[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
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
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Available via the World Wide Web: http://www.fdsys.gov
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COMMITTEE ON ENERGY AND COMMERCE
GREG WALDEN, Oregon
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
FRED UPTON, Michigan BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
TIM MURPHY, Pennsylvania ELIOT L. ENGEL, New York
MICHAEL C. BURGESS, Texas GENE GREEN, Texas
MARSHA BLACKBURN, Tennessee DIANA DeGETTE, Colorado
STEVE SCALISE, Louisiana MICHAEL F. DOYLE, Pennsylvania
ROBERT E. LATTA, Ohio JANICE D. SCHAKOWSKY, Illinois
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
GREGG HARPER, Mississippi DORIS O. MATSUI, California
LEONARD LANCE, New Jersey KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky JOHN P. SARBANES, Maryland
PETE OLSON, Texas JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia PETER WELCH, Vermont
ADAM KINZINGER, Illinois BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
GUS M. BILIRAKIS, Florida YVETTE D. CLARKE, New York
BILL JOHNSON, Ohio DAVID LOEBSACK, Iowa
BILLY LONG, Missouri KURT SCHRADER, Oregon
LARRY BUCSHON, Indiana JOSEPH P. KENNEDY, III,
BILL FLORES, Texas Massachusetts
SUSAN W. BROOKS, Indiana TONY CARDENAS, California
MARKWAYNE MULLIN, Oklahoma RAUL RUIZ, California
RICHARD HUDSON, North Carolina SCOTT H. PETERS, California
CHRIS COLLINS, New York DEBBIE DINGELL, Michigan
KEVIN CRAMER, North Dakota
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
7_____
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
H. MORGAN GRIFFITH, Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
JOE BARTON, Texas JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas KATHY CASTOR, Florida
SUSAN W. BROOKS, Indiana PAUL TONKO, New York
CHRIS COLLINS, New York YVETTE D. CLARKE, New York
TIM WALBERG, Michigan RAUL RUIZ, California
MIMI WALTERS, California SCOTT H. PETERS, California
RYAN A. COSTELLO, Pennsylvania FRANK PALLONE, Jr., New Jersey (ex
EARL L. ``BUDDY'' CARTER, Georgia officio)
GREG WALDEN, Oregon (ex officio)
(ii)
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
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
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 FDA-authorized
tests for comparison use, and the users of the tests 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, 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 report 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 Vector-borne 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.
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.
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.
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-in-
hand 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.
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 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.
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.
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 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.
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:]
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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 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:]
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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 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:]
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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-the-ground 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.
[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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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 point-of-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 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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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 persistence 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 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
mosquito-borne 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 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 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 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.
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 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.
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 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
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?
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?
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 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.
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.
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 infected. 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?
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
well-curated 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 risk-based 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----
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 influenza. 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?
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-and-see 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-
and-see,'' 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.
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 important 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
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
mosquito-control 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.
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.
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 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 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 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. 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.
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----
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.]
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