because of the ongoing hiring freeze, and that Federal support to States for Zika 

response may be discontinued. That is why Democratic members of this committee 

sent a letter to CDC last week asking whether the agency has sufficient funding 

to prepare and respond to Zika this year. It is critical that we give these agencies 

the tools they need to bolster our preparedness. 

Let me conclude by saying thank you to the agencies before us today who work 

on a daily basis to fight this disease. 

Thank you, and I yield back. 

Ms. CASTOR. Thank you, Mr. Pallone, for yielding the time. 

I’m very concerned for families all across American and particularly in the State of Florida and Puerto Rico because the birth defects related to the Zika virus are so severe and costly and because 

America’s emergency public health response to Zika is at risk right 

now. After the Congress provided a billion dollars last year, we 

ramped up an emergency public health response that included our 

local communities, States, extensive surveillance, mosquito control, 

laboratories, development of vaccines, but as we stand now, there 

are too many unanswered questions about transmission of Zika and 

the medical consequences. Our families are at risk because of that. 

They’re also at risk because we’re facing a funding cliff for the 

Zika emergency response. What is the most important in a public 

health emergency response is you have consistency. And right now, 

all of the agencies in local communities and States are looking at 

this cliff that’s going to come to the end over the next few weeks, 

definitely by September. 

I see great risk because of the hiring freeze that the Trump administration put into place that is now keeping public health professionals off the job at CDC and NIH and other important agencies. And then, with the budget that comes out today, we’re going 

to have to deal with this overarching desire by the Trump administration to pull the rug out from under families because they’re 

going to target cuts to medical research and the Centers for Disease Control all at the time where they say we’re going to give big 

tax cuts to billionaires who will have all the resources in the world 

to deal with a Zika diagnosis in their family, but meanwhile, families across America will be left with very serious consequences. 

So this committee needs to develop a plan of action in the coming 

weeks, and hopefully the expert advice from this panel will help 

guide us there. Thank you very much. 

11 

Mr. MURPHY. The gentlelady’s time is expired. 

At this point, I just want to say that I ask unanimous consent 

that the Members’ written opening statements be introduced into 

the record and, without objection, the documents be entered into 

the record. 

I now would like to introduce our panel of Federal witnesses for 

today’s hearing: Dr. Timothy Persons, Chief Scientist, U.S. Government Accountability Office; Dr. Lyle Petersen, Director, Division of 

Vector-Borne Diseases, National Center for Emerging and Zoonotic 

Infectious Diseases, Centers for Disease Control and Prevention; 

Dr. Luciana Borio, Acting Chief Scientist, U.S. Food and Drug Administration; Dr. Anthony Fauci, Director of the National Institute 

of Allergy and Infectious Diseases, National Institutes of Health; 

and Dr. Rick Bright, Director of Biomedical Advanced Research 

and Development Authority and Deputy Assistant Secretary for 

Preparedness and Response, U.S. Department of Health and 

Human Services. Thank you all for being here today and providing 

testimony. 

We look forward to a very productive discussion and how we can 

better prepare for and respond not only to Zika virus but to all the 

emerging infectious diseases and biological threats to our Nation. 

You are aware this committee is holding an investigative hearing 

and, when doing so, has a practice of taking testimony under oath. 

Do any of you have any objections to giving testimony under oath? 

Seeing none, 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 one has indicated that. Then, in that case, will you please 

rise, raise your right hand, and I will swear you in. 

[Witnesses sworn.] 

Mr. MURPHY. Thank you. You may all be seated. 

Seeing that all have answered in the affirmative, you are now 

under oath and subject to the penalties set forth in title 18 under 

section 1001 of the United States Code. We’ll ask you each to give 

a 5-minute summary of your written statement. Please pay attention to the light there. 

Dr. Persons, you are recognized first for 5 minutes. 

12 

STATEMENTS OF TIMOTHY M. PERSONS, PH.D., CHIEF SCIENTIST, GOVERNMENT ACCOUNTABILITY OFFICE; LYLE R. 

PETERSEN, M.D., DIRECTOR, DIVISION OF VECTOR–BORNE 

DISEASES, NATIONAL CENTER FOR EMERGING AND 

ZOONOTIC INFECTIOUS DISEASES, CENTERS FOR DISEASE 

CONTROL AND PREVENTION; LUCIANA BORIO, M.D., ACTING 

CHIEF SCIENTIST, FOOD AND DRUG ADMINISTRATION; ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF 

ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH; AND RICK A. BRIGHT, PH.D., DIRECTOR, 

BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 

AUTHORITY, AND DEPUTY ASSISTANT SECRETARY, OFFICE 

OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND 

RESPONSE, DEPARTMENT OF HEALTH AND HUMAN SERVICES 

STATEMENT OF TIMOTHY M. PERSONS 

Dr. PERSONS. Thank you, Mr. Chairman. Good morning and good 

morning, Ranking Member DeGette and members of the subcommittee. Thank you for the opportunity to discuss our work on 

the Federal response to Zika virus disease outbreaks with particular focus on epidemiology, diagnostic tests, and mosquito control. As this committee has pointed out even this morning, emerging infectious diseases, such as Zika virus disease, are an ongoing 

threat to the health and livelihoods of people and animals worldwide. 

Despite many advances in medical research and treatments during the past century, infectious diseases are still a leading cause 

of death. Over the past few decades, several emerging infectious 

diseases have similarly taken the global community by surprise, including H1N1 influenza, Ebola, and Zika, among others. 

In each case, the Department of Health and Human Services, 

though diligent in its work to address rapidly emerging threats, 

was nonetheless reactive in some respects, such as outbreak prevention, preparedness, detection, and response. Although HHS has 

key agencies working on various important aspects of this problem, 

currently no one person or agency is in charge of making sure the 

U.S. is ready for the next outbreak of an emerging infectious disease. 

The Zika virus attracted attention from health officials here and 

abroad after causal links were suspected between increases in reported cases of Zika virus infection and reported cases of 

microcephaly in newborns and other neurological disorders in 

Brazil in 2015. 

An effective response to an emerging infectious disease like Zika 

involves the establishment of a case definition, gaining an understanding of the disease’s spread into the population, rapidly developing and deploying reliable diagnostic tools at the beginning of the 

outbreak, and, when the disease is vector-borne as Zika is, effective 

methods of mosquito control. 

While recent Zika virus disease outbreaks have yielded new insights, several key unknowns remain, including the total number 

of infections, various biological mechanisms and risk factors, and 

13 

the full spectrum of short- and long-term outcomes of Zika virus infection, among others. 

We also identify two key challenges for Zika virus epidemiological research. One is the time and resources needed to better understand the short- and long-term effects of Zika virus disease, and 

the other is an insufficiency of data and a lack of computer models 

for predicting the spread of Zika virus. Moreover, at the beginning 

of the U.S. outbreak, there was no U.S. medical case definition, despite there being candidates from other affected countries. 

Even though the U.S. had known about and was conducting surveillance on Zika virus disease outbreaks, including those in U.S. 

territories, no accurate and reliable diagnostic tools had been authorized. The FDA had authorized over 15 diagnostic tests for the 

Zika virus under the Emergency Use Authorization process following the public health emergency declaration. 

Manufacturers of diagnostic tests face several challenges, including lack of knowledge of key scientific aspects of the virus, difficulty in accessing well-characterized clinical samples, getting access to EUA samples to use for comparison, gaining cooperation 

with international entities, and according to some, a lack of effective communication from the FDA. 

One major issue users face with these diagnostic tests is that it 

was not possible for them to easily compare the tests based on information on the product insert. Users of the tests also identified 

challenges that included, for example, complying with a test EUA 

label specifying certain equipment required to perform the test and 

determining the most accurate test, in part because of the challenges comparing performance characteristics reported in the EUA 

labels. 

Turning to mosquito-control efforts, the Federal Government has 

a limited and indirect role in supporting them since they were implemented at the State and local levels. CDC developed technical 

guidance and provided funding and technical assistance to support 

State and local mosquito-control activities but does not serve, nor 

does any other agency serve, as a central coordinator for mosquito 

control nationwide. 

We identify four challenges the Federal Government faced in 

supporting these mosquito-control efforts during the Zika virus outbreaks. One is the timing and availability of the funds, including 

the sustaining of expertise throughout the year. Second is the limited communication about the actual distribution of mosquitoes. 

Third is linking the effects of mosquito control to disease outcomes. 

And fourth is having limited information about mosquito-control 

entities themselves. 

In short, our report indicates that there’s still work to be done 

to better coordinate and more effectively implement mosquito control nationwide. In conclusion, HHS has led the way in making 

progress in our understanding of the Zika virus disease, but several 

challenges remain. Although the EUA process is aimed at getting 

the diagnostic tests out quickly in emergency situations, it is equally important to clinical users that the authorized tests be compared 

to one another with respect to key performance characteristics. 

That will allow them to determine which is the most appropriate. 

14 

We have identified several areas where improvements can be 

made and have made five recommendations. HHS agreed with four, 

partially concurred with the fifth, and provided clarifying information. In response to our recommendation to include information on 

CDC-developed tests distributed to public health laboratories, HHS 

agreed that it should share information on such tests that have received EUA. However, HHS did not agree with our recommendation that it should share information on CDC’s lab-developed tests 

that have not received EUA because CDC is unable to provide detailed information on the characteristics of these unstandardized 

tests. 

Mr. MURPHY. Dr. Persons, we are way over time. Do you have 

a final thought? 

Dr. PERSONS. Yes, sir. We maintain that sharing information 

about the lab-developed tests that are used for comparison is important because it could help other diagnostic test users about 

which tests to adopt or recommend. 

Chairman Murphy, Ranking Member DeGette, and members of 

the subcommittee, this concludes my prepared statement. Thank 

you for your sustained attention on this issue, and I would like to 

thank the GAO team who made this testimony possible. I’ll be 

happy to answer your questions. 

[The prepared statement of Dr. Persons follows:] 

15 


26480.001

For Release on Delivery 

Expected at 10:00 a.m. ET 

Tuesday, May 23, 2017 

GA0-17-612T 

United States Government Accountability Office 

Testimony 

Before the Subcommittee on Oversight 

and Investigations, Committee on 

Energy and Commerce, House of 

Representatives 

EMERGING INFECTIOUS 

DISEASES 

Actions Needed to Ensure 

Improved Response to 

Zika Virus Disease 

Outbreaks 

Statement of Timothy M. Persons, Ph.D., Chief Scientist 
16 


26480.002

Highlights of GA0-17-6J2T, a testimony 

before. the Subcommittee on Oversight and !nvesUgations, Committee on Energy and 

Commerce, House of Representatives. 

Why GAO l)id This Study 

Zika virvs di~ea~e cap cause adVerse 

health outcomes. This statement 

summarize:; th<> findings i:>f GAO's May 

2017 report that fs being released 

concurr)i!ntly on progress made and 

challenges faced bY federal age~cies 

in responding to the Zika virus 

outbreak in the United States. 

GAO examined (1) Jnforn)ation on what 

is known and not known about the 

epidemiology: of the Zika virus and 

challenges with conducting 

surveillance and epidemiological 

studies, (2) characteristics of different 

authorized diagnostic tests, challenges 

test n)aoufacturers and usersiaced, 

and the extent to which FDA and. CDC 

followed their. own communication 

guidance, ~nd (3) the strengths and 

limitations ofi>vaih3ble mosquito cohtrol methods, and challenges federal 

agencies faced. 

GAO reviewed documents and 

lntervi~wed offici~ls about the Zika 

Virus· response. GAO also convened an 

expert meeting ;vith the assistance of 

the National. Academy of Sciences to 

discuss variOuS lss'ues related to' Zika 

virus. 

What GAQ Recommends 

In its May report GAO made five 

recommendations to FDA and CDC, 

including that CDC 'iostablish a transparent process for proViding test 

manuf~cturer~, acce~~ !O, qiag~ostic 

tests for :yomparison purposes and 

FDA and cD.C provide infonnatioo to 

help ensure that. users of diagnostic 

tests can co)'npare performance. The 

agencies agreed with four 

recommendations and partially with the 

fifth and identified actions to implement 

them. 

View, GAO·J 7~12.t. For more information, cont~¢t Chief S~ientlst Timothy M., Persons at 

(202:)_ 512:-6412 or personst@gao.gov. 

EMERGING INFECTIOUS DISEASES 

Actions Needed to Ensure Improved Response 

to Zika Virus Disease Outbreaks 

What GAO Found 

Since Zika virus disease was a newly emerging disease threat in the United 

States, the Centers for Disease Control and Prevention (CDC), and the states 

were not fully equipped with needed infonnation and resources at the beginning 

of the outbreak. This presented several challenges for surveillance and research 

efforts, such as establishing a national definition for reporting cases. Knowledge 

about Zika virus epidemiology has increased in the past year, for example, its 

associated adverse health outcomes, and various modes of transmission. Most 

of the 5,197 Zika virus disease cases reported by April 5, 2017 across 49 states 

in the United States were associated with travel to affected areas outside the 

continental United States; only two states-Florida and Texas-reported local 

mosquito-borne transmission-216 were in Florida and 6 in Texas. The vast 

majority of the 36,504 cases reported in U.S. territories have been acquired 

through presumed local, mosquito-borne transmission in Puerto Rico. While 

much has been learned about the epidemiology of the Zika virus, many 

unknowns remain, including the actual number of infections in the United States 

and the full spectrum of short-term and long-term outcomes. 

The 16 Zika virus diagnostic tests authorized during the outbreak varied in their 

performance and operational characteristics. For example, they varied in their 

ability to detect the virus and provide accurate results. In developing the 

diagnostic tests, manufacturers faced challenges in several areas, including 

access to clinical samples and other authorized diagnostic tests for comparison 

purposes. Users of the tests also encountered challenges, including determining 

the most accurate test to use, having access to different tests, and obtaining 

equipment needed to conduct the tests. Some manufacturers raised concerns 

about the difficulty in developing diagnostic tests that met the Food and Drug 

Administration's (FDA) requirements for Emergency Use Authorization and some 

users expressed concerns about selecting tests amongst those authorized. GAO 

also determined that CDC and FDA did not consistently communicate sufficient 

information about diagnostic tests, including providing clear information that 

would have enabled users to more easily compare performance across different 

tests. 

Mosquito control programs in the United States are implemented at state and 

local levels and are critical to mitigating the risks associated with the Zika virus. 

Control methods include applying pesticides, reducing available water sources 

for breeding, and using personal protection. Each method has its strengths and 

limitations. For example, some control methods are more effective at reducing 

mosquito populations while others help prevent individuals from mosquito bites. 

Similarly, each method has some limitations, for example, there is varied public 

opposition to the use of certain pesticides. CDC supports state and local 

mosquito control activities primarily by providing guidance on mosquito control 

methods and funding to support certain mosquito control efforts. Challenges 

federal agencies identified in supporting these activities include sustaining staff 

expertise in mosquito control during periods when there are no outbreaks, 

funding constraints, and effectively communicating information about the 

geographical distribution of mosquitoes that transmit the Zika vlrus. 

-------------United States Government Accountability Office 
17 


26480.003

Chairman Murphy, Ranking Member DeGette, and Members of the 

Subcommittee: 

Thank you for the opportunity to discuss our work on the federal response 

to Zika virus disease outbreaks, with particular focus on epidemiology, 

diagnostic tests, and mosquito controL Emerging infectious diseases, 

such as Zika virus disease, are an ongoing threat to the health and 

livelihoods of people and animals worldwide. Despite many advances in 

medical research and treatments during the past century, infectious 

diseases are still a leading cause of death worldwide. Our testimony 

today summarizes our report entitled Emerging Infectious Diseases: 

Actions Needed to Address the Challenges of Responding to Zika Virus 

Disease Outbreaks which is being released today. 1 We have also issued 

several other reports on infectious diseases. 2 

Zika virus disease is caused by the Zika virus, which is spread to people 

primarily through the bite of an infected mosquito (Aedes aegypt1). Many 

people with Zika virus infection will not have any signs or symptoms or 

will have only mild symptoms. The Zika virus attracted attention from 

health officials in the United States and abroad after associations were 

suspected between increases in reported cases of Zika virus infection 

and reported cases of microcephaly in newborns and other neurological 

syndromes in Brazil in 2015. 3 

Several U.S. federal agencies are involved in the response to Zika virus 

disease outbreaks. Specifically, the Centers for Disease Control and 

Prevention (CDC) collects data from states on reported cases of 

nationally notifiable diseases through surveillance systems. The Food and 

Drug Administration (FDA) oversees the safety and effectiveness of 

diagnostic tests. The Secretary of Health and Human Services (HHS) can 

make a declaration of emergency that can allow FDA to issue Emergency 

Use Authorization (EUA) of medical products to be used when adequate, 

approved, and available alternatives are lacking. FDA's website includes 

1

GAO, Emerging Infectious Diseases: Actions Needed to Address the Challenges of 

Responding to Zika Virus Disease Outbreak, GA0-17-445 (Washington, D.C: May 23, 

2017). 

2For a full list of related reports please see GA0-17-445_ 

3Microcephaly is a rare nervous system disorder that causes a baby's head to be smaller 

than expected and not fully developed, which can lead to impaired thought processes, 

delayed motor function, and other adverse outcomes 

Page 1 GA0-17~612T 
18 


26480.004

a current list of available diagnostic tests and associated information 

about each test FDA has authorized two different types of diagnostic 

tests for the Zika virus-molecular and serologic. 4 

Our May 2017 report and my statement today address (1) what is known 

and not known about the epidemiology of the Zika virus, and challenges 

in conducting surveillance and epidemiological studies, (2) characteristics 

of different Zika virus authorized diagnostic tests, challenges 

manufacturers and users of diagnostic tests have faced, and the extent to 

which CDC and FDA followed their own communication guidance 

concerning diagnostic tests during the recent U.S. outbreak, and (3) 

available mosquito control methods, their strengths and weaknesses, and 

challenges federal agencies face in assisting mosquito control efforts. 5 

For our May 2017 report, we reviewed agency documents including 

reports on Zika virus epidemiology, diagnostic testing guidance, agency 

documents on mosquito control, and information on all authorized 

diagnostic tests for Zika.virus disease. We also interviewed the 

manufacturers of authorized tests, officials from key federal agencies and 

departments, selected state and local public health entities, and public 

health organizations responding to the domestic Zika virus outbreak. We 

also convened, with the assistance of the National Academy of Sciences, 

a meeting with 16 experts from federal and state governments, academia, 

and industry who combined knowledge of Zika virus epidemiology, 

diagnostic testing, and mosquito control, to identify and discuss 

experiences and challenges that arose during the Zika virus outbreak 

response. Additional information on our scope and methodology is 

available in our report. We performed the work on which this testimony is 

based in accordance with generally accepted government auditing 

standards. 

4Molecular tests are used to detect genetic matena! in samples of bodily fluids such as 

serum and urine. Serologic tests are diagnostic tests that detect antibodies against the 

Z1ka virus. 

5For the purpose of the report and this testimony, users of diagnostic tests include 

laboratory personnel, health care providers, and others in the medical and scientific 

communities 

Page 2 GA0-17-612T 
19 


26480.005

Challenges to 

Gathering New 

Information about 

Zika Virus 

Epidemiology 

Surveillance and research conducted during the recent Zika virus disease 

outbreaks around the world have established some new knowledge about 

the epidemiology of the Zika virus, including information about the 

incidence of the disease and the distribution of cases, and its associated 

adverse health outcomes. Most of the 5,197 Zika virus disease cases 

reported by April 5, 2017 across 49 states in the United States were 

associated with travel to affected areas outside the continental United 

States; only two states-Florida and Texas-reported local mosquitoborne transmission-216 were in Florida and 6 in Texas. Most of the 

36,504 cases reported in U.S. territories have been acquired through 

presumed local, mosquito-borne transmission in Puerto Rico. According 

to the World Health Organization (WHO) and CDC, there is now evidence 

that the Zika virus causes microcephaly, brain abnormalities, and other 

birth defects and neurological disorders, based on the totality of evidence 

from current epidemiological and clinical studies. 

Nevertheless, many unknowns about the Zika virus remain, including (1) 

the total number of people with symptomatic and asymptomatic 

infections, (2) the biological mechanisms, risks, reasons for geographic 

differences, and the full spectrum of outcomes associated with maternalfetal transmission, (3) the presence and duration of the virus in different 

bodily fluids, and (4) the role of prior exposure to Zika and other closely 

related viruses in risk and severity of Zika virus disease outbreaks, and 

(5) the full spectrum of outcomes associated with Zika virus infection. 

When the outbreak started in the United States, CDC, and state and local 

public health agencies, and public health organizations, faced some 

challenges in establishing and implementing surveillance systems for Zika 

virus disease and infection and its associated health outcomes. 

Challenges included establishing surveillance case definitions early in the 

outbreak when little was known about the Zika virus, timely 

communication of critical information that was rapidly evolving, and the 

lack of interoperability between surveillance systems. We also identified 

two key challenges for epidemiological research: (1) time and resources 

required for studies needed to establish association and causality 

between the Zika virus and associated health outcomes and (2) 

insufficient data and models for predicting the spread of the Zika virus. 

Page 3 GA0-17-612T 
20 


26480.006

Characteristics of 

Different Diagnostic 

Tests Varied, 

Manufacturers and 

Users Faced Several 

Challenges, and FDA 

and CDC Did Not 

Consistently 

Communicate 

Sufficient Information 

By April12, 2017, FDA had authorized 16 diagnostic tests for the Zika 

virus under EUAs, following a public health emergency declaration' In 

response to the Zika virus outbreak, CDC manufactured and received 

EUA from FDA for both molecular and serologic tests. We found that 

authorized diagnostic tests used for the recent Zika virus outbreak varied 

in their performance and operational characteristics. Molecular and 

serologic tests have different strengths and limitations, but some of the 

limitations can be mitigated by using the CDC algorithm. 

It is important to recognize that a negative molecular test does not rule 

out Zika virus infection because the amount of virus in the sample could 

be too low to be detected at the time of molecular testing. Some scientists 

expressed concern over the limit of detection for the Zika virus by some 

authorized molecular diagnostic tests, which could have resulted in 

molecular testing missing Zika infections. CDC provided guidance 

intended to reduce the risk of inaccurate results by recommending that 

molecular tests should be further tested with a serological test. One 

critical issue with serological Zika virus disease testing is potential crossreactivity when antibodies to similar viruses react. For example, crossreactions occur in the diagnostic tests for Zika and dengue because these 

viruses are closely related. 

We identified challenges that manufacturers of diagnostic tests for Zika 

virus faced including: (1) lack of knowledge of biological aspects of the 

virus and immune response, (2) difficulty in accessing well-characterized 

clinical samples, (3) getting access to EUA tests for use as a comparator 

test, and (4) gaining cooperation with international entities 7 

The first challenge manufacturers faced was uncertainty at the beginning 

of the outbreak about which sample type to use for molecular testing. For 

instance, the Zika virus had been found to be present longer in urine than 

in blood, but information on how long the virus could persist in different 

bodily fluids was still evolving making it difficult to develop diagnostic 

tests. 

6FDA authorized 13 molecular tests and 3 serologic tests. According to FDA officials, they 

revoked one test, and as a result, 15 diagnostic tests are currently authorized. 

7FDA recommends that manufacturers perform clinical evaluation studies that compare 

their tests to another ·'comparator" assay that is laboratory developed, an in-house test, or 

an EUA test 

Page4 GA0-17·612T 
21 


26480.007

Second, during the early stages of the outbreak there was a lack of wellcharacterized clinical samples for Zika virus diagnostic test development 

Several manufacturers told us that there were insufficient quantities of 

available samples, and samples that were available were expensive. 

Third, FDA recommends that manufacturers perform clinical evaluation 

studies that compare their new tests to another "comparator'' assay 

(test). 8 Similarly, a CDC document states that CDC should provide a 

consistent, fair, and transparent review process for all public-private 

initiatives, even during emergencies. According to CDC officials, the CDC 

developed EUA tests were not made available to some commercial 

manufacturers for use as comparator tests because these tests are 

distributed only to public health laboratories performing Zika virus clinical 

diagnoses. Moreover, according to CDC officials, in the early stage of the 

response CDC did not have the capacity to both adequately support 

public health laboratories and also supply commercial manufacturers with 

these tests. Ultimately, CDC distributed its tests to four manufacturers 

through technology transfers and we found that 2 of the 12 authorized 

molecular diagnostic test labels listed CDC's test as their comparator test 

However, one manufacturer told us their request to CDC for reagents to 

perform the CDC test as a comparator test was denied because they 

were a commercial manufacturer. CDC officials we spoke with were 

unclear of how the process to transfer authorized CDC tests to 

manufacturers originally started. Standards for Internal Control in the 

Federal Government state that agencies should document their 

operational processes to ensure that the organization meets its 

objectives' Without a clear and transparent process for distributing CDC 

diagnostic tests, CDC may not be able to support the development of 

capacity in the commercial sector to meet the needs during an outbreak. 

Fourth, interacting with international entities to obtain samples and 

perform testing presented challenges for manufacturers. For instance, 

foreign countries have different laws that must be followed. A 

manufacturer we interviewed tried to bring equipment to perform a 

diagnostic test into another country for testing but it faced challenges 

getting the necessary import license. 

was the first manufacturer to receive an EUA, and therefore the CDC test was the 

ftrst authorized molecular test to which other manufacturers attempting to get EUA could 

compare their tests 

9

GAO, Standards for Internal Control in the Federal Government, GA0~14-704G 

(Washington, D.C. September 2014). 

Page 5 GA0-17-612T 
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26480.008

We also found that some diagnostic test users faced challenges 

complying with equipment requirements to perform tests as specified in 

the EUA labels, and determining the most accurate test. Moreover, 

although CDC officials told us that all states had at least one public health 

laboratory that had the equipment to run a CDC test, representatives from 

several laboratories we interviewed told us they had to acquire specific 

new specialized equipment to be able to perform a certain EUA 

diagnostic test. 

An FDA document states that the agency should share information that is 

up-to-date, understandable, and easily accessible so diagnostic test 

users have some basis for choosing which medical products to purchase 

and use. We found that although performance characteristics are listed 

on individual diagnostic test labels, they are not available in a 

consolidated format. According to FDA officials, the agency began 

collecting information using reference samples because different 

manufacturers were using different types of samples and potentially 

different methods to determine the limit of detection of their tests. Until 

limit of detection data have been extracted and summarized from all the 

diagnostic test labels, it may be difficult and time-consuming for users to 

compare the performance characteristics and results of diagnostic tests. 

Another challenge users faced was that without knowing the identity of 

the comparator test, it was more difficult for them to compare 

performance characteristics across different diagnostic tests and 

determine the most appropriate test for them to use. Experts at our 

meeting agreed that identifying the comparator test would make it easier 

to compare the risks and benefits of different Zika virus diagnostic tests. 

An FDA document recommends a clear description of all methods used 

and how and what data were collected when performing comparison 

testing, including a description of the comparator test. When we 

compared product labels for different molecular tests, we found that while 

labels listed the type of test used for comparison, 6 of 12 product labels 

did not list the identity of the test used for comparison. FDA officials 

stated that the comparator test for authorized diagnostic tests can either 

be another authorized test or a validated reference method, and that 

manufacturers are not required to identify the comparator test used. FDA 

staff told us they are concerned that labels identifying comparator tests 

could be used to make inappropriate claims or be misinterpreted by end 

users. 

Standards for Internal Control in the Federal Government state that 

agencies are to communicate quality information externally through 

PageG GA0-17-612T 
23 


26480.009

reporting lines so that external parties can help an entity achieve its 

objectives and address related risks. CDC did not make publically 

available data comparing the performance characteristics of different 

CDC diagnostic tests that it distributed during the outbreak. CDC's 

website has information about the performance of its two authorized 

diagnostic tests but not the laboratory developed test it distributed. 

According to a HHS report, CDC did not provide information about one of 

its diagnostic tests because it could potentially create confusion and could 

have caused public health laboratories to discontinue use of an EUA test, 

and it had not done a comprehensive comparison of the two tests. 

Because CDC did not publicly provide performance information about its 

laboratory developed test-which was distributed to some public health 

laboratories-questions arose regarding the sensitivity of the two CDC 

tests. 

Representatives of three scientific professional societies told us that 

information about the development and verification of CDC's diagnostic 

tests should be made available to the scientific and medical communities. 

Access to such data would provide transparency and allow for optimal 

patient care, according to these representatives. According to these 

scientific professional societies' representatives, the lack of access to 

data regarding test performance prevented laboratory professionals from 

making informed decisions about which test to adopt or recommend 

during the outbreak. Without including information on the performance 

characteristics of tests it is distributing, CDC cannot ensure that 

healthcare providers and the public have the information they need to 

make informed decisions about which test is best for their use. 

In our May 2017 report we recommend that FDA consolidate information 

from individual diagnostic test labels and make it available in a form that 

enables diagnostic test users to more readily compare information across 

tests and require manufacturers of diagnostic tests to list the identity of 

comparator tests on their labels. We also recommend that CDC establish 

a transparent process to provide CDC diagnostic tests, on request, to 

manufacturers that are in the final stages of diagnostic test authorization, 

and include information on CDC-developed tests, including laboratory 

developed tests. HHS agreed with our recommendations for FDA to 

consolidate information about tests, require manufacturers to list the 

identity of the comparator assay, and that CDC establish a transparent 

process for distributing CDC-developed tests. In response to our 

recommendation to include information on CDC-developed tests 

distributed to public health laboratories, HHS partially concurred and 

provided clarifying information. HHS agreed that it should share 

Page 7 
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26480.010

Mosquito Control 

Methods Have 

Strengths and 

Limitations, and 

Federal Agencies Are 

Challenged in 

Assisting These 

Efforts 

information on CDC-developed tests that have received EUA. However, 

regarding this recommendation, HHS did not agree with our 

recommendation that it should share information on CDC's laboratorydeveloped tests that have not received EUA because CDC is unable to 

provide detailed information on characteristics of these unstandardized 

tests. We maintain that sharing information about these laboratory 

developed tests that are used for comparison testing is important 

because of the concerns that were raised regarding the sensitivity of one 

of CDC's EUA tests. We recognize that laboratory-developed tests that 

have not received EUA are not standardized, but we believe that CDC 

can provide certain information on the performance characteristics and 

quality of these tests based on its knowledge about these tests. Sharing 

this information could help other diagnostic test users make informed 

decisions about which test to adopt or recommend. HHS also noted that 

CDC does not distribute laboratory developed tests that have not 

received EUA but shares them with public health laboratories. In 

response to this comment, we modified our recommendation to reflect 

this information. 

Different types of mosquito control methods are available in the United 

States and each has strengths and limitations. The methods can be 

combined with surveillance of the mosquito population, using an 

integrated approach (i.e., pesticide use, traps, public education programs, 

and others) to optimize the application of multiple control methods. 

depending on knowledge of mosquito biology and distribution. 

Because Zika virus disease is not yet preventable by known drugs or 

vaccines, mosquito control is critical in mitigating risks associated with 

this disease. Mosquito control in the United States is implemented and 

overseen by state and local entities such as mosquito control districts and 

health agencies. CDC, through sources including the American Mosquito 

Control Association, identified over 900 entities in the United States that 

perform mosquito control; however, not all geographic areas in the United 

States are covered. Federal agencies may support such control entities 

with funding, subject matter expertise, and may regulate some control 

methods such as pesticides. 

The federal government has a limited and indirect role in supporting 

mosquito control efforts, which are mainly implemented at the state and 

local levels. According to CDC documentation, the agency developed 

technical guidance and provided funding and technical assistance to 

support state and local mosquito control activities. We identified four 

challenges the federal government faced in supporting these mosquito 

Page 8 GA0·17·612T 
25 


26480.011

control efforts during the Zika virus outbreaks: (1) timing of the availability 

of resources and sustaining expertise, (2) communicating information 

about current mosquito distribution, (3) linking the effects of mosquito 

control to disease outcomes, and (4) having limited infonmation about 

mosquito control entities. 

Federal agencies faced challenges related to the cyclic nature of 

mosquito-borne diseases, including recruiting and maintaining expertise. 

According to CDC, when the disease fades, the jobs and resources also 

go away, so that the next time the disease appears, staff must be 

retrained or new staff trained. CDC officials also told us that mosquito 

control needs vary with seasonal cycles, resulting in periods of several 

months that require more resources followed by some periods when little 

or no resources are needed. 

CDC also faced challenges in communicating the presence of mosquitoes 

in a manner that was clear and useful to different groups, such as 

mosquito control entities and the general public. CDC distributed maps of 

the estimated potential range of the primary Zika virus mosquito vectors 

on its webpages and in guidance, but imprecision in the maps can lead to 

confusion, according to some mosquito control officials. According to 

CDC officials, the maps allowed states to determine the level of effort 

needed for more precise mosquito surveillance as well as to show the 

public where they may encounter certain mosquito species. One 

mosquito control official told us of confusion about CDC's maps resulting 

from people failing to look at the qualifications stated in the map captions 

and mistakenly concluding that an entire state was infested with Zika 

virus vector mosquitoes. Further, detailed information about how the 

maps were created, including data sources and assumptions, was not 

posted on the CDC website or in documentation associated with the map. 

According to Standards for Internal Control in the Federal Government, 

management should use quality information to achieve the agency's 

objectives and should select appropriate methods to communicate 

externally the necessary quality information to achieve those objectives. 10 

This includes selecting appropriate methods to communicate externally, 

considering factors such as the intended recipients and the nature of the 

information being communicated. 

10GA0-14-704G. 

Page 9 GA0-17-612T 
26 


26480.012

Regarding information presented on CDC maps, experts we interviewed 

suggested including more details, such as collection records, measures of 

the stability of the mosquito populations, and areas of risk for 

transmission of mosquito-borne diseases. Without such context, CDC's 

maps could generate confusion about mosquito presence, resulting in 

concern among residents and public relations challenges, among other 

things. In our report we recommended that CDC provide details such as 

collection records, dates, and data limitations on posted and 

disseminated mosquito distribution maps to better inform mosquito control 

experts and the general public. HHS agreed with this recommendation. 

CDC faced challenges in determining whether mosquito control efforts 

are associated with the reduction of mosquito-borne disease. For 

example, mosquito control entity officials told us that the entities' 

mosquito control efforts are not directly linked to disease reduction. Other 

challenges to analyzing the relationships between mosquito control 

methods and disease reduction include the dependence of transmission 

on factors such as weather, human susceptibility, and immunity. 

CDC's capacity to develop a national strategy for mosquito control 

depends on its knowledge of mosquito control entities and their 

capabilities. We found that CDC relied on external sources to compile a 

list of mosquito control entities. CDC staff told us this list is likely to 

capture the larger, well-funded entities but may miss some smaller ones. 

Further, mosquito control capabilities in the United States vary by 

geographic area. A mosquito control official we interviewed agreed that 

variability in mosquito control entity capacities is significant. This 

variability makes it more challenging for CDC to determine the status of 

mosquito control efforts in different regions of the United States and to 

identify regions that may need technical guidance or assistance. 

In conclusion, federal agencies can provide important information that can 

help users compare diagnostic tests and assist mosquito control efforts 

implemented at the state and local levels. Information on performance 

characteristics presented in each diagnostic test product label was not 

consolidated across available tests, were not consistently reported for 

diagnostic tests, and the identity of the comparator test was not listed on 

some labels, making it difficult for users to make informed decisions about 

which test to use or recommend to patients. The information that CDC 

included in its maps did not include sufficient details about its estimates of 

potential distribution of mosquitoes that can carry the Zika virus, which 

Page 10 GA0-17-612T 
27 


26480.013

(101915) 

made it difficult for mosquito control experts and the public to correctly 

interpret and use such data. 

CDC developed the first two authorized diagnostic tests for the Zika virus 

and offers these tests to public health laboratories but not to some 

manufacturers. Such manufacturers additionally encountered difficulty 

acquiring authorized tests from other manufacturers. Without a clear and 

transparent process for distributing CDC-developed diagnostic tests to 

manufacturers, the agency may not be able to develop the capacity of the 

commercial sector to be able to meet the needs during an outbreak. 

Chairman Murphy, Ranking Member DeGette, and Members of the 

Subcommittee, this concludes my prepared statement. I would be happy 

to respond to any questions you may have. 

For questions about this statement, please contact Timothy M. Persons, 

Ph.D., Chief Scientist, at (202) 512-6412 or personst@gao.gov. Contact 

points for our Offices of Congressional Relations and Public Affairs may 

be found on the last page of this statement. Individuals making key 

contributions to this statement include Sushi! Sharma, Ph.D, Dr. PH, 

(Assistant Director), Ashley Grant, Ph.D, MPH, Hayden Huang, Ph.D., 

Amber Sinclair, Ph.D., and Penny Pickett, Ph.D. 

Page 11 GA0-17-612T 
28 


26480.014

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29 


26480.015

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l..j Please Print on Recycled Paper. 
30 

Mr. MURPHY. Thank you. 

Dr. Petersen, you’re recognized for 5 minutes. 

STATEMENT OF LYLE R. PETERSEN 

Dr. PETERSEN. Thank you, Chairman Murphy, Ranking Member 

DeGette, and members of the subcommittee, for the opportunity to 

discuss CDC’s response to the Zika virus outbreak. I’m Dr. Lyle Petersen, Director of the Division of Vector-Borne Diseases in CDC’s 

National Center for Emerging and Zoonotic Infectious Diseases. I 

also had the opportunity to serve as CDC’s Zika response incident 

manager throughout most of 2016, and I would like to make three 

key points to start. 

First, it has been almost 17 months since CDC activated its 

emergency operation center for Zika, and it is clear that this outbreak has resulted in CDC’s most complex emergency response to 

date. 

Second, we have accomplished a great deal very rapidly, in large 

part due to support in supplemental funding from Congress. However, we still have much to learn, and much remains to be done. 

Third, Zika remains a significant threat today, particularly to 

pregnant women and their infants. We need to remain ready for 

Zika and for mosquito-borne diseases in general as we expect more 

to emerge in the upcoming years. 

Looking at the response to date, we have learned a tremendous 

amount about a little known virus in a very short amount of time. 

First, we confirmed the link between Zika virus infection during 

pregnancy and severe birth defects, including microcephaly. Along 

with State and local territorial partners, we have begun to quantify 

the risk of birth defects, which we now know affects about 10 percent of fetuses exposed to Zika. We also discovered that Zika can 

be sexually transmitted, and we also have better information about 

the geographic range of mosquitoes that can spread Zika. The support efforts on the ground: CDC has provided $251 million in Zika-specific funding to State, local, and territorial health 

departments, as well as ongoing CDC technical assistance. 

I want to briefly turn to one of the most challenging aspects of 

the response: diagnostic testing for Zika. Because Zika’s impact on 

pregnancies can be devastating, CDC has recommended testing for 

all pregnant women who live in or have traveled to an area at risk 

for Zika. When the emergency response began in January 2016, 

women did not have access to even one Zika test authorized for 

clinical use. However, by March 2016, Emergency Use Authorizations were in place for two CDC-developed tests, allowing for distribution of these testing resources to State laboratories while also 

sharing information with manufacturers that were developing their 

own tests. CDC remains committed to improving Zika diagnostics, 

so that they’re faster and more accurate, and will continue to share 

information with public health and commercial laboratories as it 

becomes available. 

So, as we approach summer, it is impossible to predict with certainty what we will see in the way of local transmission of Zika. 

However, we anticipate that the Zika virus will continue to circulate indefinitely in most regions in the Americas where it has 

been introduced. We will undoubtedly continue to see pregnant 

31 

women test positive for Zika virus in both States and U.S. territories. 

We expect fewer Zika cases this year in some areas outside of the 

50 States, such as Puerto Rico, simply because a significant proportion of the population was infected in 2016 and is no longer susceptible to infection. 

Within the continental United States, local outbreaks remain 

possible, such as those seen in this past year in Florida and Texas. 

Any local outbreaks will, of course, be of deep concern, and we 

must be prepared for different scenarios, including more extensive 

transmission. 

Finally, we have learned to expect the unexpected when it comes 

to Zika. So it is critical to remain vigilant and sustain our response 

efforts. 

So, in closing, CDC, our sister agencies within HHS, and our 

partners have accomplished much, but we continue to face numerous challenges. One major challenge is to continue learning as 

much as we can about Zika. We know of the most devastating effect of microcephaly, but we need to follow the development of 

these babies to understand the full spectrum of long-term effects. 

Also, we can expect Zika to circulate for many years. So we must 

be prepared to scale up Zika prevention efforts at any time. Even 

after a Zika vaccine becomes available, other Zika prevention efforts, including surveillance and mosquito control, will be required. 

Lastly, the emergence of mosquito-borne diseases is accelerating. 

So we must address the threat of vector-borne diseases systematically and continually, rather than episodically and sporadically. 

Thank you again for the opportunity to appear before you today. 

[The prepared statement of Dr. Petersen follows:] 

32 


26480.016

May 23,2017 

Witness: Or, Lyle Petersen, Director, Division of Vector-Borne Diseases and former Zika Response 

Incident Manager 

Testimony: House Energy and Commerce Committee, Subcommittee on Oversight and Investigations 

Introduction 

Good morning Chairman Murphy, Ranking Member DeGette, and members of the 

Subcommittee. Thank you for the opportunity to testify before you today on the Centers for Disease 

Control and Prevention's (CDC's) ongoing efforts to prepare for and respond to the Zika virus outbreak, 

which continues to threaten the United States and the rest of the Americas. CDC is the nation's health 

protection agency, working 24-7 to save lives and protect people. 

It has been about 17 months since CDC first activated its Emergency Operations Center to 

protect the nation and U.S. territories against the threat of Zika. As the director for the Division for 

Vector-Borne Diseases for CDC's National Center for Emerging and Zoonotic Infectious Diseases, I had 

the opportunity to serve as the incident manager for the Zika response for most of 2016. This response 

has been the most complex emergency response to date. It has required expertise from across the 

agency, including experts in pregnancy and birth defects, mosquito control, laboratory science, travelers' 

health, virology, transfusion medicine, sexually transmitted diseases, and communication science. We 

have learned a great deal very rapidly about a surprising infectious disease. For the very first time, we 

have found that a virus transmitted through the bite from a mosquito can cause birth defects. However, 

we still have much to learn and Zika remains a significant threat, particularly to pregnant women and 

their infants. 

Thanks in significant part to the Zika supplemental funding provided by Congress, CDC has 

taken important steps forward. First, we established a causal link between Zika virus infection during 
33 


26480.017

pregnancy and microcephaly, including serious brain abnormalities. In early 2016, CDC established 

Zika pregnancy registries in collaboration with state, tribal, territorial, and local health departments to 

rapidly gather information about risks posed by Zika virus infection, including whether there are certain 

times during pregnancy when the risk of birth defects from exposure to Zika is greatest. These registries 

capture information about pregnant women with Zika and their babies. While the Zika pregnancy 

registries contain information on women who have been tested for Zika and are known to be infected, 

we know that not all pregnant women exposed to Zika will be tested during the relatively narrow time 

period when we can identify Zika infections. Therefore, CDC also established rapid birth defects 

surveillance to identify the same Zika-associated birth defects in babies whose mothers might not have 

been tested for Zika in the time period when maternal infection could be identified. The combination of 

the pregnancy registries and rapid birth defects surveillance are providing critical data for public health 

officials and clinicians, and these combined systems are the only way to identify all the babies affected 

by congenital Zika virus infection. 

We also determined that Zika infection can cause a form of paralysis known as Guillain-Barre 

Syndrome, which can also lead to respiratory failure and death if not treated aggressively. We found that 

in addition to being transmitted through the bite of a mosquito, Zika can also be sexually transmitted. 

CDC has been rapidly developing both molecular and serologic tests for Zika and received Emergency 

Use Authorizations (ElJA) from the Food and Drug Administration (FDA) for their clinical use. At the 

beginning of2016, no state had the capacity to test for Zika. Today, 49 states, D.C., and Puerto Rico 

have this testing capacity. Together with CDC's Laboratory Response Network, CDC has conducted 

over 160,000 Zika tests. CDC has also issued over 60 travel notices to inform the public, especially 

pregnant women, about international destinations and U.S. territories and states where Zika virus is 

circulating. 

2 
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26480.018

Partnerships with and support for state and local health departments has been essential to help 

address the threat of Zika. To date, CDC has provided $251 million in Zika-specific funding directly to 

state, local, and territorial health departments through grants. In addition to direct funding, CDC has 

awarded funding that directly supports state, local, and territorial efforts, including support to partner 

organizations, vector-borne disease regional centers of excellence, and the Puerto Rico Vector Control 

Unit. All of CDC's supplemental funds will be obligated by September 30, 2017. These financial 

resources arc coupled with technical support to states and territories through rapid response teams, as 

well as laboratory, epidemiologic, entomologic, field investigation, and data management support. In 

addition, CDC is providing on-going, in-depth support to Florida, Texas, and U.S. territories, where 

public health officials have found themselves battling local transmission of mosquito-borne Zika. 

Collaboration with our sister agencies has also been critical throughout this response. CDC has 

been working closely with multiple agencies within the Department of Health and Human Services, 

including the Office of the Assistant Secretary for Preparedness and Response (ASPR) and its 

Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of 

Health (NIH), and the FDA who are all here today. CDC is also working with partners across the U.S. 

Government, including the Department of State, the United States Agency for International 

Development (USA !D), the Department of Homeland Security (DHS), the Department of Veterans 

Affairs (VA), and the Environmental Protection Agency (EPA) to communicate with travelers and 

health care providers, update travel alerts and clinical guidance, further our understanding of the Zika 

virus, and develop improved mosquito-control methods. Finally, CDC has collaborated with a range of 

private sector and non-profit partners, including organizations ranging from the March of Dimes to 

public health associations, like the Association of State and Territorial Health Officials. 

3 
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26480.019

What We Expect in 2017 

It is impossible to predict with certainty what we will see in the way of local transmission of 

Zika, but here is what CDC's scientists anticipate: 

Zika virus will continue to circulate in most regions in the Americas where it has been 

introduced. 

Over the past year, an average of 30 to 40 pregnancies per week with laboratory evidence of 

possible Zika virus infection have been reported from the 50 states, and a much higher number 

from the U.S. territories. Dozens of new cases in pregnant women continue to be reported each 

week. 

We expect fewer Zika cases in 2017 in some areas outside of the continental U.S., such as Puerto 

Rico, because a significant proportion of the population was infected in 2016 and is no longer 

susceptible to infection. 

• Within the continental U.S., local outbreaks remain possible, such as those seen this past year in 

Florida and Texas. Zika outbreaks in the U.S. mainland may be localized due to protective 

factors like air conditioning, window screens, and less dense living conditions; however, we 

must be prepared for local outbreaks and different scenarios -- including more extensive 

transmission. 

There are about 40 million people traveling between the continental U.S. and Zika-affected areas 

each year. Therefore, all U.S.jurisdictions must continue to be prepared to evaluate, test, and 

manage patients with potential Zika virus infection, particularly pregnant women. 

With these expectations in mind, CDC continues to recommend that those living in areas of local 

Zika transmission and those traveling to areas of local Zika transmission take steps to prevent mosquito 

bites and prevent sexual transmission. At the request of state and local public health officials, CDC will 

4 
36 


26480.020

continue to send emergency response teams to states and territories with Zika outbreaks. CDC will also 

continue to provide reference and surge laboratory capacity for the nation; continue registries to track 

Zika-affcctcd pregnancies and births; help states deploy and target effective mosquito control; and 

support timely, accurate, and effective communications to the public and health care providers. In order 

to cultivate capacity and innovation in the area of vector control, CDC will work with our newly 

awarded vector-borne disease regional centers of excellence to generate the research, knowledge, and 

capacity needed to prepare the nation for ongoing vector threats, such as Zika. We will also collectively 

work with our commercial partners on diagnostic and vector control innovation. Finally, to help 

facilitate access to the specialty care that is needed by infants affected by Zika, CDC has established a 

provider referral network called Zika Care Connect that includes a hotline to help families find 

specialists and a website launched last month. Even when a vaccine becomes available and deployed, 

these CDC investments will remain critical to protect U.S. states and territories against Zika and other 

mosquito-borne threats. 

Zika Virus Diagnostic Testing 

The Zika virus has presented multiple diagnostic challenges, and while we have overcome some 

of these, several key challenges remain. 

One of our first challenges was that while Zika infection typically causes a mild illness or no 

symptoms at all, the impact of Zika on pregnancies can nonetheless be significant. Therefore, CDC 

currently recommends testing for all pregnant women who live in or travel to an area with risk of Zika 

that has a CDC Zika travel notice. At the beginning of the emergency response in January 2016, women 

did not have access to even one Zika test that was approved for clinical use. However, within three 

months of initiating the emergency response CDC received EUAs for both a molecular test (Zika nucleic 

acid test) to detect Zika in the first two weeks after infection and a serological test (lgM) to detect 

5 
37 


26480.021

infection for weeks to months after an infection. Once FDA authorized emergency use of these tests, 

CDC worked to distribute them rapidly to state laboratories and ensured state laboratories were 

proficient in their use, while also sharing information about test performance with manufacturers that 

were developing their own tests. This allowed others to benchmark their tests against the first FDAauthorized Zika tests. Today there arc 12 Zika nucleic acid tests with emergency use authorizations and 

49 state public health laboratories have Zika nucleic acid testing capacity. Forty-six states have the 

capacity to conduct CDC" s lgM test, known as MAC-ELISA, and two more IgM tests have since 

received EUAs. To further increase testing capacity at the height of demand in 2016, CDC arranged for 

referral labs to provide MAC-EUSA testing. These labs continue to provide Zika testing support, and 

now have the option of either using the MAC-ELISA or using commercially available tests now 

available under EUA. 

CDC remains committed to making ongoing improvements to Zika diagnostics and will continue 

to share information with public health and commercial laboratories about test performance for tests that 

arc approved for clinical use. Fortunately, FDA's EUA process allows for updates to be made to 

diagnostic tests as the scientific community makes discoveries that can be used to improve test 

performance. This ensures that clinicians have the best possible information to counsel their patients. As 

CDC has made these improvements, the Agency has worked to quickly update laboratory guidelines and 

notify public health partners and manufacturers of these changes. This includes updating the information 

on CDC diagnostic test inserts, the information posted on our website for CDC-developed tests that are 

FDA-authorized for distribution, and published and posted testing guidance. 

CDC also works with states to ensure that they have sufficient proficiency to perform CDC's 

tests. Additionally, CDC provided laboratory surge support to states and territories during periods of 

high testing volume, so that patients received information about their health status as quickly as 

6 
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26480.022

possible. This process has been a major challenge, but CDC remains committed to ongoing 

communication with and support of our public health partners in preventing the spread of Zika. 

Despite the progress CDC has made on the diagnostic landscape, there is still work to do. CDC 

will continue to work towards diagnostic test improvements that can detect current or recent Zika 

infection faster and with greater accuracy. This can help decrease the testing burden on the public health 

system and ensure that patients and their doctors have timely, accurate information. Additionally, 

sensitive serological tests are needed that can detect recent or previous Zika virus infection without 

cross-reacting with other flaviviruses, like dengue virus. This cross reactivity makes it difficult to 

counsel pregnant women about previous exposure to Zika virus. Finally, we need to better understand 

how long Zika virus can remain in body fluids such as blood and semen, which can inform our 

laboratory guidance as well as our prevention messaging. 

Tracking the Zika Virus 

As CDC continues to advance our ability to detect Zika in patients, we also continue to improve 

our ability to monitor the spread of Zika in communities. Zika virus is a nationally notifiable disease, 

meaning states and territories report cases of the virus to CDC. CDC conducts multi-faceted 

surveillance for Zika and other arboviruses through ArboNET, an integrated network that funds 49 

states, the Commonwealth of Puerto Rico, and six large municipalities to conduct human case 

investigations, collect and test mosquitoes, and perform laboratory analysis on arboviruses including 

Zika, through our Epidemiology and Laboratory Capacity cooperative agreement. Our most recent 

surveillance data show that we have documented 36,583 cases of Zika virus disease in the U.S. 

territories and 5,282 in U.S. states and DC. Of these cases, we have identified 224 cases ofZika in 

Florida and Texas due to local mosquito transmission. CDC has also documented 3,795pregnant women 

with laboratory evidence ofZika virus infection in U.S. territories and 1,845 in U.S. states and D.C. 

7 
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Of the nearly I ,000 births in 2016 recorded in the Zika pregnancy registries, 51 had a Zikaassociated birth defect, mostly serious brain abnormalities and microcephaly. CDC has found that 

among pregnant women with confirmed Zika virus infection, about 10 percent of their fetuses and 

babies were affected by serious Zika-associated birth defects, primarily serious damage to their brains. 

For those with Zika infections in the first trimester, 15 percent of fetuses and babies had Zika-associated 

birth defects. The Zika pregnancy registries have also allowed CDC to identify some gaps in care. 

Based on data reported to the registries, only about one in four babies born to women with Zika virus 

infection during pregnancy are receiving the recommended brain imaging after birth. Some brain 

abnormalities arc only identified with brain imaging, suggesting that the impact of Zika on babies born 

to mothers infected with the virus may be underestimated. 

In addition to monitoring the impact of Zika, CDC scientists are also monitoring the vector itself 

in order to better target prevention resources and best support state and local vector control efforts. 

Documenting the national and local range of mosquito species is an important public health activity 

because it can inform vector control activities, allowing for the selection of species-appropriate 

interventions. Zika virus is transmitted primarily by the Aedes aegypti mosquito, but also in some 

circumstances by other species such as the Aedes a/bopictus mosquito. Both of these mosquito species 

are spreading to new areas within the United States. Using county collection records, CDC has created 

maps that reflect which counties have documented these species and overlaid the best estimated range of 

these mosquitoes. However, because we must rely on voluntary county collection records of where 

mosquito species have been identified, we have been careful to caution the public that these maps rcf1cct 

our best estimate of where mosquitoes could potentially live. As CDC continues to publish additional 

information about the range of Aedes species mosquitoes, we will continue to communicate the 

limitations of these reports. Importantly, CDC's investment in the mosquito surveillance system 

MosquitoNet will allow for more extensive collection of this information, which is intended to improve 

8 
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the precision of our estimates and provide new information about insecticide resistance in communities 

across the country. 

Conclusion 

In closing, the emergence and reemergence of diseases spread by mosquitoes and other insects is 

exemplified but not limited to the present Zika outbreak. With the spread of the Aedes aegypti and other 

vector mosquito species, mosquito-borne outbreaks will continue and cannot be expected to occur in 

isolation of one another. The Commonwealth of Puerto Rico and Hawaii were already responding to 

outbreaks of dengue when Zika virus arose as an urgent public health threat. Alarmingly, the emergence 

of mosquito-borne diseases appears to be accelerating. Over the past few decades, we have seen a 

resurgence of dengue and the introduction and spread of West Nile virus, chikungunya virus, and now 

Zika virus into the Western Hemisphere. Out of the more than 200 known arboviruses in existence, CDC 

knows of 86 that can cause illness in people. It is very hard to determine which one might next cause an 

epidemic. However, we know that mosquito-borne diseases will continue to be introduced. Because of 

this, we need to address the threat of vector-borne diseases systematically, rather than episodically. 

Thank you again for the opportunity to appear before you today and for your support of our fight 

to protect the U.S. and its territories from the threat of Zika virus. I appreciate your attention to this 

continuing outbreak and 1 look forward to answering your questions. 

9 
41 

Mr. MURPHY. Thank you, Dr. Petersen. 

Dr. Borio, you’re recognized for 5 minutes. 

STATEMENT OF LUCIANA BORIO 

Dr. BORIO. Good morning, Chairman Murphy, Ranking Member 

DeGette, and members of the subcommittee. I greatly appreciate 

the opportunity to be here today and tell you about FDA’s ongoing 

actions to respond to the Zika virus outbreak. 

FDA plays a central role in the Nation’s response to public 

health emergencies. In addition to responding to Zika, our teams 

are fully engaged in responding to the H7N9 influenza virus that 

has emerged in China and the most recent outbreak of Ebola in the 

DRC. 

Since the 2009 influenza pandemic, multidisciplinary teams have 

worked collaboratively across the agency to respond to a number of 

public health crises. They bring vision, experience, and expertise to 

their work at hand, which, backed by FDA’s flexible regulatory 

framework, allows for us to make important contributions to global 

health security. So today I’m here to assure you that FDA remains 

fully engaged with our partners to help minimize the impact of 

Zika virus. 

We are focused on four work streams: supporting the expedited 

development and availability of diagnostic tests, investigational 

vaccines, and therapies; working to advance innovative strategies 

for vector control; keeping the Nation’s blood supply safe; and protecting the public from fraudulent products. And let me tell you 

more about some of these efforts. 

At the start of this outbreak, there were no clinical diagnostic 

tests for Zika available for use. We have worked urgently with our 

colleagues at the CDC to make Zika tests rapidly available. In February and March of 2016, FDA authorized the use of two CDC-developed tests under our Emergency Use Authorities. We also immediately began working interactively with interested commercial 

manufacturers. We granted an EUA for the first commercial test 

in April of 2016. 

FDA has taken several proactive steps to help advance the development and availability of Zika tests. We developed and made 

available to developers fillable forms that lay out the data requirements for an EUA. Our scientists generated reference materials to 

help developers assess the analytical performance of their molecular diagnostic tests. And our scientists in collaboration with both 

establishments are developing reference materials to help developers of serological tests. 

There’s some very complex scientific challenges associated with 

developing Zika diagnostic tests, as you heard from Dr. Petersen. 

This is especially true for serological tests designed to detect the 

presence of antibodies to Zika due to issues of cross-reactivity with 

other flaviviruses like dengue and yellow fever. FDA continues to 

work interactively with dozens of developers as they try to overcome these challenges. 

FDA has held more than 15 face-to-face meetings, 150 teleconferences, and more than 3,500 written exchanges with developers 

to help guide their programs. This highly interactive approach has 

been extremely successful. To date, we have authorized the use of 

42 

16 diagnostic tests for Zika. And even after an EUA is issued, FDA 

and developers continue to work interactively to optimize the authorized tests. We have issued 21 amendments to EUAs designed 

to improve product performance, and thanks to these efforts, a 

broad range of Zika tests with a broad range of performance are 

now available in laboratories throughout the U.S. 

As you heard from my colleague, Dr. Petersen, CDC projects that 

Zika will become established in the Americas, posing a continuing 

threat, especially to pregnant women. One of our highest priorities 

is to facilitate the development and availability of an effective vaccine. We are working closely with the NIH, BARDA, and the private sector on this, and there’s reason for optimism, with several 

vaccine’s candidates progressing at a rapidly expedited pace. 

In addition, FDA continues to work with blood collection establishments to protect the safety of the blood supply. In August of 

2016, after careful consideration of the evolving scientific and epidemiological data, we issued guidance recommending that all 

States and U.S. territories screen blood with an investigational 

screening test. 

We are very appreciative of blood collection establishments’ efforts to implement universal screening for Zika across the U.S. in 

a timely fashion. To date, the screening has been prevented nearly 

400 infected donations from entering the blood supply. 

The FDA remains fully committed to sustaining our deep engagement and aggressive activities to support a robust response to Zika. 

In closing, I would like to recognize and thank the more than 500 

staff members at the FDA who approached this work with incredible dedication, innovation, and expediency. Thank you, and I’m 

happy to answer your questions later. 

[The prepared statement of Dr. Borio follows:] 

43 


26480.025

TESTIMONY 

OF 

LUCIANA BORIO, M.D. 

CHIEF SCIENTIST (ACTING) 

FOOl) AND DRUG ADMINISTRATION 

DEPARTMENT OF HEALTH AND HlJMAN SERVICES 

BICFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

HOUSE ENERGY AND COMMERCE COMMITTEE 

lJ.S. HOUSE OF REPRESENTATIVES 

ll.S. PUBLIC HEALTH RESPONSE TO THE ZIKA VIRUS: CONTINUING 

CHALLENGES 

MAY23,2017 

RELEASE ONLY UPON DELIVERY 

U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

www 
44 


26480.026

INTRODUCTION 

Good morning Chairman Murphy, Ranking Member DeGettc, and members of the 

Subcommittee. lam Dr. Luciana Borio, Acting Chief Scientist at the Food and Drug 

Administration (FDA). Thank you for the opportunity to appear today to discuss FDA's actions 

in response to the Zika virus outbreak. 

Zika virus was first identified in 1947 in Uganda. Since then, sporadic cases and a few outbreaks 

have been recognized in a number of locations, including parts of Africa, Asia, and the Pacific. 

However, the situation has changed dramatically since May 2015, when the first local 

transmission of Zika virus in the Americas was confirmed in Brazil. According to the World 

Health Organization, fi·om 2015 through March 10,2017,61 countries and territories-including 

the United States, the Commonwealth of Puerto Rico, the U.S. Virgin Islands, and American 

Samoa-have had ongoing transmission following a new introduction of Zika virus or with a 

reintroduction into an area where transmission had been interrupted. 1 Additionally, 13 countries 

have reported evidence of person-to-person transmission, 31 countries or territories have 

reported microcephaly and other central nervous system malformations that arc potentially 

associated with Zika virus infection, and 23 countries or territories have reported an increase in 

the incidence of Guillain-Barre Syndrome (GBS) or laboratory confirmation of Zika virus 

infection among GBS cases. 1 

1 WHO Zika Virus Situation Report, 1 0 March 2017: http://apps.who.int/irislbitstrcam/J 0665/25471411 lzikasitrep I OMar 17-

eng.pdr?ua:::::J 

--2 
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In the United States, there have been 5,282 Zika virus disease cases reported in the states [5,010 

cases in travelers returning from affected areas, 224 cases acquired through presumed local 

mosquito-borne transmission in Florida (218 cases) and Texas (6 cases), and 48 cases acquired 

through other routes, including sexual transmission] and 36,583 Zika virus disease cases reported 

in the US territories [143 cases in travelers returning from affected areas and 36,440 cases 

acquired through presumed local mosquito-borne transmission] as of May 17, 20172 As of May 

09,2017, there are 1,845 pregnant women in the states and District of Columbia and 3,795 

pregnant women in the US territories with laboratory-reported evidence of possible Zika virus 

infection 3 

FDA RESPONSE TO THE ZIKA VIRUS OUTBREAK 

FDA has taken several steps to rapidly respond to the Zika virus outbreak and remains actively 

engaged with other components ofthe Department of Health and Human Services (HHS)--

including the Office of the Assistant Secretary for Preparedness and Response (ASPR) and its 

Biomedical Advanced Research and Development Authority (BARD A), the National Institutes 

of Health (NIH), and the Centers for Disease Control and Prevention (CDC)-as well as with 

partners across the U.S. Government, the private sector, and the international community to 

minimize the impact of this outbreak. FDA's primary areas of activity include: (I) supporting the 

development and availability of diagnostic tests that may be useful for identifying the presence 

of, or prior exposure to, Zika virus; (2) providing advice and consultation to facilitate rapid 

development of investigational vaccines and therapeutics; (3) advancing the use of innovative 

2 CDC 2017 Case Counts in the US; https://wvv\v.cdc.gov/zika!geo/unitcd-states.html2016 Case Counts in the US; 

https://www.cdc.gov/zika/rcporting/2016~case~counts.html, and 2015 Case Counts in the US; 

hnps://v.,.'\vw.cdc. gov!zikalreporting/20 15-case-counts.html. 

J CDC Pregnant Women with Any Laboratory Evidence of Possible Zika Virus Infection in the United States and Territories; 

https://w\V\v.cdc.gov/zikalgeo/pregwomen~uscases.html 

--3 
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strategies under FDA's regulatory authorities to help suppress the population ofZika viruscarrying mosquitoes; (4) protecting the public from fraudulent products that claim to prevent, 

diagnose, treat, or cure Zika virus disease; and (5) protecting the safety of the nation's blood 

supply and human cells, tissues, and cellular and tissue-based products (such as corneas, bone, 

skin, heart valves, and semen) used for medical, surgical, or reproductive procedures. 

Diagnostic Tests 

At the start of the Zika virus outbreak in the Americas, there were no diagnostic tests for the 

detection of Zika virus authorized for use in the United States. FDA worked with CDC, which 

was developing diagnostic tests, to make Zika diagnostic tests rapidly available. FDA was able 

to authorize the usc of two CDC tests under FDA's Emergency Usc Authorization (EUA) 

authority in February and March of2016. FDA also-in keeping with FDA's normal practice for 

responding to emerging infectious disease outbreaks-reached out to diagnostic manufacturers to 

encourage them to develop needed diagnostic tests for Zika virus. FDA immediately began 

working interactively with manufacturers interested in developing diagnostic tests for Zika virus 

to help accelerate development programs-including clarifying EUA data requirements for the 

Zika diagnostic tests-and to ensure that their tests are properly validated before they are used to 

inform patient care. FDA granted an EUA for the first commercial test in April 2016. 

FDA has taken several proactive steps to help advance the development of diagnostic tests for 

Zika virus. For example, FDA developed and made available EUA review templates delineating 

data requirements for a Zika virus diagnostic EUA. FDA has fulfilled more than l 00 requests for 

the EUA templates. In addition, to help Zika diagnostic manufacturers develop nucleic acid 

testing-based diagnostic devices, FDA created Zika virus reference materials that are available to 

--4 
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Zika diagnostic manufacturers that have a pre-EUA submission with FDA and have established 

the analytical performance of their assay. 4 FDA has fulfilled 17 requests for the reference 

materials. 

FDA has continued to work interactively with Zika virus diagnostic manufacturers throughout 

the product development process to address scientific challenges, review data, and provide 

feedback based on the latest available scientific information. For example, FDA has had more 

than 15 face-to-face meetings, 150 teleconferences, and more than 3,500 emails with diagnostic 

developers or Zika experts to suppo1i the development of Zika diagnostics. This collaboration 

has been extremely successful, and to date, FDA has authorized the use of sixteen diagnostic 

tests for Zika virus under FDA's EUA authority-13 nucleic acid testing-based tests to diagnose 

active infection (12 of which are currently availab!e5

) and 3 serological tests to assess whether 

individuals who may have recently been exposed to Zika had actually been infected. It is 

important to note that, as a result of these efforts, diagnostic tests for Zika virus arc now 

available in laboratories throughout the United States including automated, high throughput tests. 

The serological tests to assess whether individuals who may have been exposed to Zika recently 

had actually been infected are especially important for women given the link between Zika virus 

infection and congenital Zika syndrome, including microcephaly and other birth defects, in 

babies of mothers who were infected with Zika virus during their pregnancy. 

FDA continues to work with diagnostic manufacturers once their tests are authorized under EUA 

to further product development, improve product performance, and make sure that authorized 

4 FDA has created an email account specifically for requesting the EUA review templates (CDRH~ZIKA~ 

Temp!ates@fda.hhs.gov), 

5 Atthc request of Roche Molecular Systems, Inc., on March 13, 2017, FDA revoked the EUA for emergency use of the 

company's LightAfix:.__iD Zika rRT-PCR Tesl that was issued on 26 August 2016, reducing the number of tests to diagnose active 

infection to 12. 

--5 
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tests continue to meet EUA standards and public health needs. For example, FDA has issued 21 

amendments to EUAs for the authorized Zika diagnostic tests-upon request from the product 

manufacturers-to add additional instruments or specimen types for testing. In addition, FDA is 

continuing to work to help advance the development of diagnostic tests for Zika virus. For 

example, FDA is supporting the validation and usc of a World Health Organization reference 

panel to be developed into an international standard for serological assays. FDA also monitors 

the performance of Zika diagnostic tests authorized under EUA and works with manufacturers 

and laboratory personnel to quickly resolve any issues that may arise. Toward that end, FDA has 

established an email account that laboratory personnel using Zika diagnostic assays under EUA 

are encouraged to use to report performance concerns directly to FDA (CDRII-EUAReporting@fda.hhs.gov ), in addition to reporting concerns to the manufacturer. 

All information about diagnostic tests for Zika virus authorized under EUA, such as letters of 

authorization, labeling that includes the tests' performance data, and fact sheets for patients and 

health care providers, arc readily available on the FDA wcbsitc.6 

Vaccines and Therapies 

There are no vaccines or treatments for Zika virus at this time. Development programs are in the 

relatively early stages, but several vaccine candidates continue to progress at an expedited pace. 

FDA is actively engaged with NIH and BARDA, the international community, and product 

developers to help accelerate development programs. FDA is working with medical product 

developers to provide technical support and clarify regulatory and data requirements necessary to 

move products forward in development as quickly as possible. One of our highest priorities is to 

facilitate the development and availability of an effective Zika virus vaccine as quickly as 

6 Zika Virus Emergency Use Authorizations; https://\v\vw.fda.gov/MedicaiDevices/Safcty/ErnergencvSituations/ucml6l496.htm#zika 

--6 
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possible and we are working closely with NIH, BARD A, CDC, and the private sector on this. 

Although therapeutic development proposals are generally at an earlier stage than for vaccines, 

FDA has also engaged in preliminary discussions of potential approaches to the development of 

therapeutics and is open to ongoing interactions to provide input on such development proposals. 

Vector Control 

In the United States, mosquito control is typically achieved by a multi-faceted approach that 

relies on a range of tools, including surveillance of mosquito activity, reduction in breeding sites, 

and the use of chemical and biological control methods. FDA's involvement in mosquito control 

is through the oversight of products that help suppress the population of virus-carrying 

mosquitoes that fall under FDA's regulatory authorities. With respect to Zika virus, there has 

been public discussion of a new method to potentially help control mosquito populations through 

the use of a genetically engineered (GE) line of the mosquito Aedes aegypti (OX513A) 

developed by Oxitec, Ltd. The release of male Oxitec GE mosquitoes is intended to cause 

suppression of the mosquito population in a release area over time because the offspring 

resulting from the mating of male GE mosquitoes with wild-type females do not develop to 

adulthood. 

FDA reviewed information in an Investigational New Animal Drug (INAD) file from Oxitec Ltd. 

regarding the potential use of the company's GE mosquito with the intent of suppressing the 

population of Aedes aegypti mosquitoes at the release site in Key Haven, Florida.7 On August 5, 

2016, FDA completed the environmental review for a proposed field trial ofOxitec's GE 

7 FDA ordinarily cannot acknowledge or discuss INAD files due to confidentiality concerns; however FDA is able 

to do so in this case because Oxitec has publicly announced that they have opened an INAD file. 

--7 
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mosquitoes in Key Haven, Florida, and published a final environmental assessment-or EAand finding of no significant impact-or FONSI-stating that the proposed field trial will not 

have significant impacts on the environment. This enabled the field trial to proceed, provided all 

other local, state, and federal requirements arc met. Ultimately, Oxitec, together with its local 

partner, the Florida Keys Mosquito Control District, decided not move forward with the Key 

Haven field trial as the result of a November 8, 20 I 6, referendum on the use of GE mosquitoes 

that found Key Haven residents did not support the trial. Since then, FDA and Oxitec have 

maintained an open line of communication and FDA stands ready to promptly review any 

submissions should, for example, Oxitcc decide to pursue a field trial in another location. 

Meanwhile, in January 2017, FDA issued draft guidance (developed in coordination with the 

Environmental Protection Agency (EPA)) that clarifies that mosquito-related products intended 

to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for 

population control purposes arc not "drugs" under the Federal Food, Drug, and Cosmetic Act 

(FD&C Act). If the guidance is finalized, these products will be regulated by EPA as 

"pesticides" under the Federal Insecticide, Fungicide, and Rodenticide Act. FDA would continue 

to have jurisdiction over mosquito-related products that otherwise meet the FD&C Act drug 

definition, such as those intended to prevent, treat, or cure a disease or to reduce the viral or 

pathogen load in a mosquito. The 30-day public comment period for the draft guidance closed on 

February 21, 2017. FDA is currently considering the comments. 

Fraudulent Product Claims 

Unfortunately, during emerging infectious disease outbreaks such as this, fraudulent products 

that claim to prevent, treat. or cure a disease frequently appear on the market. FDA is actively 

--8 
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monitoring for fraudulent products and false product claims related to Zika virus and will 

implement enforcement actions, as warranted, to protect the public health. 

Blood Supply aud Tissue Safety 

One of FDA's first actions in response to the Zika virus outbreak was to take important steps to 

help protect the safety of the blood supply. FDA issued guidance in February 2016 that 

recommended the deferral of individuals from donating blood if they had been to areas with 

active Zika virus transmission, were potentially exposed to the virus, or had a confirmed 

infection. The guidance also recommended that areas with active Zika virus transmission, like 

Puerto Rico, obtain whole blood and blood components from areas of the United States without 

active virus transmission until a blood donor screening test for Zika virus became available to 

ensure the safety of their blood supply. Until blood donor screening tests for Zika virus became 

available, HHS arranged for and funded shipments of blood products from the continental United 

States to Puerto Rico to ensure an adequate supply of safe blood for its residents during this 

interim period. Concomitantly, FDA worked closely with the test kit developers in a highly 

accelerated time frame to make available the first investigational test for blood screening in 

March 2016. The availability of this investigational test, which has been in use in Puerto Rico 

since early April 2016, enabled blood establishments to resume safe blood collection in areas 

with active Zika virus transmission. A second investigational blood screening test was made 

available in June 2016. Together, these tests enabled blood donor screening to be put in place 

across the United States where active Zika virus transmission was established as well as in areas 

where local virus transmission was anticipated, helping to maintain an adequate and safe blood 

supply. 

--9 
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In August 2016, after careful consideration of the evolving scientific and epidemiologic data 

(including the significant number of travel-associated cases of Zika across the continental US), 

consultation with other public health agencies, and taking into consideration the potential serious 

health consequences of Zika virus infection to pregnant women and children born to women 

exposed to Zika virus during pregnancy, FDA issued updated guidance recommending that all 

states and U.S. territories screen blood with an approved investigational blood screening test. 

The guidance recommended a staggered implementation of blood screening across the nation, 

with immediate implementation in states and territories with one or more locally-acquired 

mosquito-borne cases of Zika virus, implementation within four weeks in states with proximity 

to areas with locally-acquired Zika virus cases or other epidemiological linkages to Zika virus 

(such as a high number of travel-associated Zika cases), and implementation within 12 weeks in 

all other states and territories. 

FDA worked with blood collection establishments to facilitate implementation of the revised 

guidance across the U.S. and its territories. As of May 2, 2017, 376 presumptive viremic blood 

donations have been prevented from entering the blood supply in the United States and its 

territories. 8 

FDA is continuing to monitor the evolving scientific and epidemiologic data on Zika virus and 

will update its guidance for blood donor testing as necessary based on additional information that 

may become available that would support reassessing the blood donor testing situation while 

adequately protecting the blood supply. 

8 CDC Zika Virus Case Counts in the US; https://www.cdc.gov/zika/geo/united-states.html 

--10 
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Zika virus also poses a risk for transmission by human cells, tissues, and cellular and tissuebased products (HCT/Ps) such as corneas, bone, skin, heart valves, and semen used for medical, 

surgical, or reproductive procedures. Because of this risk, FDA issued guidance in February 

2016 recommending that donors ofHCT/Ps be considered ineligible if they were diagnosed with 

Zika virus infection, were in an area with active Zika virus transmission, or had sex with a male 

with either of those risk factors, within the past six months. FDA is continuing to assess the 

evolving scientific and epidemiologic data on Zika virus as well as supporting research to help 

better understand the persistence of Zika virus in cells and tissues, and will update its guidance if 

necessary to better reduce the risk of Zika virus transmission through HCT/Ps used for medical, 

surgical, or reproductive procedures. 

CONCLUSION 

FDA is fully committed to remaining highly responsive and adaptive to the complex range of 

issues the Zika vims outbreak has presented and will continue to present. Developing the 

medical products necessary to help bring this outbreak under control is highly complex and will 

require a sustained effort. Close cooperation and collaboration within FDA, within the U.S. 

Government, with our international partners, and with product developers is essential to help 

facilitate the development and availability of medical products to respond to Zika virus as 

quickly as possible. FDA is wholly prepared to leverage its authorities to the fullest extent 

practicable to help accelerate the development and availability of safe and effective products 

with the potential to help mitigate the Zika virus outbreak as quickly as the science will allow. 

Thank you. I am happy to answer your questions. 

--11 
54 

Mr. MURPHY. Thank you, Dr. Borio. 

Dr. Fauci you’re recognized for 5 minutes. 

STATEMENT OF ANTHONY S. FAUCI 

Dr. FAUCI. Mr. Chairman, Ranking Member DeGette, Vice Chairman Griffith, members of the committee, thank you for giving me 

the opportunity to present to you today in a few minutes the role 

of the NIH research endeavor in addressing the Zika outbreak. I 

have some visuals that I’ll show if we can get them up. 

As you know, I have testified about Zika before this committee 

before, and what I outlined for you was that the NIH’s responsibility ranges from the fundamental basic research, clinical research, expansion of research capacity with the ultimate goal in 

mind to develop the countermeasures that we have been discussing 

thus far in the form of diagnostics, therapeutics, and vaccines. 

With regard to diagnostics, the CDC, as you had mentioned and 

that Dr. Petersen responded, is primarily responsible for on-theground development rapidly of diagnostics that could address this 

outbreak. However, the NIH’s role in that is to try and develop a 

pipeline of rapid, specific, low-cost diagnostic tools that are delineated on this slide. 

[Slide shown.] 

They’re divided into a few subgroups. The first are molecular 

tests to detect the presence of the virus itself in a highly sensitive 

and specific manner. The second are serological tests, which are 

the most problematic, namely to detect the immune response of 

someone who has already been infected and to distinguish that immune response to infections to other flaviviruses, such as dengue. 

And, third, research resources, namely to make reagents and viral 

strains available to our collaborators throughout the world. 

[Slide shown.] 

In addition, we’re responsible for clinical research. I will give you 

one example of that, and that has to do with the Zika in Infants 

and Pregnancy, or ZIP, study in which we are performing in collaboration with the Fiocruz Institute in Brazil. 

[Slide shown.] 

It is a prospective cohort study observational of 10,000 pregnant 

women, following them for the incidence of Zika infection, following 

their pregnancies to determine the incidence of involvement of the 

fetus with congenital abnormalities, and then following birth to follow the infants for at least 1 year of age. 

[Slide shown.] 

However, probably the most important and impactful of what we 

do is the development of a vaccine. 

[Slide shown.] 

Now, this slide shows five candidate vaccines that are in various 

levels of development for Zika. The first one that is on the slide is 

the DNA vaccine. I want to caution the committee that just because something is temporally ahead of something else in development doesn’t necessarily mean it is going to ultimately turn out to 

be the best vaccine. But we have been fortunate because we have 

been able to rapidly put several of these into trial, and I want to 

just mention one of these for the purposes of the discussion this 

morning. And that is the DNA vaccine. 

55 

[Slide shown.] 

This is a vaccine that is a 21st century version of vaccinology; 

namely, we no longer isolate the virus, grow it and activate it or 

attenuate it, but we use molecular biological techniques. 

On this slide is shown how a DNA vaccine works. You get a circular piece of DNA, which is referred to as a plasmid. You insert 

a gene of a particular protein that you want to make an immune 

response to, and you then inject that into an individual, and then 

what happens is that, in response, a virus-like particle is formed, 

and the body makes a good immune response. 

[Slide shown.] 

On March 2nd of 2016, I testified before this committee that we 

were still in animal model, and I said that we would get into a 

human phase 1 trial very likely by the fall of 2016. And, in fact, 

we did in September and then again in December, showing that the 

vaccine was safe, and it induced the kind of response that you 

would at least predict would be protective. 

We also said we hoped to get into a phase 2 trial by the first 

quarter of 2017. 

[Slide shown.] 

And, in fact, at the end of March of this year, we actually initiated a phase 2 trial, first in Texas and Puerto Rico, and then, in 

the next few months, we’re going to advance this into the countries 

shown by the red dots on the slide. We have a flexible capability 

so that, if there are outbreaks in one country more than the other, 

we’ll be able to divert the resources to be able to get the vaccine 

deployed in an area where there is an outbreak. 

Now there’s no guarantee that this is going to be effective or that 

there are going to be enough cases to at least prove that it is effective, but we are at least on time in our endeavor, and I would hope 

that, as we follow up on this in the coming year or so, we will be 

able to come back to this committee and say that we do, in fact, 

have a safe and effective vaccine. 

I’ll stop there, Mr. Chairman, and be happy to answer questions 

later. Thank you. 

[The prepared statement and slide presentation of Dr. Fauci follow:] 

56 


26480.036

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

NATIONAL INSTITUTES OF HEALTH 

Research Conducted and Supported by the National Institutes of Health (NIH) 

in Addressing Zika Virus Disease 

Testimony before the 

House Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations 

Anthony S. Fauci, M.D. 

Director 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health 

May 23,2017 
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26480.037

Mr. Chairman, Ranking Member DeGette, and Members of the Subcommittee: 

Thank you for the opportunity to discuss the ongoing National Institutes of Health (NIH) 

research response to Zika virus. I direct the National Institute of Allergy and Infectious Diseases 

(NIAID), the lead NIH institute for conducting and supporting research on emerging andreemerging infectious diseases that pose threats to public health. NIAID funds a comprehensive 

research portfolio, from basic studies of the mechanisms of disease, to applied and clinical 

research focused on developing interventions such as diagnostics, therapeutics, and vaccines. We 

have a dual mandate to support research on established disease threats and to respond rapidly to 

newly emerging and re-emerging infectious diseases. 

Emerging and re-emerging disease threats are perpetual challenges, in part due to the 

inherent capacity of microbial pathogens to evolve rapidly and adapt to new ecological niches. 

NIAID anticipates and responds to these threats by leveraging fundamental, basic research; 

mobilizing domestic and international research infrastructure; and partnering with governments, 

non-governmental and multilateral organizations, academia, and industry, both nationally and 

internationally. 

I am pleased to be able to discuss with you our research efforts to protect the American 

people from Zika virus. 

OVERVIEW OF ZIKA VIRUS 

Zika virus is a flavivirus. These viruses typically are transmitted by mosquitoes or ticks 

and often can spread quickly to new geographic locations due to the abundance of these vectors. 

Other well-known flaviviruses include dengue virus and yellow fever virus; like Zika, these 

viruses are transmitted by Aedes mosquitoes. Zika virus, first identified in monkeys in Uganda in 

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1947, is endemic to Africa and Southeast Asia; however, it recently has spread to other parts of 

the world. An unprecedented Zika outbreak began in Brazil in May 2015 and has spread 

throughout South and Central America and into the United States. Widespread local transmission 

has occurred in U.S. territories including Puerto Rico, and limited local transmission has 

occurred in areas of Florida and Texas. Although recent Zika case reports in the Americas have 

decreased from the unprecedented spread of the virus in 2015 and 2016, continued transmission 

of Zika virus to a greater or lesser degree is expected throughout the western hemisphere. 

While infections caused by Zika virus are usually asymptomatic, about 20 percent of 

infected individuals experience mild clinical symptoms such as fever, rash, muscle and joint 

pain, and conjunctivitis (red eyes). Increases in cases of Guillain-Barre Syndrome, a rare, acute, 

immune-mediated peripheral nerve disease that leads to weakness, sometimes paralysis, and 

infrequently, respiratory failure and death, also have been noted in association with Zika 

outbreaks in Brazil and elsewhere. Of most concern, the recent outbreaks of Zika virus disease 

have coincided with a marked increase in the number of infants born with microcephaly, a birth 

defect characterized by an abnormally small head resulting from an underdeveloped and/or 

damaged brain. Recent studies have conclusively shown that Zika virus causes microcephaly in 

infants, as well as an array of congenital abnormalities such as eye defects, hearing loss, 

impaired grO\vth, seizures, difficulty moving limbs, and other complications known collectively 

as congenital Zika syndrome. Although it has been established that Zika infection during 

pregnancy can cause congenital Zika syndrome in the infant, further research is needed to better 

understand the disease and how to prevent it. Currently, no FDA-licensed vaccines or specific 

therapeutics arc available to prevent or treat Zika virus disease. Improved diagnostic tests also 

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arc needed as Zika virus infection can be difficult to diagnose and distinguish clinically from 

other mosquito-borne infections, such as dengue, West Nile, and chikungunya. 

DEVELOPING COUNTERMEASURES TO COMBAT ZIKA VIRUS 

NIAID has responded to the Zika epidemic by accelerating ongoing flavivirus research 

efforts to speed the development of biomedical tools that could help control current and future 

outbreaks of Zika virus. 

Vaccines 

A safe and effective Zika vaccine would be an invaluable tool to help stop the spread of 

infection and prevent future outbreaks. NIAID is developing and investigating multiple Zika 

vaccine candidates, including vaccines based on technologies that have shown promise against 

other flaviviruses. The NIAID Vaccine Research Center (VRC) has developed a candidate DNAbased Zika vaccine akin to a West Nile virus vaccine that we previously developed. The DNAbased Zika vaccine candidate entered a Phase I clinical trial in 2016, and initial study results 

indicate that the vaccine is safe and induces an immune response in the range that would predict 

that it would protect against Zika virus. NIAID launched a multi-site Phase 2a/2b clinical trial of 

this vaccine in March 2017 that aims to enroll at least 2,490 healthy participants in various sites 

in the Americas, including the continental United States and Puerto Rico, Brazil, Peru, Costa 

Rica, Panama, and Mexico. The trial will further evaluate whether the experimental vaccine is 

safe and able to stimulate an adequate immune response, and importantly whether it can prevent 

disease in areas with ongoing mosquito-borne Zika transmission. 

NIAID scientists also are developing live-attenuated Zika vaccine candidates using an 

approach similar to that taken with an experimental vaccine against the closely related dengue 

virus. This vaccine candidate will enter an NIAlD Phase l trial in late 20 !7. Another version of 

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this approach, an experimental vaccine designed to protect against Zika and all four circulating 

strains of dengue virus, is scheduled to enter clinical testing by 2018. NIAID is working with 

academic partners in Brazil to plan later-stage trials of this combination vaccine referred to as a 

chimeric vaccine. 

NlAID also is collaborating with the Biomedical Advanced Research and Development 

Authority (BARDA) and the Walter Reed Army Institute of Research (WRAIR) to evaluate a 

Zika purified inactivated vaccine (ZPlV) candidate. Multiple Phase 1 clinical trials of ZPIV 

began in November 2016 in several U.S. sites. 

NIAID-supported researchers also arc evaluating investigational mRNA vaccines, which 

arc broadly similar to DNA vaccines. The NIA!D VRC is working with academic and industry 

partners to evaluate various mRNA vaccine technologies to identify potential candidates for 

further development. These include an investigational vaccine under development by the NIAlD 

VRC and a pharmaceutical company that may enter clinical trials in late 2017. 

NIAID grantees also are in the early stages of developing a Zika virus vaccine candidate 

based on a recombinant vesicular stomatitis virus the same animal virus used successfully to 

create an investigational Ebola vaccine. This Zika vaccine construct will be evaluated in tissue 

culture and animal models. NIA!D is supporting diverse early-stage Zika vaccine strategies to 

maximize our chances of success in rapidly reaching the goal of a licensed vaccine. 

While these multiple approaches are promising, it is important to realize that the 

development of investigational vaccines and the clinical testing required to establish their safety 

and effectiveness take time. The pace of these trials in reaching a conclusion will depend on both 

the inherent effectiveness of the vaccine and the amount of Zika virus transmission near clinical 

trial sites. If a Zika outbreak occurs during the phase 2a/2b vaccine trial, it is conceivable that we 

4 
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will have an indication of whether the vaccine works within l to 1.5 years. However, with the 

recent decline in Zika cases across the Americas, Zika vaccine clinical trials may require more 

time to discern whether the vaccine candidates are successful in preventing Zika virus infection. 

While we have begun clinical testing of several Zika vaccine candidates, a safe, effective, and 

fully licensed Zika vaccine likely will not be available for several years. 

Therapeutics 

NIA!D has accelerated its program originally designed to screen for antiviral drugs with 

activity against viruses in the flavivirus family, including dengue, West Nile, yellow fever, and 

Japanese encephalitis viruses, as well as the closely related hepatitis C virus. N1AID has 

enhanced these efforts by developing an assay to test compounds for antiviral activity against 

Zika virus, and has made this test readily available to the broader research community. As of 

April 30, 2017, NIAID has tested 679 antiviral molecules and identified 39 compounds with high 

or moderate activity against Zika virus. Promising drug candidates identified by this assay are 

being further tested in animal models of Zika virus infection developed with NIAID support. For 

example, N1AID evaluated BCX4430, a broad-spectrum antiviral drug originally developed by a 

pharmaceutical company as a candidate therapeutic for Ebola and Marburg viruses, and found 

that the drug protected mice and non-human primates from Zika virus. 

NlA!D-supportcd researchers also have identified a human antibody, ZlK V -117, that 

neutralizes multiple strains of the Zika virus. ZlKV- 1 17 reduces levels of the virus in 

reproductive tissues and decreases fetal disease in a pregnant mouse model of Zika infection, 

suggesting that such broadly neutralizing Zika antibodies could be used to treat or prevent Zika 

virus infection in humans. 

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Diagnostics 

Accurate diagnostic tests are needed to distinguish Zika virus infection from other 

flavivirus infections and to identify women who have been infected with Zika virus during 

pregnancy and may be at risk of having an infant with fetal complications. Currently, molecular 

diagnostic tests for viral RNA can detect Zika virus during the acute phase of infection and for a 

limited period after the onset of symptoms. After this limited period, prior infection can be 

detected by testing for the presence of antibodies against Zika virus. However, assays for Zika 

antibodies also may detect or cross-react with antibodies against other flaviviruses, particularly 

dengue virus. For this reason, a positive antibody test does not definitively confirm prior Zika 

virus infection, particularly in geographic areas with ongoing dengue virus infection. In cases of 

possible co-infection or prior infection with dengue and other related viruses, separate 

confirmatory testing is required. This is a particular concern in South America, where people 

have a high level of exposure to other mosquito-borne viruses, especially dengue and 

chikungunya. 

NIAID is facilitating the development of improved Zika virus diagnostic tests through 

support for NIAID investigators and grantees working to generate antibodies and recombinant 

protein antigens that can be used to distinguish between Zika virus and dengue virus. Studies 

also arc underway to create new diagnostic methods that simultaneously measure antibody 

responses to several flaviviruses to clearly distinguish which virus caused a recent infection. In 

addition, NIAID grantees are working to identify unique biosignatures for Zika infection that 

could form the basis of other rapid diagnostic tests. 

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IMPROVING UNDERSTANDING OF ZIKA VIRUS TRANSMISSION 

NIAID conducts and supports research on the natural history and transmission of Zika 

virus. These studies will increase our understanding of the effects of Zika virus during pregnancy 

and help identify strategies to limit mosquito-borne transmission of the virus. 

Natural History 

NIAID is partnering with the Eunice Kennedy S'hriver National Institute of Child Health 

and Human Development, the National Institute of Environmental! Iealth Sciences, and the 

Brazilian research institute Fiocruz to study the link between Zika infection and adverse 

outcomes such as the congenital Zika syndrome. This study, Zika in Infants and Pregnancy 

(ZIP), is a multi-center, international, prospective study of 10,000 women in Zika-affected 

regions. Enrollment of women early in their pregnancy is ongoing, and their children will be 

followed for at least one year after birth. The information gained from this study will help 

improve our understanding of congenital Zika syndrome, enhance care for pregnant women and 

their infants, and guide interventions for affected children. 

Vector Control 

For many years, NJAID has supported extensive research on the biology of mosquitoes to 

help develop tools to limit the spread of deadly mosquito-borne diseases such as dengue and 

malaria. This research informs vector control strategies to reduce mosquito bites or limit 

mosquito populations. In the Americas, Zika virus is transmitted primarily by Aedes aegypti 

mosquitoes, and vector control or other methods to prevent exposure to these mosquitoes are 

currently the only ways to prevent Zika infection. 

NIAID is supporting vector competence studies to test various mosquito species for their 

ability to carry and transmit Zika virus, as well as research to prevent resistance of mosquitoes to 

7 
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26480.044

insecticides and identify the emergence of resistance early so it can be managed appropriately. 

Understanding the specific mosquito species involved in Zika outbreaks and which insecticides 

may be effective against them will aid current vector control efforts. In addition, NIAID is 

supporting innovative vector control research, including evaluation of novel repellents, mosquito 

traps. and the use of bacterial symhionts to affect mosquito biology and reproduction. 

CONCLUSION 

NIH is committed to robust collaborations with partners across the U.S. government, 

academia, and industry to further advance research to address Zika virus infection. As part of its 

mission to respond rapidly to emerging and re-emerging infectious diseases globally, NIAID is 

elucidating the biology of Zika virus and developing tools to diagnose, treat, and prevent disease 

caused by this virus. As a high priority, NIA ID will continue to pursue the development of safe 

and effective vaccines and therapeutics against Zika virus. All of these efforts will expand our 

understanding of this current public health threat, improve our preparedness for the next 

emerging infectious disease outbreak, and continue to provide evidence-based strategies to 

promote public health. 

8 

26480.111

Hearing of the House Energy and Commerce, Oversight and Investigat

Subcommittee 

'& 

The Role of the 

ational Institutes of Health 

IIIII 1n IIIII searc 

ika 

ress1n 

IIIII 1rus 

Anthony S. Fauci, M.D. 

Director 

National Institute of Allergy 

and Infectious Diseases 

National Institutes of Health 

May 23,2017 

Infectious 

26480.112

Therapeutics 

Vaccines 

Novel Vector Control 

Expansion 

Researc

Capacity 

Clinical 

Research 

26480.113

Therapeutics 

Vaccines 

Novel Vector Control 

Expansion o

Research 

Capacity 

Clinical 

Research 

26480.114

NIAID Zika Diagnostics Research 

Goal: Development of rapid, specific, low-cost 

diagnostic tools, e.g. 

Molecular tests 

- To detect the presence of the virus itself in a 

highly sensitive and specific manner 

• Serological tests 

-To detect the immune response (usually 

antibody) to the virus and distinguish from 

responses to other flaviviruses 

Research resources 

- Reagents and viral strains made available to 

collaborators 

26480.115

Therapeutics Novel Vector Control 

Vaccines 

26480.116

Zika in Infants and Pregnancy (ZIP) 

Study 

- ." •. 

Sponsored NIH Oswaldo .,> .. f:l Cruz Foundation (F1ocruz) of >' 

Brazil 

Prospective cohort study of 10,000 r.:: ..... ., ..... Nllf'"'r"'..,""' pregnant women 

Following women for incidence of 

Zika infection 

Following infants through at least 

one year of age 

Key endpoints: pregnancy 

outcomes, congenital anomalies, 

other developmental abnormalities 

26480.117

Therapeutics 

...----..,..-------, 

Novel Vector Control 

Expansion 

Researc

Capacity 

Clinical 

Research 

26480.118

NIH Zika Vaccine Candidates 

DNA vaccine (NIAID VRC) 

• Zika purified inactivated vaccine 

(WRAIRINIAID/BARDA and Sanofi Pasteur) 

• Live-attenuated Zika/dengue chimeric 

virus (NIAID intramurai/Butantan) 

mRNA vaccine candidate (NIAID VRC, 

GSK) 

• Vesicular Stomatitis Virus vectored 

vaccine (NIAID extramural) 

26480.119

NIH Zika Vaccine Candidates 

I DNA vaccine (NIAID VRC) 

- 

• Zika purified inactivated vaccine 

(WRAIRINIAID/BARDA and Sanofi Pasteur) 

• Live-attenuated Zika/dengue chimeric 

virus (NIAID intramurai/Butantan) 

mRNA vaccine candidate (NIAID VRC, 

GSK) 

• Vesicular Stomatitis Virus vectored 

vaccine (NIAID extramural) 

26480.120

DNA Vaccine Approach 

Gene encoding 

surface protein 

from Zika virus 

Inject DNA 

containing 

Zika gene 

Body's cells 

produce virus-l

particles, the ba

of the vaccin

26480.121

Zika DNA Vaccine Timeline 

2016 

CYQ1 Q2 

I I 

Q3 

I 

Q4 

I 

2017 

Q1 Q2 Q3 Q4 

I I I I 

Intramural NIAIO and partnerships 

2018 

Q1 Q2 Q3 Q

I I I 

Extramural NIAID and partn

26480.122

Phase 212b: ZIKV DNA Vaccine 

andidate 

VRC 705: A Phase 2/2b, 

Randomized, 

Placebo-Controlled Trial to 

Evaluate the Safety and 

lmmunogenicity of a Zika 

Virus DNA Vaccine, 

VRC-ZKADNAOSS-00-VP 

30+ sites in the US, 

Caribbean, Central and 

South America 

Launched March 31, 2017 
77 

Mr. MURPHY. Thank you, Dr. Fauci. 

Dr. Bright, you’re recognized for 5 minutes. 

STATEMENT OF RICK A. BRIGHT 

Dr. BRIGHT. Good morning, Chairman Murphy, Ranking Member 

DeGette, and distinguished members of the subcommittee. I’m Dr. 

Rick Bright, the Director of the Biomedical Advanced Research and 

Development Authority, otherwise known as BARDA. I’m also the 

Deputy Assistant Secretary for Preparedness and Response in the 

Office of the Assistant Secretary for Preparedness and Response, or 

the ASPR, within the U.S. Department of Health and Human Services. 

I appreciate the opportunity to speak with you today. This is the 

first opportunity I have had to testify since being named the 

BARDA Director last November. 

As a component of ASPR, BARDA was established to aid in securing our Nation from chemical, biological, radiological and nuclear threats as well as from pandemic influenza and other emerging infectious diseases. 

BARDA supports the transition of medical countermeasures, 

such as vaccines, drugs, and diagnostics, from research stages 

through advanced development toward consideration for approval 

by the FDA and often into the Strategic National Stockpile. Our 

mission is accomplished through the successful public-private partnerships with industry to share the risk, improve efficiency, and 

accelerate development, all while sustaining the marketplace for 

countermeasures that are vital for our national security. 

BARDA also collaborates and coordinates very closely with our 

Federal colleagues through the participation in the Public Health 

Emergency Medical Countermeasures Enterprise, which is chaired 

by the HHS ASPR. To support the overall HHS response to Zika, 

BARDA has established three goals to address medical countermeasure gaps: first, the prevention of Zika virus infection through 

the development of safe and effective vaccines; second, for the rapid 

detection of infection through the development of diagnostics; and, 

third, to ensure a safe blood supply by the development of screening tests for Zika and technologies that will inactivate pathogens 

in donated blood products. 

For diagnostics, our goal is to stimulate and accelerate the development of rapid and accurate serological tests. BARDA has 

partnered with five companies to support these tests. Some of these 

tests are laboratory based, and some of these tests are for pointof-care use. 

BARDA is also supporting the development of two tests that are 

now being used under an FDA investigational new drug protocol to 

screen Zika virus in donated blood. BARDA is also supporting the 

development of four Zika vaccine candidates. One candidate began 

as a collaboration between BARDA, the U.S. Department of Defense, and NIAID. And it is currently in multiple clinical trials. 

This candidate has now transitioned to an industry partner for further development. 

To introduce additional innovation into this outbreak, we are 

also supporting the development of a vaccine candidate that is 

based on a novel messenger RNA platform that is now in clinical 

78 

trials. This is a new vaccine platform that has potential to develop 

and produce vaccines rapidly. This is essential for an effective response to emerging threats. 

Funding from Congress has been critical for our response to Zika. 

However, additional support will be needed to continue our 

progress. There is great value in keeping multiple candidates in 

the pipeline to increase the chance of success. Looking ahead, also 

having a Federal emergency response fund would contribute to a 

rapid medical countermeasure response for future public health 

threats. 

BARDA and ASPR are committed to using innovative technologies and innovative contractual tools to accomplish our mission. 

A nimble and flexible, yet consistent and transparent approach is 

critical to successful public-private partnerships, not only to address the early valley of death, but also to address challenges of 

market entry and sustainability that our industry partners face 

when products are approved. It is important to sustain capacity, capability, and partnerships with the private sector to be ready and 

able to respond when we confront threats to our national security 

and public health. 

Mr. Chairman, ASPR and BARDA are working with HHS colleagues, our interagency colleagues, and our private sector partners 

to prepare our Nation for range of national security and public 

health threats. Medical countermeasure development is a long, 

complicated, and a high-risk process. BARDA is greatly appreciative of the resources and authorities that Congress has provided 

to us to accomplish its mission. I look forward to working with 

members of this subcommittee and your congressional colleagues. 

I’m grateful for the opportunity to address you today, and I’m 

happy to take your questions. 

[The prepared statement of Dr. Bright follows:] 

79 


26480.045

Written Testimony 

Committee on Energy and 

Subcommittee on Oversight 

Investigations 

Zika Virus Outbreak and Response 

Statement of 

Rick A. Bright, PhD 

Deputy Assistant Secretary for and and 

Director of the Biomedical Advanced Research 

Authority 

Office of the Assistant for Preparedness and 

U.S. De artment of Health and Human Services 

For Release on Delivery 

Expected at 10:00 a.m. May 23,2017 
80 


26480.046

Good morning, Chairman Murphy, Ranking Member DeGette, and distinguished members of the 

House Energy and Commerce Subcommittee on Oversight and Investigations. I am Dr. Rick 

Bright, Director of the Biomedical Advanced Research and Development Authority (BARDA) 

and Deputy Assistant Secretary for Preparedness and Response in the Office of the Assistant 

Secretary for Preparedness and Response (ASPR). I appreciate the opportunity to speak with 

you today, the first opportunity I have had to testify since being named the BARD A director in 

November 2016. After spending a number of years developing influenza vaccines and 

therapeutics at the Centers for Disease Control and Prevention (CDC) and working in senior 

management positions in the biopharmaceutical industry, I joined BARD A in 2010. Before 

assuming the director role, I served in various roles in BARDA that focused on the development 

of vaccines, therapeutics, and diagnostics and as the director of the Division of Influenza and 

Emerging Infectious Diseases. My experience in medical countermeasure development in 

government, non-government organizations, and industry provide a firm foundation for my role 

as the BARD A director. 

As a component of ASPR, BARD A was established in 2006 under the Pandemic and AllHazards Preparedness Act (PAHPA). BARDA has a role in securing our nation from chemical, 

biological, radiological, nuclear, pandemic influenza and emerging infectious disease threats by 

supporting the transition of medical countermeasure candidates from early development across 

the "Valley of Death" and into advanced research and development towards an application for 

approval by the Food and Drug Administration (FDA). BARD A executes this mission by 

providing push and pull incentives to stimulate a robust pipeline of medical countermeasures for 

these threats and by forming public-private partnerships with industry to reduce risk, improve 

2 
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efficiency and sustain a marketplace for development and procurement of these countermeasures. 

BARD A is comprised of a staff of highly skilled, technical experts, many of whom have decades 

of experience in the pharmaceutical industry. Since 2006, we have established partnerships with 

over l 00 pharmaceutical and biotechnology companies and more than 25 academic and other 

institutions. 

BARD A has established an array of specialized core services to support medical countermeasure 

advanced development efforts. These services facilitate access to experienced subject matter 

experts in a variety of disciplines germane to product development (such as clinical trial strategy 

and execution, regulatory sciences, quality control and quality assurance, production process 

engineering). BARDA also provides leadership by collaborating with HHS partners in animal 

model development and preclinical laboratories, by maintaining a clinical studies network (a 

network of companies to formulate and fill vaccines into final containers), and through 

BARD A's Centers for Innovation in Advanced Development and Manufacturing (CIADM). 

These national assets, known collectively as BARDA's National Medical Countenneasures 

Response Infrastructure, support BARDA's core mission of promoting biodefense product 

development and enhance BARD A's response capability. These capabilities are currently being 

leveraged for the Zika response in a similar way as they supported the response to Ebola and 

pandemic inf1uenza. 

BARD A collaborates strategically with its U.S. Government colleagues around medical 

countermeasure development through participation in the Public Health Emergency Medical 

Countermeasures Enterprise (PHEMCE). The PHEMCE, chaired by the ASPR, is a standing 
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26480.048

virtual enterprise that coordinates the entire life cycle associated with the development and 

procurement of medical countermeasures for these emergency public health threats. It engages 

all of the key Federal departments and agencies that develop, procure, or distribute these 

important medical countermeasures and was created to improve coordination and collaboration 

within the Department and with our external stakeholders including nonprofits, other Federal 

departments, the private sector, and the international community. 

Against this backdrop and overarching objectives for Zika response, BARDA established four 

strategic goals to address the medical countermeasure needs for the domestic and global Zika 

response. These are prevention of Zika virus infection through safe and effective vaccines; 

detection of acute and previous Zika virus infections through rapid diagnostics; ensuring a safe 

blood supply from Zika virus through screening and virus inactivation; and activation of our 

National Medical Countermeasure Response Infrastructure to assist in the development of 

medical countermeasures for Zika. 

With funds provided from Congress in fiscal years 2016 and 2017, we have contributed to the 

overall HHS response to Zika by supporting the development of new Zika-specific vaccine 

candidates; vaccine platform technologies that will be able to address multiple emerging 

infectious diseases; development of rapid serological diagnostics to determine whether someone, 

including pregnant women and their male partners, has been infected recently with the Zika 

virus; tests to screen the blood supply for presence of Zika virus; and pathogen reduction 

technologies that will inactivate Zika virus and other pathogens in donated blood to reduce the 

risk of Zika virus transmission through blood transfusions. 

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26480.049

In February 2016, BARDA participated, with its U.S. Government colleagues, in drafting 

aligned strategies for development of vaccines and diagnostics for Zika. For diagnostics, our 

goal was to stimulate and accelerate the development of diagnostic tests to speed the availability 

of results and inform people of their Zika virus exposure. We rapidly modified our Broad 

Agency Announcement to allow us to receive proposals to address this requirement. The 

response from industry was robust. Compiling funds received from repurposed Ebola 

appropriations with other sources of funding, BARD A awarded four contracts during the 

summer of 2016 for the development of Zika diagnostics that would determine whether people 

have had recent exposure to Zika. Industry partners currently supported by BARD A include 

lnBios and DiaSorin to develop a laboratory-based serological test to detect lgM antibodies 

(indicating recent infection), and OraSure and Chembio to develop a point-of-care diagnostic test 

that would allow for rapid results for the clinician and patient. Two of these companies have 

received Emergency Use Authorizations from the FDA for their Zika test: lnBios for their ZIKV 

Detect lgM Capture ELISA and DiaSorin for their LIAISON XL Zika Capture IgM Assay. In 

addition, BARD A, in close coordination with CDC, addressed a critical barrier for diagnostic 

developers by collecting blood specimens that contained Zika virus to create well-characterized 

panels for use in assessing how well the tests perform. 

BARD A's role in addressing the blood supply shortage in Pue1to Rico is another notable success 

story. On February 16,2016, the FDA issued Zika-rclated blood donor guidance recommending, 

among other things, that areas with active Zika virus transmission, like Puerto Rico, obtain 

whole blood and blood components for transfusion from areas of the United States without active 

Zika virus transmission unless a blood donor screening test for Zika virus is used. Additionally, 
84 


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the guidance recommended the deferral of individuals from donating blood if they have been to 

areas with active transmission such as Puerto Rico, potentially have been exposed to Zika, or 

have had a confirmed Zika virus infection. Because there were no blood donor screening tests 

available for Zika virus at that time, BARDA worked with CDC, FDA, and the Office of the 

Assistant Secretary of Health (OASH) to define requirements, conduct market research, obtain 

legal advice, and award a contract to transport blood products from the U.S. mainland to Puerto 

Rico to avoid a blood product shortage until a blood donor screening test became available. 

With BARDA's financial support, Roche Molecular Systems was able to test blood donations 

from Puerto Rico starting April2016 under their FDA approved investigational ZIKV nucleic 

acid test. This entire process was completed in only six business days after being notified of the 

impending blood product shortage. This is just one of many examples of progress made possible 

thanks to our response-based programs and close collaboration with our colleagues across the 

Department. 

BARD A has been working closely with our government and industry partners to identify and 

develop Zika vaccine candidates. BARD A hosts a carefully designed program, called 

Tech Watch, that invites any individual or company to request a meeting with BARD A through 

our medicalcountermeasures.gov website. Our Tech Watch program serves two primary 

functions: first to inform and communicate our medical countermeasure requirements to 

potential industry partners and second, to learn about medical countermeasure candidates that are 

in development. BARDA has hosted several Tech Watch "marathons" to engage with companies 

that are developing Zika vaccine, therapeutic, and diagnostic candidates. BARD A is able to 

provide subject matter expertise, advice, and referrals at these engagements. Some of these 

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meetings lead to the submission of a white paper or proposal to BARD A to consider advanced 

development support of the specific candidate. 

One essential function of BARD A is to work with industry partners to guide product candidates 

across advanced development towards an application for FDA approval. As it currently stands, 

many of the Zika vaccine candidates that are supported by BARDA are in the early stages of or 

making progress towards clinical development. Among these candidates, Sanofi Pasteur, 

Takeda, and the Institute Butantan are working on whole virus inactivated vaccine candidates. 

This is a more traditional, conservative approach to development of a vaccine type that has 

shown to be successful for other flaviruses, such as the Japanese encephalitis vaccine. This 

vaccine approach has been used for many vaccines and has a proven track record for safety and 

immunogenicity. The vaccine being developed by Sanofi Pasteur is an extension of a 

collaboration that started with the Department of Defense's Walter Reed Army Institute of 

Research (WRAIR), the National Institute of Allergy and Infectious Diseases (NIAID) and 

BARD A. Sanofi Pasteur is in the process of licensing this technology from WRAIR. The initial 

vaccine, developed by WRAIR. is currently in several Phase I clinical trials in the United States 

that are being funded by NIAID and WRAIR. Takeda is also making good progress in the 

development and production of its Zika vaccine candidate and is planning to start its first Phase 1 

clinical trial this fall. The Institute Butantan, based in Sao Paulo Brazil, has received BARDA's 

support to develop a Zika vaccine for use in Brazil and other countries. This partnership builds 

on a past successful collaboration with Butantan on the development and production of influenza 

vaccines. 

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BARD A is also working with Moderna to develop a Zika vaccine based upon its novel 

messenger RNA (mRNA) platform. This is an exciting new vaccine platform that has the 

potential to rapidly develop and produce vaccines at a large scale-which is essential for 

response to emerging threats. Modcrna recently published encouraging clinical data using this 

platform for an influenza vaccine candidate and, with BARDA's collaboration, it is currently 

conducting Phase 1/2 clinical trials that will assess the safety and immunogenieity of its vaccine 

candidate for Zika. Moderna is also expanding and optimizing its vaccine manufacturing scale 

to produce vaccine in preparation for later stage clinical studies. 

Clinical efficacy trials for Zika vaccine candidates pose an added challenge. One objective of 

such trials is to collect data to support that a vaccine is safe and effective at preventing infection 

from Zika virus. However, at this point in time, the Zika virus has already spread through major 

urban centers in Brazil, throughout Puerto Rico, and other regions in Central America. This 

means that many people have already been exposed to the Zika virus and are likely already 

immune to reinfection. In order to conduct large-scale efficacy clinical trials for Zika vaccines, 

it is important to pre-position clinical sites where we assess that there may still be a significant 

population naive to Zika but also where the virus is likely to appear. Thus, it can lead to a chase 

of the virus around the globe. Our BARD A modelers, in elose coordination with CDC and NIH, 

arc working to estimate where Zika may appear next. This work is informing our clinical and 

regulatory strategies and options to consider as we progress with vaccine development. 

The funds that BARD A has received to date have been put to work to accelerate the development 

of Zika vaccines, diagnostics, and methods to ensure a safe blood supply. While these funds 
87 


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were instrumental in pushing these candidates into initial clinical trials, additional funding is 

needed to suppoti Phase 3 clinical trials for the most promising Zika vaccine candidates, At 

BARD A, we know the value of having multiple candidates in the pipeline to reduce the 

development risk and increase the chance of getting one or more vaccines to the finish line, 

With Zika virus, we continue to learn new things about the virus and the disease that it causes 

almost every week, Now is the time to keep the development pressure strong, to remove any 

barriers to rapid development and clinical evaluation of these vaccines, and to strive to have a 

vaccine that can be used to address any outbreak of Zika virus in the near future, Our ultimate 

goal is to have a vaccine available that will prevent anyone from getting infected with Zika virus, 

This could have a significant impact on preventing the outcomes we are now seeing from babies 

born to mothers who have been infected with Zika during pregnancy, BARDA and ASPR are 

committed to using innovative contractual methods, such as other transactional authorities, while 

exploring more flexible incentives and financial tools, A nimble and flexible approach is 

critical to address both the "Valley of Death" between basic research and advanced development, 

as well as the challenges that our development partners in industry may face when their products 

are licensed or cleared and enter the market. 

The challenges ahead for Zika virus medical countermeasures include those inherent with 

flaviviruses, an unpredictable virus that could make both clinical development and sustaining an 

eventual market for countermeasures difficult. The creation of a Federal Emergency Response 

Fund could enable rapid response to public health outbreaks, Zika is once again a reminder of 

the challenges we seem to increasingly face in response to emerging diseases, Every day of 

delay in an emergency response can often be measured by I ives lost or a negative impact on our 

9 
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health or societal stability. Our efforts on Zika virus vaccines and diagnostics have shown once 

again that the BARD A model is very effective for a rapid medical countermeasure development 

response. 

Mr. Chairman, ASPR and BARD A are working with our HHS and interagency colleagues and 

our private sector partners to prepare our nation for a range of public health threats. We are 

making efficient use of the resources Congress has provided and we are making investments and 

progress as transparent as possible considering proprietary and contractual obligations. This is a 

long and complicated process, but rest assured, we are up for the challenge. I look forward to 

working with members of this committee and your Congressional colleagues as l IHS continues 

its response to Zika. 

10 
89 

Mr. MURPHY. Thank you. 

That is quite a bit of knowledge here. So let me recognize myself 

for 5 minutes to start this process. 

Dr. Fauci, I guess you have been around since 1968, working 

through about eight Presidents here. So you may have learned a 

thing or two about this, but I just wonder, how did the pace of this 

progress on Zika vaccine compare with how quickly vaccines were 

developed for some of the other viruses? 

Dr. FAUCI. Thank you for that question, Mr. Chairman. It actually is the fastest that we have done, because, if you look at the 

time from either the isolation of a pathogen or sequencing of it— 

so that you could do a molecular biological approach to the vaccine—Zika is the fastest we have done in history. It is about 3 

months from the time that we actually had the sequence that we 

started putting it into an animal situation. So we really, from the 

standpoint of the development of a vaccine, which, as you know, 

with all the things that we have to go through with a vaccine, it 

takes some time to ultimately get the product, but to hit the 

ground running from the microbe to the actual vaccine in a preclinical is the quickest we have ever done. 

Mr. MURPHY. You also said in your testimony you require more 

time because of the recent decline in Zika case trials across the 

Americas. What kind of statistical power do you need here to give 

you enough numbers on clinical trials? Are you advancing with 

enough cases here? 

Dr. FAUCI. Yes. When you look at the activity that’s going on 

right now, it would probably take a much longer period of time. It 

is a combination of the statistical power of the end with the 

amount of time that it would take to get it. So, if you have X number of cases a year, you may take 4 or 5 years to get it. If you get 

those amount of cases in a particular period of time, like a few 

months—for example, if there’s an outbreak in Puerto Rico as we 

get into the summer of this coming year in Puerto Rico, we may 

get enough cases to be able to get an efficacy signal. If there’s not, 

then we may need to wait a longer period of time. 

It is a combination of the more effective the vaccine is and the 

more number of cases, those both come together. If you have you 

a really effective vaccine and a modest number of cases, then you 

get your efficacy signal. 

Mr. MURPHY. Would this likely then move toward approval for 

the Emergency Use Authorization of the FDA? 

Dr. FAUCI. Well, that really depends, because if you get a good 

enough signal, you could get Expanded Access; you might not even 

need to use an Emergency Use Authorization. It really depends on 

the data and the robustness of the data. 

Mr. MURPHY. Let me quickly ask another question here, because 

we focus a lot on neonatal and prenatal development, et cetera. 

Any news on studies on men and the impact of Zika virus on men? 

Dr. FAUCI. Well, we’re continuing to study. As you are I’m sure 

aware, there was a study that showed, in adult mice, that there’s 

an effect on the testes with oligospermia and testicular atrophy. 

Right now, there’s no indication that that’s the case of an adult 

male human who gets infected, but we’re doing prospective studies 

now in individuals, and that’s related to determining the persistVerDate Mar 15 2010 11:18 Dec 13, 2017 Jkt 037690 PO 00000 Frm 00093 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X34ZIKAASKOK121117\115X34ZIKAPENDING WAYNE
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ence of Zika in the semen. And you could do two studies. You could 

see if there’s Zika in the semen, and you could also do sperm 

counts. So we’ll be able to know if, in fact, infected individuals have 

a degree of oligospermia. But that’s something that we’re looking 

at in the future. 

Mr. MURPHY. I appreciate that. 

Dr. Petersen, according to an internal CDC investigative report, 

the CDC Chief of Diagnostic and Reference Activity in the 

Arboviral Disease Branch, who had become a whistleblower about 

the CDC’s promotion of the trioplex test for Zika, was moved from 

that position by DVBD leadership in May 2016. You’re the Director 

of DVBD, and the branch is a part of your division. Why was the 

CDC expert whistleblower moved out of his position in the middle 

of the Zika emergency response, and why was he then reinstated 

as Chief in July of 2016? 

Dr. PETERSEN. Thank you for that question. I cannot speak to 

personnel issues, but I can present a little bit of background about 

the situation. 

There was some discussion among our scientists about the analytic sensitivity of the CDC trioplex test versus a laboratory-developed test known as the monoplex test, and at the time, the trioplex 

test had actually been EUA approved and was already being distributed to State public health laboratories and laboratories within 

the laboratory response network. So that test had been distributed 

already. 

An investigation was done into the whistleblower complaint by 

an independent panel with our Office of Laboratory Safety and 

Science. And that panel concluded that there was no wrongdoing 

on the part of CDC. Those results were reviewed by HHS and the 

Office of General Counsel, which came to the same conclusion. 

In the end, we had to make a very rapid decision because there 

were many women wanting test results. We decided to stay with 

the trioplex. In the end, it turned out that the trioplex, when tested 

with a larger panel of samples, was actually an extremely good 

test, in fact, one of the best out there. 

Mr. MURPHY. Thank you. I’m out of time. 

Ms. DeGette, you’re recognized for 5 minutes. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

As I said in my opening remarks, I’m really interested both in 

our position going into the 2017 mosquito and travel season, but 

also our preparedness in the future. 

Dr. Persons, in your audit, you found that agencies like the CDC 

and FDA face a number of challenges when it came to addressing 

the Zika threat. One of the challenges is that the Federal Government had insufficient modeling capability for predicting the spread 

of the Zika virus. Is that correct? 

Dr. PERSONS. Yes. 

Ms. DEGETTE. And you also found that the CDC and its public 

health partner agencies faced challenges in establishing and implementing Zika surveillance systems. Is that correct? 

Dr. PERSONS. Yes. 

Ms. DEGETTE. And, also, Dr. Persons, your audit found that authorized diagnostic tests used for the Zika virus outbreak in the 

91 

U.S. varied in both their performance and operational characteristics. Is that right? 

Dr. PERSONS. Yes. 

Ms. DEGETTE. Now, we’re facing an increased array of pandemic 

threats: Ebola, avian flu, dengue, and now Zika. Although Zika is 

a unique virus, those challenges that we faced last year suggest the 

need for better preparedness overall. I’m concerned that what these 

things I just talked about have grave implications for our overall 

preparedness posture. 

I’m wondering if you can comment briefly about what the broader implications of the challenges on Zika are as they relate to the 

overall preparedness and where we need to still look at having preparedness for other infectious diseases that might come along. 

Dr. PERSONS. Yes, thanks, Ms. DeGette, for the question. As I 

think our study showed, Zika is a key issue at this point and another case, but it is still one of a type. So it is a pattern, as you 

all had pointed out. I think what is necessary is a more proactive 

framework for emerging infectious diseases that will include perhaps the idea of perhaps establishing a case definition earlier on, 

as soon as you can maybe iterate on that, rather than waiting until 

things happen here in the U.S. and that has to develop and we 

have sort of a U.S. stamp on that. 

Another thing is just getting data and information as quickly as 

possible about the accuracy and the limitations of reliable diagnostic tests. It also will be important to have evidence for diagnostic users or practitioners to have that, practitioners would be including scientists as well as clinicians, and certainly, whenever 

there’s a mosquito- or vector-borne disease like this one, I think 

we’re going to need to have more proactive standing infrastructure 

in terms of dealing with mosquito control. 

Ms. DEGETTE. Dr. Petersen, does your agency feel like those are 

good recommendations and we can use those in the future? 

Dr. PETERSEN. Those were very good recommendations. We certainly need a more proactive approach to dealing with mosquitoborne diseases, and the one thing we have learned, with the onset 

of, incursion of West Nile, then chikungunya, now Zika virus, is 

that these pathogens are coming to our shores at a more rapid rate 

than ever before, and we feel that we need to respond and prepare 

for the unexpected. Nobody would have predicted that Zika virus 

would be sexually transmitted. Nobody would have predicted any 

of the factors with that virus. 

Ms. DEGETTE. Right. Thank you. You know, last year, Congresswoman DeLauro proposed the creation of an emergency fund that 

would allocate $5 billion in funds for public health response efforts 

in advance of disease outbreaks simply because these things are 

also unpredictable, which would help us from having to scramble 

at the last minute to find this money. 

Dr. Fauci, what do you think about the idea of an emergency 

fund of this nature? 

Dr. FAUCI. I think it’s a good idea, and I’ve actually suggested 

it myself, as has Tom Frieden, when he was the Director of the 

CDC. And the reason that we did that is the experience that you 

alluded to in some of the comments from the committee and that 

92 

the President had asked for a certain amount of money in February 

of 2016, 1.9 billion. And it wasn’t until the end of September—— 

Ms. DEGETTE. Right. 

Dr. FAUCI [continuing]. That we got it. And that was really 

tough. 

Ms. DEGETTE. Because the season was almost over by then. 

Dr. FAUCI. Yes. And we had to move money from other areas to 

be able to start our activities. And we moved them from Ebola. We 

moved them from other things. 

Ms. DEGETTE. I remember. I was in those meetings. 

Let me just ask you one more question, Dr. Fauci. What does 

Congress need to do to better help your agency and the other agencies on this panel better prepare for the next infectious disease epidemic? 

Dr. FAUCI. Well, I think, as this committee has done in the 

past—and we are very grateful for that—is that continuing support, of the consistency of our support, because this is a marathon. 

If you have a sprint for every single outbreak, that’s not good. This 

whole thing is a marathon, and we have to be prepared in a consistent way over the years with consistent support. 

Ms. DEGETTE. Over time. 

Dr. Bright, you’re nodding yes. 

Dr. BRIGHT. I absolutely agree. I think it’s important that—we’ve 

appreciated all the support from Congress, but I think it’s important to keep it constant, keep it consistent, keep the process transparent so we can bring innovation to the table to be able to be more 

proactive for these threats and not less reactive. 

Ms. DEGETTE. Thank you. 

Thank you, Mr. Chairman. 

Mr. MURPHY. Thank you. 

We will recognize Mr. Walden, chairman of the committee, for 5 

minutes. 

Mr. WALDEN. Thank you, Mr. Chairman. 

I want to commend our public health agencies for their extensive 

and very valuable work that you’ve accomplished during the response to Zika last year. In particular, the pace of Zika virus vaccine research and development has been really impressive, and 

we’ve talked about this before, and I congratulate you on that. 

Dr. Fauci, when do you think a Zika vaccine will be available for 

patients? What’s your current view of that? 

Dr. FAUCI. Thank you for the question, Mr. Walden. But I have 

to be honest with you: I can’t predict that. And the reason you can’t 

predict it, it’s going to be based on two factors: one, how inherently 

good the vaccine is, and how long it takes us to prove how good 

it is. 

So you might have a very good vaccine, and, because of good public health measures or just luck, we don’t have a lot of cases of 

Zika—it may take years before you finally prove statistically that 

it’s good enough for the FDA to approve it. On the other hand, if 

you have a vaccine that’s moderately effective but not really good 

effective, it still may take longer. 

So the best-case scenario from the standpoint of a vaccine, but 

not from the standpoint of the unfortunate people who suffer from 

the disease, is that if you have an outbreak over, let’s say, the next 

93 

season, and you have your vaccine implemented and deployed in 

place, you may be able to get an efficacy signal sometime, for example, in the beginning or mid of 2018. 

And then how good that signal is, the FDA will, in an unbiased 

way, evaluate that and make a decision. That’s the best possible 

scenario. 

Mr. WALDEN. All right. So we’re a ways off. 

Dr. FAUCI. Right. 

Mr. WALDEN. Dr. Bright, I understand there are many candidates for diagnostic tests and vaccines in development today, far 

more than when we first learned about Zika last year. How do public-private partnerships expedite the development of medical countermeasures? 

Dr. BRIGHT. Thank you for your question. It’s very important to 

understand and recognize the contribution of the private sector, especially in responding to a public health emergency. Many of these 

companies are already focused on other more lucrative products 

and candidates in development. 

And to be able to bring the public and private sectors together 

for these emergency responses allows us to share the risk of development of these candidates, allows us to share the cost of development of these candidates, and it reduces and mitigates some of the 

pitfalls that we will face in a traditional, less supportive approach 

to developing medical countermeasures. So the public-private partnership is a critical component of success. 

Mr. WALDEN. All right. 

Dr. Petersen, your written statement noted that, and I quote, 

‘‘Alarmingly, the emergence of mosquito-borne diseases appears to 

be accelerating,’’ close quote. Why does the CDC believe that the 

pace of emerging infectious diseases is accelerating? What’s behind 

that? 

Dr. PETERSEN. I think there’s several causes. One of the major 

causes is world population growth. We have the growth of mega cities in places where these viruses normally circulate in the tropical 

world. Combined with increases in travel and trade brings these viruses very rapidly to every corner of the Earth in a very short period of time. 

There’s other factors that may be involved, such as climate 

change and other factors. And it’s kind of a mixture of factors 

that’s all promoting the emergence of these diseases. 

Mr. WALDEN. And in your written statement, you also mention 

that we need to address the threat of vector-borne diseases systematically rather than episodically. How would the CDC suggest that 

we address the threat systematically? 

Dr. PETERSEN. Well, I think we need to do two things. One is we 

need to increase our efforts towards innovation and discovery. We 

need better mosquito control methods, for example. We need better 

surveillance, et cetera, which will help us with the incursion of any 

kind of a pathogen, vector-borne pathogen that’s coming in. 

The other aspect is, is that we need to develop a more national 

and sustained approach towards vector control and laboratory testing; in other words, a more comprehensive approach towards—a 

programmatic approach towards dealing with these vector-borne 

diseases. Improving laboratory diagnostics, improving mosquito 

94 

control, improving surveillance, for example. And this will require 

a sustained effort to rebuild the infrastructure that has been lost 

in the previous years. 

Mr. WALDEN. All right. My time has expired. Thank you all for 

your testimony and your good counsel. 

And I yield back. 

Mr. MURPHY. The gentleman yields back. 

I recognize Mr. Pallone for 5 minutes. 

Mr. PALLONE. Thank you, Mr. Chairman. 

It’s clear to me that the ongoing Zika outbreak poses a serious 

threat to the health and well-being of the American public; in particular, pregnant women and infants are especially vulnerable. In 

the coming months, it will be crucial that pregnant women infected 

with Zika, as well as infants born with microcephaly, have access 

to necessary care and services. 

So I wanted to ask a couple questions, first with Dr. Petersen. 

Can you speak to the role that contraceptives and preventive care 

services play in our efforts to combat the Zika threat? 

Dr. PETERSEN. First, I think it’s important to keep in mind that 

about half of the pregnancies in the United States are unplanned, 

and about two-thirds of the pregnancies in Puerto Rico are unplanned. 

Contraceptives and access for women to long-acting reversible 

contraceptives is one way that women can delay pregnancy, if they 

wish to. And so some women may choose to delay pregnancy, but 

it’s not the Federal Government’s role in advising women to delay 

pregnancy. But our goal is really to provide women with the most 

accurate information possible so they and their physicians can 

make the determination about pregnancy. 

Mr. PALLONE. Let me ask Dr. Fauci, can you describe what kind 

of treatment and longer-term care will be necessary for infants 

born with microcephaly? 

Dr. FAUCI. Well, in the tragic situations with babies who are 

born with microcephaly, the long-term care is both difficult and 

highly expensive. There have been estimates that the lifetime care 

of a microcephalic baby who actually survives could be measured 

in the millions of dollars. 

Babies who are microcephalic and have severe defects very often 

do not live beyond a certain limited period of time. And during that 

period of time, the amount of medical care that’s required, the 

amount of time, both emotional and physical, that’s invested in the 

family is extraordinary. So it’s a very difficult and tragic situation 

that’s both emotionally difficult and highly expensive. 

Mr. PALLONE. Well, unlike other countries, in the United States 

we’re fortunate to have these elite public health agencies, like CDC 

and NIH, as well as a strong public health infrastructure to prevent outbreaks from becoming full-blown epidemics. 

But, Dr. Fauci, why is a strong public health infrastructure in 

this country often key to avoiding the types of epidemics that we 

see play out in other parts of the world? 

Dr. FAUCI. I’m sorry. I didn’t hear the last—why is it—— 

Mr. PALLONE. Well, in other words, my impression is that because we have such great public health agencies, we’re able to prevent Zika outbreaks from becoming full-blown epidemics. 

95 

Dr. FAUCI. Right. Yes. 

Mr. PALLONE. And that’s not necessarily true in the rest of the 

world. So, you know, if you wanted to just comment on—— 

Dr. FAUCI. Sure. 

Mr. PALLONE [continuing]. How we’re able to avoid these 

epidemics because of our public health infrastructure. 

Dr. FAUCI. Well, as infectious diseases and public health officials, 

as some of us—maybe all of us—at the table are, you’ll never be 

able to prevent an outbreak of a new infection like Zika or Ebola. 

The trick is to prevent it from becoming an epidemic or a pandemic. 

And I think the reason that we do so well is because of just what 

you’ve alluded to, Mr. Pallone, that we have in place systems. And 

I think I can add a tip of the hat to the CDC, because we have, 

in our Nation, unquestionably the best public health agency in the 

world by far. 

And that’s one of the reasons why we have the capability of doing 

what they do so well, is to identify, to track, and to control. And 

they’ve done that with virtually every threatening outbreak that 

we’ve had and have done an extraordinary job. And not every country in the world has that capability. 

Mr. PALLONE. You know, with this in mind, of course, President 

Trump has proposed slashing Medicaid by over 800 billion. I believe this would decimate the Medicaid program, which plays a key 

role in our public health infrastructure. And cutting Medicaid 

would also further reduce our ability to provide care to those who 

may need it as a result of Zika, especially pregnant women and 

children born with microcephaly. 

So, Mr. Chairman, you know, again, I think we should be building up our healthcare infrastructure to prepare and respond to 

Zika. And it’s of the utmost importance that we ensure access to 

the care and services that will be necessary to mitigate this threat. 

Dr. Petersen, very quickly, you mentioned contraceptives, but 

what about preventive care in general in our efforts to combat the 

Zika threat, not just the contraceptives but the preventive care? 

Dr. PETERSEN. Well, first, we’re trying to link pregnant women 

who may have been exposed to the virus to effective care through 

our Zika Care Connect program, which we funded in a number of 

States and areas to do. 

Again, we think that the best way to deal with Zika is to prevent 

it. And for that reason, we have issued travel advisories to more 

than 62 countries, and they’re still working—trying to get the right 

epidemiology to advise women appropriately on what measures 

they could take to prevent Zika virus, as well as what areas may 

or may not be safe to travel to to prevent Zika virus infection. 

Mr. PALLONE. All right. Thank you. 

Thank you, Mr. Chairman. 

Mr. MURPHY. Thank you. 

I now recognize Mr. Barton for 5 minutes. 

Mr. BARTON. Thank you, Mr. Chairman. 

I would just point out to my good friend from New Jersey that 

what we’ve done with Medicaid is simply slow the rate of growth 

that we are going to save some money over a 10-year period. We’re 

96 

not cutting Medicaid. So I just want to set the record straight on 

that. 

We seem to have the top people from all the various medical 

agencies that are fighting or investigating the Zika virus. Which 

one of you would be considered the number one official in charge 

of the research? Somebody answer. 

Dr. FAUCI. So I’m not sure what you mean by ‘‘in charge of research.’’ The NIH is the primary agency responsible for the research associated with what we’re talking about today. The CDC 

is the agency predominantly responsible for the public health 

issues of detecting, preventing, and responding. 

BARDA is involved in helping the pharmaceutical companies, 

and all of us develop products that are in intervention, such as diagnostic therapeutics. So there isn’t one person that does all of 

that. 

Mr. BARTON. So there’s no one in charge. 

Dr. FAUCI. Well, there is, because at the Department of Health 

and Human Services, all of this is under the PHEMCE, which is 

the Public Health Emergency Medical Countermeasures Enterprise, that involves BARDA, NIH, and CDC, and FDA. 

Mr. BARTON. But that person’s not here? 

Dr. FAUCI. That person’s not sitting here, but there is a person 

that does that. 

Mr. BARTON. So there is somebody that is—— 

Dr. FAUCI. Yes, the Assistant Secretary for public health, for prevention and response. 

Mr. BARTON. I’m not trying to be argumentative. It would just 

seem to be, given the seriousness of this particular virus and the 

priority that we put upon funding to try to find a vaccine for it, 

that there would be a unified approach as opposed to all the various groups, all of which have super motives doing their own thing. 

Dr. FAUCI. Right. We have the Acting Deputy Assistant Secretary here. So, Rick, do you want to comment? 

Dr. BRIGHT. I can add to that, what Dr. Fauci is explaining as 

well, yes. So the PHEMCE enterprise is chaired by the Assistant 

Secretary for Preparedness Response, the ASPR. 

Right now, we have an acting ASPR, Dr. George Korch. In 2015 

and early 2016, our ASPR actually was very proactive in leaning 

forward and coordinating a meeting across HHS called a disaster 

leadership group. In early December 2015, we had that first meeting. 

In early January of 2016, we had additional meetings that included our partners across the PHEMCE organization, which is 

outside of the HHS department actually. 

Mr. BARTON. Well, this individual—does that individual have the 

authority to direct funding to the various agencies? 

Dr. BRIGHT. That individual has the responsibility for the coordination and alignment of the activities to assure that we are working as efficiently as possible in reducing duplication so the resources are used most efficiently. 

Mr. BARTON. I’m not sure I understand that answer. 

Dr. FAUCI. The Congress gives us, individually, our resources. 

Mr. BARTON. So we—— 

Dr. FAUCI. Right. 

97 

Mr. BARTON [continuing]. Through the authorization and the appropriation process, we fund each agency—— 

Dr. FAUCI. Yes. 

Mr. BARTON [continuing]. And then this individual coordinates? 

Dr. FAUCI. Correct. 

Mr. BARTON. Well, I guess my bottom-line question is, since 

you’re on the front lines, each of those individuals here, do you believe that we have a unified approach and that money is not being 

spent in duplicative efforts? 

Dr. FAUCI. Yes, I believe we do. In fact, if you look at the Zika 

response that we’ve had right from the very beginning, as well as 

the Ebola response, we actually had the Secretary of HHS involved 

frequently on, like, weekly conference calls, and in the real hot part 

of it, multiple per-week conference calls. 

But the description that Rick just mentioned is the Assistant 

Secretary for Preparedness and Response, the ASPR, is the one individual that coordinates what we do—BARDA, FDA, NIH, and 

CDC—and that’s been the case throughout the outbreaks. 

Mr. BARTON. OK. I’ve only got about 30 seconds. 

Dr. Fauci, you’re certainly the senior person here in terms of 

service. You didn’t really give a direct answer to Chairman Walden’s question about when we might expect an effective vaccine. 

Can you give us a little more definitive, next 2 years, next year, 

3 to 5 years? You put some charts up in your testimony. Just give 

us kind of a ballpark figure. I’m not holding you to the exact date 

and second, and just generically. 

Dr. FAUCI. Yes. A long time ago, a Secretary of HHS gave a ballpark figure for an HIV vaccine, and I think she’s still regretting 

having said that. So I’m not going to give you a time when we’ll 

have a Zika vaccine, except to say that the process for getting to 

that vaccine is right on time. And I would think it would be measured in several years at the most and maybe a couple of years at 

the best. 

Mr. BARTON. That’s good enough for me. 

Dr. FAUCI. OK. 

Mr. BARTON. Thank you, Mr. Chairman. 

Mr. MURPHY. Thank you. 

Ms. Castor, you’re recognized for 5 minutes. 

Ms. CASTOR. Thank you, Mr. Chairman. 

GAO’s report today identified several areas of concern with our 

country’s ability to surveil, track, and respond to Zika. Dr. Persons, 

is it accurate that the Zika virus case counts likely underestimated 

the total number of Zika infections, and would you explain that? 

Dr. PERSONS. That’s correct. When you talk about the Zika virus, 

a person can be infected but then not have symptoms in four out 

of five times. So 80 percent of the folks walking around are called 

human reservoirs and may not know they have that, and that’s 

where the risk of mosquito control, person-to-person, and/or sexual 

transmission. 

Ms. CASTOR. Right. So given these challenges, how will we be 

able to conduct predictive modeling to forecast the number of cases 

in the future and prepare for an outbreak? 

Dr. PERSONS. It’s going to be a matter of collecting high-quality 

data, taking models that are currently in existence and trying to 

98 

modify them. There are, for example, computational models on sexually transmitted diseases. There’s computational models on mosquito-borne and vector-borne diseases, but never the twain shall 

meet until this point. And so that is going to be a key focus in 

terms of getting data for that and then testing those models 

against the datasets as the epidemiology. 

Ms. CASTOR. That’s not something that we should start and stop. 

We need a consistent pathway forward. 

Dr. PERSONS. Consistent research will be required for something 

this complex. 

Ms. CASTOR. And, Dr. Petersen, I’m aware that there were a 

number of presumptively positive Zika tests that never went onto 

confirmatory testing. How many of those are out there? 

Dr. PETERSEN. I do not have an exact number, but one of the biggest problems we actually had was in Puerto Rico, because what 

we found in Puerto Rico is because people who had a previous exposure to dengue—which 90 percent of the population there has— 

even the confirmatory test could not—for the antibody test—could 

not separate—even wasn’t good enough to differentiate dengue 

from Zika. 

Ms. CASTOR. So was that an issue confined to Puerto Rico, or did 

we have a presumptively positive Zika test here in the U.S. that 

also didn’t go onto confirmatory testing? 

Dr. PETERSEN. The vast majority of women in the Continental 

United States, we were able to confirm the antibody test result 

simply because most of those women did not have previous exposure to dengue, which then causes the test to cross-react. 

Ms. CASTOR. So how did you decide which specimens would get 

tested or not? 

Dr. PETERSEN. So in the Continental United States, we tested 

them all with a confirmatory testing as part of the algorithm. In 

Puerto Rico, we found out that didn’t work, and so we stopped that 

confirmatory test with a test known as the PRNT. 

Ms. CASTOR. OK. Since the States and all of the agencies started 

keeping track of how many—since we started keeping track, how 

many cases of babies born with birth defects tied to Zika have 

there been? 

Dr. PETERSEN. Right. Well, one of—I do not have that number 

off the top of my head. I can get back to you with that. What we 

do know is that this is an ongoing process, because many of the 

women that have been infected so far have not delivered yet. And 

so this is an ongoing process of—— 

Ms. CASTOR. Certainly, the CDC would have, to date, just since 

we started keeping track, the number of cases of microcephaly and 

other birth defects tied to Zika, knowing that we have to monitor 

these babies probably for many years. 

Dr. PETERSEN. So I think it’s very important to monitor these 

women as they deliver and see the ultimate impact on their 

fetuses, both at delivery and long-term consequences. We do know 

that in the U.S. territories, there’s been more than 3,700 women 

that we’ve identified who have become infected during their pregnancy and about 1,700 in the Continental United States. 

Ms. CASTOR. Right. I have—based upon the CDC update last 

week, we’ve had about 5,640 pregnant women with a known Zika 

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virus. And I was just trying to get to how many we have today born 

with birth defects, and so if you can please provide that. 

And these are heartbreaking consequences for these families. 

And I do know, based upon recent research, that they are calling 

this a spike in birth defects across America because of Zika. Would 

you characterize it that way? 

Dr. PETERSEN. I think there is a spike of infections—I mean, of 

these birth defects simply because this outbreak was so large last 

year and these women are now delivering. 

I was just handed the answer to your question. 

Ms. CASTOR. OK. 

Dr. PETERSEN. And in Puerto Rico, they’re currently reporting 35 

cases with birth defects and 72 in the Continental United States. 

However, we know from our studies that about 10 percent of the 

women who were infected during pregnancy will go on to deliver 

a baby that has been affected by Zika virus. 

Ms. CASTOR. There are so many other questions, Mr. Chairman. 

I look forward to the committee’s continued attention to this. 

Thank you. 

Mr. MURPHY. Thank you. 

I now recognize Mr. Griffith for 5 minutes. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. 

And I’m going to start with Dr. Bright. In your just general info 

on BARDA, it says: BARDA meets its mission by supporting product innovation, advanced development, acquisition and stockpiling, 

and building manufacturing infrastructure. 

Given the threat of emerging, infectious mosquito-borne diseases, 

would BARDA’s mission for developing medical countermeasures 

also include the development of mosquito-control technology? 

Dr. BRIGHT. Thank you for that question. It is a very important 

question. And currently, the short answer is no, our scope does not 

include a vector control. However, we have been monitoring it very 

closely as an innovation in vector control and are considering is 

there data to support that vector control can also be associated as 

a medical countermeasure in the reduction of the disease. And so 

we are working closely with the companies to better understand 

those technologies. 

Mr. GRIFFITH. That’s interesting, and I’ll see what I can figure 

out, but I agree. It’s probably something that ought to be in your 

wheelhouse, so to speak. 

I’m going to switch and jump off of some of the issues that we’ve 

heard today. And Dr. Petersen talked about the situation in Puerto 

Rico a few minutes ago related to dengue and the testing to determine whether or not Zika is there when you have a population that 

has been exposed to dengue. 

And, Dr. Fauci, that raises the question, when you were testifying about the vaccines and the DNA vaccine where you take a 

part of the gene of the Zika virus and the body then responds to 

the protein, because of the close relationship with other diseases 

like dengue and chikungunya, does that mean that there’s a possibility, and should we be looking for it, that the vaccine, for one, will 

inadvertently or maybe intentionally create a vaccine for all three 

of those diseases which are so closely related? 

100 

Dr. FAUCI. Well, we should be so lucky. But unfortunately, that’s 

not the case. Because even though there’s cross-reactivity of antibodies, for example, from Zika to other flaviviruses like dengue and 

yellow fever, there’s not cross-protection. So if you have an antibody against one, you don’t protect against, even though they can 

be confused in a laboratory test. They’re not physiologically protective. 

But having said that, Mr. Griffith—— 

Mr. GRIFFITH. I was hoping. 

Dr. FAUCI. Well, wait a minute, hope springs eternal. Because 

having said that, there is work going on right now to actually try 

and develop a universal flavi vaccine where the component of the 

vaccine that you present to the body is a common part of the 

flavivirus that actually is in all the flaviviruses. Whether or not 

that part is going to induce a protective response is unclear, but 

there is work thinking exactly as you’re thinking right now: Can 

you actually get a universal—the same ways we’re trying for universal influenza vaccine. 

Mr. GRIFFITH. All right. I appreciate that. Thank you. 

Dr. Petersen, you raised the issue, of course, about Puerto Rico 

and dengue, and they, of course, had so much exposure last year 

to Zika that they won’t show as much exposure this year because 

such a large percentage of the population was already exposed. And 

I was just wondering, what work is being done. 

And I’m going to switch gears on you just slightly, so bear with 

me. I read a report and was somewhat concerned that—even 

though it was a very small study that—back in March, the American College of Cardiology said that there’s a link between Zika and 

heart disease. And since we have a large population that was, in 

fact, exposed to Zika, is there any work being done to see if there’s 

a larger study that could be done to determine what the links between Zika and heart disease, if any, are out there? 

Dr. PETERSEN. We do not have a specific study looking at heart 

disease—looking at that link between heart disease and Zika. What 

we are looking at is of the general spectrum of syndromes associated with infection with the Zika virus, heart disease being just 

one of them. 

There’s a variety of neurological conditions that we’re looking at 

as well. So it’s part of a longer, larger effort to look at the complete 

spectrum of disease manifestations with Zika virus. 

Mr. GRIFFITH. And when you say you’re looking at other neurological issues, that’s not just in newborns or the fetus. Is that correct? 

Dr. PETERSEN. Correct. 

Mr. GRIFFITH. All right. I appreciate that. 

Dr. Persons, GAO reports that the grant funds awarded for mosquito control may not make it to some local control districts and 

that the CDC does not directly monitor mosquito control entities 

for the use of grant funds. 

Assuming that is correct, what do we need to do to make sure 

that the money we’re spending is actually being monitored and it 

actually goes to where we think it’s going, which is to control mosquitos? 

101 

Dr. PERSONS. I just thank you for the question, Mr. Griffith. I 

think persistent oversight, guidance, perhaps changes in policy in 

terms of the rules or the structure in which CDC does these block 

grants so that they can be specifically targeted only for mosquito 

control efforts and not for other things that a State may wish to 

sponsor, I think is—— 

Mr. GRIFFITH. I appreciate it. 

Dr. Petersen, I’m sorry, I’m out of time. So I would give you a 

chance, but I don’t have the time to respond, so I have to yield 

back. Or to give you a response. 

Mr. MURPHY. Thank you. 

Ms. Schakowsky, you’re recognized for 5 minutes. 

Ms. SCHAKOWSKY. Thank you. 

First, let me apologize. I’m the ranking Democrat on a hearing 

that’s going on upstairs, and so I apologize that I missed your testimony. 

Given the importance of developing a Zika vaccine, hundreds of 

millions of Federal dollars have been obligated to conduct clinical 

trials. I understand there’s 32 vaccine candidates that are being 

studied in the U.S., and the U.S. Government has helped to partially or fully fund a number of those vaccine candidates. 

So it’s my understanding also that the drug manufacturer Sanofi 

has received over $40 million from the U.S. Army to conduct a 

phase 2 trial for one of the vaccines, with the possibility of accessing up to 130 million more in taxpayer funding for phase 3 trials. 

All told, nearly $300 million of Federal dollars have been obligated 

for vaccine development to date. So stick with me for a minute. 

While it’s critical that we develop and manufacture an effective 

vaccine to combat Zika virus, it’s just as critical that the vaccine 

be available to everyone who needs it. I’m also very concerned that 

Sanofi recently rejected the Army’s request for a, quote, ‘‘fair,’’ unquote, price for the vaccine. 

Earlier this year, I led 10 of my House colleagues in sending a 

letter to the Army raising concerns about their plans to issue an 

exclusive license to Sanofi for the vaccine that U.S. taxpayers 

helped develop. In addition, Governor Edwards of Louisiana, one of 

the States that has been hit hardest by the Zika virus, sent a letter 

to the Army that raised similar concerns. 

I’d like to ask unanimous consent to enter both of these letters 

into the record. 

Mr. MURPHY. Could we review this? I’m assuming that would be 

OK, without objection. 

Ms. SCHAKOWSKY. OK. Dr. Fauci, given the enormous investment 

of taxpayer dollars into the development of a Zika vaccine, do you 

agree that we need to use every tool of the Federal Government to 

ensure that the vaccine is affordable? 

Dr. FAUCI. The answer to that question is yes, but it is a complicated issue, Congresswoman, as you well know, because we don’t 

really have the mechanisms to influence pricing of a product, even 

products in which we make a major investment for the development of. 

Certainly, we feel, as scientists and public health officials, that 

the work that we do in the development of vaccines should be 

available to everyone and anyone who needs it. So, if you’re asking 

102 

is that the answer to the question, it is absolutely, I feel that we 

need to do that. Whether or not we have mechanisms in place right 

now to guarantee that, I don’t think we do. 

Ms. SCHAKOWSKY. But it is true, isn’t it, that vaccines are most 

effective when the vast majority of the public is immunized? So if 

it’s priced out of reach of many, won’t this be a problem in getting 

control of the whole disease? 

Dr. FAUCI. Sure. Yes, it would, obviously, it would be. I mean, 

if you cannot vaccinate the people who need it—and you correctly 

said that a vaccine, particularly in an outbreak situation, the more 

people that get vaccinated, the more control you get over the outbreak. So I agree with you that it’s essential, to the extent that we 

can do that, to vaccinate where appropriate as many people as we 

possibly can. 

Ms. SCHAKOWSKY. It’s just a big concern to me since the Army 

actually said that they would not guarantee a fair price, and yet 

we’re prepared to use taxpayer dollars to lay out perhaps as much 

as $130 million—— 

Dr. FAUCI. Right. 

Ms. SCHAKOWSKY [continuing]. To them potentially without any 

ability to control that. 

Let me just raise another concern. It’s important also to remember the damaging impact that the repeal bill that just passed the 

House of ObamaCare and the Trump budget would have on Medicaid and our ability to respond to public health crises, like another 

Zika outbreak. 

The per-capita cap included in both the—in TrumpCare and the 

Trump budget would make it nearly impossible for States to expand services and the number of eligible individuals during a public health emergency, as Michigan did during the Flint water crisis. 

Moreover, under a per-capita cap, there is simply no way any 

State could provide access to a high-priced drug to all of its Medicaid beneficiaries. And depending on how the final Zika vaccine is 

priced, Medicaid programs could already face challenges in trying 

to pay for the drug, and those problems would only be compounded 

if Medicaid was drastically restructured as Republicans have called 

for. 

As this committee investigates the public health response to the 

Zika virus and considers how we might prepare for future challenges, it’s critical to remember the important role that Medicaid 

has played in responding to public health emergencies and the devastating effect that Republican proposals to cap Medicaid would 

have on our ability to respond to those emergencies. 

I yield back. 

Mr. MURPHY. Thank you. 

Dr. Burgess, you’re recognized for 5 minutes. 

Mr. BURGESS. Thank you, Mr. Chairman. 

And I would just point out that Bill Clinton, in 1995 and 1996, 

proposed a per-capita cap for Medicaid because he was worried 

about running out of other people’s money. And he was praised by 

the editorial board of the New York Times at the time, and every 

Democratic Senator then sitting wrote a letter to the President 

wishing him success in that endeavor. 

103 

So I actually have a question that I’m going to ask, but it’s going 

to be for the record. We did hear comments about an emergency 

fund proposed by one of the appropriators. And for just general 

purposes, we are an authorizing committee. We’re not an appropriating committee. 

The difference between authorizers and appropriators—and, of 

course, at the NIH and the CDC you know this—the difference between authorizers and appropriators is there are no buildings 

named for authorizers. But we are the authorizing committee, and 

I think we have already authorized that that Representative 

DeLauro asks for. 

And I’m referencing now a compilation of the U.S. Code from 

January 4, 2012, title 42, chapter 6(a), subchapter 2, Powers and 

Duties, under part B in general: ‘‘The Secretary shall award competitive grants or cooperative agreements to eligible entities to enable such entities to improve surge capacity and enhance community and hospital preparedness for public health emergencies.’’ 

So I believe the authorizing language is already there. And so my 

question that I’m going to submit to you for the record is, is that 

a correct statement? Do you feel that you have the authorization 

that you need and now we need to pay attention to the appropriations side of this? Or is, indeed, there different authorizing language that you would require? 

Dr. Petersen, let me just ask you, because you—I wasn’t going 

to bring this up, but then you referenced it and so you provoked 

me, and now I’m going to do it. You said the best way to deal with 

this disease is to prevent it. And I agree with that. I agree wholeheartedly. And when you said that, I went on your Web site and 

I looked at your Zika page and I looked at your travel warnings. 

And can I just tell you, they’re muted. Someone talked about the 

computational models for the dispersion of this virus throughout 

various populations. I don’t think there was any computational 

model that predicted what happened in the country of Brazil a few 

years ago. I mean, I think it caught people by surprise. I don’t 

think the computational models for Ebola 2 years ago quite conformed to what people thought they would. 

So while I’m sympathetic to the fact that computational models 

can help, my concern is, especially with Zika—I mean, I’m one of 

two States where Zika has been locally transmitted. But, I mean, 

these are rare, rare, rare conditions. Most of the people that get 

Zika had to go somewhere and get it and then bring it home to 

Texas or Florida. Is that not correct, Dr. Petersen? 

Dr. PETERSEN. That has been the experience to date as true. 

Mr. BURGESS. And, again, along your lines of wanting to prevent 

it is the best strategy, and I agree with that, I’ll just say, I think 

we should be doing more as far as educating the public. When 

we’ve had discussions with the State Department and your agency, 

it seems to be this: We’re pointing to each other to do the work. 

Someone needs to tell people don’t go if you don’t want this disease, 

particularly at certain times of the year. 

Now, I recognize that there’s certain altitudes you can go to and 

won’t be affected, but generally it is not a good idea, particularly 

if you’re in a family that is contemplating a pregnancy somewhere 

in the future. Maybe you might not want to do this. 

104 

Dr. Borio, let me just ask you—and I know we’ve talked about 

this before, but it has been some time ago. And you had in your 

written testimony the issue of vector control with the Oxitec mosquito. 

And there was great concern last summer, this was a public 

health emergency that was declared by the President, and yet the 

difficulty with getting the technology for that genetically modified 

mosquito into areas where it could actually help, it seemed to be 

very difficult. 

In the 1950s, they eradicated the screw-worm fly—and I don’t 

recommend googling that during brunch—but they eradicated the 

screw-worm fly rather effectively with using that same type of technology, maybe a little bit different now than it was then, but terribly effective. 

And one of your statements says that perhaps there’s guidance 

coming from the FDA that we could approach this in a different 

way now than what we did last August? 

Dr. BORIO. Thank you for your question, Dr. Burgess. 

So, you know, first, I would just like to stress how important vector control is, and it’s an area of unmet need. It’s quite challenging 

to control the vectors that we need to control, as we were till last 

year, in the areas of local transmission. And as a physician and scientist, I have to stress that this technology seems very promising, 

and it really deserves to be evaluated more thoroughly. It’s in early 

development, but it deserves its chance to show whether it can assist in this area of unmet need. 

The company had a plan to do a field trial in the area of Key 

Haven, Florida, last year. And for a variety of reasons, including 

significant resistance by the population that voted against in the 

local area, the study did not proceed. We continue to maintain a 

very open line of communication with the company to explore additional studies. 

In the meantime, we have published draft guidance that would 

transfer the authority for oversight of this technology to the EPA, 

and we are in the comments period right now. We’re reviewing 

comments received. 

But the goal for this draft guidance would be to provide a more 

consistent and cohesive framework for regulating these types of 

technologies under a more, you know, consistent regulatory agency, 

which really has a lot of responsibility for vector control when 

they’re for pesticides. 

Mr. BURGESS. Thank you. 

Mr. MURPHY. Before I recognize Mr. Tonko, Ms. DeGette, you 

have a request. 

Ms. DEGETTE. I just wanted to renew Ms. Schakowsky’s request 

for—unanimous consent request for the two letters, which I agree 

with them, but also just to make the record complete for Sanofi’s 

response dated May 22, 2017. 

Mr. MURPHY. Without objection, those will be accepted. 

[The information appears at the conclusion of the hearing.] 

Mr. MURPHY. Mr. Tonko, you’re recognized for 5 minutes. 

Mr. TONKO. Thank you, Mr. Chair. 

I’d like to look at the diagnostic testing of Zika. To effectively respond to a Zika epidemic, we must be able to determine who is inVerDate Mar 15 2010 11:18 Dec 13, 2017 Jkt 037690 PO 00000 Frm 00108 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X34ZIKAASKOK121117\115X34ZIKAPENDING WAYNE
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fected. But diagnostic testing of Zika remains one of the most 

pressing challenges. There’s a number of diagnostic tests authorized by FDA, but these tests have limitations. 

GAO’s report today identified these challenges. Specifically, GAO 

stated that certain tests detect the presence of a virus, which may 

or may not be Zika. 

So, Dr. Borio, why has it been difficult for some tests to isolate 

the Zika virus? 

Dr. BORIO. Sure. So these are—there’s inherent scientific challenges with developing diagnostic tests for Zika, especially the serological tests. But I think it’s important to recognize that all of the 

tests that have been authorized by the FDA meet performance 

standards, all of these tests. And if used appropriately, as recommended by the CDC, these tests perform well and should be 

able to give an answer to patients about whether they’ve been exposed or infected with Zika virus. 

The only remaining challenge today with the tests that are available really has to do with the population in Puerto Rico, which, as 

Dr. Petersen explained, because of coinfection with other 

flaviviruses it may not be really possible to make a definitive diagnosis. 

Other than that, we have developed—you know, used the limitations of the performance of these tests, but relied on algorithms to 

be able to give us the answers we need. They all meet standards. 

Mr. TONKO. OK. Thank you. 

And, Dr. Borio, I also understand that the window during which 

the Zika virus can be detected is relatively short. How does that 

complicate diagnostic testing? 

Dr. BORIO. Sure. So the window really impacts on the utility of 

the molecular-based test, the PCR-based test, which is able to detect a virus in the clinical specimen in the acute period of infection. 

If the window is so limited, it’s possible that all the tests might 

miss detecting the virus when it’s present. 

For that reason, the CDC algorithm recommends that for those 

patients for the population that is being tested, a negative test 

should be followed by the serology test, which measures the antibodies against Zika. 

Mr. TONKO. Thank you. 

Dr. Persons, according to your report, a total of 15 diagnostic 

tests are authorized and vary in their performance. But your audit 

found a number of issues with developing accurate diagnostic tests. 

So my question is, why is it key that when an infectious disease 

confronts the U.S. we quickly develop an effective diagnostic test? 

Dr. PERSONS. Yes. So thank you, Mr. Tonko, for the question. 

The answer is simple in terms of the efficacy of the diagnostics 

goes right to the data that feeds into the epidemiology, which feeds 

into the clinical treatment, which feeds into the modeling and 

things that might be required to be more predictive and proactive 

in these things. So it’s all a system that’s complex and adaptive, 

but it hangs together. And diagnostics are very important to this 

conversation. 

Mr. TONKO. So what does it mean for our overall preparedness 

that there were these difficulties regarding diagnostic test development for the Zika virus? 

106 

Dr. PERSONS. I think it just means that in taking a more 

proactive approach, we need to try and get—a lot of our recommendations are really data or information providing oriented. 

For example, if you’re a manufacturer, you need to get wellcurated data samples to understand, you know, which one contains 

Zika, in this case, which one does not, so you’re really getting down 

to those very important metrics on performance. 

Also, just getting out to the user, so whenever you have the best 

available science and those numbers, those test results from the diagnostic testing regime, that they get put out to the user base so 

they efficiently are able to compare apples to apples and do a riskbased analysis at the point of care on which ones might be available and might best be used. 

Mr. TONKO. Are there other things that we should be doing differently? 

Dr. PERSONS. As I mentioned before, I just think the idea of a 

more proactive framework on doing that data is gold in this case, 

so really focusing on that. Putting resources on that data is not 

going to come for free, but maybe being more expansive about 

which data you might be able to get. 

Again, having a framework for the rapid divulgence of science 

and best available competitive science as well as information to the 

marketplace so that they can develop rapidly and go through the 

regulatory process under EUA in this case. 

Mr. TONKO. Thank you very much. 

Mr. Chair, I yield back. 

Mr. MURPHY. Thank you. 

Before we recognize the next, Dr. Burgess, you have a UC request. 

Mr. BURGESS. Mr. Chairman, I ask unanimous consent to insert 

an article from the journal Obstetrics & Gynecology on emerging 

infectious diseases. 

Mr. MURPHY. Without objection, we’ll include that article in the 

record. 

[The information appears at the conclusion of the hearing.] 

Mr. MURPHY. Mr. Collins, you’re recognized for 5 minutes. 

Mr. COLLINS. Thank you, Mr. Chairman. I want to thank the witnesses. 

If I’m a young woman watching this hearing, I want to ask a few 

questions because there might still be some confusion. So, Dr. 

Borio, if a woman wants to know if she has contracted Zika, would 

you simultaneously recommend she get a PCR test and an ELISA 

test, I mean, just to pick up either the antibodies or in the PCR? 

Dr. BORIO. Dr. Petersen might correct me, but my understanding 

is that if a woman who is at risk for Zika infection is pregnant, she 

should be tested. And the algorithm requires that she will have a 

PCR-based test, and if it’s negative, it’ll be followed up with a serology test. And that way—— 

Mr. COLLINS. So you wouldn’t do them simultaneously. You’d 

make her come back a second time? 

I mean, if the PCR test is negative—I mean, clearly that—it may 

have just passed her bloodstream, and then would she have to 

come back and have another test done? Why wouldn’t we do 

them—— 

107 

Dr. PETERSEN. Both tests could be done on the same blood sample, so it would not necessarily require her to come back. 

Mr. COLLINS. OK. So the protocol would be they draw her blood, 

they test it with the PCR test. If that comes back positive, well, 

then she knows she’s been infected. If it comes back negative, using 

the same sample, she doesn’t have to come in again. Protocol would 

be to run through an ELISA. 

Dr. PETERSEN. Right. Well, it’s complicated, but there’s actually 

two different scenarios. Somebody that has symptoms—as opposed 

to an asymptomatic pregnant woman. For somebody who has symptoms, the algorithm depends on the time that they present to medical care after their symptoms develop. That will determine what 

algorithm is actually used. 

For an asymptomatic pregnant woman, the current guidelines 

suggest that she has an IgM test first and an antibody test followed by a PCR test. We are reconsidering those recommendations 

at the current time, and we expect to have a new algorithm in the 

upcoming weeks as new information becomes available. 

So we are working actually on trying to streamline the testing 

algorithm to try and make it both simpler for the woman as well 

as the physician ordering the test. 

Mr. COLLINS. I mean, I would think there’s a lot of asymptomatic 

women that just want the peace of mind and that that would be 

a fairly normal thing. 

So another question maybe, Dr. Petersen. We’ve heard that if a 

woman is tested positive for Zika, she’s not pregnant, do you have 

a timeframe during which she would feel comfortable or safe in getting pregnant subsequent? Is it 3 months, 6 months, a year? Or at 

what point in time would a young woman who has tested positive 

for Zika feel comfortable getting pregnant? 

Dr. PETERSEN. Well, there’s two issues here. One issue is does infection before conception actually lead to birth defects, and that answer is still not known. We have no evidence that that’s the case 

so far, but out of an abundance of caution, we are advising women 

to wait—I can’t remember the exact number—2 to 3 months—8 

weeks. Sorry. Thank you, Tony—8 weeks to conceive after potential 

exposure. 

Mr. COLLINS. Again, that would be good information. 

Now, Dr. Fauci, you did mention, you know, the individual 

thought we might have an HIV vaccine at some point, which we 

don’t. So HIV is an RNA-based virus, so is influenza, so is Zika. 

So on these viruses that tend to mutate, like that’s why we have 

to come up with a different strain of influenza year after year after 

year and—what would be different about Zika compared to something like influenza or HIV where we wouldn’t have a single definitive vaccine, but yet would have to keep looking at potential 

mutations each season? 

Dr. FAUCI. That’s a very good question. And there is a big difference between the mutations of the RNA virus influenza and the 

mutations of viruses like dengue, like Zika, like yellow fever. 

The mutations that are associated with influenza have a major 

impact on the efficacy of a vaccine. So you can have mutations that 

have no impact on the virus’ phenotype, namely what the virus 

looks like and how the body sees it. That’s not the case with influVerDate Mar 15 2010 11:18 Dec 13, 2017 Jkt 037690 PO 00000 Frm 00111 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X34ZIKAASKOK121117\115X34ZIKAPENDING WAYNE
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enza. When influenza makes those mutations, you almost always 

have to get a new vaccine. That’s the reason why we get a new vaccine every season practically. 

But when you have other RNA viruses, like flaviviruses, when 

they mutate, they tend to have mutations that don’t have a functional effect, usually. I mean, you’ll have an exception to that, but 

the mutations that generally occur with flaviviruses are mutations 

that don’t impact with the vaccine. 

So, for example, yellow fever is an RNA virus. That will have 

mutations. If you do sequences of one versus the other, you will always see mutations because RNA viruses like to mutate. The critical issue is, is the mutation functionally relevant? And for the 

most part, for the ones we’re talking about today, they’re not functionally relevant. 

Mr. COLLINS. So that should give us all a little more optimism—— 

Dr. FAUCI. Yes. 

Mr. COLLINS [continuing]. Related to Zika compared to things 

like influenza. 

Dr. FAUCI. You’re right. You’re absolutely correct. 

Mr. COLLINS. Thank you for that clarification. 

I yield back. 

Mr. MURPHY. Congressman Ruiz is recognized next for 5 minutes. 

Mr. RUIZ. Thank you very much. 

I’m really glad that we’re having this hearing. It’s the right topic 

at the right time. We really sincerely and genuinely have to learn 

from the past and what we did the first time so that we don’t make 

mistakes that are detrimental to people. And why is that important? Because these are real people who have to take the burden 

of the human toll. 

And what’s most distressing to me and we know most distressing 

to all of us, but me as a physician and now as a father, is the toll 

it has on children that are born with microcephaly, the developmental problems, the lifelong distress and concern and stress on 

that kid and the neighborhood and the parents, not to mention, the 

illnesses that may appear on adults and kids that we still don’t 

know yet but that confirms with Guillain-Barre, heart disease, and 

other things that may appear 10, 15, 20 years down the road. 

So I want to focus on the funding and the approach to 

pandemics. First, Dr. Petersen, did you get what you asked for? 

Did the CDC get what they asked for in the initial round? And if 

not, what was the gap? 

Dr. PETERSEN. The CDC got a sufficient amount of funding to 

then mount a very robust response to the outbreak. It wasn’t what 

we asked for, but it was sufficient to certainly prioritize resources 

to the highest risk areas, such as Puerto Rico, Texas, Florida, et 

cetera. 

Mr. RUIZ. So when you say that you didn’t get what you asked 

for and yet you say that you have to do the research that you need, 

if you don’t get what you ask for, if you don’t get what you need, 

then that can delay the research that needs to be done in order to 

expedite a vaccine, expedite treatment, expedite understanding. 

Correct? 

109 

Dr. PETERSEN. I think what’s important to know—— 

Mr. RUIZ. No. I’m asking about whether or not the funds that 

you get on the front end will affect the time it takes to develop a 

vaccine and the treatment and the research to understand how to 

combat it better. Is that correct? 

Dr. PETERSEN. Yes. 

Mr. RUIZ. Yes. And what are the consequences, therefore, meaning that if you don’t have a vaccine, if you don’t have a treatment, 

if you don’t understand, then we can be a year, 2 years, 3 years 

delayed in making sure that we’re prepared the next time this happens. 

Dr. Fauci, I want to talk about the response and the approach 

that we did on the last pandemic that approached our territories 

and also in the U.S. There is a difference between the wait-andsee approach because we just don’t have enough information, we 

don’t know what this is going to look like, or the rapid-response 

prevention so that we can contain a pandemic at the site so it 

doesn’t spread and have a human toll, whether it’s in the territories, in the U.S. 

Tell me why the wait-and-see approach with pandemics is the 

wrong approach to treat a pandemic. 

Dr. FAUCI. Well, it depends, sir, what you mean by ‘‘wait-andsee,’’ to do what? With regard to the vaccine, which I’m responsible 

for, we didn’t wait to see anything. The virus was isolated. It 

was—— 

Mr. RUIZ. The wait-and-see approach in terms of, once you identify, do we go and respond to contain the virus or do we wait to 

see how virulent and how intense or how rapid it will spread? 

Dr. FAUCI. Well—— 

Mr. RUIZ. Do you wait to contain and see what happens, or do 

you want to go rapid response to prevent it at the scene? 

Dr. FAUCI. OK. So that’s a question that’s a CDC question, and 

the CDC didn’t wait. And I’ll hand it over to Dr. Petersen because—— 

Mr. RUIZ. No. I’m not saying they waited. I’m talking about our 

ability to fund the programs initially. It was Congress that waited 

to give the funds. 

Dr. FAUCI. Well—OK. So if you’re talking about funding, then 

let’s just go back and reframe the answer. When we were aware 

of the difficulty—both the CDC and ourselves and the FDA and 

BARDA—we actually proposed a budget for each of us that the 

President asked for, and we didn’t get that until months later. 

However—— 

Mr. RUIZ. There was some delay time. And I think that the point 

I’m making is that there’s a latency, and sometimes you don’t see 

the immediate effects of a virus until later through the years, and 

that all depends on the virus. It’s not as gruesome as the Ebola. 

Let me take a step back and look at the big picture. If you were 

a Zika virus and you wanted to wreak havoc on this world and you 

wanted to infect as many adults and as many children as possible, 

then you would want to decrease funding to stop or slow down the 

development of a vaccine, the treatment, or mosquito vector transmission prevention programs, and you would want to decrease 

funding in the NIH budget and the CDC budget. 

110 

If you were a Zika virus and you wanted to infect as many 

women and children as possible, then you would think about 

maybe finding a way to deny coverage for maternity care or make 

it optional—— 

Mr. MURPHY. The gentleman’s time has expired. 

Mr. RUIZ [continuing]. And even oral contraceptives. And that’s 

exactly what we have to think about. 

Mr. MURPHY. The gentleman’s time has expired. I think the gentleman should be careful with the accusations you’re saying on 

that. 

Who’s next? 

Mr. Walberg, you’re recognized for 5 minutes. 

Mr. RUIZ. For the Zika virus, maybe. 

Mr. WALBERG. Thank you, Mr. Chairman. 

Dr. Fauci, while much has been learned about Zika virus, we 

talked about that today, many unknowns remain. With regard to 

research into the link between the Zika virus and microcephaly, is 

there any research about other factors? For example, since mercury 

has been linked to microcephaly for microcephaly cases in northeast Brazil, is any research being conducted on the levels of 

methylmercury and the mothers of the microcephaly babies? 

Dr. FAUCI. To my knowledge, Mr. Walberg, the idea of looking at 

mercury as a factor in this is not being done, and I believe—not 

I believe—I know the reason why we’re not focusing on that is that 

the evidence that the virus itself is capable of causing these defects 

is now pretty overwhelming as being the cause. Now, the idea of 

there being other secondary cofactors, there’s no evidence offhand 

that there are any other contributing factors such as mercury. 

Mr. WALBERG. OK. Well, similarly then, is any research being 

conducted into the effect that a previous infection with another 

flavivirus, such as dengue or chikungunya, could have on the rate 

of severity of microcephaly? 

Dr. FAUCI. Yes. That is a good question and a good point. And 

the answer is, we are looking now from an epidemiological cohort 

study of individuals who have prior exposure, because there is this 

phenomenon that may or may not be relevant, we don’t know, of 

antibody enhancement, at least in individuals who get infected 

with one form of dengue, one serotype and then another serotype. 

There’s no solid evidence that preexisting response to one flavivirus 

like dengue has an impact on another flavivirus like Zika or yellow 

fever. There’s no evidence yet that that’s the case, but we are looking at that. 

Mr. WALBERG. OK. Thank you. 

Mr. Petersen, what research has the CDC undertaken or what 

research do you plan to undertake into the link between Zika and 

microcephaly and other birth defects? 

Dr. PETERSEN. Right. So I think we’ve definitively established 

that Zika virus causes microcephaly, and I agree with Dr. Fauci, 

the studies we’ve done have not identified other cofactors, to date, 

that would influence that progression towards severe diseases in 

infants. 

It’s important that we—to know that we really don’t understand 

the full spectrum of Zika virus infection and its effect on fetuses 

and children born to mothers exposed to the Zika virus. So it’s imVerDate Mar 15 2010 11:18 Dec 13, 2017 Jkt 037690 PO 00000 Frm 00114 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X34ZIKAASKOK121117\115X34ZIKAPENDING WAYNE
111 

portant that we continue our birth defects registries, as Dr. Fauci 

has mentioned, both here and in the U.S. territories so that we can 

really establish the full spectrum of diseases, disease outcomes associated with this virus. 

Mr. WALBERG. Dr. Persons, could you identify some critical challenges that could likely arise with the next emerging infectious disease outbreak? 

Dr. PERSONS. So, yes, thank you for the question. The critical 

challenges we would see, again, is if we’re more reactive, you’re 

going to see a lot of the same sort of things. If it’s particularly in 

the case of mosquito-borne, we’re going to be much more reactive 

in terms of how we’re dealing with that. We’re going to be surging 

this way and lurching that way as an entire system. You’re going 

to have a lot of rush to try and do something, and then, of course, 

that’s always counterbalanced against the idea of getting, you 

know, getting data but then getting quality data and then acting 

upon that data and building your response effectively. So those are 

the things that we think will continue to happen. 

Mr. WALBERG. OK. I yield back. 

Mr. MURPHY. Mrs. Walters, you’re recognized for 5 minutes. 

Mrs. WALTERS. I would like to thank the chairman for holding 

this hearing and the witnesses for their comments. 

On March 31, the California Department of Public Health announced that two breeds of mosquitoes that can carry the Zika 

virus have been found in 10 California counties, and my district is 

located in one of those 10 counties. 

Dr. Fauci, just recently, it was determined in Laos that there is 

a third mosquito more prevalently found throughout the United 

States that can carry the Zika virus. Is this correct? 

Dr. FAUCI. Yes, that is correct, Mrs. Walters, but I think it’s important to point out, since this subject always comes up, that the 

demonstration of the potential of a particular mosquito that can 

transmit the virus is not necessarily correlated with that mosquito 

in the field transmitting it. 

Right now, it’s very clear that the overwhelming dominant mosquito that is responsible for this is the Aedes aegypti. Even though 

there have been studies in the lab where you take a group of mosquitoes of different species and you see if, in fact, the virus can survive in those mosquitoes, and the answer is yes, there are multiple 

mosquito types that can. The question is, will they, in fact, in the 

field do that? And there’s very strong doubt that that is the case 

right now. 

Mrs. WALTERS. So would you say that this would present any additional risk to the United States? 

Dr. FAUCI. No. I wouldn’t say zero, but I think that what we’ve 

seen over the past now 2 years is the dominance of the Aedes 

aegypti mosquito. And if you look at, for example, the risk that 

we’ve seen now in Florida and in Texas, the mosquitoes that are 

in that area, the Gulf Coast area, are the Aedes aegypti mosquitoes, and it is almost certain that that’s the mosquito that’s doing 

the kind of local transmission that we’ve seen in Florida and the 

local transmission that we’ve seen in Texas. 

Mrs. WALTERS. OK. While the Department of Public Health has 

acknowledged that the transmission risk of Zika throughout the 

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State of California is low, we must still be diligent in combatting 

the spread of invasive mosquitoes. Part of that includes education 

efforts that encourage residents to focus on controlling mosquito 

growth through proactive measures like eliminating all indoor and 

outdoor standing water and using window screens. Significant 

strides have been made, but more work and outreach is needed to 

avoid a Zika epidemic. 

Dr. Bright, what role has mosquito or vector control played in 

our response to Zika in the United States? 

Dr. BRIGHT. Thank you for your question. So right now, the CDC 

has had the lead on vector control and understanding vector control 

and repellants and insecticides, and their use and how it will impact and reduce the spread of Zika. 

BARDA has not been focused, at this point, as a vector control 

as a form of a medical countermeasure, so we haven’t supported 

those areas, but CDC has the lead on other vector control. 

Mrs. WALTERS. What would you say that the role of the Federal 

Government should play in mosquito control? 

Dr. BRIGHT. I believe if the data would support that vector control and reduction of mosquitoes carrying the disease that can 

cause significant public health impact, then there would be a significant role for the Government to ensure that that medical countermeasure or that approach is used as an effort to reduce the 

transmission of that disease. 

I do not think at this point we have a significant amount of data 

that show clearly that even if you reduce the population of certain 

mosquitoes, it correlates with a reduction of disease in those areas. 

So we need to get additional data in that area. 

Mrs. WALTERS. OK. Is spraying insecticide an effective solution 

when dealing with breeds that carry Zika? 

Dr. BRIGHT. I don’t have data on that. I would defer to my CDC 

colleague, Dr. Petersen, to address that. 

Dr. PETERSEN. What we do know is that in Florida, the mosquitocontrol efforts that we did there appear to have stopped the outbreak in south Florida. It’s important to know that spraying pesticides is just one part of a comprehensive strategy to mitigate 

against vector-borne diseases such as Zika virus. 

Mrs. WALTERS. OK. 

I yield back the balance of my time. Thank you. 

Mrs. BROOKS [presiding]. The Chair now recognizes the gentleman from Pennsylvania for 5 minutes. 

Mr. COSTELLO. Thank you. Currently, there is not a specific therapy or vaccine approved for the Zika virus by FDA, but several vaccines are in various stages of development, with one experimental 

vaccine currently in phase 2 trials being tested in humans. 

Dr. Fauci, that’s correct? 

Dr. FAUCI. Yes. 

Mr. COSTELLO. And are there preliminary test results for the 

vaccine that is in the phase 2 trial? 

Dr. FAUCI. Yes. So right now, the data that we have so far in the 

DNA vaccine, the one to which you’re referring, Mr. Costello, is 

that clearly there are no safety red flags. The signal that we’re 

having is that there does not seem to be any safety issues. 

113 

In the phase 1 study, in the early part of the phase 2 study, it 

has become clear that this vaccine induces the kind of response 

that you would predict from an extrapolation from the animal 

model that it would be protective. In other words, the titers of antibody are high enough that are induced by this vaccine that you 

would make a prediction, if it acts like the virus acts in the 

nonhuman primate model, that it would be protective upon exposure. 

Mr. COSTELLO. And this question may have been asked, I apologize if it has, an updated timeline as to the completion of the vaccine that is in the phase 2. 

Dr. FAUCI. Sure. The phase 2a, and now we’re going to go into 

2b in a few months, is scheduled for about 2,500 individuals. That 

may go up to 5,000 individuals. The timeline of when you’re going 

to get an efficacy signal is very variable because it depends on two 

things: one, what the inherent efficacy of the vaccine is, because a 

very effective vaccine is going to give you a signal more quickly. 

The other probably more important determining factor is going to 

be how much infection there is in the community in which you’re 

testing. 

So if there’s a very, very low level of Zika this coming season, 

particularly, for example, in the summer in Puerto Rico, it may 

take a few years before you get enough cases in the vaccine versus 

placebo to say it works. So that’s the reason why, when I answered 

a similar question, I said it’s really unpredictable. It can be as soon 

as a couple of years, a year and a half, 2, or as far as 3 or 4 or 

5 years. 

Mr. COSTELLO. Thank you. 

Does anyone else have anything to add to that? 

If not, I’ll yield back. 

Mr. BURGESS. Will the gentleman yield? 

Mr. COSTELLO. I’d like to yield my time to Dr. Burgess. 

Mr. BURGESS. Dr. Fauci, in 2014 when we were dealing with 

Ebola at the end of August, early September, that we were about 

at this phase with the Ebola vaccine, then the Ebola epidemic sort 

of went away, do we have an Ebola vaccine at this point, based on 

the work that was done in September of 2014? 

Dr. FAUCI. Yes. And then I’ll get to it just in a sec the difference 

between those two, and they’re really quite different. 

So with Ebola, when we did a randomized placebo-controlled trial 

in Liberia, by the time we got it going and there were enough individuals in Liberia, it just stopped. There were no cases. So you 

couldn’t test the efficacy of it. The similar vaccine—the same one— 

was used in a ring vaccination trial in Guinea. It wasn’t the design 

of a trial to definitively prove that something worked, but it looked 

really good from the standpoint of the data. 

So we do have vaccine candidates, one of which has some considerable data that it looks like it might be effective, but we haven’t 

definitively proven that yet. And right now, we’re doing a trial in 

Guinea and in Liberia comparing two vaccines: the VSV vaccine, 

which was the one that was used in the ring vaccination study in 

Guinea, versus what’s called an adenovirus plus an MVA boost 

from Johnson & Johnson, and we’re comparing those two. 

114 

Just one last word about the differences between the two is that 

Ebola is the kind of disease, there’s an outbreak, and then it goes 

away. Just like we’ve seen right now in West Africa. When you 

have a mosquito-borne virus like flavivirus, it almost certainly is 

not going to disappear completely. So we may not have enough 

cases of Zika in Puerto Rico this summer or in Brazil the next few 

seasons, but it isn’t going to go to zero. And that’s the big difference between Ebola and this flavivirus. 

Mr. BURGESS. Let me just ask you one other question. Are you 

to the point with the Ebola vaccine that you can communicate to 

Dr. Bright that he ought to consider the purchase of that vaccine 

for the national stockpile? 

Dr. FAUCI. I’d yield that to Dr. Bright, but I think his answer is 

going to be no. 

Dr. BRIGHT. Actually, we were quite encouraged by the progress 

in the development and the data supporting the Ebola vaccines. 

Again, some of these vaccines could be considered for use in the ongoing outbreak now we’re seeing in the Democratic Republic of the 

Congo. 

Mr. BURGESS. But part of the issue is, I guess, what Dr. Fauci 

said, it was hot as a pistol in August of 2014 and then it’s not. So 

for the utility of BARDA to be able to purchase to provide that substrate that the companies that are manufacturing need the dollars 

to purchase their product, that’s you, right? 

Dr. BRIGHT. Yes. So, actually, at least one of these vaccines we 

do plan to transition over to purchase for the strategic national 

stockpile for Project BioShield support in this coming fiscal year, 

in the next fiscal year. It’s important to remember that Ebola is not 

just a public health threat, it is also a national security threat. It 

is considered and has been deemed a material threat determination. And so we do support the use of those vaccines and procurement of those with Project BioShield. 

Mr. BURGESS. Thank you for clarifying. 

Ms. Chairwoman, I yield back. 

Mrs. BROOKS. Thank you. 

The Chair will now recognize myself for 5 minutes. 

And staying on that line of questioning, Dr. Bright, as you know, 

specific language was included in last year’s 21st Century Cures to 

restore the contracting authority back to BARDA as it had been 

originally executed when the authority was established. And our 

intent was, in reaffirming the underlying statute, was to remove 

unnecessary layers of bureaucracy, increase your flexibility, and 

make sure BARDA can be nimble in making those development decisions without being second-guessed and slowed down through the 

extraneous layers of review which caused the delays and uncertainty. 

And so now that this is law or again it has been made law, 

what’s been the impact of this provision specifically on getting development contracts in place on Zika virus? 

Dr. BRIGHT. Thank you for your question. And that’s a very important area. And we actually are very grateful that Congress has 

recognized the need for improved efficiency, especially improved efficiency in our contracting ability and working with industry to be 

able to move as quickly and nimbly as possible to respond to 

115 

emerging threats and in our daily work for other threats that we 

address for our Nation. 

We are grateful for the 21st Century Cures Act and its passage. 

To date, it has not been implemented yet, as we are waiting for the 

permanent ASPR to take position hopefully in the near term, and 

we will be able to work hand-in-hand with that ASPR for full implementation of every provision in the 21st Century Cures Act. 

Mrs. BROOKS. So it’s actually because the ASPR individual has 

not been named, confirmed, that is holding up the execution and 

use for Zika vaccine? 

Dr. BRIGHT. We are working very hard at drafting proposals for 

the ASPR to consider. As you know, BARDA is a part of the ASPR, 

the Assistant Secretary for Preparedness Response, and so it’s critical that we have that permanent ASPR in place to ensure that 

what we’re putting in place for long-term is going to be coordinated 

and work hand-in-hand with the vision of that ASPR. 

We have not yet implemented and changed the contracting authority back to BARDA at this point; however, we are working as 

efficiently as we can with the ASPR’s office of contracting to be 

able to move forward. 

Mrs. BROOKS. OK. And I guess I’d just like to make sure I understand, because that provision was signed into law, and so it’s unknown when a permanent ASPR—there’s an acting ASPR individual, is there not? 

Dr. BRIGHT. There is an acting ASPR, yes. 

Mrs. BROOKS. And do we not have the Secretary of Health and 

Human Services in place that’s been in place for some time, does 

the Secretary realize that that part of the law has not been implemented yet? 

Dr. BRIGHT. I’m not able to speak on behalf of the Secretary, but 

I do know the Secretary recognizes the importance of efficiency and 

the importance of our ability to work with industry as efficiently 

and nimbly as possible. I do know that the acting ASPR is working 

with us on proposals, but we have not moved forward in implementing that yet. 

Mrs. BROOKS. Do we have a timeframe on which the acting ASPR 

is going to, you know, put this matter before the Secretary? 

Dr. BRIGHT. I do not have a timeframe on that. 

Mrs. BROOKS. OK. How much money was provided to BARDA in 

2016 through the emergency funding to assist in the development 

of a Zika vaccine? 

Dr. BRIGHT. In 2016, BARDA received $132 million, and that was 

distributed for vaccines and diagnostics and our pathogen reduction 

technologies. So vaccine specifically in 2016, we spent about $94 

million. 

Mrs. BROOKS. And can you describe then how BARDA did use 

these funds for the development of the vaccines, the 94 million? 

Dr. BRIGHT. Yes. Those funds were to support the technologies 

we have in our portfolio now, four different companies, who are 

working on Zika vaccines, and it supported the development and 

the initial manufacturing of those vaccine candidates and the 

movement of those vaccine candidates into phase 1 clinical studies. 

It was with the additional funds we received in fiscal year 2017 

from the Zika supplemental, an additional $245 million, they were 

116 

able to put to work to move those vaccines and diagnostic candidates into midstage phase 2 clinical trials. And at that point, that 

is as far as we can move with the funding that we have. 

Mrs. BROOKS. Thank you. And I’m going to switch very briefly. 

Dr. Borio, one thing we have not brought up and you brought up 

in your testimony, can you please describe the impact, as quickly 

as possible, of the Zika outbreak on the blood supply and how those 

blood supplies are currently being screened? 

Dr. BORIO. So this is an area that we have worked very early on 

to mitigate the threat to the blood supply. Initially, before a screening test became available in the areas of Puerto Rico, for example, 

BARDA was very proactive and helped us ensure adequate blood 

supply to Puerto Rico, so the blood supply was imported into the 

island from the Continental United States. Eventually, blood donor 

screen tests became available under IND, and those were deployed. 

It became apparent last year that, with a number of travelers returning to the U.S., pretty much the entire continent was at risk 

of the blood supply of the entire United States, and we implemented guidance to make sure that all the blood supply then was 

screened for Zika. 

Mrs. BROOKS. Thank you. Thank you. My time is up. 

I now call on Mr. Carter of Georgia for 5 minutes. 

Mr. CARTER. Thank you, Madame Chair, and thank all of you for 

being here. Folks, what we do up here is important, but what you 

do is lifesaving, and we recognize that. We appreciate all your efforts of that. 

I have the honor and privilege of representing the entire coast 

of Georgia, over 100 miles of coastline where a third of the saltwater marsh in the country on the Atlantic Coast is located. We 

have mosquitoes. We have them bad. We’re concerned about this, 

and I think rightfully so. 

I’ve had the opportunity to visit a number of mosquito control 

centers in our area, particularly in the two most populus counties 

in the coastal region, and they’re doing a great job. I dare say that 

we could not, regardless of Zika, just the mosquito problem, we 

could not inhabit that area if we didn’t have mosquito control, so 

it’s extremely important. 

I wanted to ask just a couple of questions real quick. And, first 

of all, I have a question, Dr. Petersen, about the pregnancy register 

and registry, because from what I understand, and staff has told 

me, that there’s some concerns that possibly it’s not fully effective 

and that the outcomes that—and we’re not getting the outcomes 

that we should in the people that are listed. 

Have you got any concerns with it? Is there anything we can do 

to assist you to help with any problems you might be having with 

it? 

Dr. PETERSEN. I think that the pregnancy registry so far has 

been very effective in terms of trying to figure out what the risks 

of Zika virus infection in the mother is on their developing fetus. 

What we really don’t know and what we need continued support 

for is trying to figure out the whole spectrum of the illness associated with this virus. And that’s just going to take time. 

Because what we know now is that some of the babies that may 

appear completely normal actually aren’t. And so trying to figure 

117 

out over a period of time and long enough followup is exactly needed to determine what the whole clinical spectrum of this disease actually is. 

Mr. CARTER. What’s the problem between the territory and Puerto Rico and America? I understand there’s a significant difference 

there in the registry. Is there a reason for that or is there a concern there? 

Dr. PETERSEN. Right. So in the beginning, of course, we didn’t 

really know much about the clinical syndrome associated with 

Zika. In the Continental United States, we took a very—used a 

very broad definition to try and capture all the potential outcomes 

associated with this infection. Puerto Rico, on the other hand, used 

a very narrow definition. They were really focused on the most severe cases of microcephaly. And so that led to some discrepancies 

in numbers between the Continental United States and Puerto 

Rico. 

However, we have reconciled this. Puerto Rico is now using our 

case definition for congenital Zika syndrome and will be reporting 

out shortly similar numbers to what we have in the Continental 

United States. 

Mr. CARTER. OK. All right. 

Dr. Borio, I want to ask you about public-private partnerships 

and how we can use them to speed up the vaccines and the development to market. Have you had experience with these? Is this 

something that does help that we can work on? 

Dr. BORIO. Sure. The FDA has established public-private partnerships. I mean, this is very much a model that we work with to 

support the vaccine development. We have an important role as 

regulators, and we have to maintain some firewalls between us and 

the development. 

Mr. CARTER. Right. 

Dr. BORIO. But I have to explain to you that, you know, our technical teams are deeply involved with all the different working 

groups that are developing vaccines and providing very much, in 

realtime, feedback and active guidance—— 

Mr. CARTER. Very quickly, any hurdles that you see that perhaps 

we can assist you with? 

Dr. BORIO. No. We deeply appreciate the support we have. We 

feel like we have the authorities today. And this year, we received 

resources to be able to support the Zika response. We’re in pretty 

good shape. Thank you. 

Mr. CARTER. Good, good. 

Very quickly, Dr. Bright, I wanted to ask you, it’s my understanding in your testimony you mentioned that you’re working with 

a company in Brazil to come up with a vaccination. Just out of curiosity, their regulations and their licensing arrangements and clinical trial requirements, et cetera, et cetera, are they significantly 

different from what we have here in America? Can you see of anything that we can do better here in America to help along this line? 

Dr. BRIGHT. Thank you. They have an independent regulatory 

authority, ANVISA. We’ve worked with the companies in Brazil for 

the last 10 years in developing, manufacturing, and vaccine development capacity for pandemic influenza and other vaccines, and 

we’ve also noticed they are very closely collaborating with our U.S. 

118 

FDA. So there’s an agreement between our U.S. FDA and the Brazilian regulatory authority that allows them to exchange information and best practices and protocols to accelerate the development 

of vaccines, actually in our country, as well as theirs. 

Mr. CARTER. I’m encouraged to hear that. In fact, I want to compliment all of you. I’m encouraged by what I’ve heard today, and 

I appreciate your work on this. And from what I’m hearing, we’re 

making progress. So thank you very much. 

And I yield back. 

Mrs. BROOKS. Thank you. 

The Chair now recognizes the gentleman from Florida, Mr. Bilirakis, for 5 minutes. 

Mr. BILIRAKIS. Thank you, Madame Chair. I appreciate it. Thank 

you for allowing me to sit in on the hearing, because I’m not on 

this subcommittee, so I really appreciate it. And I want to thank 

the panel too. I’m from the State of Florida, so obviously we’ve been 

affected by the Zika virus, so I appreciate all your assistance. I 

have a few questions. 

Dr. Persons, could you discuss how we can best streamline agency coordination to prevent bureaucratic overlap and redundancies, 

which can lead to waste and unnecessary delays and hamper the 

effectiveness of response? 

Dr. PERSONS. Thanks, Mr. Bilirakis. So I appreciate the question. 

Mr. BILIRAKIS. Sure. 

Dr. PERSONS. I’ll answer it in two ways. One is GAO has a standard manual for internal controls, and it’s called the Green Book. So 

just the efficacious implementation of those internal control standards, which primarily often have to do with interdepartmental communication and things which often is at the core of this. As you 

know, all the agencies here have very important—they’re doing 

very important work, very important roles in things, but that systematic look at something and being able to coordinate is easy to 

say but harder to do and yet very important and critical to a timely 

response. 

The second answer I would say is related to just our overall 

work. GAO, as you may know, does work on overlap and duplication, and so we have a standing methodology on looking at what 

constitutes overlap, duplication, or even fragmentation among Federal programs. That report just went out recently, and there’s 

methodology behind the thinking on that that might be commendable to this conversation. 

Mr. BILIRAKIS. Thank you. 

Next question for Dr. Bright. With a coordinated interagency response, are there interagency goals that drive responsive preparedness strategies? If so, what are those goals? 

Dr. BRIGHT. Our goals. So our Assistant Secretary coordinates all 

of our research efforts and response efforts to the Zika response 

and other public health emergencies. And so we established, early 

on in the outbreak, an awareness of the Zika outbreak that we 

would have interagency alignment and vaccine production and diagnostic production and other countermeasure development. And 

we established and drafted HHS-wide, U.S. Government-wide goals 

to achieve the milestones for those vaccines and diagnostics. 

Mr. BILIRAKIS. Thank you. 

119 

Dr. Petersen, CDC established a Zika registry last year. What 

data is captured in this registry? How is this data being utilized? 

Dr. PETERSEN. So we gather data on evaluations that are done 

on the mother and fetus throughout pregnancy, and importantly, 

also on the condition of the fetus and medical consequences of infection following birth. We hope to continue this work and to follow 

these infants born to mothers infected during pregnancy to determine what the full impact of the virus infection in the mother actually is on the fetus. And that’s still an open question. 

Mr. BILIRAKIS. OK. What’s the value to researchers of tracking 

beyond 1 year or tracking 5 years? What are the benefits to that? 

Dr. PETERSEN. Well, I think the benefits are primarily, number 

one, telling people what to expect. Two is to provide appropriate 

medical care and social services for those infants in this condition. 

Mr. BILIRAKIS. So you would recommend tracking 5 years as opposed to just one? 

Dr. PETERSEN. Recommend follow—excuse me? 

Mr. BILIRAKIS. Yes, you would recommend the 5 years? 

Dr. PETERSEN. I think we need to follow these infants up for, you 

know, probably 5 years or possibly even longer, depending on what 

we find. 

Mr. BILIRAKIS. Even longer? Very good. Thank you very much. 

Good information. 

Dr. Persons, earlier this year, the administration released a brief 

budget outline that proposed a coordination point for Zika-related 

activity. Can you share observations on how such a central coordinating point could help? 

Dr. PERSONS. So, yes, thank you for the question. I think this 

again is—this incidence with Zika as an emerging infectious disease is one of a kind, and it’s unique in one way, but we’ve seen 

the pattern before. And so I think as you shift more toward a 

stronger central coordinating factor, I would say, for example, 

there’s the importance Dr. Fauci mentioned earlier on ASPR and 

that within or interdepartmental coordination with HHS is certainly critical. There’s also sort of a whole-of-Government thing 

that I think was on display when the previous administration had 

appointed an Ebola czar back during the Ebola timeframe, just because there are oftentimes things, even outside of big HHS and all 

the important work they’re doing, there’s often whole-of-Government response that may involve, for example, DOD, or in this case 

with mosquito-borne vector disease, you’re talking about the regulator of pesticides, EPA, or various other things. 

So I think there’s some potential commendable thinking on what 

that central function coordinating might look like even in the 

whole-of-Government sense on something this complex and this 

rapidly evolving. 

Mr. BILIRAKIS. OK. I want to thank all of you for your efforts, 

and I look forward to working with you. We can combat this virus. 

So I really appreciate the testimony. 

And I yield back, Madame Chairwoman. Thank you. 

Mrs. BROOKS. Thank you to our colleague from Florida. 

And to close out—— 

120 

Ms. CASTOR. Yes. Madame Chair, I wanted to thank you and 

Congressman Murphy for organizing this hearing on Zika, and 

thanks to all of our expert panelists. 

We’ve got to remain vigilant and address the funding cliff that’s 

coming up, and also the elephant in the room today with the 

Trump budget; we’re never going to be able to protect our families 

and businesses across this country if we don’t keep America as the 

world leader in medical research and in disease prevention. Proposed cuts to things like CDC’s Center on Birth Defects would 

come at the exact wrong time when we’re seeing an increase in 

birth defects largely driven by Zika. 

Democrats and Republicans came together in the last funding 

bill and said we are the world leader, and we’re going to keep it 

that way in medical research and disease prevention. And I trust 

that we can all work together to keep it that way again. And thank 

you again. 

Mrs. BROOKS. And I’d like to thank all of the witnesses. Thank 

you for your incredible dedication. And I’d like to thank all of your 

agencies for continuing to work together in the most efficient and 

most effective way, because the issue of Zika is obviously not going 

away. Issues of other infectious diseases, whether it’s Ebola in 

West Africa, whether it’s cholera in Yemen and other diseases, we 

must make sure that we as a Government are keeping our citizens 

safe, that we’re learning as much as we can based on all of the outstanding work of your agencies. And we will continue to work with 

you to make sure that you do have the resources that you need. 

And in conclusion, I’d like to thank all the witnesses and Members that participated in today’s hearing. Remind Members they 

have 10 business days to submit questions for the record. I ask 

that the witnesses all agree to respond promptly to those questions. 

And the subcommittee is adjourned. Thank you. 

[Whereupon, at 12:37 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

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26480.055

TO: 

FROM: 

RE: 

U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON ENERGY AND COMMERCE 

Members, Subcommittee on Oversight and Investigations 

Committee Majority Staff 

May 19,2017 

Hearing entitled "U.S. Public Health Response to the Zika Virus: Continuing 

Challenges" 

The Subcommittee on Oversight and Investigations will hold a hearing on Tuesday, May 

23, 2017, at 10:00 a.m. in 2123 Rayburn House Office Building, entitled "U.S. Public Health 

Response to the Zika Virus: Continuing Challenges." Last year, the Committee held a hearing on 

March 2, 2016, entitled "Examining the U.S. Public Health Response to the Zika Virus," 1 where 

the Subcommittee examined the emergence of the virus across the Americas. the potential link 

between Zika and other illnesses, and the public health plan to respond to the virus. The 

Subcommittee held this hearing early relative to the initial outbreak of the virus and, as a result, 

the non-partisan Government Accountability Office (GAO) was only able to share preliminary 

observations in its testimony. On March 23,2016, the Committee sent a letter to GAO 

requesting that they finish their work and issue a final report once their work is complete 2 

At this Subcommittee hearing, the GAO will publicly release its final report entitled, 

·'Emerging Infectious Diseases; Actions Needed to Address the Challenges of Responding to 

Zika Virus Disease Outbreaks."3 This hearing will examine the findings and recommendations 

from the GAO report, as well as lessons learned from the federal government's response to the 

initial spread of the Zika virus last year. These findings are critical to improving the federal 

government's response to future outbreaks of the Zika virus and other emerging infectious 

diseases. The Subcommittee will also hear from federal officials about advancements made in 

the past year, including in vaccine and diagnostic test development. 

1 L\.amining the C'.S. Public /lealth Response to the Zika Virus, Hearing Beforl! the H Comm. on Energy & 

Commerce, I 14th Con g. (March 2, 20 16), m•ailable at: https:/'energycommerce.house.gov/hearings-andvotcs/hcarings/exarnining-us-public-health-rcsponse-zika-virus. 

2 On file with the Committee. 1 U.S. Government Accountability Office, Emerging Diseases· Actions .\'eeded to Address the Challenges 

of Responding the /.ika Virus Disease Outbreaks, May [hereinafter GAO Report]. References to the GAO 

Report in this memorandum are references to the draft version, on file with the Committee. The final report was not 

available at the time of drafting. Any changes to final report are not expected to a1Tect information referenced in this 

memorandum. 
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Majority Memorandum for May 23, 2017, Subcommittee on Oversight and Investigations Hearing 

Page 2 

I. WITNESSES 

• Timothy Persons, Ph.D., Chief Scientist, U.S. Government Accountability Office; 

• Lyle R. Petersen, M.D., M.P.H., Director, Division of Vector-Borne Diseases, National 

Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and 

Prevention; 

• Luciana Borio, M.D., Acting Chief Scientist, U.S. Food and Drug Administration; 

• Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases, 

National Institutes of Health; and 

• Rick A. Bright, Ph.D., Director, Biomedical Advanced Research and Development 

Authority; Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness 

and Response, U.S. Department of Health and Human Services. 

II. BACKGROUND 

a. History and Spread of the Virus 

Despite medical and scientific advances in the last century, infectious diseases account 

for one out of every five deaths worldwide. 4 Scientists first identified the Zika virus in 194 7 

among monkeys living in the Zika forest of Uganda. The first human cases of Zika were 

detected in Africa in 1952, with the first outbreaks reported on Yap Island in Micronesia in 2007 

and French Polynesia in 2013. 

The Zika virus spreads primarily through the bite of an infected mosquito. The virus is 

carried predominantly by the Aedes aegypti mosquito, and possibly by the Aedes albopictus 

mosquito, also known as the Asian tiger mosquito.5 These mosquitoes also carry yellow fever, 

dengue, and chikungunya. In addition to mosquito bites, the virus can spread through sexual 

transmission, blood transfusion, and from mother to child during pregnancy. 

According to the Centers for Disease Control and Prevention (CDC), the most common 

symptoms of a Zika infection are fever, rash, headache, joint pain, conjunctivitis (red eyes), and 

muscle pain. The illness is usually mild with symptoms beginning two to seven days after 

infection and lasting for several days to a week. In past outbreaks, about four out of five people 

infected with Zika appeared not to have had any symptoms at all.6 The high rate of infected 

'GAO Report. 5 A recent study in a laboratory demonstrated that the Aedes vexans mosquito could also spread Zika. See 

https:l/www.researchgate.net/publication/315061412 _ AmericanAedes vexans _Mosquitoes, are __ Competent_ Vecto 

rs of Zika Virus. 6 Exa7nining the U.S. Public Health Response to the Zika Virus, Hearing Before the H. Comm. on Energy & 

Commerce, 114'' Cong. (Mar. 2, 2016) (statement of Dr. Thomas K Frieden, Director, CDC), available at 

https://energycommerce.bouse.gov/bearings-and-votes/hearings/examining-us-public-health-response-zika-virus. 
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Majority Memorandum for May 23, 2017, Subcommittee on Oversight and Investigations Hearing 

Page 3 

individuals who are asymptomatic, and therefore do not seek diagnostic testing or medical 

treatment, makes it difficult to have an accurate case count of Zika virus infections. 

Further, a causal link has been established between Zika infection during pregnancy and 

congenital birth defects. Since the outbreak started last year, there have been numerous reports 

of microcephaly and other poor health outcomes in babies of mothers infected with Zika while 

pregnant. Microcephaly is a serious birth defect in which a baby is born with a head smaller than 

expected and exhibits improper brain development. On February I, 2016, the World llealth 

Organization (WHO) determined that the rapid spread of Zika infections and the suspected link 

to microcephaly constituted a "Public I Icalth Emergency of International Concern" under the 

International Health Regulations7 Further, the former Secretary of the U.S. Department of 

Health and Human Services (HHS), Sylvia Burwell, designated the Zika virus a public health 

emergency in Puerto Rico in August 2016. 8 

The outbreak in Latin America began in Brazil in February 2015, and was identified as 

Zika virus in May 20 !59 As of March 2017, the WHO reported that there arc 84 countries, 

territories, or subnational areas with evidence of vector-borne Zika virus and 13 countries have 

reported evidence of person-to-person transmission of the virus. 1

° Further, there are 31 countries 

or territories that have reported microcephaly and other central nervous system malformations 

potentially associated with a Zika infection, or suggestive of congenital infection and there are 

23 countries or territories that have reported an increase of incidence of Guillain-Barre syndrome 

(GBS) and/or laboratory confirmation of a Zika infection among GBS cases. 11 

According to the recent report released by the Government Accountability Office (GAO), 

94 percent of all cases in the United States are travel-associated cases, and most of these were 

associated with travel to the Caribbean, Central America, and South America. 12 Between January 

I, 2015, and May 12, 2017, reported Zika virus cases numbered 5,273 in the United States and 

36,581 in the United States Territorics. 13 

Of the 5,273 cases reported in the continental United States: 

• 5,001 cases arc travelers returning from affected areas; 

7 WHO statement on the first meeting of the International Health Regulations Emergency Committee on Zika virus 

and observed increase in neurological disorders and neonatal malformations, Feb, 1, 2016, 

http://www. who .int/mediacentre/news/statements/20 16/1 st -cmergency-comm ittee-zi ka/ en/. 8 \J.S. Department of Health and Human Services, Public Health Emergency, Aug. 12,2016, available at 

https://www.phe.gov/emergency/news/healthactions/phc/Pages/zika-pr.aspx. 

9 World Health Organization, Zika. Strategic Response Framework & Joint Operations Plan, Feb. 2016 [hereinafter 

WHO Framework]. 10 World Health Organization, Lika Virus, Microcephaly, and Cui/lain-Barre Syndrome Situation Report. Mar. I 0, 

20 I 7, available at http://apps. who.int/iris/bitstream/1 0665/254714/1/zikasitrep I OMar 17 -eng.pdf?ua~ I. 11 /d 

"GAO Report. 13 Centers for Disease Control and Prevention, Zika Virus, available at https:l/www.cdc.gov/zika!reporting/2017-

case-counts.html. 
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Majority Memorandum for May 23, 2017, Subcommittee on Oversight and Investigations Hearing 

Page 4 

• 224 cases were acquired locally through mosquito-borne transmission in Florida 

(21 8) and Texas ( 6 ); and 

• 48 cases were acquired through other routes, including sexual transmission. 

Of the 36,581 cases reported in the United States Territories: 

• 143 cases are travelers returning from affected areas; and 

• 36,438 cases were acquired locally through mosquito-borne transmission. 14 

The first identified outbreak of mosquito-borne Zika infection in the continental United 

States occurred in Florida. To date, only two states in the continental United States-Florida and 

Texas-have documented cases of locally acquired mosquito-borne transmission of the Zika 

virus. While only two states have confirmed cases of locally acquired mosquito-borne 

transmission, except for Alaska, every state and three territories have reported cases of Zika. 15 

This month, Brazil announced the end to its Zika public health emergency declaring that 

from January to April 2017, there were 95 percent fewer Zika cases reported in comparison to 

the same time period in 2016. 16 This dramatic decline in reported cases is attributable to both 

Brazil's aggressive mosquito eradication program and herd immunity among the population due 

to such a large portion of the population being infected by the virus. 17 In the United States, there 

arc no known current active transmission cases. 

b. Status of Zika virus research 

Research into the Zika virus, particularly into the impact of infection during pregnancy, is 

ongoing. The National Institutes of Health (NIH) recently implemented a cohort study with a 

goal of enrolling as many as I 0,000 pregnant women at up to 15 sites internationally in order to 

study the outcome of women who test positive for the Zika virus as well as those who test 

negative and their infants. 18 The goal of this study is to assess the different risk factors for 

congenital disease in pregnant women and evaluate the short- and long-term clinical outcomes of 

babies born to women infected with the Zika virus. 19 

In addition, the CDC established the U.S. Zika Pregnancy Registry, which is used to track 

and monitor pregnant women who contracted the Zika virus. In the United States, the registry 

publicly reports biweekly numbers of pregnant women with laboratory evidence of a possible 

14 Sexually transmitted cases are not reported for the Territories because, with the local transmission of Zika, it is not 

possible to determine whether infection occurred due to mosquito~bome or sexual transmission. 15 GAO Report. 16 The Atlantic, Brazil Declares an End to Its Zika Health Emergency, May 12, 2017, available at 

https ://www. theat1 anti c.com/news/archivc/20 I 7/05 /brazil-ends-zi ka-emergency J 5 26 5 09/. 

"BBC News, Zika Virus: Brazil Says Emergency is Over, May 12. 2017, available at 

http://www.bbc.com/news/world-latin-america-39892479. 

18 /d. 

19 /d. 
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Majority Memorandum for May 23,2017, Subcommittee on Oversight and Investigations Hearing 

Page 5 

Zika virus infection. 20 According to the CDC, as of May 15, 2017, there have been I ,409 

completed pregnancies with or without birth defects, 58 liveborn infants with birth defects, and 

eight pregnancy losses with birth dcfects. 21 

On April4, 2017, CDC released a report that indicates roughly one in ten women in the 

United States with a confirmed Zika virus infection during pregnancy resulted in a fetus or infant 

with virus-related birth defects. The chances of birth defects were even higher among fetuses or 

infants whose mothers were infected with Zika during the first trimester of their pregnancies.22 

In addition to the concerns regarding microcephaly, as of March 10, 2017, the WHO has 

documented 23 countries and territories that have reported an increase in the incidence of GBS 

or laboratory confinnation of Zika virus infection among GBS cases. 23 ClBS "is an uncommon 

sickness of the nervous system in which a person's own immune system damages the nerve cells, 

causing muscle weakness, and sometimes, paralysis."24 "Current research suggests that GBS is 

strongly associated with Zika; however, only a small proportion of people with recent Zika virus 

infection get GBS. CDC is continuing to investigate the link between GBS and Zika."25 

c. Current Status of Diagnostics, Vaccines, and Other Treatments for Zika 

Though there are no commercially available diagnostic tests cleared by U.S. Food and 

Drug Administration (FDA) for the detection of Zika virus, the FDA has authorized two different 

types of diagnostic tests for the Zika virus-molecular and serologic. 26 Molecular tests are used 

to detect genetic material of the virus in samples of bodily fluid such as urine or serum. 

Serologic tests detect antibodies against the virus in blood. The FDA authorized 16 Zika virus 

diagnostic tests via Emergency Use Authorizations (EUA) during the outbreak-13 molecular 

tests and three serologic tests 27 FDA officials later revoked one of the tests, leaving 15 

diagnostic tests that are currently authorized. 28 

Id 

Centers for Disease Control and Prevention, Zika Virus, Outcomes of Pregnancies with Laboratory Evidence of 

Possible Zika Virus Infection in the United States, as of April 25, 2017, available at 

https://www.cdc.gov/zika/geo/pregnancy-outcomes.html. 

22 Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Vital Signs: Update on Zika 

Virus-Associated Birth Defects and Evaluation of All U.S. Infants with Congenital Zika Virus Exposure- U.S. Zika 

Pregnancy Registry, 2016, Apr. 7, 2017, available at 

https:/ /www.cdc.gov/mmwr/volumes/66/wr/mm6613e l.htm?s _ cid=mm66!3e 1 ·-w. 23 \\1

orld Health Organization, 7ika Virus, /14icrocepha/y, and Ciuillain-Barre Syndrome Situation Report, Mar. I 0, 

2017, available at http::!apps. who.int!iris!bitstreaml/0665125471411/zikasitrepl OMar/7-engpdfhm= /. 24 Centers for Disease Control and Prevention, Zika and Guillain-Barre Syndrome, Last Updated Aug. 9, 2016, 

available aL https://\\'Ww.cdc.gov/zika/healtheffects/gbs-qa.html. 

"ld 

26 GAO Report. 

"ld 

"Zika Virus Response Updates from FDA, Emergency Use Authorization (Ell~), last updated May 17, 2017, 

available at 

https:/ /www. fda.gov /Emergency Preparedness/Counterterrorism/Medica!Countermeasures/MCMJss ues/ucm48 51 99. 

htm#eua. 
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Majority Memorandum for May 23, 2017, Subcommittee on Oversight and Investigations Hearing 

Page 6 

While this number appears high and promising, the GAO found that the tests varied in 

their performance and operational characteristics-most notable was the variation in the ability 

of the diagnostic tests to detect the virus and provide accurate results. Each of the existing 15 

tests have varying strengths and limitations; therefore, multiple tests and sample types are often 

required to diagnose an individual with the Zika virus. Furthermore, CDC and FDA guidance 

are critical in assisting health care providers and laboratories in determining the most appropriate 

test(s) for each individual. 

During the first two weeks after onset of symptoms, Zika can be diagnosed by 

performing a reverse transcriptase-polymerase chain reaction (RT-PCR) test on serum.29 This 

test can accurately determine whether a person has been infected with Zika, but is only effective 

while the virus is still present in the blood or other fluid. After this initial period, tests to 

examine the presence of antibodies must be used. These antibodies can persist for several weeks 

after an infection-currently, an Enzyme-Linked Immunosorbent Assay (ELISA) test is used 

about four days to 12 weeks post onset of symptoms. However, the presence of similar 

antibodies from dengue, chikungunya, or even a yellow fever vaccine can cross-react and give a 

positive result. As a result, a plaque-reduction neutralization testing (PRNT) may be needed to 

measure virus-specific antibodies and discriminate between cross-reacting antibodies 30 The 

PRNT test is described as a highly specialized and lengthy test. GAO found that the delays 

between getting initial antibody test results and the PRNT confirmatory results may have led 

some clinicians and patients to make family planning decisions without confirmation of Zika 

virus infection. 31 

Throughout the developmental stages of the diagnostic tests, manufacturers encountered 

obstacles including access to clinical samples and other diagnostic tests for comparison purposes. 

Users of the tests also faced challenges, including determining the most appropriate test to usc, 

access to different tests, and obtaining the equipment needed to conduct the tests. 32 Concerns 

remain regarding the accuracy of the diagnostic tests and CDC's guidance for testing procedures. 

A recent report notes that retests of a 2016 batch of samples from Washington, D.C. found that 

three patients tested positive for the virus, 26 were inconclusive, and 394 remained negative. 33 

One of the three positive test results was for a pregnant woman. Since the retesting, CDC has 

sent updated testing procedures to public health labs throughout the United States. 

Currently, there is not a specific therapy or vaccine approved for the Zika virus by the 

FDA. Several vaccines are in various stages of development, with one experimental vaccine 

currently in Phase II trials being tested in humans. More vaccine candidates are expected to enter 

Phase II trials this year. Last month, Dr. Anthony Fauci, the Director of the NIH National 

Institute of Allergy and Infectious Diseases (NIAID), stated that the DNA vaccine candidate 

29 Centers for Disease Control and Prevention, Diagnostic Testing, page last updated May 5, 2017, available at 

http:l/www.cdc.gov/zikaJhc-providers/diagnostic.html (last accessed May 15, 2017). 

lO Jd 

31 GAO Report. 

"ld 

33 3 Retest Positive for Zika in DC; CDC Updates Testing Procedures, NBC Washington, May 8, 2017, available at: 

http://www.nbcwashington.com/news/health/3-Retest-Positive-for-Zika·in-DC·CDC·Cpdates-Tcsting-Procedures· 

421656883.html. 
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Majority Memorandum for May 23, 2017, Subcommittee on Oversight and Investigations Hearing 

Page 7 

developed by scientists at NIAID's Vaccine Research Center had been a success in animal trials 

and in the first human trial of the vaccinc 34 

d. Vector Control 

There arc four types of mosquito control methods that are available in the United States: 

physical control or nonchemical mosquito control, larval mosquito control, adult mosquito 

control, and using personal protection. 35 According to the CDC, the best way to prevent diseases 

spread by mosquitoes is to avoid mosquito bites. Official recommendations include using insect 

repellent, wearing long-sleeved shirts and long pants, protecting your baby or child, and taking 

steps to control mosquitoes inside and outside your home 36 For pregnant women, special 

precautions include not traveling to areas with risk of Zika and using protection during sex 

during your entire pregnancy due to the risk of infection via sexual transmission.37 

Additional efforts to prevent the spread of Zika include surveillance of the mosquito 

population. GAO identified different mosquito control methods that target different stages of the 

mosquito lifecycle. 38 Therefore, surveillance of the mosquito population is a critical component 

of preventing the spread of vector-borne diseases such as Zika. The Aedes aegypti mosquito can 

breed in very small containers of fresh water, including in roadside trash, discarded tires, flower 

pots, and even bottle caps. The mosquito bites during the day and night-and favors biting 

humans over animals. This characteristic makes the use of pesticides challenging because 

daytime spraying would be required for the pesticides, or adulticidcs, to be most effective. 

Public resistance is a significant limitation to utilizing this method. Further, mosquitoes arc 

becoming increasingly resistant to currently available pesticides. Reduction of the breeding sites 

is an effective means to control the mosquito population, but this method depends heavily on 

broad public participation and education. Other emerging technologies continue to be explored, 

including the release of genetically modified mosquitoes, biological control, and autodissemination traps. 

In the United States, vector control is handled at the state and local level. The federal 

government has a very limited role in implementing mosquito control. Many states create 

mosquito control districts funded by the state, locality, or both. The level of services varies 

greatly-some local jurisdictions provide services directly, others contract for services with 

private companies. 

While the federal government does not appear to specifically provide funds for mosquito 

abatement, grants provided by the CDC to states through Epidemiology and Laboratory Capacity 

(ELC) grants allow for funds to be used to detect, monitor, and control mosquito- and tick-borne 

34 C1'iN, Promising Zika vaccine moves to next stage, April 10, 2017, available at 

http:iwww.cnn.com/20 17 /030/31/health/zika-vaccine-nih-trial/ 15 GAO Report. 16 Centers for Disease Control and Prevention, Zika Virus: Prevent Mosquito Bites, available at 

https://www.cdc.govizika/prevention/prevent-mosquito-bites.html (last updated Jan. 17, 20 17). 37 Centers for Disease Control and Prevention, Zika Virus: Pregnant Women, available at 

https://www.cdc.gov/zikaipregnancy/protect-yourself.html (last updated May 3, 2017). 18 GAO Report. 
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Page 8 

diseases in the United States39 However, not all localities arc served by vector control. Further, 

grant funds awarded for mosquito control may not make it to some local mosquito control 

districts. The GAO found that the federal government faced challenges in supporting mosquito 

control efforts, including sustaining staff expertise in mosquito control during periods when there 

are no outbreaks, and effectively communicating information about the geographical distribution 

of mosquitoes that transmit the Zika virus. 

e. Unknowns and Challenges Remain 

While the scientific and public health communities have learned much about the Zika 

virus over the past year, the GAO report identifies many areas where unknowns remain, 

includingA0 

• The total number of infections in the United States; 

• The biological mechanisms, risks, reasons for geographic differences, and full 

spectrum of outcomes associated with mother-to-child transmission; 

• The risk of transmission from different bodily fluids and routes, including maternalfetal transmission; 

• The role of prior Zika virus infections or exposure to other related arboviruses; and 

• The full spectrum of short-tenn and long-term outcomes of Zika virus infection, with 

or without clinical symptoms. 

Based on the totality of evidence from epidemiological studies, scientific consensus is 

now that Zika virus causes microcephaly, brain abnormalities, and other birth defects. The CDC 

has also reported that its own research suggested a strong association between GBS and Zika 

virus. At this point in time, we do not know the complete risk of Zika to an individual 

pregnancy, nor do we know the definitive risk of Zika in causing additional disorders such as 

GBS. Some researchers have speculated that, in the future, we may sec cases where a child 

presents as normal, but has mental or physical disabilities after becoming infected with Zika in 

utero. 41 Further, recent research done by the NIH shows that the virus may also have a 

negative-and possibly long-lasting-impact on male fcrtility. 42 The research results come from 

39 Centers fOr Disease Control and Prevention, Epidemiology and Laborat01y Capacity for Inji:xtious Diseases, 

available at http://www.cdc.gov/ncezid/dpei/epidemiology-laboratory-capacity.html#blank (last updated Dec. 21, 

20 16); American Mosquito Control Association, Funding for National Disease Surveillance Network through 

Epidemiology and Laboratory Capacity (ELC) Grants from the Centersfor Disease Control, available at 

http://www.mosquito.org/cdc-funding-position-paper. 

40 GAO Report. 41 Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Description of 13 Infants 

Born During October 20 I5-Januwy 2016 with Congenital Zika Virus Infection Without Microcephaly at Birth··-

Brazil, Dec. 2, 2016, available at https:l/www.cdc.gov/mmwrivolumes/65/wr/pdfs/mm6547e2.pdf. 42 National Institutes of Health, NIH Director's Blog, Could Zika Virus If ave Lasting Impact on Male Fertility? 

Nov. 8, 20 !6, available at https://directorsblog.nih.gov/201 6ill/08icould-zika-virus-havc-lasting-impact-on-malefertilityl. 
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Majority Memorandum for May 23,2017, Subcommittee on Oversight and Investigations Hearing 

Page 9 

a mouse study, which found that the Zika virus can persist for weeks in the reproductive systems 

of male mice. As a result of the infection, levels of testosterone and other hormones drop, sperm 

counts fall, and in some cases, the testicles shrink, possibly irreversibly.43 In addition, we do not 

know whether individuals who contract Zika but are asymptomatic will have any negative effects 

for themselves or their children, nor do we know if previous infection from a related virus, such 

as dengue or yellow fever, has an impact on the effects of Zika on an individual. 

Another challenge is the lack of modeling for infectious diseases. Modeling is crucial to 

combat a virus such as Zika because it would help both public health officials and vector control 

units prepare for, identify, detect, and predict where the disease is likely to spread. Modeling 

would also help predict the need for lab and testing capacity in a given region, the demand for 

vaccines if and when they come to market, and where to prioritize effective mosquito control. 

The lack of sufficient data, methods, and the unique aspects of the Zika virus pose challenges for 

conducting modeling and simulation studies. According to CDC documents and officials 

interviewed by the GAO, the CDC has not been able to predict how much the Zika virus will 

spread in the continental United States.44 On May 5, 2017, NIH issued a grant opportunity for 

"Modeling of Infectious Disease Agent Study Research Projects."45 According to the 

announcement, the purpose of this funding opportunity "is to support innovative research that 

will develop and apply computational tools and methods for modeling interactions between 

infectious agents and their hosts, disease spread, prediction systems and response strategies."46 

Finally, challenges remain regarding the development and use of diagnostic tools. 

Despite the fact that the U.S. has known about the Zika virus, at the time of the discovery that 

Zika infection during pregnancy could lead to severe birth defects, there were no accurate and 

reliable authorized diagnostic tools for the Zika virus disease. As previously noted, by April 12, 

2017, FDA had authorized 15 diagnostic tests for the Zika virus (12 molecular tests and three 

serologic tests) under EUAs following the public health emergency declaration. One major issue 

with these tests is that it is not possible to compare the tests with one another based on the 

information on the product insert. Communicating such information could have enabled users to 

more easily identify the test that could detect the smallest amount of virus in a sampleY 

Manufacturers of diagnostic tests faced several challenges, including: (I) lack of 

knowledge of key scientific aspects of the virus; (2) difficulty in accessing well-characterized 

clinical samples; (3) gaining access to EUA tests for use as a comparator assay; (4) gaining 

cooperation with international entities; and (5) manufacturers' mixed opinions about the 

effectiveness of communication from FDA.48 Users of the tests also identified challenges, 

including: (I) complying with the test's EUA label, which specifies equipment required to 

perform the test, and (2) determining the most accurate test, in part because of challenges 

4J Id 

44 GAO Report. 45 Grants.gov, Department of Health and Human Services, National Institutes of Health, May 5, 2017, available at 

https:i/www.grants.gov/web/grants/view-opportunity.html?opp[d~293636. 

46 Id 

GAO Report. 

l8 !d. 
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Majority Memorandum for May 23, 2017, Subcommittee on Oversight and Investigations Hearing 

Page 10 

comparing performance characteristics reported in the EUA labels 49 GAO found that the CDC 

and FDA did not follow their guidance in communicating information about Zika virus 

diagnostic tests that could have enabled users to more easily identify the test that could detect the 

smallest amount of virus in a sample. 5° 

In particular, there were issues with CDC communications about molecular diagnostic 

test sensitivity. Last year, a CDC scientist and expert on arboroviruses, who later became a 

whistleblower, alleged that CDC endangered public health when it failed to disclose that the 

CDC test used to detect the Zika virus, known as a Trioplex (an FDA EUA), was less sensitive 

than another CDC laboratory-developed test (not authorized under FDA EUA), known as a 

Singleplex 51 Following an Office of Special Counsel investigation, CDC agreed to reinstate the 

scientist. An internal CDC investigation about the allegations found that the evidence did not 

support the allegations. 5

2 

The GAO found, however, that the CDC investigation did not attempt to gather 

additional information on comparing the tests from public health laboratories using the 

Singleplex. 53 Further, later actions taken by the CDC appear to validate the whistleblower's 

concerns regarding the Trioplex test. The original Trioplex test was authorized using a smaller 

input volume, while the Singleplex was not subject to the limitation because it had not been 

submitted to the FDA for review. 5

4 Smaller input volume lessens the sensitivity of the test. 

CDC submitted a substantial amendment to the Trioplex test for FDA authorization to increase 

the input volume of the test in August 2016, and in January 2017, the authorization was amended 

again to allow laboratories to use a Singleplex reaction on the Trioplex assay.55 The larger input 

volume has been demonstrated to increase the sensitivity of the Trioplex assay, according to 

CDC. A journal article later showed that the original Trioplex test was less sensitive than the 

Singleplex test. 5

6 Representatives of three scientific professional societies told GAO that 

information about the development and verification of CDC's diagnostic tests should be made 

available to the scientific and medical communities. 57 

f. GAO Recommendations 

The GAO recommended two actions for FDA: (I) Consolidate information from 

individual diagnostic test labels and make this information available in a form that enables users 

to more readily compare information across tests; and (2) Require manufacturers to list the 

49 /d. 

50 !d. 

51 Lena H. Sun, CDC whistleblower claims agency has been using wrong Zika test, Washington Post. September 28, 

2016. 

50 U.S. Department of Health and Human Services, Report of1nvcstigation. OSC File Number Dl-16-3709, attached 

to September 2, 2016 from HHS Secretary Sylvia M. Burwell to The Honorable Carolyn N. Lerner, Special 

Counsel, Office of the Special Counsel. 

GAO Report. 

''Jd. 

55 !d. 

56Jd 

"!d. 
131 


26480.065

Majority Memorandum for May 23, 2017, Subcommittee on Oversight and Investigations Hearing 

Page 11 

identity of comparator assays on their diagnostic test labels. The FDA concurred with both 

recommendations. 

The GAO recommended three actions for CDC: (1) Establish a transparent process to 

provide CDC diagnostic tests, upon request, to manufacturers that are in the final stages of 

diagnostic test authorization; (2) Include information on CDC-developed tests distributed to 

public health laboratories on CDC's website, including any laboratory-developed tests; and (3) 

Provide details such as collection records, dates, and data limitations on posted and disseminated 

mosquito distribution maps to better inform mosquito control experts and the general public. 

CDC concurred with Recommendations (1) and (3), and partially concurred with 

Recommendation (2). 

In recent decades, emerging infectious diseases have continued to garner global attention. 

Diseases such as SARS, H!Nl, Ebola, pandemic influenza, and now Zika have continued to 

surface leaving little time for public health officials to react. In each of the aforementioned 

cases, the GAO found that HHS was reactive in its response to outbreak prevention, 

preparedness, detection, and response. This was the theme of the Subcommittee's hearing on 

biodefense preparedness held on February 12, 2016, focused on the bipartisan report of the Blue 

Ribbon Study Panel on Biodefense. 58 Given global travel and migration patterns, infectious 

diseases spread more easily than ever before. With the emergence of more infectious diseases 

around the corner, the federal government needs to find ways to be more proactive instead of 

reactive. 

g. Status of Zika Funding 

Funding for federal government spending on the Zika virus has come from multiple 

sources. On April 6, 2016, the White House Office of Management and Budget and the 

Secretary ofHHS identified $589 million that could be redirected and spent on the response to 

the Zika virus 59 

In addition, through the Zika Response and Preparedness Act, 2017, Congress provided 

an additional $1.1 billion in supplemental funds to the U.S. Department of Health and Human 

Services, the U.S. Department of State, and the U.S. Agency for International Development. 

HHS received $933 million of the $1.1 billion. Ofthe $933 million, the CDC received $394 

million, the NIH received $152 million, and the Public Health and Social Services Emergency 

Fund received $387 million, with $245 million of that going to the Biomedical Advanced 

Research and Development Authority (BARDA).60 

As of April 30, 2017, HHS has obligated $635 million of the $933 million appropriated 

in the Zika Response and Preparedness Act.61 The breakdown by agency is as follows: 

58 Outbreak<, Allacks, and Accidents: Combating Biological Threats. Hearing Before the H. Comm. on Jo;nergy & 

Commerce, !14th Cong. (Feb. 12, 2016), available at https:!/encrgycommerce.housc.gov/hearings-andvotes/hearings/outbreaks-attacks-and-accidents-combatting-biological-threats. 

59 Congressional Research Service, Zika Response Funding: Request and Congressional Action, Sept. 30,2016. 60 U.S. Dep't of Health & Human Servs., Zika Supplemental Funding Spend Plan, Oct. 26, 2016. 61 Email from HHS staff to Committee staff, May 18,2017. 
132 


26480.066

Majority Memorandum for May 23, 2017, Subcommittee on Oversight and Investigations Hearing 

Page 12 

• CDC: $332.2 million obligated; 

• NIH: $68.8 million obligated; 

• ASPR/BARDA: $110.6 million obligated; 

• HRSA: $57.3 million obligated; and 

• CMS: $66.1 million obligated. 

HHS has informed the Committee that remaining funds not yet obligated have been committed, 

and that the funding will last through the end ofthc fiscal year. 

III. ISSUES 

The following issues will be examined at the hearing: 

• How can the CDC and the states be better equipped to respond to any potential 

Zika outbreaks in the U.S. this summer? 

• How can the FDA and CDC establish a transparent process for providing test 

manufacturers access to diagnostic tests for comparison purposes and provide 

information to help ensure that users of diagnostic tests can compare 

performance? 

• How can state and local implementation of mosquito control programs be 

improved and more effectively supported by federal agencies? 

• What is the current state of research into (a) the causal link between Zika and 

other health conditions, including microcephaly and GBS; and (b) the efficacy 

and availability of currently available rapid diagnostic testing for Zika? 

• What is the status of diagnostic testing development, vaccine development, or 

other therapeutics for Zika? 

IV. STAFFCONTACTS 

If you have any questions regarding the hearing, please contact Alan Slobodin, Brittany 

Havens, or Jennifer Barbian at (202) 225-2927. 
133 


26480.067

fltongrt~~ of tbt Wntttb ~tatt~ 

&laSbiugtou,lMt:. 20515 

Robert M. Speer 

Acting Secretary of the Army 

l 0 l Army Pentagon 

Washington, DC 2031 0-01 0 1 

Dear Acting Secretary Speer: 

February 15,2017 

We write to you to strongly urge the Department of the Army not provide an exclusive 

license to Sanofi Pasteur, Inc. for two pending patents to manufacture the Zika vaccine. If such a 

license is issued, we are very concerned that the price of the vaccine, which was developed with 

taxpayer dollars, will be unaffordable tor people in the United States and around the world. As 

you know, the cost of the drugs is one of the most pressing public health concerns and rising 

drug costs continue to harm patients who need access to those drugs and taxpayers who both pay 

to develop many drugs and fund public insurance programs like Medicare and Medicaid. 

Our concerns have been echoed by organizations such as Doctors Without Borders, who 

fear that without safeguards in place to ensure the vaccine is affordable, it will be inaccessible to 

people in developing countries who can ill-afford such costs. Moreover, President Trump has 

repeatedly called for action to lower drug prices, and we fear awarding an exclusive license for a 

critical vaccine developed with public funds to a single drug manufacturer will set a dangerous 

precedent. 

When the Zika virus surfaced and infectious disease experts at the National Institutes of 

Health (NIH) determined the threat it posed to the American public, it became a national priority 

for Congress to take swift action and allocate funding for developing an effective vaccine to 

combat the spread and infection of the Zika virus. As a result, Congress acted to provide NIH 

with more than $40 million to develop and test such a vaccine. Despite that substantial 

investment by taxpayers, on December 9'h, the Department of the Army filed with the Federal 

Register a Notice of Intent to grant Sanofi exclusive licenses for two pending government patents 

to manufacture the Zika vaccine. The Notice of Intent would give Sanofi a monopoly for the 

Zika vaccine without any restrictions or requirements that they ensure the vaccine is affordable 

for all those who need it. 

In order to ensure that the investment made by taxpayers was worthwhile, it is critical that we 

ensure the vaccine to prevent against the Zika virus is accessible to anyone who requires it 

Again, we strongly urge the Department of the Army not provide an exclusive license to Sanofi 
134 


26480.068

Letter to Acting Secretary Speer 

February 15,2017 

Page 2 

to manufacture this vaccine. If the Department of the Army does decide to move forward with 

their proposal, we implore you to instead issue a limited license and put in place requirements 

that this vaccine must be available at an affordable price and allow the federal government to 

intervene if Sanofi prices the drug at a level that would make it inaccessible to the millions of 

Americans who need access to a vaccine they paid to develop. Without these changes, we are 

fearful that Americans and people in developing countries will not be properly protected against 

future outbreaks of the Zika virus. 

We look forward to your response, and to working with the Administration to ensure that the 

price ofthe Zika vaccine does not threaten public health by deterring access to this vital therapy. 

Sincerely, 

Member "'~ of Congress 

_j,~-

\dYD DOGGETT 

Member of Congress 

Member 

J~ of Congress 

'6?,'4 ft J2Itu uwRosA L. DELAURO 

Member of Congress 
135 


26480.069

Letter to Acting Secretary Speer 

February 15,2017 

Page 3 

~~ PRAMILA JA YAPAL 

Member of Congress 

MICHELLE LUJAN GRISHAM 

Member of Congress 

PETER WELCH 

Member of Congress 

Member of Congress 

tf#:ez;;;. LI 1\ E. CUMMINGS .• ~t/ Me er of Congress 

Cc: Francis Collins, Director, National Institutes of Health 

Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National 

Institutes of Health 
136 


26480.070

JOHN BEL EDWARDS 

GovERNOR 

Robert M. Speer 

Acting Secretary of the Army 

I 0 I Army Pentagon 

Washington, DC 20310-0101 

Dear Mr. Speer, 

@ffire of tbe ~obernor 

~tate of J!.ouisiann 

May 10,2017 

P .0. Box 94004 

BATON RoUGE, LOUISIANA 70804-9004 

(225) 342-7015 

GOV.LA,GOV 

As Governor of the State of Louisiana, I write to express my serious concern 

about the Department of Defense's proposed exclusive license of patents on a Zika 

vaccine to Sanofi, particularly if the license does not address the pricing of the vaccine to 

U.S. residents. 

Louisiana remains one of the Gulf states most likely to be affected in the event 

that the Zika virus continues to spread. A decision to give one company, Sanofi, a 

monopoly, without any constraints on the price for the vaccine, could cripple state 

budgets and threaten public health in the event of local Zika transmission. As many as 

540,000 Louisiana residents on Medicaid alone could benefit from an effective Zika 

vaccine, but all my constituents deserve access in the event of local transmission. I am 

concerned that an unaffordable Zika vaccine willurmecessarily expose our state's most 

vulnerable citizens, our babies, to risk for serious lifelong complications of preventable 

Zika infection. 

It is my understanding that considerable federal support has gone into creating the 

vaccine, including federally-funded clinical trials, a $43 million BARDA grant to Sanofi 

for Phase II trials, with the option for an additional $130 million in funding for the later 

trials if needed for the vaccine's approval by the FDA. Sanofi would also be eligible for a 

valuable priority review voucher, worth millions of dollars, and possibly benefit from 

several years of exclusive rights on the data from the clinical trials the U.S. government 

has funded. The extent of public investment in the development of the vaccine calls into 

question the need for an exclusive license, and it certainly provides a compelling reason 

to ask questions about the price ofthe vaccine now, before a license is signed, rather than 

after a monopoly has been granted. 

Furthermore, because the vaccine in question is the Zika Purified Inactivated 

Virus (ZPIV) and makes use of the inactivated virus to produce an immune response, it 

may have added benefits and value as a booster vaccination to DNA Zika vaccines. 

Preliminary studies by NIAID found that the ZPIV induced antibodies that neutralized 

the virus and protected animals from disease when they were challenged with Zika. 
137 


26480.071

Robert M. Speer 

May 10,2017 

Page2 

I am concerned that the Department of Defense has yet to address concerns about 

pricing and affordability for the vaccine, despite requests from nearly a dozen nongovernmental organizations representing patient interests. In April 2017 the Department 

of Justice ordered Sanofi to repay nearly $20 million in overcharges to the Department of 

Veterans Affairs. Sanofi is known to charge U.S. residents far more than residents of 

other industrialized countries for other medications, such as Sanofi's multiple sclerosis 

drug Aubagio (teriflunomide). 

We believe our interests would be better served by avoiding the grant of an 

exclusive license on the Army's Zika patents. Barring that, U.S. residents, particularly 

those that I represent in Louisiana, deserve assurances that the vaccine will be affordable 

to people who have already paid for most of the research and development costs. 

No one should have to worry about their child being born with microcephaly or 

other birth defects, and certainly no one should have to face that frightening prospect 

simply because the vaccine is unaffordable. Louisiana taxpayers have already paid once 

for this invention, and it is reasonable to expect that the Department of Defense at 

minimum ensure that our residents pay reasonable prices on the otl_ler end. 

Sine r ly, 

Bcl~ 

cc: Barry Datlof 
138 


26480.072

SANOFI 

May 22,2017 

The Honorable Tim Murphy 

Chairman, House Energy and Commerce 

Oversight & Investigations Subcommittee 

2125 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Murphy and Ranking Member DeGettc: 

The Honorable Diana DcGette 

Ranking Member, House Energy and Commerce 

Oversight & Investigations Subcommittee 

2125 Rayburn House Office Building 

Washington, DC 20515 

Thank you for scheduling a hearing on the U.S. Public Health Response to the Zika Virus: Continuing 

Challenges. Sanofi Pasteur, the vaccines division ofSanofi, is pleased to participate in this effort by 

pat1nering with the Walter Reed Army Institute of Research (WRAIR) and the Biomedical Advanced 

Research and Development Authority \BARDA) on a Zika vaccine candidate, an important component of 

Zika response. 

The development of any vaccine is a high-risk endeavor, particularly for emerging infectious diseases 

marked by changes in epidemiology and trajectories that are still evolving. In fact, in November of2016, 

the World Health Organization indicated the Zika outbreak is no longer a public health emergency. That 

was followed by the government of Brazil on May 12, 2017, declaring an end to its Zika public health 

emergency after 95% fewer cases were recorded between January and mid-April, 2017, compared to the 

same period the prior year. Each of these examples underscores the unpredictability of seasonal endemic 

diseases. To effectively address these types of public health challenges, it is essential for vaccine 

manufacturers to collaborate with governmental scientific organizations to effectively leverage our 

complementary resources, expet1ise, and strengths. 

In advancing this Zika vaccine candidate in collaboration with the U.S. government, we have contributed 

significant resources, including over 60 full time scientists, proprietary technical manufacturing expertise, 

and utilization of our robust t1avivirus clinical trials network to bring the vaccine candidate through Phase 

II studies. Sanofi Pasteur has engaged in this endeavor in the face of opportunity costs associated with 

delaying other R&D programs in order to advance this vaccine at an unprecedented pace. Despite claims 

to the contrary, we do so not based on projected commercial return, but out of our sense of corporate 

responsibility to contribute our capabilities to address a potential public health crisis. 

Significant attention has been paid to whether our public-private partnership with the WRAIR may 

constitute a monopoly for Sanoti Pasteur. Questions have also been raised regarding the potential pricing 

of a future Zika vaccine. In truth, dozens of other companies, many with funding from the U.S. 

government, are also developing Zika vaccine candidates, some using similar approaches, others using 

other novel technologies. It is unclear at this time which approach, if any, will ultimately succeed. 

However, as we continue to negotiate the terms of a licensing agreement with WRAlR for its patents, and 

whether that agreement ultimately is exclusive or non-exclusive, our potential license would not cover all 

vaccine technologies and thus would not prevent other companies from pursuing vaccine candidates 

based on alternative technologies in order to create a robust and competitive Zika vaccine marketplace. 

SANOFI US 1455 Pennsylvania Avenue, NW Suite 500, Washington. DC 20004 USA Tel: 202.585.3000 
139 


26480.073

·""' 'tl 

SANOFI 

Additionally, it is premature to consider or predict Zika vaccine pricing at this early stage of development. 

As noted earlier, ongoing uncertainty around epidemiology and disease trajectory make any commercial 

projections theoretical at best. However, if we ultimately reach a licensing agreement with the WRAIR 

and bring a Zika vaccine to market, Sanofi Pasteur has a history of working with governments and nongovernmental organizations around the world to make our vaccines available at affordable prices, 

Evidence of our commitment to safe, affordable, and accessible vaccines is demonstrated by our industryleading ranking on the Access to Vaccines Index (https://accesstovaccinesindex.org/report-cards/sanofi/) 

and the publically available pricing of our products both in the United States and abroad. It is in the 

public-health interest to price this and other vaccines in a way that will facilitate access to and usage of a 

preventive vaccine. We have demonstrated that commitment in the past, and, if we bring a Zika vaccine 

to market, we intend to do so for Zika as well. 

Given the many uncertainties surrounding the future of Zika, we believe the WRAIR and BARD A are to 

be commended for their approach to partnership with industry. In fact, given the high risk nature of 

vaccine development and unpredictability for diseases like Zika, if the U.S. government changes its 

historic approach to licensing terms, it could undermine the intent of these types of collaborations. 

Sincerely, 

Adam Gluck 

Vice President and Head, U.S. Government Relations 

Sanofi 

Cc: 

The Honorable Morgan Griffith 

The Honorable Joe Barton 

The Honorable Michael Burgess 

The Honorable Susan Brooks 

The Honorable Chris Collins 

The Honorable Tim Walberg 

The Honorable Mimi Waters 

The Honorable Ryan Costello 

The Honorable Buddy Carter 

The Honorable Greg Walden 

The Honorable Janice Schakowsky 

The Honorable Kathy Castor 

The Honorable Paul Tonka 

The Honorable Yvette Clarke 

The Honorable Raul Ruiz 

The Honorable Scott Peters 

The Honorable Frank Pallone 

SANOFI US 1455 Pennsylvania Avenue, NW Suite 500, Washington, DC 20004 USA Tel: 202.585.3000 
140 


26480.074

Clinical Expert Series 

Emerging Infectious Diseases in Pregnancy 

Richard H. Beigi, MD, MSc 

It has been recognized for centuries that pregnant women have unique susceptibilities to many 

infectious diseases that predispose them to untoward outcomes compared with the general 

adult population. It is thought a combination of adaptive alterations in immunity to allow for the 

fetal allograft combined with changes in anatomy and physiology accompanying pregnancy 

underlie these st~sceptibllities. Emerging infectious diseases are defined as those whose 

incidence in humans has increased in the past two decades or lhreaten to increase in the near 

future. The past decade alone has witnessed many sud1 outbreaks, each with its own unique 

implications for pregnant women and their unborn fetuses as wen as lessons for the health care 

community regarding response and mitigation. Examples of such outbreaks include, but are not 

limited to, severe acute respiratory syndrome, the 2009 H1N1 pandemic influenza, Ebo!a virus1 

and, rnost recently, the Zika virus. Although each emerging pathogen has unique features 

requiring spedfic considerations, there are many underlying principles that are shared in the 

recognition, communication, and mitigation of such infectious outbreaks. Some of these key 

principles include disease-specific delineation of transmission dynamics, understanding of 

pathogen-specific effects on both mothers and fetuses, and advance planning and contempo~ 

raneous management that prioritize communication among public health experts, clinicians, and 

patients. The productive and effective working collaboration among the Centers for Disease 

Control and Prevention, the American College of Obstetricians and Gynecologists, and the 

Society for Maternal~Fetal Medicine has been a key partnership in the successful communication 

and management of such outbreaks for women's health care providers and patients alike. Going 

forward, the knowledge gained over the past decade will undoubtedly continue to inform future 

responses and will serve to optimize the education and care given to pregnant women in the 

face of current and future emerging infectious disease outbreaks. 

(Ohstel Gynecol2rr17;129:896-906) 

DOl: 10 .. 1097/AOC.OUO/XiOOOOOOIJ19711 

E merging infectious diseases are deflned as patho~ 

genic outbreaks whose incidence in humans has 

increased in the past two decades or threaten to increase 

in the ncar future. L The hnportance of emerging infec~ 

mtdiml nlumtion for tlli~ or/idt is ttNtilah!t til ltttp;!!link.dztJW. 

171t rwtlwl" has imfimtcd that ht lws met lllr journal~~ requiremrntr for 

autlumhif>. 

Cnrre.JjiOilthng twtluw Ridmrd 1/. Reig,i, MD, .MSc, J)epartmtnl of Obstrtrirs. 

Gynemlogy, & Reproductint Scimres, AIUlfi'C" Womms !-lospilrtl of UPMC, 300 

1/alket Sirett, Piwburgh, PA J5213i mulil: rbrigi(oimail.ma!jeu:du. 

Fi7lancia/ Disclosure 

1Jrc mlflwr did not rt:pMt any potential amjlids vfinlm:xi. 

C· 2017 by 'll1e Amrriran College of Obstelriri(lnS and (.)'naologis(.i. Published 

Woltrn Kfuwer llea!th, lnr. Afl rights rrsrrucd. 

001!i 7H4·l/!7 

896 VOL. 129, NO. S, Mi\Y 2017 

tious diseases has been recognized for al least 20 years 

and continues to increase in importance and scope for 

many societal and ecologic reasons.:.:,;! Such outbreaks 

of novel pathogens frequently cross national and terTilorial boundaries (in parl as a result of the robust travd 

of modern life) and include recently highlighted and 

severe pathogens such ~L<'i severe acute respiratory syndrome (SA!l.S), the 2009 HlNl pandemic influenz"', 

Ebola virus, and, most recently, the Zika virus. In addi~ 

tion to these highly publicized outbreaks of recent 

times, emerging pathogen te1minology also includes 

less dramatic~ but often no less menacing, considen~­

lions such as l) new infections resulting from changC's 

or evolution of existing organisms, 2) known infections 

spreading to new geographic areas or populations, :1) 

previously unrecognized infections appearing in areas 

underg<>ing ecologic transfonnation, and 4) old infections recmeq,~ng as a result of the development of 

antimicrobial resistance to known standard agents or 

OBSTETRICS & GYNECOLOGY 
141 


26480.075

breakdowns in public health measures. t-:l Commonly 

cited emerging infectious diseases of intcre.st and some 

pathogen specifics are compiled in Box I, 

It has been appreciated for centuries that pregmmt 

women have unique immunologic and physiologic 

characteristics lhal predispose tht'tn to heighten~d rntes 

of serious and sometimes filtal outcomes from varied 

infectious diseases. This observation is mostly athib~ 

Box 1. Commonly Noted Emerging and 

Reemerging Pathogens of Interest 

Pandemic influenza viruses 

Novt>l infh.wnza strains, emerg,tng from .mtigPnic shift in 

tl1e influPflZJ virus, Lausing n{·cashmal sevcrt' itlflupnza 

p<11l<it•mic:. 

SARS-associated coronavirus 

Highty pathogenic, novP! severe re'lpiratory virus that 

emerged .1nd r<~pid!y sprt.'dd globally from a sm.1ll 

location in China 

Ebola virus 

Prcviousl)l rccogni7Pd ~erious p"tthogen Jssociat-ed with 

mock•st-s!7Pd outhre.:1ks beforC' 2014 (l.trgt'!it outbreak); 

strikingly high mortJ!ity ratE' 

Zika virus 

PrevhJusly under~lpprt:.•ci._1ted path()gcn until tmgoing 

outbreak \vith its association with fet.1l rn~llfonn.ltiuns 

(mt>st notably rnit·ro(·(•phd!y); its unique characterislics 

this outbreak at the intersec1ion of Pmerging infecrliseasQS, reproductive rights, and glnh,1! hP.1Ith 

security 

West Nile virus 

The mo.;t common mosquito-bornC' infection in the 

United States; no docunwnted direct fetal dfect 

Chikungunya virus 

Mosquito-honw viru~ that was pr(•viously found in Asi,l, 

Africa, and Europe that h.1s rPcently !:>e(m detected in the 

Anwricas; no documented direct fetal eff(•('t 

Methicillin.resislanl Staphylococms aureus 

\Nell-known rePml•rging pathogen given its aggressive 

clinical nalure and re!.Jtivdy limitPd antimicrobial 

treatnwnt options 

Vancomycin~resistant enterococci 

Classic reemerging pathogen th.1t sC'rves as an ongoing 

reminder of thP ever prc:.enl .mel evolving t•pidernic of 

antimicrobial rrsistanc{' 

SARS, S(•vert' ,\Cut(' n·spir,llory !'}'ndromc. 

VOL 12'l, NO. S, MAY 20'17 

uted to the combination of somewhat altered cellular 

immunity capabilities (presumably to allow for the fetal 

allogmft) combined with changing anatomic specifics 

that can challenge primmily cardiovascular and respiratory systems with advru1Cing· gestational agc:H) More 

recent research has focused on relative concentrations 

and potencies of various immunoglobulins (immunoglobulin G) during pregnancy as part of the explmmtion lor altered pregnancy immunity."' Additionally, 

ongoing investigations are assessing lhe role of the placenta and its inherent ability to block some viral pathogens from access to the ldus. 1 1 Ongoing research will 

continue to delineate the specifics of the immunology 

of pregnancy and its effect on disease transmission and 

pathogenesis. 

The heightened susceptibility to adverse outcomes 

is most often noted f()r viral pathogens, with bacterial 

and parasitic infections occasionally also having this 

predilection. In addition, preg11ant women also have 

unique charactedstics worthy of attention with regru·d 

to infectious diseases (and their countermeasures) from 

clinicians including, but not limited to, the teratogenic 

potential of m1 infecting pathogen, diiTeJing transmission susceptibilities and specific implications for fetal 

infection during different stages of pregnancy, and the 

effect of an in utero infection on subsequent neonat..'ll 

and infant development. !rnporurntly, despite a predilection for worse outcomes, it docs not appear (for 

the majority of pathogens) tlutt pregnancy makes 

women more susceptible to acquiring an infection with 

the possible exceptions of human immunodeficiency 

virus, malaria, and potentially listeriosis. 1 :l 

In addition to the inherent risks posed by 

cmert,ring infectious diseases to pregnant women, the 

concept of the medical establishment's preparedness 

and response in the face of novel outbreaks has also 

recently received considerable attention. Much of the 

early focus toward preparedness was centered on the 

likelihood of an impending influenza pandemic.'"· 1

·

1 

However, the concepts and collaborations have now 

matured to include guidance and directives that are 

s-imultaneously relevant for a broad range of patho·· 

gens as well as specific outbreaks. 15-· 17 This is most 

recently evidenced by the appropriate attention 

received by, and prioritization given to, the ongoing 

Zika virus outbreak. A robust collaboration among 

the Centers for Disease Control and Prevention 

(CDC), the American College of Obstetricians and 

Gynecologists (the College), and the Society for 

Maternal-Fetal Medicine has also been paramount in 

highlighting important up-to-date knowledge, thereby 

enabling practice that is based on the best available 

data during the evolution of Zika and others. The 

Beigi Enwrgin~ lnfectiuos !Jisc'<b('~ in Pr"e,gnancy 697 
142 


26480.076

women's health field has successfully aligned in 

response to these recent outbreaks in a manner that 

will undoubtedly serve pret,'1Hmt women optimally. 

This article highlights a series of recent high-profile, 

specific emerging pathogens of significant maternalfetal importance given their important lessons to the 

obstetric and public health community. In addition, 

the pathogens chosen for discussion have some 

unique and challene,~ng features and provided unique 

fOundations for progress in the area of health cure 

provider, facility, national, and international pre~ 

paredness planning and disease mitigation. 

SEVERE ACUTE RESPIRATORY SYNDROME 

Severe acute respiratory syndrome is a previously 

unrecognized emerging infectious disease caused by 

a novel pathogen that challenged the global health 

community's ability to effectively communicate and 

cooperate toward a goal of eventual contaimnent. 

Believed to have originated in China's Gnangdong 

Province late in 2002, it appears to have been spread 

internationally in the winter of 200cl by a physician 

who had traveled to the region to provide care against 

a new mystedous respiratory pathogen. 'Traveling 

home from China, he stayed one night at what later 

came to be referred to as Hotel M (from the epidemi· 

ologic perspective) in Hong Kong and was noted to 

have been ill for approximately 7 days prior with the 

same respiratory symptoms as his patients. Subsequent to his short, 24-hour stay, approximately 12 

additional guests fell ill from this same unknown pathogen (the majority of whom were staying on the same 

floor as him in the hotel, yet without significant close 

contact) and then proceeded to travel abroad and per· 

petuate the global spread of what is now known as 

SARS. Involved countries included Canada, Vietnam, 

Singapore, Ireland, and the United States. In total, the 

World Health Organization (WHO) recogni,;ed at 

least 8,400 associated cases, with more than 800 

deaths in greater thlUJ 32 counllics recorded over 

roughly 6 months."·'" It was accordingly dubbed the 

first 21st century pandemic. 

The infection was characterized by a rapid onset of 

fever plus other nonspecific symptoms (headache, 

malaise1 and myalgia) followed by a nonproductive 

cough that progressed to shortness of breath and 

respiratory failure in a subset of patients. Characteristic 

laboratory abe1rations include lymphopenia and elevated lactate dehydrogenase levels. The causative agent 

was later noted to be a novel corona virus likely present 

in animals being sold in local markets and subsequently infecting those handling the animals (zoonotic 

spread). Importantly, the subsequent humml-lo-human 

spread was throug·h respiratory droplets, yet early on, 

given the many unknowns, infection control pradices 

included all phases of precautions: respiratory, conlad, 

and droplet. 

Cohorting (grouping of persons [patients or 

health cm·t> workers] who have been exposed to 

a disease, a form of isolating groups to minimize 

disease spread wilhin in a loc..'ltion} and isolating of 

patients in facilities as well as widespread public 

education, contact tracing, quarantine practices, border surveillance, and travel advisories were instituted 

and successfully contTibuted to the eventual global 

control within approximately fi months of first notilkation. ;,, 1" In the few affected obstetric hospitals, 

dose attention was paid to minimizing exposure to 

unaffected patients and staff by way of cohorting 

exposed and infected patients1 visitor limitations, vig~ 

ilance toward the use of personal protective equipment (such as masks and gowns), clinical flexibility, 

facility temporary closure, working collectively to 

establish coordinated and regionalized care, and a willingness to consider and establish care models 

that minimized mixing of patients and obstetric health 

care providcrs.IH,I9 All of these nonpharmaccutical 

interventions are important for all facilities providing 

care to preg11ant women to consider and plan for in 

advance. This is a key lesson from the SARS cpi· 

dcmic; traditional nonpharmaceutical countermeas~ 

ures are very effective for curbing disease spread, 

even in the absence of pharmaceutical interventions. 

Understanding tl1e effects of SARS on pregnancy 

is more challenging given the relatively low numbers 

of women infected, The few small available case series 

suggest that pregnant women had at leasl equal, and 

likely higher, rates of severe illness, intensive care unit 

admission, and death (similar to other serious respi~ 

ratory pathogens in pregnancy).'"·~" As noted in other 

severe respiratory infections, some women underwent 

preterm cesarean delivery presumably for maternal 

respiratory benefit. No documented cases of perinatal 

transmission were noted despite relatively rigorous 

methods of investigation for viral particles, serologic 

responses, nr both in neonates born to infected mothers. The low numbers of infected pregnant women 

were also attributable in part to the critically important and rigorous infection control practices noted 

(cohorting, regionalization of care, minimizing patient 

and health care worker mixing, use of personal protective equipment) used in hospitals that were successful in interrupting disease transmission. 1 H-~w The 

importance of the traditional infection control mcas~ 

ores in and of themselves cannot be overemphasized. 

Important lessons for obstetric health cal'e providers, 

OBSTETRICS & GYNECOLOGY 
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26480.077

Box 2. Important Lessons learned for Health 

Care Providers and facilities From Select Recent 

Emerging Infectious Disease Outbreaks 

SARS virus 

• Novel emerging pathogens originating 

can become local problems quickly given 

temational travel patterns ana methods of 

coordinated nonpharmaceutk~:t1 responses 

to disease outbreaks are critically important mitigation and control 

• Nonphatmaceutical efforts minimize nosocomial spread of infectious are critically 

important, especially in busy and delivery 

units with its inherent risks of exposure to numer~ 

ous body fluids 

• Clinical flexibility for facilities management is an 

important principle when dealing with a serious 

infectious disease with high potential for local 

spread among patients and health care providers 

Influenza virus 

• Even when predicted, expected, or both, emerging 

and reemerging infectious diseases (pandemic influcause significant morbidity and mortality 

pregnancy 

• Timely availabifity and use of influenza vaccJne in 

pregnancy is a major priority lor obstetric providers to recqmmend both in seasonal and pandemic outbreaks 

• Influenza can be a se\lele respiratory disease that 

can be transmitted person to petSOn before symptom 

onset, complicating mitigation efforts 

• Early use o( anti-influenza antivirals are very important and may lessen .the severity of .infection for 

mothers and their offspring 

• Immediately postpartum women (2 weeks) are at 

similar heightened risk of morbidity and mortality 

as pregnant women from influenza 

Ebola virus 

VOL 129, N(\ 5, MAY 2017 

Zika virus 

• Unexpected new or reemerging infections can arise 

at any time, from any location, and can threaten the 

entire global health community 

• The combination of the exact nature of !rnnsmission 

and !he effect ol an emerging iniect:lolls disease 

drives the .societal attention and medical e>~abllshment's response in real time 

• When little substantiated data are available at the 

onset ol outtir€al<s, more conservative public health 

gukl.lnce is appropriately delivered 

• Public health guidance must be appropriately updated, altered, or both a;s the nature and understanding of a novel outbreak evolves 

• The true and full effect of outbreaks with teratogenic 

potential is not known for many years after the outbreak ensues 

patients, and health care facilities from this particular 

outbreak are highlighted in Box 2. 

INFLUENZA VIRUS 

Influenza is a well-recognized cause of recurrent 

yearly global epidemics of febrile respiratory disease 

and has been documented as such for at least the 

previous four centuries. During this time, records 

suggest that the global community has experienced at 

least 30 influenza pandemics. The most severe recorded influenza pandemic was the 1918-1919 Spanish 

flu with estimates of global mortality of at least 20 

million,6,7 More recently the global community 

endured tbe 2009 H!Nl influenza pandemic and its 

associated morbiclity and mortality, mostly noted in 

adults younger than 50 years of age, including disproportionate numbers of pregnant and puerperal 

women. The natural history of influenza mutation 

combined with the inevitability of antigenic shift (producing pandemic strains) makes influenza an emerging pathogen of interest.6•

7 

Influenza infection is primarily transmitted person 

to persou through large droplets generated by coughing and sneezing from an already infected (and often 

asymptomatically incubating) person. In adclition to 

respiratory droplets, transmission is also possible by 

contact, either directly to a susceptible host or by 

passive transfer through an intermecliate object (ie, 

contaminated hands or objects). The incubation period 

for influenza is approximately l-4 days followed by 

acute onset of fever, chills, nonproductive cough, nasal 

Beigi Emerging Infectious Diseases in Pregnancy 899 
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26480.078

congestion, headache, sore throat, malaise, and fatigue. 

Mosl patients have a combination of systemic symptoms <md respiratory symptoms, and this finding can 

help differentiate influenza from other common respiratory pathogens. However, influenza is primarily 

a respiratory disease m1d most associated serious morbidity and mortality are attributable to respiratory compromise. Impork1ntly, patients are infectious and 

transmit the virus during the short incubation period 

before symptom onset. This fact explains some of the 

challenges with prevention of spread in the population 

and in facilities.11 

The occunence of an upcoming influenza pandemic was well-predicted and expected (ba,ed mostly 

on the time lapse since the last flu pandemic). However, 

the source, timing, and location of the outbreak were not 

predicted and provided some early challenges for 

a global response.':l,l4."1

·"2 Previous 20th century influem.a pandemics consistently demonstrated that pregnant 

women suffered from disproportionate morbidity, high 

wtes of pregnancy wastage, and higher rates maternal 

mortality (when compared with the general adult population).6,W,H This same phenomenon was again noted 

during the 2009 HI N I pandemic. Multiple publications 

demonstrate higher rates of morbidity, critical care 

admission, preterm labor and birth, and higher rates 

of death (approximately 5-fold to 20-fold higher than 

expected from population-based data) among pregnant 

and early postpartum womenY 1

- 27 Although this experience wa..<i not surprising, it provides a sober reminder 

of the uniquely susceptible nature of pregnant and mu·ly 

postpartum women to severe respiratory viral infections. 

Moreover, this recent experience clearly reinforced the 

importance of influenza vaccines and the use of other 

therapeutic measures during pregnancy. 

In this author's opinion, a beneficial and longlasting effect of the 2009 H!Nl influenza pandemic 

(notwithstanding its occasionally devastating effects 

on pregnant women) was that the unique nature of 

pregnant women was elevated to an international 

level of recognition never noted before. Coincidental 

to the 2009 H!NJ pandemic was a contemporaneous 

publication demonstrating in a randomized controlled 

fa,hion that immunization of pregnant mothers 

against influenza can also provide neonatal protection 

against influenza for up toG months of life.28 This key 

finding, which has been replicated in subsequent investigations coupled with additional publications 

highlighting the higher rates of untoward outcomes 

from 2009 HlN1 among pre&'Tlant women, provided 

a renewed scientific and policy focus on the potential 

for disea~e prevention for mothers and infant< 

through maternal immunization."" This focus contin900 Beigi Emerging Infectious o;seases in Pregnancy 

ues today and provides novel opportunities \A..ith 

new vaccine products designed specifically for use in 

pregnancy to 1ninhnize the maternal and neonatal 

infectious disease burden. 

No less important was novel clinical observational data demonstrating that the use of oseltamivir in 

pregnancy appears to mitigate to some extent t11e 

severity of infection. These data that had previously 

been noted in the general population were now 

validated in pregnancy and justify the usc of <mtivirals 

early in cases of suspected or proven influenza 

infection. Crcanga ct al showed that severity of illness 

among pregnant women in New York City and timing 

of !Ultiviral treatment are correlated. Pregnant patients 

who started therapy beyond the ·18-hour (after symptom onset) recommended window of treatment were 

more likely to have severe influenza illness (3% 

compared with as high as 44% having severe illness, 

comparing less than 48-hour to greater than 5-day 

treatment onset, respectively, P=.002)."" Similarly, 

a separate larg-er domestic invesli1,;ation of 788 pregnant 

women with 2009 H1Nl demonstrated a significantly 

elevated relative risk of G.O (95% confidence interval 

:3.5-1 0.6) for admission to the intensive care unit for 

women treated more than 4 days after symptom onset 

(compared with less than 48 hours)."' Combining the 

limited ability to predict which pregnant women will 

rapidly decompensate v.iih the fact that severe outcomes are more likely, universal early oseltamivir treatment should be given by obstetric health care providers 

in all clinical settings as recommended. ao 

The other important phenomenon that the 2009 

HlNI influenza pandemic demonstrated was that 

despite significlmt efforts toward preparedness, the 

production and distribution capabilities of the vaccine 

industry did not optimally match the timeline of need 

(ie, early in the outbreak). Optimal protection from 

a mass vaccination program occurs when the vaccine 

is given at least 2 weeks before peak population 

exposure risk. Despite progress made in terms of 

vaccine manufacturing and timeliness in the lead-up 

to the pandemic, the majority of vaccines became 

available during or after the most significm1t wave of 

infection in the f~tll of 2009.'" This situation continues 

to stimulate alternative methods for mass vaccine production and administration that may mitigate the 

supply-·demand mismatch in future influenza pandemics. Important lessons learned from the 2009 

H 1 N J experience are highlighted in Box 2. 

EBOLA VIRUS 

Ebola virus has been recognized as a severe viral 

pathogen responsible for viral hemmThat,>ic fever for 

OBSTETRICS & GYNECOLOGY 
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26480.079

approximately 40 years. The strain responsible for the 

most recent outbreak was first identified in 1!)76 along 

the Ebola River in what is now the Democratic 

Republic of Congo during a local outbreak of viral 

hemorrhagic fever. It is another zoonotic infection that 

humans most commonly initially contract from the 

natural reservoir of fruit bats. Once established in 

humans, subsequent infection is transmitted very 

efficiently from person to person by direct contact of 

mucous membranes or skin with bodily fluids or 

contaminated objects. Sexual transmission may occur. 

Incubation is typically 7-10 days and humans become 

infectious once fever and other nonspecific symptoms 

ensue. After the onset of generalized manifestations, 

severe gastrointestinal symptoms become apparent. 

Given the viruses' predilection for cytokine dysregulation, progression to multiorgan failure and hemor· 

rhagic shock commonly occurs. Case fatality rates 

range from 55-900fo, demonstrating its aggTessive 

nature. This is also partly the result of the lack of 

Ebola-specific therapy, leaving supportive care as the 

option. 15 

The recent Ebola virus outbreak in regions of 

West Africa thal started in 2014 and continued into 

2015 was the largest ever recorded with a total of 

28,652 cases, 15,261 of which were laboratoryconfirmed, and a total of !1,325 deaths (40-75% case 

fatality rate) .

32 The WHO declared this outbreak an 

International Public Health Emergency on August 8, 

2014, and the outbreak continued for many months 

thereafter. ll is worth noting that few pathogens bave 

the ability to undergo widespread dissemination like 

Ebola and also carry such a high mortality rate. The 

overwhelming majority of cases were in the West African countries of Guinea, Sierra Leone, Liberia, and 

Nigeria. However, there were health care workerassociated cases (as a result of travel from Western 

Africa) in a handful of Western countries, including 

the United States, which prompted significant domestic efforl.~ toward management of the potential for 

exposed and infected patients arriving in Western 

health care facilities. Many will remember significant 

domestic efforts in the fall of 2014 in response to 

a missed opportunity for identification and containment. Although the outbreak situation has mostly 

resolved, the CDC keeps a small force of roughly 

75 workers in affected regions to have capabilities to 

detect and mitigate any potential new or smoldering 

outbreaks. 

The interface between Ebola virus infection and 

pregnancy was partially appreciated at the outset of 

the recent outbreak. Historically women have been 

more likely to contract Ebola infection compared with 

VOL. 129, NO.5, MAY 2017 

men, likely related to cultural practices and caregiver 

roles. No data exist to suggest that pregnancy affects 

susceptibility to infection. However, historical reports 

suggest that pregnant women are more likely to suffer 

worse clinical disease and succumb to illness. The two 

largest case series reported before tbe recent epidemic 

note a cumulative mortality in excess of 90% during 

pregnm1cy from Ebola.33•

34 Affected pregnant women 

were equally represented across all gestational ages 

and presented with similar symptoms as the nonpregnant population with the notable exception of near 

universal reports of hemorrhage (mostly genital tract). 

No differences in clinical presentation or course of 

disease ba,ed on age or parity were documented. 

Additionally, very high rates of spontaneous miscarriage (approximately 60-70%) and pregnancy-related 

hemorrhage (both during delivery and abortion) were 

noted as well as the fact that no neonates born to 

infected mothers have survived longer than 3 

weeks. 15•

3•,as Interestingly, recent data demonstrate 

the presence of Ebola virus RNA in amniotic fluid, 

cord blood, and the placenta after delivery with associated implications.35 Overall, the recent epidemic 

substantiates the earlier findings of higher risk for 

morbidity and mortality in pregnancy. An additional 

trend recently noted suggests that the overall decline 

in regional health care workers during the 2014-2015 

Ebola outbreak plus a reluctance to care for infected 

pregnant women (presumably as a result of gravid 

women's high infectivity at the delivery) may have 

disproportionately predisposed pregnant women to 

receive less overall supportive care, leading to worse 

outcomes.36,

37 The full extent to which these trends 

may have affected outcomes remains to be fully 

realized. 

Data from the most recent 2014 outbreak also 

provide additional relevant information for perinatal 

healtb for obstetric health care providers to understand. The recent outbreak verifies that vertical 

transmission of maternal Ebola virus infection to 

tbe fetus can occur during an acute Ebola infection, 

subsequently leading to intrauterine fetal death, 

stillbirth, or neonatal death.37 Importantly, Ebola 

virus has been found in the breast milk during acute 

disease and may have led to infection in one infant, 

suggesting vertical transmissibility during lactation. 

Ebola also persists in many body sites for months, 

including semen~ raising concerns about persistent 

vertical and sexual transmission montl1s after clinical 

recovery,37 This has large implications for proper 

infection control practices during future outbreaks. 

Additional take-home concepts from the recent Ebola virus outbreak are elaborated in Box 2. 

Beigi Emerg;ng Infectious Diseases in Pregnancy 901 
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26480.080

ZIKA VIRUS 

The ongoing Zika virus pandemic, with its documented association with fetal anomalies and other 

adverse neonatal and adult neurologic morbidities, 

has captured the world's attention over the past 12-18 

months. Modern society has not experienced a teratogenic viral outbreak since the Rubella epidemic in the 

1960s.:'" A vague, poorly appreciated and understood 

single-stranded RNA vims, Zika was first recognized 

in the 1940s in Africa and has until recently been 

associated with sporadic small regional outbreaks 

of minimal global importance."" This most recent epidemic with its epicenter in Brazil and associated effects on fetuses has awoken the global public health 

community lo potential devastation from a novel 

emerging infectious disease. Attention must not fade 

as we learn more about the specific implications of 

Zika infection in pregnancy and the virus establishes 

natural endemicity. 40 

Zika is primarily a mosquito-borne infection and is 

a member of the sa.me fru11ily of Flaviviruses as 

Dengue, Chikungunya, and Yellow fever. The most 

comn10n vector for transmission is the Aedes aegypti 

mosquito (similar to other flaviviluscs) with Aedes albopictus also able to transmit. Most patients infected with 

Zika are unaware of the infection (asymptomatic ln 

approximately 75"1o of cases); if they rue symptomatic, 

the clinical illness is invariably mild and self~limited. 

Clinical reports suggest a nonspecific constellation of 

fever, conjunctivitis, a.tihralgias, and maculopapular 

rash with the illness typically lasting 1 week or less. 

Associated nonspecific symptoms such as headache, 

myalgias, pruritus, and vomiting are also reported 

and share a self-limited nattu·e. Additionally, Zika virus 

has been associated with Guillain-Barre syndrome and 

it appears previous infection confers lifelong 

immunity.:19 

In addition to the primru-y mode of vector-borne 

transmission, additional forms of transmission include 

sexual, laboratory, and likely bloodborne (through 

transfusion). The combination of vector-borne and 

sexual transmission makes this scenario unprecedented; 

never before has a documented teratogen been noted to 

be transmitted in Uus combined fashion. Furthermore, 

this combination generates a multitude of public and 

sexual health issues and questions. In April 20 1(), thendirector of the CDC Dr. Thomas Frieden noted, "Never 

before in history has there been a situation where a bite 

from a mosquito could result in a devastating malformation."·" Thls situation has generated much discussion about outbreak managemen~ eontainmen~ and 

improved fetal outcomes. Additionally, considerations 

902 Beigi Emerging Infectious Diseases in Pregnancy 

around how to appropriately design investigations and 

expeditiously license pharmaceuticals and vaccinations 

for mitigation against this outbreak have received sig~ 

nHktmt attention. -IIA2 

The most striking congenital finding gamering 

global attention is the atypically high numbers of 

neonates born with microcephaly acros-s regions in 

Brazil noted to have had high numbers of cases of 

Zika. The disease outbreak was originally noted in the 

spring of2015, ru1d early reports of higher numbers of 

microcephalic neonates began to accumulate late in 

the fall of2015. In February 2016, the WHO declru·ed 

the Zika outbreak a public health emergency of 

international concem."""" The constellation of findings 

that is now being coalesced into being referred to as the 

"congenital Zika syndrome" includes, but is not limited 

to, severe microcephaly with a pmiially collapsed skull; 

thin cerebral cortices; macular scatTing and retinal mottling; congenital contractt1res; ;md marked early hypertonia with associated symptoms of extrapymmidal 

involvement;l:l Additionally, given Zika's predilection 

for neural tissue, some have postulated the high potential for adverse neurodevelopmental outcomes among 

neonates with both overt and unrecognized Zika exposure throughout gest.ation.:W,H 

Currently there are no medical countermeasures 

available to prevent, mitigate, or manage active Zika 

infection. Indeed, numerous trials of various vaccine 

candidates are underway within academia, the pharmaceutical industry, and the National Institutes of 

Health:'·' Although there are promising candidates in 

early-stage trials, it is unlikely that a vaccine product 

will be available on a wide-scale basis for use among 

reproductive-aged women (likely target population 

for first use) in the near future, even with the accelerated efforts underway. Until such a product exists, the 

bulk of the management centers on education of 

prospective patients as well as obstetric health care 

providers about I) the specific recommendations surrounding travel restrictions to Zika-affected areas (an 

ever-increasing geogmphic list), 2) sexual activity considerations to minimize or eliminate the possibility of 

exposure of both men and women, and :i) minimizing 

risks for mosquito bites occurring in areas with active 

Zika transmission. These specific recommendations, 

areas with travel advisories~ and specifics in regard 

to methodology of testing for Zika infection are well 

delineated on both the CDC's a11d the College's websitcs1 and the reader is referred to these locations for 

a comprehensive discussion:'"··"' A brief summary of 

high-level recommendations for the obstetric community is detailed in Box 3. Importantly, the CDC has 

also developed two pregnancy registries for women 

OBSTETRICS & GYNECOLOGY 
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26480.081

!lox 3. Zika Virus-Specific Obstetric Guidance 

Sexual transmission p~ven!lon 

VOL. 129, NO. MAY 2017 

T es!ing specifics 

infected with Zika in the United States and in Puerto 

Rico. 47AH As these valuable 

collect data, they will continue \o 

and neonatal communities on 

This outbreak continues to unfold 

medical and communities of the 

threat of infectious diseases and unpredictable effects human toll they can impart 

PREPAREDNESS FOR EMERGING INFECTIOUS 

DISEASE OUTBREAKS 

Beigt Emerging Jntf!ctious in Pregnancy 903 
148 


26480.082

u.s. 

advanced 

n1ensures undertake in advance 

future emerging disaster scenarios given the challenge 

of real-time marmgement Proactive considerations are 

facilities obstetric 

lists some 

904 Beigl Emerging Infectious in Pregnancy 

DISCUSSION 

recent outbreaks and their imj)licati<lUS 

child health. These continue to be relevll!lt 

for all current and future emerging outbreaks, wherever 

they may originate imd whatever toll they may impart. 

REFERENCES 

OBSTETRICS & GYNECOlOGY 
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26480.083

GREG WALDEN, OREGON 

CHAiRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

C!l:ongress: of tbt Wnttcb fetatcs: 

Dr. Timothy Persons 

Chief Scientist 

J!,loulit of 1.\tprclientatibrli 

COMMITIEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515~6115 

June 19, 2017 

U.S. Government Accountability Office 

441 G Street, N.W. 

Washington, DC 20226 

Dear Dr. Persons: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Tuesday, 

May 23,2017, to testify at the hearing entitled "U.S. Public Health Response to the Zika Virus: 

Continuing Challenges." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (1) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Wednesday, June 14, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.F,ulling:iVmail.house.gQy. 

Thank you again for your time and effon preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

Tim 

~~ Murphy 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
150 


26480.084

GAO u.s 441 G St. N.W. 

Washington, DC 20548 

June 29, 2017 

The Honorable Tim Murphy 

Chairman 

GOVERNMENT ACCOUNTABILITY OFFICE 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

Subject: Zika Virus Response - GAO Response to Questions for the Record 

This letter notifies you of our enclosed responses to questions for the record. following the May 

23, 2017 hearing, "Emerging Infectious Diseases: Actions Needed to Ensure Improved 

Response to Zika Virus Disease Outbreaks." I am pleased to be able to provide you with the 

requested information. If you or your staff have any questions about our responses, please 

contact me at (202) 512-6412 or personst@gao.gov. 

Timothy M. Persons, Ph.D. 

Chief Scientist 

Enclosure 
151 


26480.085

The Honorable Tim Murphy 

1. Why does the GAO think that it is important that the FDA consolidate information 

about tests, and require manufacturers to list the identity of the comparator 

assay? 

Currently, the lack of access to performance data prevents diagnostic test users from making 

informed decisions about which diagnostic test to adopt or recommend during the outbreak. 

Information on performance characteristics presented in each diagnostic test product label was 

not consolidated across available tests, and the identity of the comparator assay was not listed 

on some labels, making it challenging for users to make informed decisions about which test to 

adopt or recommend to patients. As a result, recommendations on diagnostic tests in our May 

2017 report encourage increased access to performance data on diagnostic tests to allow for a 

more informed environment for patient care (i.e., increased access to performance information 

for clinicians as well as a higher quality of insight in support of patient decision-making). 1 

2. You reported that some diagnostic test users also faced challenges complying 

with some equipment requirements to perform specific tests. (How) has this 

problem been addressed, how did the costs of obtaining new equipment affect 

localized budgets, and can you provide some examples? 

Since our work focused on selected organizations, we are not aware of the extent to which, if 

any, this problem has been addressed across public health laboratories such as the Laboratory 

Response Network (LRN), or other laboratories at the local, state, and federal level. Even so, 

representatives from several public health laboratories we interviewed stated that they had to 

acquire specific new equipment to be able to perform a certain authorized diagnostic test and 

that it posed some unexpected budgetary burden upon them. For example, according to 

Department of Defense (DOD) officials, many DOD laboratories needed to procure the 

equipment required to perform the Centers for Disease Control and Prevention (CDC)'s lgM 

antibody capture enzyme-linked immunosorbent assay (MAC-ELISA).2 There was delayed 

implementation of this serological assay within DOD laboratories primarily due to the need for 

Army LRN participating laboratories, which constitute the majority of the DOD's LRN 

participating laboratories, to acquire the equipment required to perform the assay. The Army 

was able to secure funding for the purchase of the equipment, which was subsequently 

distributed down to the individual laboratories for their procurement action. As another example, 

a state public health laboratory we interviewed stated that they were hesitant to change to an 

Emergency Use Authorized test because they would have to purchase specific new equipment. 

CDC officials stated that the agency is working to expand diagnostic testing capacity within both 

public health and commercial laboratories in the United States. 

The Honorable Kathy Castor 

1. Please provide an update on vaccine development and clinical trials. 

1

GAO. Emerging Infectious Diseases: Actions Needed to Address the Challenges of Responding to Zika Virus 

Disease Outbreaks, GA0-17-445 (Washington, D.C.: May 23, 2017). 

2

The MAC-ELISA is used to detect antibodies created against the Zika virus. ELISA is a technique designed for 

detecting and quantifying substances such as antibodies. Antibodies are made by the body in response to antigens 

such as viruses. 

Page 11 
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At present no vaccine has been approved by the Food and Drug Administration to prevent Zika 

virus disease but there are several vaccines that are in different development phases. For 

instance, according to National Institutes of Health (NIH) officials, the National Institute for 

Allergy and Infectious Diseases (NIAID) is developing and investigating multiple Zika vaccine 

candidates, including vaccines based on technologies that have shown promise against other 

related diseases.3 One candidate Zika vaccine entered a Phase 1 clinical trial in 2016. 

According to officials, NIAID launched a multi-site Phase 2a/2b clinical trial of this vaccine in 

March 2017 that aims to enroll at least 2,490 healthy participants in various sites in the 

Americas. The study will evaluate whether the experimental vaccine is safe and able to 

stimulate an adequate immune response, and importantly whether it can prevent disease in 

areas with ongoing mosquito-borne Zika transmission. NIAID scientists also are developing 

other Zika vaccine candidates using a variety of approaches that are anticipated to start clinical 

trials in late 2017 and 2018. According to NIAID officials, while multiple vaccine approaches are 

promising, it is important to realize that the development of investigational vaccines and the 

clinical testing required to establish their safety and effectiveness take time and a safe, 

effective, and fully licensed Zika vaccine likely will not be available for several years. 

2. Please provide the latest information on the Zika vaccine licensing agreement 

between the U.S. Army and Sanofi and any relevant details. 

We have not conducted the work necessary to answer this question. The U.S. Army should be 

able to provide an up-to-date answer on this inquiry. 

3. With many members of Congress, states and public health advocates worried that 

the Zika vaccine being developed at Walter Reed Army Institute of Research with 

taxpayer dollars will be priced too high, how is the federal government working to 

ensure Sanofi, when/if a licensing agreement is made, will sell this taxpayer 

funded vaccine at an affordable price to federal and state governments and to 

consumers? 

We have not conducted the work necessary to answer this question. The U.S. Army should be 

able to provide an up-to-date answer on this inquiry. 

4. How has public health advice regarding Zika evolved over the past few years for 

young men and women? What do we know now that we did not before and what 

new information could be on the horizon? 

Since the Zika virus was a newly emerging infectious disease threat in the United States 

relatively little was known about the virus prior to 2016. There was a lack of knowledge of Zika 

virus biology and infections, especially at the beginning of the U.S. outbreak. In January 2016, 

the Centers for Disease Control and Prevention (CDC) released interim guidelines for pregnant 

women that recommended that all pregnant women consider postponing travel to areas where 

Zika virus transmission is ongoing, and pregnant women with a history of travel to an area of 

Zika virus transmission should be evaluated for Zika virus infection.4 In February 2016, the CDC 

3

Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, Research Conducted and Supported 

by the National Institutes of Health (NIH) in Addressing Zika Virus Disease, testimony before the House Committee 

on Energy and Commerce Subcommittee on Oversight and Investigations, May 23, 2017. 

4

E. E. Petersen, J. E. Staples, D. Meaney-Delman, et al. "Interim Guidelines for Pregnant Women During a Zika Virus 

Outbreak- United States, 2016." Morbidity and Mortality Weekly Report, vol. 65, no. 2 (2016):30-33. 

Page 12 
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also published guidelines for sexual transmission that recommended that men who reside in or 

have traveled to areas with active Zika virus transmission with pregnant partners should abstain 

from sexual activity or use condoms for the duration of the pregnancy. 5 For men with partners 

that are not pregnant CDC recommended taking several factors into account but did not suggest 

a timeframe that Zika virus may persist in the semen. CDC updated guidance in April2016, 

stated that women with possible Zika virus exposure are recommended to wait to conceive until 

at least 8 weeks after symptom onset (if symptomatic) or last possible Zika virus exposure (if 

asymptomatic).6 Based on new data, CDC updated guidance in September 2016 recommending 

that all men with possible Zika virus exposure who are considering attempting conception with 

their partner, regardless of symptom status, wait to conceive until at least 6 months after 

symptom onset (if symptomatic) or last possible Zika virus exposure (if asymptomatic). 7 

At the beginning of the outbreak, there was uncertainty regarding, which sample type to use for 

diagnostic testing. For instance, the Zika virus had been found to be present longer in urine than 

in serum or plasma, but information on just how long the virus could persist in different bodily 

fluids was still evolving. We now know that compared to related viruses, the Zika virus is present 

at low levels in bodily fluids of patients during an active infection. Information is still evolving 

about antigens that are unique to the Zika virus and how long the virus persists in various bodily 

fluids, making it difficult to develop diagnostic tests for the virus. 

Knowledge about Zika virus has increased in the past year, including information about Zika 

virus disease incidence and distribution of cases and its associated adverse health outcomes. 

For example, researchers have concluded that a causal relationship exists between prenatal 

Zika virus infection and microcephaly and other serious brain abnormalities. While much has 

been learned about the Zika virus, many unknowns still remain in regards to its epidemiology, 

including the total number of infections, the biological mechanisms, risks, reasons for 

geographic differences, the full spectrum of outcomes associated with maternal-fetal 

transmission, the presence and duration of the virus in different bodily fluids, the role of prior 

Zika virus infections or exposure to other related flaviviruses, and the full spectrum of short and 

long-term outcomes of Zika virus infection. 

5. When does each federal agency believe they will run out of money to respond 

properly to Zika, including vector control, surveillance, vaccine and diagnostics 

development/improvement and research? 

We have not conducted the work necessary to answer this question but the Zika supplemental 

appropriation funds provided for in the Zika Response and Preparedness Appropriations Act, 

2016 (Pub. L. No. 114-223, div. B) must be obligated by the end of the Fiscal Year 2017 (i.e., 

September 30, 2017). The Act also includes a provision that GAO conduct oversight of the 

activities supported with funds appropriated by the Act, which we have begun. 

5

A. M. Oster, J. T. Brooks, J. E. Stryker, eta/. "Interim Guidelines for Prevention of Sexual Transmission of Zika Virus 

-United States. 2016." Morbidity and Mortality Weekly Report, vol. 65, no. 5 (2016):120-121. 

6E. E. Petersen, K. N. D. Polen, D. Meaney-Delman, eta/. "Update: Interim Guidelines for Health Care Providers 

Caring for Pregnant Women and Women of Reproductive Age with Possible Zika Virus Exposure - United States, 

2016." Morbidity and Mortality Weekly Report, vol. 65, no. 5 (2016):315-322. 

7

E. E. Petersen, D. Meaney-Delman, R. Neblett-Fanfair, eta/. "Update: Interim Guidance for Preconception 

Counseling and Prevention of Sexual Transmission of Zika Virus for Persons with Possible Zika Virus Exposure -

United States, September 2016." Morbidity and Mortality Weekly Report, vo. 65, no. 39 (2016):1077-1081. 

Page 13 
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26480.088

GREG WALDEN, OREGON 

CHAIRMAN 

Dr. Lyle R. Petersen 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

C!Congre~~ of tbe Wntteb ~tate~ 

~ou!le of l\eprc!!tntatl\le!l 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE o.FICE BUILDING 

WASHINGTON, DC 20515-6115 \202)2:!b"2927 

!202.lZ2"S<'H:;41 

June 19,2017 

Director, Division of Vector-Borne Diseases 

National Center for Emerging and Zoonotic Infectious Diseases 

Centers for Disease Control and Prevention 

1600 Clifton Road 

Atlanta, GA 30329 

Dear Dr. Petersen: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Tuesday, 

May 23, 2017, to testify at the hearing entitled "U.S. Public Health Response to the Zika Virus: 

Continuing Challenges." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

hold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Wednesday, June 14, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fullipg(wmail.housc_,_gm:. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

~~ Tim Murphy 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
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26480.089

Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations 

Hearing: "U.S. Public Health Response to the Zika Virus: Continuing the Challenge" 

May23,2017 

Questions for the Record for Dr. Lyle R. Petersen, Director, 

Division of Vector-Borne Diseases 

National Center for Emerging and Zoonotic Infectious Diseases 

Center for Disease Control and Prevention 

The Honorable Tim Murphy 

l. How many facilities in the United States can perform the various Zika diagnostic tests? 

There arc three laboratory tests used for Zika: I) a nucleic acid-based test (NAT), which are 

performed on acceptable specimens including human serum, plasma, blood, or urine collected 

during the first two weeks after symptom onset to detect Zika; 2) serological test (e.g., IgM), 

which detects Zika antibodies within 2 to 12 weeks of exposure; and 3) the PRNT test, which is 

used for the qualitative detection of Zika virus lgM antibodies to confirm the findings of the lgM 

test. Forty-nine states, Puerto Rico, and Guam are able to perform the NAT test developed by 

CDC (Trioplex Real-time RT-PCR Assay). Forty-six states and Puerto Rico are able to perform 

the lgM test developed by CDC (Zika Mac-ELISA). Two CDC laboratories and six state public 

health laboratories in California, Florida, Maryland, Massachusetts, Michigan, and New York 

can perform PRNT testing. Four of these state labs (Massachusetts, Michigan, California, and 

New York) have agreed to serve as reference labs for other states that do not have the capability 

to perform the PRNT test. Commercial testing for both NAT and IgM assays is also available in 

all 50 states. 

a. What steps is the CDC taking to disseminate these tests, particularly the PRNT test, more 

widely? 

For the PRNT test, individual laboratories are responsible for developing and validating 

their own PRNT protocols, and CDC does not distribute, oversee, or approve PRNT 

testing in non-CDC laboratories. CDC does provide technical assistance upon request to 

laboratories seeking to implement PRNT testing. 

b. How many PRNT tests can the CDC process in one day? 

CDC laboratories can perform up to approximately 600 PRNT tests per week. The PRNT 

test is a multi-day, multi-step test. The turn-around time for a test result may range from 

14 to 22 days. 

c. How do you plan to ramp up your capacity to process Zika diagnostic tests, in particular 

the PRNT test, in the coming months? 

If additional testing capacity is needed, CDC has plans in place to increase the number of 

tests performed at its laboratories each week to 1 ,000. In addition, the four reference labs 
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mentioned above are available to conduct PRNT testing on behalf of other states, if the 

need exceeds CDC's testing capacity. These four PRNT reference laboratories have 

agreed to perform this service through September 2017 with current emergency response 

funding. 

2. The PRNT test is considered the "gold standard" but is not scientifically proven. How can 

something be considered the "gold standard" when it has not been scientifically proven? 

PRNT is a well-recognized, established, and standard laboratory technique that is used to 

confirm the lgM test by testing for the presence of Zika antibodies. Due to cross-reaction with 

other flaviviruses such as dengue or chikungunya, results from other testing methods may be 

difficult to interpret, therefore, presumed positive, equivocal, or inconclusive tests must be 

forwarded for confirmation by the PRNT. CDC will continue to invest in improving the test, in 

accordance with available resources. 

3. How many pregnant women with Zika infections have been accounted for in the United States? 

As of May 23, 2017, there were I ,883 pregnant women with laboratory evidence of possible 

Zika virus infection in the United States and the District of Columbia. In the U.S. Territories of 

Puerto Rico, American Samoa and the U.S. Virgin Islands, there have been 3,916 pregnant 

women with laboratory evidence of possible Zika virus infection, as of May 23,2017. 

a. How many of these women completed their pregnancy? 

Of the 1,883 pregnant women with laboratory evidence of possible Zika virus infection in 

the United States and the District of Columbia, 1,579 women have reported completing 

their pregnancy, as of May 23, 2017. The number of completed pregnancies with or 

without birth defects include those that ended in a live birth as well as pregnancy losses. 

The reported number of pregnant women with laboratory evidence of possible Zika virus 

infection is cumulative and includes not only women who have completed their 

pregnancies, but also ongoing pregnancies that have not been completed. There are some 

delays in reporting. For some jurisdictions, the latest total number of pregnant women 

with Zika are available on the individual websites for each jurisdiction. In addition, 

reported numbers may increase or decrease as preliminary information is clarified. 

Between October 13,2016, and May 23,2017, CDC did not report the number of 

completed pregnancies or outcomes for all completed pregnancies with laboratory 

evidence of possible Zika virus infection in the US Territories. 

b. How many of these fetuses or infants had congenital birth defects? 

As of May 23,2017, CDC was aware of72 infants born with Zika associated birth 

defects and 8 women had pregnancy losses with birth defects in the United States and the 

District of Columbia. 

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The Honorable Michael Burgess, M.D. 

1. What has CDC done to support the limited capacity oflocal public health departments through 

technical assistance and grants, and where has the agency found challenges in supporting local 

responses to the Zika epidemic? Furthermore, how docs HHS plan to further support capacity 

building efforts in the coming months, particularly as we get into the months where we could see 

local transmission of Zika in the United States? 

CDC is coordinating closely with stale and local partners to ensure local public health 

departments are equipped to prevent, respond to, and eliminate the threat of Zika virus. These 

actions range from regular communications to direct personnel support. Examples include: 

Developed the Zika Interim Response Plan for use by state. territorial, local and tribal 

jurisdictions 1

, including posting online with resources such as an epidemiologic 

investigation toolkit, and a communication planning guide 

• Created Zika virus testing kits, which state public health laboratories receive free of 

charge 

Conducted additional testing for states that lacked sufficient capacity 

Provided guidance on mosquito control and evaluation of mosquito control district plans 

and interventions, as requested 

Created the U.S. Zika Pregnancy and Infant Registries to collect health data about 

pregnant women with laboratory evidence of Zika virus infection and their babies 

through the first year of life and created rapid Zika Birth Defects Surveillance system to 

identify babies born with birth defects associated with Zika regardless if their mother's 

Zika infection was detected during pregnancy. 

Established Zika Care Connect 2

, a network of specialty health care providers that 

connects pregnant women, parents, and caregivers of infants and families affected by 

Zika to specialized care 

Placed field assignees on-site at 26 local health departments in communities with 

pregnant women with laboratory evidence of possible Zika virus infection through the 

Local Health Department Initiative 

Deployed CDC Emergency Response Teams (CERT) to 14 different cities to support 

local communities in responding to Zika 

As of May 15, 2017, CDC has provided $251 million directly to state, local, and territorial health 

departments through grants from redirected and supplemental funding. CDC also provided $44 

million in Public Health Emergency Preparedness (PHEP) reimbursement funding to states and 

territories in October 2016. CDC directed emergency funding to areas with the greatest need and 

continues to provide ongoing, in-depth support to Florida, Texas, and U.S. territories where 

public health officials are battling local transmission of mosquito-borne Zika. 

In addition to direct funding, CDC has awarded funding that supports state, local, and territorial 

efforts, including support to partner organizations, vector-borne disease regional Centers of 

Excellence, and the Puerto Rico Vector Control Unit. These financial resources have been 

1 Zika Interim Response Plan https://www.cdc.gov/zika/pdfs/zika*draft-interim-conus-plan.pdf 

2 Zika Care Connect- httos://www.zikacareconnect.org/ 
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coupled with technical support to states and territories through rapid response teams, as well as 

laboratory, epidemiologic, entomologic, field investigation, and data management support. 

CDC has plans for all remaining supplemental funds, including needs that may arise with the 

2017 mosquito season. The majority of remaining funds will be provided directly to state, local, 

and territorial health departments through the Epidemiology and Laboratory Capacity 

cooperative agreement for Zika activities, including epidemiology and laboratory capacity, 

vector surveillance and control, and the U.S. Zika Pregnancy and Infant Registries. Remaining 

funds will also support CDC operations, including staff, travel, rapid response teams (if needed), 

and laboratory supplies and equipment. 

2. Last year as we began to discuss appropriating funds to support our efforts in addressing the Zika 

epidemic, there were discussions around the potential establishment of a new, flexible 

emergency preparedness fund for addressing future, emerging threats like Zika and Ebola. There 

arc two existing revenue streams that the CDC receives that I would like to examine as potential 

infrastructure for developing such a fund: the Public Health Emergency Preparedness 

Cooperative Agreement and the Public Health Emergency Fund. Current appropriations levels 

aside, what flexibility has the CDC been able to wield in utilizing either of these funds, and what 

barriers would prevent the CDC from utilizing either of these funds in the future? 

The distribution of Public Health Emergency Preparedness (PHEP) cooperative agreement funds 

is calculated using a formula established under section 3!9C-l(h) of the Public Health Service 

Act. Once a PHEP award is provided to an eligible entity, an awardee may not redirect the 

cooperative agreement funding to a public health emergency unless the awardee requests and 

HHS grants approval to use PHEP funds for emergency activities that fall within the existing 

PHEP cooperative agreement scope of work. The majority of CDC's Zika response activities 

were funded through the Public Health Preparedness and Response (PHPR) Zika cooperative 

agreement (see: https://www.cdc.gov/phpr/readiness/funding-zika.htm). 

The Public Health Emergency Fund has not received any appropriations for a number of years. 

The Public Health and Social Services Emergency Fund has received appropriations, but is 

managed by the Department of I Iealth and !Iuman Services. 

The Honorable Frank Pallone 

1. HHS recently reported that CDC has obligated $332.2 million of its fiscal year 2017 Zika funds. 

How much funding does CDC have remaining for 2017 Zika preparation and response? Does 

CDC have sufficient funds remaining to support these efforts for the remainder of fiscal year 

2017? 

As of May 15, 2017, CDC has obligated a total of $338 million of the $394 million appropriated 

in the Zika Response and Preparedness Act (division B of Public Law 114-223). 

CDC has plans for all remaining supplemental funds, including needs that may arise during the 

2017 mosquito season. The majority of remaining funds will be provided directly to state, local, 

and territorial health departments through the Epidemiology and Laboratory Capacity 

cooperative agreement for Zika activities, including epidemiology and laboratory capacity, 

vector surveillance and control, and the U.S. Zika Pregnancy and Infant Registries. The rest of 

4 
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the remaining funds will support CDC operations, including staff, travel, rapid response teams (if 

needed), and laboratory supplies and equipment. 

The Honorable Kathy Castor 

I. Please provide an update on vaccine development and clinical trials. 

This question is best addressed by the National Institute of Health (NIH) and Biomedical 

Advanced Research and Development Authority (BARD A). 

2. Please provide the latest information on the Zika vaccine licensing agreement between the U.S. 

Army and Sanofi and any relevant details. 

Questions related to the licensing agreement between the U.S. Army and Sanofi are best 

addressed by the Department of Defense (DoD), Department of the Army. 

3. With many members of Congress, states and public health advocates worried that the Zika 

vaccine being developed by the Walter Reed Army Institute of Research with taxpayer dollars 

will be priced too high, how is the federal government working to ensure Sanofi, when/if a 

licensing agreement is made, will sell this taxpayer funded vaccine at an affordable price to 

federal and state governments and consumers? 

This question is best addressed by the DoD, Department of the Army. 

4. How has public health advice regarding Zika evolved over the past few years for young men and 

women? What do we know now that we did not before and what new information could be on 

the horizon? 

Prior to 2015, there was limited knowledge about Zika virus and no awareness of the potential 

effects of Zika on infants exposed to the virus during pregnancy. Zika was a newly emerging 

infectious disease in the Western Hemisphere and had only been seen previously in outbreaks 

among small populations. We have since learned that pregnant women and infants are the most 

vulnerable to adverse outcomes associated with Zika virus infection, including: 

In April 2016, CDC 3 published the evidence to confirm that Zika virus is the first known 

mosquito-borne virus to cause birth defects in humans. 

• A CDC study 4, issued in March 20 17, has demonstrated that Zika virus directly attacks the 

developing infant's brain, causing microcephaly and other birth defects. A distinct pattern 

of birth defects, called congenital Zika syndrome 5

, has emerged among fetuses and infants 

of some women infected with Zika during pregnancy. Congenital Zika syndrome likely 

represents the most severe impact of congenital infection (infection acquired during 

pregnancy) that can be seen at birth. This syndrome includes severe microcephaly (small 

'The New England Journal af Medicine. "Zika Virus and Birth Defects- Reviewing the Evidence for Causality." 

http://www.nejm.org/doi/fuii/10.1056/NEJMsr1604338?query=featured_zika 

4

Emerging Infectious Diseases. "Zika Virus RNA Replication and Persistence in Brain and Placental Tissue." 

https:/ /wwwnc.cdc.gov I eid/article/23/3/16-1499 _article 5 JAMA. "Characterizing the Pattern of Anomalies in Congenital Zika Syndrome for Pediatric Clinicians." 

http:/ /jamanetwork.com/journals/jamapediatrics/fullarticle/2579543 

5 
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head size) resulting in a partially collapsed skull; decreased brain tissue with brain damage; 

damage to the eye; limited range of joint motion, such as clubfoot, and too much muscle 

tone restricting body movement. However, the full spectrum of poor birth outcomes caused 

by Zika virus infection during pregnancy remains unknown. With other congenital 

infections, some babies are born apparently healthy but have later onset problems such as 

deafness. In order to understand the full range of disabilities that might occur, it is essential 

to follow up with infants and children who were exposed to Zika during pregnancy until 

they arc at least 2-3 years of age, and longer will be needed to understand the full impact of 

congenital Zika virus infection. 

CDC has also discovered a link between Zika virus and Guillian-Barre syndrome (GBS). Current 

CDC research suggests that GBS is strongly associated with Zika infections; however, only a 

small proportion of people with recent Zika virus infection get GBS. CDC is continuing to 

investigate the link between GBS and Zika to learn more. 

CDC has collected and communicated information to assist men, women and families in 

understanding I) the risks ofZika, 2) ways to prevent Zika, 3) diagnostic methods for Zika, and 

4) clinical services that may assist with the long-term consequences of Zika during pregnancy. 

Guidance from CDC as part of its public health response to Zika has been directly informed by 

several major findings gleaned from surveillance data: 

I) CDC issued guidance to the American population in early 2016 to advise pregnant 

women and couples planning pregnancy not to travel to areas with Zika. This guidance 

was issued as a precautionary measure even before Zika was a proven cause of adverse 

outcomes, and we will never know how many families were protected from Zika as a 

result of this rapid action. 

2) Data captured through the Zika Pregnancy and Infant Registries, newly established public 

health surveillance systems, provide rough estimates of the potential risk of fetal/infant 

birth defects associated with a maternal Zika virus infection at different timcframes 

during pregnancy. These data are used by healthcarc providers counseling patients and 

are the first population-based risk estimates available. 

In April 20 I 7, CDC reported on data from the Zika Pregnancy and Infant Registries 6 

indicating that among I ,000 pregnant women with evidence of Zika with completed 

pregnancies in 2016, 10 percent of those with confirmed Zika infection had babies 

with Zika-associated birth defects. 

3) Surveillance data have shown that the risk for birth defects among infants exposed during 

pregnancy is the same regardless of whether an infected pregnant woman had symptoms 

of Zika virus. This was the first time it was determined that women without symptoms 

were at risk, which strengthened the current recommendations to avoid travel and to 

screen pregnant women for Zika virus infection. 

4) In July 2016, CDC confirmed 7 that Zika virus can be sexually transmitted from person to 

person. This has the most profound impact on young men and women who become 

pregnant or are planning a pregnancy because of the risks of simultaneous sexual 

transmission of Zika and conception. 

6 Morbidity ond Mortolity Weekly Report. "Vital Signs: Update on Zika Virus-Associated Birth Defects and Evaluation of All 

U.S. Infants with Congenital Zika Virus Exposure- U.S. Zika Pregnancy Registry, 2016." 

https://www.cdc.gov/mmwr/volumes/66/wr/mm6613e1.htm 

7 Morbidity and Mortality Weekly Report. "Update: Interim Guidance for Prevention of Sexual Transmission ofZika VirusUnited States, July 2016." https://www.cdc.gov/mmwr/volumes/65/wr/mm6529e2.htm?s_cid=mm6529e2_w 

6 
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5) Surveillance data indicates that Zika virus may persist in the body longer than expected. 

This directly impacts recommendations for couples planning a pregnancy. 

Current research indicates that Zika virus RNA can remain in semen up to 6 months, 

longer than in other body fluids, including vaginal fluids, urine, and blood. 

Emerging data from case reports 8 of some pregnant women published in October 

2016 indicates that Zika virus RNA persists in some pregnant women longer than the 

1-2 weeks previously reported and may provide a window into the way the virus 

crosses the placenta. 

Many questions remain. Among the most urgent are: 

What is the full spectrum of adverse outcomes caused by Zika virus infection during pregnancy? 

CDC established the Zika Pregnancy and Infant Registries to monitor pregnancy and infant 

outcomes to learn more about the timing, absolute risk, and spectrum of outcomes associated 

with Zika virus infection during pregnancy. The surveillance effort is dependent on the 

collaboration of clinicians and state, tribal, local, and territorial health departments and 

sustained resources. 

What is the best way to detect and diagnose congenital Zika virus infection? 

Much of the data about the detection and persistence of Zika virus is limited. It is unclear 

what the best testing paradigm is that provides a timely diagnosis and correlates with risks. In 

addition, the findings of Zika virus persistence requires further exploration to determine how 

this can help men, women and families plan for pregnancy. 

What are the long-term medical and developmental outcomes for infants and children affected by 

congenital Zika syndrome? 

Many infants enrolled in the Zika Pregnancy and Infant Registries are now approaching one 

year of age, which limits the ability to study long-term effects of the disease. Information is 

needed by families, healthcare providers, communities, governmental organizations and 

others to identify needs and plan for necessary services. 

Recognizing that coordinated surveillance systems are the only way to obtain accurate 

information about the scope and nature of impacts of the Zika virus infection, CDC awarded 

funds to 45 jurisdictions to collect information about birth defects thought to be related to 

Zika virus infection. The surveillance system closes the gap in reporting by including infants 

with birth defects and congenital Zika virus exposure who may have been missed by 

pregnancy and infant registries if the mother's Zika infection was not detected prenatally. 

5. When does each federal agency believe they will run out of money to respond properly to Zika, 

including vector control, surveillance, vaccine and diagnostics development/improvement and 

research? 

All remaining supplemental funds will be obligated by September 30,2017. The majority of 

remaining funds will be provided directly to state, local, and territorial health departments through 

the Epidemiology Laboratory Capacity cooperative agreement for Zika activities, including 

8 Obstetrics & Gynecology. "Prolonged Detection of Zika Virus RNA in Pregnant Women." 

http://journals.lww.com/greenjournai/Pages/articleviewer.aspx?year=2016&issue=lOOOO&article=00007&type=Fulltext 

7 
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epidemiology and laboratory capacity, vector surveillance and control, and the U.S. Zika Pregnancy 

and Infant Registries. The rest of the remaining funds will support CDC operations, including staff, 

travel, rapid response teams (if needed), and laboratory supplies and equipment. 

8 
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26480.097

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

<!Congre%5 of tbe Wniteb ~tate% 

;l'!)ou!lr of l\cprciicntatillel) 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAveuRN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515.{5115 1202:)2:?!),2927 

1202! 225-.3641 

June 19,2017 

Dr. Luciana Borio 

Acting Chief Scientist 

U.S. Food and Drug Administration 

1 0903 New Hampshire A venue 

Silver Spring, MD 20993 

Dear Dr. Borio; 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Tuesday, 

May 23, 2017, to testify at the hearing entitled "U.S. Public Health Response to the Zika Virus; 

Continuing Challenges." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to pel1Tlit Members to submit additional questions for the record, which are 

attached. The fol1Tlat of your responses to these questions should be as follows; (1) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Wednesday, June 14, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fulling@mail.hous~. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

~~ Tim Murphy 

Chai!1Tlan 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
164 


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('7f lmJ U.S. FOOD & DRUG \~..,~ - AOM!NISTRATION 

The Honorable Morgan Griffith 

Vice Chairman 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

Washington, D.C, 20515 

Dear Mr. Vice Chairman: 

OCT 19 2017 

Thank you for providing the Food and Drug Administration (FDA or the Agency) with the 

opportunity to testify at the May 23, 2017, hearing before the Subcommittee on Oversight and 

Investigations, House Committee on Energy and Commerce, entitled "U.S. Public Health 

Response to the Zika Virus: Continuing Challenges." This letter is a response for the record to 

questions posed by the committee. 

If you have further questions, please let us know. 

U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20903 

wwwJda.gov 

Principal Associate Cormnissioner 

for Legislation 
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26480.099

We have restated your questions below in bold, followed by our responses. 

The Honorable Tim Murphy 

1. Dr. Borio, the FDA revoked the authorization for one ofthe Zika tests. What would 

lead the FDA to revoke a test after just being authorized? 

FDA revoked the emergency use authorization (EUA) for the LightMix® Zika rRT-PCR Testwhich was initially authorized for emergency use on August 26,2016- on March 13,2017, in 

response to Roche Molecular Systems Inc.'s request dated March 10,2017, to withdraw the 

EUA due to technical perfonnance and business considerations. 

The Honorable Frank Pallone 

1. How much funding does FDA have remaining for 2017 Zika preparation and response? 

Does FDA have sufficient funds remaining to support these efforts for the remainder of 

fiscal year 2017? 

The Zika Response and Preparedness Act (division B of Public Law 114-223) did not provide 

any funding to FDA for Zika response activities. To help support these activities at the start of 

the fiscal year, FDA used base appropriations provided by the Continuing Appropriations Act, 

2017 (division C of Public Law 1!4-223), and reallocated $5 million of the $25 million 

appropriated for Ebola response activities by the Consolidated and Further Continuing 

Appropriations Act, 2015 (title VIII of division A of Public Law 1 13-235). As of May 19, 2017, 

FDA had obligated $1.8 million of the reallocated Ebola funding, and anticipates obligating the 

remaining balance by the end ofFY 2017. 

In May 2017, the Consolidated Appropriations Act, 2017 (title VII of division A of Public Law 

115-31) provided an additional $! 0 millim1 in no-year funding for FDA "to prevent, prepare for, 

and respond to emerging health threats, including the Ebola and Zika viruses, domestically and 

internationally and to develop necessary medical countermeasures and vaccines, including the 

review, regulation, and post market surveillance of vaccines and therapies, and for related 

administrative activities''. This funding-in addition to FDA's base appropliations and the $5 

million reallocated from approp1iations fbr Ebola response-should provide FDA with sufficient 

funding to support continued Zika virus response activities in FY 2017, provided a110ther public 

health emergency does not occur that would necessitate a reprioritization of funding. 

The Honorable Kathy Castor 

1. Please provide an update on vaccine development and clinical trials. 

FDA is actively engaged with the National Institutes of Health (NIH) and t11e Biomedical 

Advanced Research and Development Authority (BARD A), the international community, and 

ptoduct developers to help accelerate vaccine development programs. However, FDA generally 
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26480.100

cannot comment on the status of any particular vaccine development program because of 

confidentiality requirements. We would refer this question to NIH and BARD A. 

2. Please provide the latest information on the Zika vaccine licensing agreement between 

the U.S. Army and Sanofi and any relevant details. 

Questions related to the licensing agreement between the U.S. Army and Sanofi are best 

addressed by the Department of Defense (DoD), Department oftheAnny. 

3. With many members of Congress, states and public health advocates worried that the 

Zika vaccine being developed at the Walter Reed Army Institute of Research with 

taxpayer dollars will be priced too high, how is the federal govemment working to 

ensure Sanofi, when/if a licensing agreement is made, will sell this taxpayer funded 

vaccine at an affordable price to federal and state governments and to consumers? 

This question is best addressed by DoD, Department of the Army. 

4. How has public health advice regarding Zika evolved over the past few years for young 

men and women? What do lYe know now that we did not before and what new 

information could be on the horizon? 

This question is best addressed by the Centers for Diseuse Control and Prevention. 

5. When does each federal agency believe they will run out of money to respond properly 

to Zika, including vector control, surveillance, vaccine and diagnostics 

development/improvement and research? 

In May of2017, the Coi1solidated Appropriations Act, 2017 (title Vll of division A of Public 

Law 1!5-31) provided $10 million in no-year funding for FDA "to prevent, prepare for, and 

respond to emerging health threats, including the Ebola and Zika viruses, domestically and 

internationally and to develop necessary medical countermeasures and vaccines, including the 

review, regulation, and post market surveillance of vaccines and therapies, and for related 

administrative activities". FDA anticipates expending this funding from FY 2017 through FY 

2019 to support preparedness and response activities. This additional funding-in addition to 

FDA's base appropriations-should provide FDA with sufficient funding to support continued 

Zika virus response activities in that timeframe, provided another public health emergency does 

not occur that would necessitate a reprioritization of funding. 
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26480.101

GREG WALDEN. OREGON 

CHAIRMAN 

Dr. Anthony Fauci 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

<!ongre535 of tbe Wntteb ~tates 

j!)ouse of ~epnsentati\:Jr:s 

COMMITIEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFicE BuiLDING 

WASHINGTON, DC 20515--6115 

June 19,2017 

Director, National Institute of Allergy and Infectious Diseases 

National Institutes of Health 

9000 Rockville Pike 

Bethesda, MD 20892 

Dear Dr. Fauci: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Tuesday, 

May 23,2017, to testify at the hearing entitled "U.S. Public Health Response to the Zika Virus: 

Continuing Challenges." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (l) the name of the 

Member whose question you arc addressing, (2) the complete text ofthe question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Wednesday, June 14,2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fulling(uimail.housc.gQY. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

~~- Tim Murphy U (]"" 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
168 


26480.102

Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations 

Hearing: "U.S. Public Health Response to the Zika Virus: Continuing the Challenge" 

May 23,2017 

Questions for the Record for Dr. Anthony Fauci, Director, 

National Institute of Allergy and Infectious Diseases, National Institutes of Health 

The Honorable Tim Murphy 

1. What is the expected production volume for the vaccine once it is approved? 

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National 

Institutes of Health (NIH), facilitates research and development of vaccine candidates, which 

typically includes the support of early stage clinical trials to investigate vaccine safety and 

efficacy. The production volume of an FDA-approved Zika vaccine would be determined by the 

vaccine manufacturer, and will depend in part on the licensed indications and approved usage of 

the vaccine in the U.S. and elsewhere. 

a. Which population will be prioritized for the vaccine and why? 

The initial target population for an approved Zika vaccine will likely be adults and 

adolescents of reproductive age, excluding pregnant women. This is the same target 

population as for the Phase Il/Jlb clinical trial testing of the NIAID Vaccine Research 

Center (VRC) investigational DNA vaccine. 

NIAID also is supporting research on other vaccine candidates, including live-attenuated 

approaches that could potentially induce longer-lasting protection, possibly for decades. 

These vaccines might be evaluated in children, anticipating that vaccination in childhood 

could protect individuals through childbearing years. A strategy of childhood vaccination 

may be particularly effective in areas where Zika virus is endemic and there is greatest 

risk of congenital Zika syndrome. In the future, Zika vaccine candidates that have been 

found to be safe in non-pregnant populations may be investigated to determine if they are 

safe and effective in pregnant women. 

2. Why does Zika cause microcephaly, yet other flaviviruses such as dengue, chikungunya, 

and yellow fever are not known to cause microcephaly? 

NIAID is actively engaged in efforts to better understand the Zika virus, including any 

differences between Zika virus and other related flaviviruses that may help explain why Zika can 

cause microcephaly. For example, NIAID-supported investigators have developed animal 

models of Zika virus infection during pregnancy to better understand congenital Zika syndrome, 

which is a pattern of birth defects that includes severe microcephaly. These NIAID-funded 

animal studies have shown that Zika virus is capable of crossing the placental barrier and 

impairing fetal brain development in pregnant animals. 

1 
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In addition, NIH-supported investigators have discovered that neural precursor cells, which give 

rise to new cells in the developing brain, have receptors that make these cells particularly 

vulnerable to infection by Zika virus. NIH-supported researchers are now investigating how 

Zika virus exploits the cellular, molecular, and biochemical pathways within these cells to 

propagate the virus and cause these cells to die. They also are investigating how the immune 

system interacts with Zika virus within the central nervous system to better understand which 

aspects might be enhanced to help control the virus and whether the brain's immune response to 

the virus might also cause collateral damage that contributes to cell death. 

NIAID also is supporting research to address concerning reports of infants born to Zika virusinfected mothers that appear healthy at birth but later experience slowed head growth during the 

first year followed by postnatal microcephaly. NIAID is partnering with the Eunice Kennedy 

Shriver National Institute of Child Health and Human Development, the National Institute of 

Environmental Health Sciences, and the Brazilian research institute, Fiocruz, to better understand 

these observations. This study, Zika in Infants and Pregnancy (ZIP), is a multi-center, 

international, prospective cohort study of 10,000 women in Zika-affectcd regions. Enrollment of 

women early in their pregnancy is ongoing, and their children will be followed for at least one 

year after birth. The information gained from this study will help improve our understanding of 

congenital Zika syndrome, enhance care for pregnant women and their infants, and guide 

interventions for affected children. 

The Honorable Frank Pallone 

I. I IHS recently reported that NIH has obligated $68.8 million of its fiscal year 2017 Zika 

funds. How much funding does NIH have remaining in 2017 for Zika preparation or 

response? Does NIH have sufficient funds remaining to support these efforts for the 

remainder of fiscal year 20 17? 

As of May 15, 2017, the National Institute of Health (NIH) has obligated $71.36 million of the 

$152 million in NIH supplemental funds provided by the Zika Response and Preparedness Act 

2016 (division B ofPublie Law 114-223). The remaining $80.64 million will be obligated by the 

end of FY 2017. We anticipate these funds will be sufficient to support Zika-related activities 

currently planned through FY 2017. 

The Honorable Kathy Castor 

1. Please provide an update on vaccine development and clinical trials. 

A safe and effective Zika vaccine would be an invaluable tool to help stop the spread of infection 

and prevent future outbreaks. NIAID is developing and investigating multiple Zika vaccine 

candidates. 

DNA-based Zika vaccine candidate: NIAID recently launched a multi-site Phase IIIITb clinical 

trial of the NIAID VRC's DNA-based vaccine candidate in March 2017 following positive 

2 
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results in Phase I testing. This trial aims to enroll at least 2,490 healthy participants in various 

sites in the Americas, including the continental United States, U.S. territories, and countries in 

Central and South America. This Phase lllllb study will further evaluate whether the 

experimental vaccine is safe and able to stimulate an adequate immune response, and importantly 

whether it can prevent disease in areas with ongoing mosquito-borne Zika virus transmission. 

The clinical trial will enroll adults and adolescents of reproductive age. Part A of the study will 

enroll90 healthy men and non-pregnant women ages 18-35 years at Baylor College of Medicine 

(Houston, Texas) and University of Puerto Rico Medical Sciences Campus (San Juan, Puerto 

Rico). Part B will enroll 2,400 healthy men and non-pregnant women ages 15-35 years in these 

Part A sites and Brazil, Peru, Costa Rica, Panama, and Mexico. The effects of the vaccine on a 

developing fetus are unknown, and therefore women who arc pregnant or plan to become 

pregnant will not be eligible for the trial. The study is expected to conclude in 2019, although 

the exact timing of the trial will depend on the intensity of Zika virus transmission and the 

efficacy of the vaccine candidate. 

Zika purified inactivated vaccine (ZPIV) candidate: NIAID is collaborating with the 

Biomedical Advanced Research and Development Authority (BARDA) and the Walter Reed 

Army Institute of Research (WRAIR) to evaluate a ZPIV candidate developed by WRAIR. 

ZPIV is based on an approach used to develop vaccines against the related dengue and Japanese 

encephalitis viruses. NIAID is co-funding the Phase I clinical trials program with WRAIR. 

Trials testing ZPIV began in November 2016 at the WRAIR Clinical Trial Center in Silver 

Spring, Maryland; the Center for Virology and Vaccine Research, part of Beth Israel Deaconess 

Medical Center and Harvard Medical School in Boston; the Center for Vaccine Development at 

the Saint Louis University School of Medicine; and the clinical research center CAlMED, part of 

Ponce Health Sciences University in Puerto Rico. The Saint Louis University School of 

Medicine site is an NIAID-fundcd Vaccine Evaluation and Treatment Unit (VTEU) that is able 

to enroll large numbers of volunteers and vaccinate them in a rapid, safe, and effective manner. 

Having the rapid-response capability of the NIAID VTEUs in place ahead of an outbreak allows 

for accelerated testing of vaccines designed to address Zika virus and other emerging public 

health threats. 

Live-attenuated Zika vaccine candidates: NIAID scientists are developing live-attenuated 

Zika vaccine candidates using an approach similar to that taken with an experimental vaccine 

against the closely related dengue virus. This vaccine candidate will enter an NIAID Phase I 

clinical trial in late 2017. Thereafter, this Zika-only candidate will be combined with the 

tetravalent dengue vaccine candidate designed to protect against all four circulating strains of 

dengue virus. A Phase I trial of this new pentavalent combination Zika/dengue candidate vaccine 

is scheduled to enter clinical testing by 2018. NIAID is working with development partners in 

Brazil to plan later-stage trials of this combination vaccine. 

Early-stage Zika vaccine candidates: NIAID-supported researchers are evaluating 

investigational mRNA vaccines, which are broadly similar to DNA vaccines. The NIAID VRC 

and other NIAID intramural researchers are working with academic and industry partners to 

evaluate various mRNA vaccine technologies to identify potential candidates for further 

development. These include an investigational vaccine under development by the NIAID VRC 

and the pharmaceutical company GSK that may enter clinical trials in late 2017. 

3 
171 


26480.105

2. Please provide the latest information on the Zika vaccine licensing agreement between 

the U.S. Army and Sanofi and any relevant details. 

The ZPIV candidate was developed by WRAIR, and NIAID is supporting Phase I clinical testing 

of this vaccine as described above. NIAID is not involved in the development of the Zika 

vaccine licensing agreement between the U.S. Army and Sanofi. You may wish to contact the 

Department of Defense to address any specific questions on the vaccine licensing agreement for 

the ZPIV candidate between the U.S. Army and Sanofi. 

3. With many members of Congress, states and public health advocates worried that the 

Zika vaccine being developed at the Walter Reed Army Institute of Research with 

taxpayer dollars will be priced too high, how is the federal government working to ensure 

Sanofi, when/if a licensing agreement is made, will sell this taxpayer funded vaccine at 

an affordable price to federal and state governments and to consumers? 

NIAID is not involved in the development of the Zika vaccine licensing agreement between the 

U.S. Army and Sanofi. You may wish to contact the Department of Defense to address any 

specific questions on the vaccine licensing agreement for the ZPIV candidate between the U.S. 

Army and Sanofi. 

4. How has public health advice regarding Zika evolved over the past few years for young 

men and women? What do we know now that we did not before and what new 

information could be on the horizon? 

NIAID defers to the Centers for Disease Control and Prevention to respond to this question about 

public health advice regarding Zika. 

5. When does each federal agency believe they will run out of money to respond properly to 

Zika, including vector control, surveillance, vaccine and diagnostics development/ 

improvement and research? 

The remaining NIH funds provided by the Zika Response and Preparedness Act 2016 (division B 

of Public Law 114-223) will be obligated by the end of FY 2017. We anticipate these funds will 

be sufficient to support Zika-related activities currently planned through FY 2017. 

4 
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26480.106

GREG WALDEN, OREGON 

CHAIRMAN 

Dr. Rick A. Bright 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, ,JR., NEW JERSEY 

R.O.NKING MEMBER 

Cltongre%% of tbe Wniteb ~tate% 

1l,lousr of l\rpnstntatibcs 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 M.:1juntv (2021225-79:n 

MllliFity 31341 

June 19,2017 

Director, Biomedical Advanced Research and Development Authority 

Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response 

U.S. Department of Health and Human Services 

200 Independence Avenue, S.W. 

Washington, DC 20201 

Dear Dr. Bright: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Tuesday, 

May 23, 2017, to testify at the hearing entitled "U.S. Public Health Response to the Zika Virus: 

Continuing Challenges." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Wednesday, June 14, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fulling@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

~~ Tim Murphy 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
173 


26480.107

House of Representatives Energy and Commerce 

Subcommittee on Oversight and Investigations 

Hearing: "U.S. Public Health Response to the Zika Virus: Continuing Challenges" 

Tuesday, May 23,2017 

Question for Dr. Rick Bright, Director, Biomedical Advanced Research and 

Development Authority (BARD A); Deputy Assistant Secretary, Office of the Assistant 

Secretary for Preparedness and Response (ASPR) 

The Honorable Tim Murphy 

1. What is our current capacity to test for the Zika virus in the United States? 

The United States needs laboratory diagnostic tests to detect acute Zika infection and 

manage Zika infection in pregnant women. Active Zika infection is diagnosed using 

molecular assays [e.g., Polymerase Chain Reaction (PCR)] that detect Zika virus RNA in 

acceptable specimens including human serum, plasma, whole blood and urine. Because 

80 percent of Zika infections are asymptomatic, people do not often seek medical care 

during the period when the Zika virus can be best detected. Serology tests (e.g., ELlA, 

lgM) that detect antibodies produced in response to Zika virus arc used to detect Zika 

virus infection in people who are past the window when molecular tests are 

effective. HHS agencies have been working aggressively and collaboratively since early 

2016 to make both molecular and serologic Zika diagnostic testing available to U.S. 

states, territories, and affiliated islands through public health laboratories and in clinical 

laboratories. 

a. In your opinion, is this capacity sufficient to meet demand for diagnostic 

tests, particularly among pregnant women in the summer months? 

Local transmission of Zika virus may occur this summer in parts of the United 

States, particularly in parts of Florida, Texas, and Hawaii that have previously 

experienced local transmission of dengue or chikungunya. Considering the 

number of molecular and serologic tests that are now readily available for clinical 

use (hospital, commercial laboratories) and public health laboratories, there is 

likely a sufficient capacity to provide Zika molecular and serologic testing. This 

capacity should serve the anticipated demand from pregnant women who may 

have been exposed to Zika, symptomatic individuals with risk of exposure in a 

localized outbreak, and travelers returning from Zika endemic regions. 

b. How does HHS plan to ramp up this capacity in the coming months, 

particularly as we get into the months where we could see local transmission 

of Zika in the United States? 

1 
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The Zika MAC ELISA and the Trioplex rRT-PCR assays, developed by the 

Centers for Disease Control and Prevention (CDC), are available through the 

CDC Laboratory Response Network (LRN), and other public health and 

Department of Defense (DoD) laboratories in the United States and its territories. 

Both assays arc provided by CDC under an Emergency Use Authorization (EUA) 

provided by the U.S. Food and Drug Administration (FDA). 

BARD A and FDA have been working to bring commercial diagnostic tests to 

market, which would make testing available outside of the public health 

laboratory system. Eleven Zika PCR assays developed by commercial 

manufacturers arc available under FDA EUA for use in certain private sector 

clinical laboratories (hospitals, large commercial laboratories). Any Clinical 

Laboratory Improvement Amendments (CLIA) accredited laboratory wishing to 

perform Zika molecular testing is able to purchase these tests from any one of 

eight different companies, or send their specimens to three different reference 

laboratories for Zika PCR testing. Due to the diverse nature of the U.S. clinical 

laboratory system and preferences by individual labs for different tests, it is not 

possible to estimate the total number oftests these laboratories can 

perform. Large commercial laboratories such as Quest and LabCorp generally 

have capacity to perform many hundreds oftests each week, and capacity to surge 

for additional testing demand if needed. These laboratories are equipped for rapid 

turn-around time and electronic reporting, which speeds up access to results from 

the ordering physician to the patient. 

Testing for IgM antibodies to Zika is challenging due to cross-reactivity of other 

flavivirus antibodies, such as dengue. As such, FDA, BARD A and CDC have 

coordinated support to develop tests that perform at least as well as the CDC 

MAC-ELISA. Two tests developed by commercial manufacturers with support 

from BARD A are now available under FDA EUA for use in private sector clinical 

laboratories (hospitals, large commercial laboratories). The first, lnBios Zika 

DetectTM lgM Capture ELISA, does not require specialized equipment and can be 

performed in CLIA accredited laboratories with proficiency in ELISA 

procedures. As of June 2016, JnBios has manufactured and distributed 5,486 kits 

(as of 6/16/17; each kit can test 28 specimens). The second assay, DiaSorin 

LIAISON® Zika Capture IgM assay, runs on a proprietary, automated, high 

volume instrument that can perform 24 tests an hour. Several large clinical 

laboratories are currently evaluating this assay for use this summer. Other tests, 

including some tests supported by BARD A, at least one test that uses a high 

throughput analyzer and two tests that may be performed without any 

2 
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26480.109

instrumentation, are in development and under review with FDA. Once 

authorized by FDA, these assays will add to the national testing 

capacity. Moreover, BARDA is supporting the advanced development of two 

point-of-care diagnostic tests that would allow for rapid results for the clinician 

and patient. 

The Honorable Frank Pallone 

I. HI-IS recently reported that ASPR has obligated $110.6 million of its fiscal year2017 

Zika funds. How much funding does BARD A have remaining in 2017 for Zika 

preparation or response? Does BARD A have sufficient funds remaining to support 

these efforts for the remainder of fiscal year 20 17? 

Of the $245 million in Zika supplemental funding that ASPRIBARDA received in the 

Zika Response and Preparedness Act (division B of Public Law 114-223), $8.257 million 

remains unobligated as of May 15, 2017. These remaining funds will be obligated before 

the end of the fiscal year. BARD A has sufficient funding to support all of FY20 17 

planned activities for Zika response and preparation 

The Honorable Kathy Castor 

!. Please provide an update on vaccine development and clinical trials. 

BARDA is working closely with I-11-IS interagency partners [National Institutes of Health 

(NIH)/Nationallnstitute of Allergy and Infectious Diseases (NIAID), FDA, and CDC], 

DoD [Walter Reed Army Institute of Research (WRAIR)] and the pharmaceutical 

industry to accelerate the development of several Zika vaccines. In particular, BARD A is 

supporting the development of four Zika vaccines based on two different platform 

approaches: I) whole virus inactivated vaccines with alum adjuvant (Takeda, Sanofi 

Pasteur and Instituto Butantan), and 2) mRNA-based gene delivery (Moderna 

Therapeutics). All three inactivated vaccine candidates are in preclinical development 

stages. Phase 1/II clinical trials arc planned in fall 2017 (Takeda) and late summer 2018 

(Sanofi Pasteur). Instituto Butantan, located in Sao Paulo, Brazil, is receiving support for 

the development and preparation of Zika vaccine under good manufacturing practices 

that will enable clinical studies at a later date. Moderna Therapeutics is presently 

conducting a Phase I clinical trial across three sites in the United States. Enrollment 

continues and data is expected later this year. A larger Phase II clinical trial in Latin 

America is being planned by Moderna for late 2017. 

2. Please provide the latest information on the Zika vaccine licensing agreement between 

the U.S. Army and Sanofi and any relevant details. 

3 
176 

Æ 


26480.110

BARD A is not involved in a decision to provide a license to Sanofi. Licensure 

negotiations are between Sanofi Pasteur and DoD/WRAIR. 

3. With many members of Congress, states and public health advocates worried that the 

Zika vaccine being developed at the Walter Reed Army Institute of Research with 

taxpayer dollars will be priced too high, how is the federal government working to 

ensure Sanofi, when/if a licensing agreement is made, will sell this taxpayer funded 

vaccine at an affordable price to federal and state governments and to consumers? 

BARD A is keenly aware of the issues related to affordable and fair pricing of the medical 

countermeasures it develops. Many of the products BARD A develops are also procured 

by BARD A, CDC, DoD and are on the open market. Thus, procurement contracts are 

negotiated to allow for the greatest savings to the U.S. taxpayer. However, the Zika 

vaccine contracts were executed for the sole purpose of development and not intended for 

procurement by the government at this time. BARD A employs a portfolio approach that 

awards multiple vaccine development contracts to increase the probability in making 

available a safe and effective Zika vaccine. However, this approach promotes 

competition between manufacturers, thus potentially yielding lower costs in the 

marketplace. 

4. How has public health advice regarding Zika evolved over the past few years for 

young men and women? What do we know now that we did not before and what new 

information could be on the horizon? 

BARD A respectfully defers to CDC on public health advice. 

5. When does each federal agency believe they will run out of money to respond 

properly to Zika, including vector control, surveillance, vaccine and diagnostics 

development/improvement and research? 

BARD A currently has sufficient funding to support initial clinical studies for 

investigational vaccine candidates and diagnostics. Existing funds will be obligated 

on or before September 30, 2017. 

4