[Senate Hearing 114-680]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2017
----------
THURSDAY, FEBRUARY 11, 2016
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:02 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Roy Blunt (chairman) presiding.
Present: Senators Blunt, Moran, Cochran, Alexander, Capito,
Lankford, Murray, Durbin, Reed, Mikulski, Shaheen, Merkley, and
Schatz.
Emerging Health Threats and the Zika Supplemental Request
opening statement of senator roy blunt
Senator Blunt. The Appropriations Subcommittee on Labor,
Health, and Human Services, and Education, and Related Agencies
will come to order.
I am pleased that we have Dr. Tom Frieden from CDC, and Dr.
Tony Fauci, who is the infectious diseases head at the National
Institutes of Health, here with us today.
Obviously, this hearing is to discuss the outbreak of Zika
and the administration's $1.8 billion supplemental budget
request. We look forward to hearing your testimony.
It doesn't seem that long ago that we were here having a
similar hearing on Ebola. Maybe one of the things we can talk
about some today is, as these problems face us, is there any
way in the regular budget we could be better at anticipating
and monitoring what happens around the world, so that we can
prevent some emergencies and be even better positioned to
respond to others.
But we are glad you are here. I think we will have a number
of members come. I anticipate a vote at 10:30. If that happens,
I'm assuming that we will have members here that will allow us
to go back and forth, and continue the hearing. We will go
individually and give our vote, and get back while we continue
to have questions and your responses.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Good morning. Thank you, Dr. Frieden and Dr. Fauci, for appearing
before the Subcommittee today to discuss the Zika outbreak and the
Administration's $1.8 billion supplemental funding request. We look
forward to hearing your testimonies.
No sooner than the global health concerns over Ebola subsided, we
are faced with another looming threat. The Zika virus has developed
from an illness with mild, flu-like symptoms to one that may lead to
severe birth defects or paralysis. There is no rapid test, specific
treatment, or vaccine.
Little has been done in the United States to prepare for the threat
of the Zika virus. While the National Institutes of Health and Centers
for Disease Control and Prevention spend some funding on viruses like
Zika that are transmitted by mosquitoes, neither agency currently
spends any significant resources specifically on Zika.
After the Department of Health and Human Services received $2.7
billion to spend on Ebola and other infectious diseases, more than half
remains unspent, and none of the remaining funding thus far has been
used for the current Zika outbreak.
This shows the fundamental problem in our public health system: it
has a short attention span. We immediately forget about the outbreak
that came before and do not adequately plan for the ones on the
horizon. Today, we are asking about Zika. Last year, it was Ebola. What
will it be next year?
As we examine the Administration's request for supplemental
funding, we need to make certain that we are focusing resources not
just on today's crisis, but on the infrastructure to prepare for
tomorrow's as well. It is time to approach emerging health threats more
proactively. We need to examine our capacity to respond to ever-
changing threats, take precautions, and focus efforts on strategic
planning.
Thank you.
Senator Blunt. Certainly, I am pleased to recognize our
ranking member, Senator Murray, for whatever comments she might
have.
Senator.
STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Thank you very much, Chairman Blunt.
Dr. Fauci, Dr. Frieden, thank you both for joining us this
morning to talk about the Zika virus and other emerging health
threats. I am sure we are all hearing from families in our home
States who are concerned about this virus and its impacts. So I
am glad we have the opportunity today to continue gathering the
facts and discussing ways to fight the Zika virus at home and
abroad.
I'm very hopeful that we can put politics aside and work
across the aisle to protect our families and communities, and
ensure that we are putting all the needed tools and resources
into this effort.
Our understanding of the Zika virus and the public health
community response is rapidly evolving. Last week, the World
Health Organization declared Zika-linked birth defects a global
health emergency. A day later, health officials in Dallas
confirmed the first known case of sexual transmission of the
disease.
In the current outbreak, it is a virus that most people had
never heard of until recently, and it has quickly spread across
the Americas, potentially threatening expectant mothers and
their newborns wherever it develops.
There is still a lot we need to learn about this virus, but
one thing that is clear is that we cannot wait to act. The
scientific consensus at this stage is that four out of five of
those who become infected show no symptoms. For the other 20
percent who do, the most common result is a week of flu-like
symptoms.
However, in rare instances, there are indications that some
people infected with the virus have developed Guillain-Barre
syndrome, a potentially life-threatening neurological
condition. And there is growing evidence that Zika can lead to
microcephaly, a birth defect that usually results in abnormal
brain development with serious long-term consequences. In the
past year, Brazil has experienced a 25-fold increase in the
number of infants born with microcephaly, and scientists
believe the Zika is the reason.
The same mosquitoes that carry the virus in South America
can be found in many parts of the United States, including
right outside our door here on Capitol Hill. Evidence now
indicates the virus has spread to Puerto Rico, putting pregnant
woman there at risk. And many are concerned that it will make
its way to the mainland when the warm weather returns.
Speaking for moms and grandmothers across the country, this
is really deeply concerning to all of us. So now is the time to
prepare for that possibility and to develop strategies for
controlling the mosquitoes that harbor the virus.
To make that possible, the administration has requested
emergency funding to assist States and local communities with
these efforts, including resources to expand mosquito-control
efforts, as well as laboratory and diagnostic capabilities.
Given the limitations of existing diagnostics and treatments,
the request would provide additional funding to accelerate
research and development of effective lab tests, antiviral
drugs, and, of particular importance, a vaccine.
The request would also help fill in the gaps in our
knowledge about the disease. Additionally, the administration's
proposal would include funding to educate healthcare providers,
pregnant women, and their partners about the virus, and would
improve health services for low-income pregnant women in areas
where Zika poses a risk.
I believe it is critical that, in Zika-affected countries,
we do everything we can to ensure that women have access to a
full range of reproductive healthcare. That is something that I
will continue to be focused on.
We know other viruses that can cause pregnancy
complications are often associated with a broad spectrum of
possible conditions, so there may be other consequences for
pregnant women who become infected. I'm glad this is a concern
CDC is focused on answering.
While a mosquito bite is the most likely way to contract
Zika, as the news from Dallas last week illustrated, we also
need to understand other means of transmission, and whether
there are any risks to our Nation's blood supply.
Time is of the essence, so I look forward to discussing the
administration's proposal, and I hope that we will be able to
work in a bipartisan manner to move legislation in the coming
weeks, because when it comes to protecting our families from
potentially serious threats like this, there shouldn't be, of
course, any partisanship or politics. We should be able to work
together to get this done.
Mr. Chairman, I am hopeful we will be able to do so.
Senator Blunt. Thank you, Senator Murray.
Let's get the official titles on the record.
I want to welcome Dr. Frieden again, the director of
Centers for Disease Control and Prevention, and Dr. Fauci, the
director of the National Institute of Allergy and Infectious
Diseases. We are looking forward to your testimony.
Dr. Frieden, if you want to go first, followed by Dr.
Fauci.
STATEMENT OF THOMAS R. FRIEDEN, M.D., DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Frieden. Thank you very much, Chairman Blunt, Ranking
Member Murray, Senator Mikulski, and others, for being here,
and for inviting us to discuss Zika, which is, as you said, Mr.
Chairman, the latest in a series of threats that we are dealing
with.
At the outset, I want to make a few things really clear
about where we are with Zika. First off, we are discovering
more literally every day. This is a new phenomenon, and we are
working around the clock to learn as much as we can as quickly
as we can, and share that information with people, and take
appropriate action.
Zika is new. New diseases can be scary, particularly when
they affect the most vulnerable among us.
Right now, the most important thing for Americans to know
is, if you are pregnant, it is better not to travel to a place
where Zika is spreading. If you're pregnant in a place where
Zika is spreading, do everything you can to protect yourself
against mosquito bites.
The mosquito that spreads Zika is very difficult to
control, and we are working 24/7 to try to figure out how we
can best reduce the risks to pregnant women, which is the key
goal at this time. This is the latest in a series of
unpredicted and unpredictable health threats.
What is predictable, as you say exactly, is our need to
improve systems to find, stop, and prevent health threats
wherever they emerge, because we really are connected as a
world, and it is very easy for disease to spread from one part
of the world to another.
The virus was first identified in 1947. It wasn't until
2007 that the first outbreak was identified. CDC (Centers for
Disease Control and Prevention) scientists investigated that
outbreak on the island of Yap in Micronesia. Seventy-three
percent of the adult population became infected. About four out
of five people had no symptoms. It was generally considered a
mild illness--rash, fever, sore joints, pinkeye.
But the mosquito that spreads it is the same mosquito that
spreads the dengue and chikungunya. If I can just show you a
couple slides of how that happens, this is the mosquito. It is
very difficult to kill. It lives indoors. To really knock down
the risk of dengue to a population, you may have to kill 90
percent or more of these mosquitoes.
This is the distribution of dengue around the world. It has
spread rapidly over the past decade as people move more, and it
is ideally suited to environments where there is standing
water.
Chikungunya, also spread by the same mosquito, spread for
more than 50 years in Africa and Asia, and only recently came
to this hemisphere, but rapidly spread throughout the United
States.
This is the current known transmission of these viruses,
but I have to say ``known'' underlined, because there are areas
where it is spreading, and we may not know because we don't
have really good tracking systems. That is one of the things
that we need to scale up in the longer term.
I want to share what happened just less than 2 years ago.
The first known case of chikungunya spread by the same mosquito
on the island of Puerto Rico occurred on May 5, 2014. I'm going
to show you a series of slides that are a time-lapse of just 2
weeks. Two weeks later, it had begun to spread. Two weeks after
that, it spread widely. Two weeks after that, even more wisely.
Two weeks, 2 weeks, 2 weeks, and then by October, it
essentially was all over the island. So within 2 months, we had
seen a really explosive spread.
This is because, in Puerto Rico, the particular mosquito is
very abundant, and the environment is such that screens and
air-conditioning are not as prominent as they are in some other
places, so people are at a much higher risk.
The link to microcephaly is unprecedented. We have never
before, that we know of, seen a mosquito-borne disease that
could cause this kind of severe fetal malformation. Rubella was
identified in 1941 as the cause of rubella syndrome, another
virus in 1962, and then in more than 50 years, we haven't found
something else that has done that.
Guillain-Barre would not be unusual. We do see paralysis
after infection rarely in a number of conditions.
So I would like to just say right now what we are going to
do going forward and what is likely to happen going forward.
First, we are going to learn more. We're going to do
everything we can to understand the relationship with
microcephaly, which increasingly looks like a causal
association, though it is not completely proven yet. We are
going to advance our ability to diagnose Zika. Currently, it is
imperfect. And we are going to do better or try to do better at
controlling this mosquito, which is very challenging to
control.
We will undoubtedly see many travelers returning to the
United States with Zika. There are about 40 million people who
travel from the United States to Zika-affected areas each year.
Many of those will come back with Zika. If it is like dengue
and chikungunya in the past, we will see hundreds or thousands
of travelers returning to the United States.
Unfortunately, some of those individuals will be pregnant
women. We have already had one woman from Hawaii who was in
Brazil in the spring, delivered late last year, and did have a
child with microcephaly. So we think this may occur among
travelers returning to the United States. That is one
phenomenon that we are likely to see.
The second is, as I indicated, the likelihood of widespread
transmission in parts of the United States such as Puerto Rico
and the territories--the U.S. Virgin Islands, American Samoa,
and others--where this mosquito is very prevalent and dengue
can spread very rapidly. So we may see a very large number of
cases there. That is the area that is most urgent for us in
this response.
Third, we may see possible cases and clusters of other
parts of the United States that have the same mosquito.
Florida, Texas, Southern U.S., have the mosquito that spreads
this very well. That is why we want to be able to support them
to do a better job both diagnosing people that may have Zika
and controlling mosquitoes that may spread Zika.
We may also see sporadic cases around the United States
from another mosquito that doesn't spread it as efficiently or
rare cases of sexual transmission.
And unfortunately, we are likely to continue to see some
substantial spread around the world with a pace that sees lots
of Zika and then, if it is associated with birth defects, 6, 5,
9 months later, lots of children born who may be affected.
As Senator Murray said, we are not sure whether the
children who don't have apparent microcephaly are completely
normal, or whether they may have other problems as well. We are
looking at that, but it may take years to sort some of these
things out. Some things we will learn in days or weeks. Some
things may take much longer.
Zika requires an emergency response. Our request for the
CDC component of that is $828 million for Puerto Rico, for the
rest of the United States, and for our international partners.
That is an approach that looks at prevention, detection,
response.
On prevention, we want to reduce the risk that pregnant
women are bitten by an infected mosquito and prevent other rare
forms of transmission.
On detection, we want to continue to scale up our ability
to find the virus in people's blood. In the CDC laboratory, we
have established the only tests in the United States that can
identify Zika. One of these will do it accurately when someone
is actively ill. That test was accelerated and produced in just
3 weeks, because of support Congress had given to the CDC
before to do advanced molecular detection and genomic
manipulation, to more rapidly do it.
The other tests are much more challenging to diagnose prior
to Zika infection, because there is a lot of cross-reactivity
between Zika and other viruses. So they may be falsely
positive. But pregnant women who have been in such areas want
to know, so we are scaling this test up and working with health
departments all over the country to diagnose better.
We will also continue to look for and analyze microcephaly.
Just yesterday, our weekly bulletin, Morbidity and Mortality
Weekly Report, published the strongest evidence to date linking
Zika with microcephaly. There was another report in the New
England Journal also yesterday about a different situation. But
here you see the actual Zika genome in the brain tissue of
infants who tragically died within the first 24 hours of being
born.
We also will respond as rapidly as responsible possible in
controlling mosquitoes; providing clinical care; encouraging
effective clinical care for mothers, infants, and people with
Guillain-Barre syndrome.
We know that health threats will continue to emerge. We
want to respond as an emergency to this situation, to protect
pregnant women and reduce the risk to Americans and others of
this disease. We want to understand it better, but also
continue to strengthen systems around the world that can find
threats when they first emerge, stop them as soon as possible,
and prevent that wherever that's possible.
Thank you very much. I look forward to answering your
questions.
[The statement follows:]
Prepared Statement of Thomas Frieden, M.D., MPH
introduction
Good morning Chairman Blunt, Ranking Member Murray, and members of
the Subcommittee. Thank you for the opportunity to testify before you
today with regard to the President's request for more than $1.8 billion
in emergency funding to respond to the Zika virus outbreak that
threatens the United States and the world. The emergency funding
requests a total of $828,000,000, for CDC with no-year availability, in
support of domestic and international response, with particular
attention to emergency assistance to the U.S. Territory of Puerto Rico
and the U.S. Territories and States with local transmission of Zika
virus.
Vaccines and antibiotics have made many infectious diseases a thing
of the past; we've come to expect that public health and modern science
can conquer all microbes. But nature is a formidable adversary, and
Zika is our newest threat, particularly to pregnant women. CDC has some
of the world's leading experts both in diseases spread by mosquitoes
and in birth defects. We must act urgently and swiftly to stop the
spread of the Zika virus. There are many things we do not know yet
about the Zika virus, including the following: the nature of maternal-
to-child transmission, what cofactors may play a part in various
consequences of the virus, relationship to microcephaly, Guillain-Barre
and other sequelae, level of risk including symptomatic vs.
asymptomatic transmission, duration of infectivity in semen. We are
also doing work to accelerate optimal vector control strategies, better
diagnostics, and vaccine discovery.
We are working to find information about these areas and will need
the additional funding requested in the supplemental to do so. We are
figuring out more about Zika literally every day, and will share
information--and adjust our guidelines and recommendations--as we learn
more. That is the nature of a scientific response to an emerging health
threat. The doctors, scientists, veterinarians, and others at CDC are
working around the clock to protect Americans from this and other
health threats. We already have made significant progress identifying
the virus in brain tissue of affected infants, developing and
distributing new diagnostic tests, issuing guidance, conducting
epidemiological investigations along with affected countries, and
improving monitoring and surveillance in the United States including
Puerto Rico and the territories. Much of what we know about Zika and
similar viruses today is based on the work done by CDC scientists who
have dedicated their lives to working in this area. But as hard as we
work, there are still many things we cannot know now, and cannot do
now. We will continue to use the best of modern science to protect the
American people.
zika and its history
Zika is an emerging health threat; we face a rapidly changing
situation involving numerous partners in this country and abroad. Zika
virus causes understandable concern among people throughout the
Americas, including those here in the United States. CDC is discovering
better ways to prevent, detect, and respond to Zika and its
complications. We are committed to ensuring that the American people
have access to the most accurate, timely information about Zika virus
and the current outbreak. Many areas of the United States have the type
of mosquitoes that can become infected with and transmit Zika virus.
Although we cannot predict with certainty the impact of Zika virus in
the United States, we believe we will see additional cases in the U.S.
based on experience with dengue and chikungunya, which have been spread
locally in parts of the Southern United States, Hawaii, and the
Territories and are spread by the same type of mosquito as dengue and
chikungunya. Recent chikungunya and dengue outbreaks in the United
States suggest that Zika outbreaks in the U.S. mainland may be
relatively small and localized. Better housing construction, less
crowding, regular use of air conditioning, use of window screens and
door screens, and State and local mosquito-control efforts have helped
to contain transmission of these mosquito-borne viruses. However, we
understand that any local outbreaks will be of deep concern to the
people living there. For the Commonwealth of Puerto Rico as well as the
U.S. Virgin Islands and American Samoa, the outlook is different. There
have been case reports of local transmission in all three territories.
Furthermore, recent outbreaks of dengue and chikungunya suggest that
Zika virus may spread widely in those areas. As we continue to learn
more about Zika virus, including potential transmission risks, we are
working 24/7 to incorporate our most accurate and up-to-date
understanding of the virus. Given this, we need to be fully prepared,
especially as the spring and summer months arrive. We are particularly
concerned about Puerto Rico and the U.S. territories that may
experience substantial spread of Zika. For comparison, more than 80
percent of adults in Puerto Rico have been infected with at least one
strain of dengue, and about a quarter have been infected with the more
recently introduced chikungunya virus. So, while only 9 cases of local
transmission of Zika have been identified in Puerto Rico, it would be
reasonable to expect that percentage to rise. Most people who may be
exposed to Zika virus will have only mild symptoms. In fact, about four
out of five people infected with Zika appear not to have symptoms at
all. But increasing evidence that suggests that Zika virus infection
may be associated with more serious health outcomes.
This emergency funding request is designed to support immediate
response activities to reduce the Zika risk in the United States and
around the world. CDC has unparalleled experience responding to
emerging infectious disease threats. CDC's focus on Zika is consistent
the core principles of public health:
--PREVENT or mitigate avoidable outbreaks and lessen the spread of
disease.
--DETECT epidemics and new disease threats quickly.
--RESPOND effectively to public health emergencies, protecting lives
abroad and in the U.S.
CDC is working in collaboration with other components of the
Department of Health and Human Services (HHS), including the Office of
the Assistant Secretary of Preparedness and Response (ASPR) and within
that the Biomedical Advanced Research and Development Authority
(BARDA), the Office of Global Affairs, the National Institutes of
Health, and the Food and Drug Administration. We are working as well
with partners across the U.S. Government to communicate with healthcare
providers and the general public; issue travel alerts and clinical
guidance; and step up our efforts on research to better understand the
Zika virus, and on the development of tests, treatments, and vaccines,
as well as improved mosquito-control methods.
Zika is a flavivirus, which is closely related to dengue, yellow
fever and West Nile viruses. Zika virus is primarily spread to people
through the bite of an infected Aedes species mosquito. These mosquitos
also spread dengue and chikungunya viruses. The mosquitoes become
infected when they bite a person already infected with Zika virus.
These infected mosquitoes can then spread the virus to other people
through bites. Case reports of other modes of transmission include
spread through sexual transmission and blood transfusion. Of great
concern, Zika virus also can be passed from a mother to her developing
baby during pregnancy.
Zika is not a new virus. It was first recognized in 1947, and it
was recognized to cause occasional illness in Africa and Asia, but the
first outbreak we know of occurred in 2007 in the small Pacific island
of Yap. Last May, the first local transmission of Zika in the Americas
was reported in Brazil, and by the end of 2015, Brazilian authorities
estimated that the outbreak there involved perhaps a million suspected
cases of Zika virus. In recent months, the virus has spread rapidly
throughout Latin America and the Caribbean, as well as to parts of the
Pacific. As of February 9, 2016, more than 30 countries and
territories, including the Commonwealth of Puerto Rico, a U.S.
Territory, as well as the U.S. Virgin Islands and American Samoa have
reported local transmission of the Zika virus. The World Health
Organization Emergency Committee on Zika declared the recent cluster of
microcephaly cases and other neurological disorders reported in Brazil,
following a similar cluster in French Polynesia in 2014, a Public
Health Emergency of International Concern. On February 1, the World
Health Organization (WHO) declared the recent cluster of microcephaly
cases and other neurological disorders reported in Brazil, following a
similar cluster in French Polynesia in 2014, constitutes a Public
Health Emergency of International Concern (PHEIC), a reflection of the
seriousness of this unfolding epidemic.
symptoms and adverse outcomes
Many people who may be exposed to Zika virus will have only mild
symptoms. Those who do become ill usually have mild symptoms such as
fever, rash, joint pain, and red eyes or conjunctivitis. The symptoms
last a couple days to up to a week, and it is very rare for Zika to
cause serious illness or death.
Increasing evidence suggests that Zika virus infection may be
associated with more serious health outcomes. In October 2015,
Brazilian authorities recognized a concerning increase in microcephaly,
which has occurred following Brazil's outbreak of Zika virus.
Microcephaly, is a usually rare, serious condition among newborns where
a baby's head is smaller than expected. Microcephaly is not a diagnosis
in and of itself but a sign that the brain did not develop as it should
in the womb. Babies with microcephaly can have a range of problems,
including seizures, developmental delay, feeding problems and hearing
loss. In some cases these problems can be life threatening.
Laboratory tests at CDC strongly suggest a link between Zika virus
infection during pregnancy and microcephaly. We do not know whether
this link is causal, or, if so whether there are important cofactors
such as other infections, nutritional factors, or environmental toxins.
We also do not know what, if any, other outcomes might be associated
with Zika infection during pregnancy. Microcephaly in infants can be
devastating to the affected families, and this ongoing outbreak is
concerning to everyone, especially for pregnant women, and their
families who may travel to or live in the infected areas. Zika virus
spread in the Americas and its effect on pregnancy are new developments
that we are working with partners to better understand.
Our primary concern at this point is to protect pregnant women from
Zika virus infection. That's why, during the same week we identified
Zika in brain tissue specimens from affected infants, we issued a
travel advisory warning to advise pregnant women not to travel to
affected areas. And that's why we are working around the clock with
Puerto Rico and other areas to get support to women who are or who may
become pregnant and to do what we can to reduce the threat of Zika
there.
Health authorities in Brazil and elsewhere have also reported an
increase in suspected cases of Guillain-Barre syndrome, a rare
neurologic disorder in which a person's own immune system damages nerve
cells leading to nerve damage or paralysis that lasts for several weeks
or several months. Most people fully recover, but it can take a few
months or even years to do so. Some people with Guillain-Barre syndrome
have permanent damage and in rare cases, people have died. It is
difficult to determine if any particular pathogen ``caused'' or
``triggered'' Guillain-Barre syndrome. Currently, we do not know if
Zika virus infection causes Guillain-Barre syndrome. However, the
development of Guillain-Barre syndrome is a recognized after-effect of
many different infections with viruses similar to Zika. CDC is
currently working with public health officials in Brazil to investigate
whether there is any link between Zika infection and Guillain-Barre.
preparedness and response
We know that there will be many more Zika virus cases in affected
areas in Latin America and the Caribbean. That is why the President's
Zika emergency funding request includes support for CDC's efforts to
enhance international capacity for virus surveillance, and to expand
the expertise in mosquito surveillance and control, laboratory testing,
healthcare provider training, and epidemiological investigations in
countries at highest risk of Zika virus outbreak.
While we have not yet seen transmission of the Zika virus by
mosquitoes within the continental United States, we know that many
returning travelers will have Zika infection--for comparison, there
were 3,270 travelers in the United States diagnosed and reported with
chikungunya infection in 2014 and 2015. So we expect that many
travelers to the United States will be diagnosed with Zika infection,
and the number of Zika cases among travelers visiting or returning to
the United States will likely increase.
domestic activities
CDC has a long history of assisting county, State, tribal and
territorial public health partners to detect, prevent, and control
diseases spread by mosquitos. Surveillance is essential to monitor and
quickly identify areas with local transmission. We conduct multi-
faceted surveillance for arboviruses, including Zika, through ArboNET,
an integrated network which funds, through our Epidemiology and
Laboratory Capacity cooperative agreements, staff in 49 States, Puerto
Rico, and six large municipalities to conduct human case
investigations, collect and test mosquitos, and perform laboratory
analysis on arboviruses including Zika. State and local public health
agencies are working with the CDC to maximize disease detection and
reporting of Zika. CDC is also working with several States and Puerto
Rico to determine a baseline prevalence of microcephaly so that any
increase, should it occur, can be quickly and accurately identified.
With support from the President's emergency request, CDC will build
on its current efforts to provide financial and technical resources to
States and territories through cooperative agreements to strengthen
their capacity to prepare for and respond to emerging threats such as
Zika virus. These resources may be used to help health departments
expand their capacity to prepare for cases of local Zika virus
transmission in their areas and to implement community education and
prevention programs to reduce human-mosquito contact and therefore
reduce the risk of Zika transmission. Resources may also be used to
implement vector control strategies to prevent further spread of Zika
virus in areas where local transmission has been found.
It also is critical that States and territories are able to receive
specimens and test for Zika virus in order to diagnose and report
travel-related and locally acquired cases of Zika. CDC, under the
emergency request, will expand its efforts to assist public-health labs
nationwide with the reagents necessary to test for Zika and the
guidance on how to interpret test results. In addition, CDC is
available to provide testing of any Zika samples upon request. Building
on experience applying advanced molecular detection technology to
address the emergence of chikungunya virus, CDC scientists have been
working to develop and validate a Zika test that could detect emerging
strains for use in laboratories throughout the Western Hemisphere.
Significant progress has been made toward being able to detect the
virus within three weeks of having received the first Zika virus
sample. With older methods, this would have required three to 4 months.
CDC also developed the IgM ELISA and Zika Virus Plaque reduction
neutralization test in use at CDC to detect evidence of previous Zika
infections. Currently, CDC scientists are also working to develop a
faster, next-generation neutralization test that could detect prior
Zika infection.
CDC experts are working intensively to learn more about the
outbreak and provide people with the information they need to protect
themselves. The same week the CDC laboratory identified Zika virus in
samples from affected infants in Brazil, we issued a travel advisory
indicating that pregnant women should consider postponing travel to
Zika-affected areas. We issue travel alerts for the affected areas as
confirmation of the virus is reported, and we'll keep you alert as the
situation changes. CDC is also working with FDA to ensure the safety of
the blood supply from Zika virus, particularly in regions experiencing
local outbreaks. Finally, CDC also has provided guidance for doctors
and other clinicians on the evaluation, treatment and follow-up care of
pregnant women and infants with possible exposure to Zika virus.
Our guidance has and will continue to be updated as our knowledge
increases. We have recently updated our guidance to provide
recommendations for the clinical care and management of pregnant women
living in areas where Zika transmission is widespread, with special
consideration to the on-going risk of maternal Zika virus infection
throughout pregnancy. These guidance documents were prepared in
consultation with the American College of Obstetricians and
Gynecologists, the Society for Maternal Fetal-Medicine, and the
American Academy of Pediatrics. We issued a health advisory to help
clinicians in recognizing, managing, and reporting Zika and recently
held a clinician outreach call that reached nearly 3,000 participants
and more than 150 partner organizations. CDC will continue regular
ongoing engagement of clinicians through direct outreach and
partnerships with key medical societies.
CDC also wants to ensure that the general public knows what they
can do to protect themselves. Pregnant women should consider postponing
travel to regions with ongoing Zika virus transmission. If they must
travel, or if they live in affected areas, CDC recommends pregnant
women talk to their doctors or other healthcare providers first and
strictly follow steps to prevent mosquito bites. Reducing exposure to
mosquitoes is important for anyone traveling to or residing in areas
where the virus is circulating by wearing long sleeves, long pants,
using EPA-registered repellents such as DEET and permethrin-treated
clothing (both of which are safe to use in pregnancy), and using other
protections such as air-conditioning to reduce exposure to daytime
mosquitoes. For women living in areas with Zika virus outbreaks, CDC
appreciates that the timing of pregnancy is a personal and complex
decision for a woman to make in consultation with her doctor or other
healthcare provider. Given the potential for Zika virus to be spread
through sex, if male partners have or are at risk for Zika virus
infection, pregnant women and their male partners should consider using
condoms or abstaining from sex for the duration of the pregnancy. This
is a rapidly-changing situation and our understanding of the risks
concerning Zika virus infection, including those surrounding
transmission from mother to fetus and those concerning transmission
between sexual partners, is incomplete and evolving. As we get new
information, we will update our recommendations.
global activities
CDC is coordinating its response with the Pan-American Health
Organization, the regional body of WHO, with other parts of WHO, and is
collaborating with many international partners to learn more about this
outbreak. We are working with the Brazilian Ministry of Health on
research partnerships. Specifically, one partnership will be studying
the link between Zika virus infection and microcephaly, while another
is examining the relationship between Zika virus and Guillain-Barre.
Research teams from CDC are also in other countries to explore
collaborations that will shed light on the risk of microcephaly with
maternal Zika virus infection during pregnancy.
In addition, CDC has offered to all countries to test samples from
microcephaly cases for serologic evidence of Zika virus infection and
to help these countries establish in-country diagnostic capacity. To
that end, we are currently, in conjunction with the Pan American Health
Organization of the World Health Organization, providing training to
laboratorians in South and Central America on diagnostic tests,
including two recent workshops in Brazil and Nicaragua.
CDC's Global Disease Detection (GDD) program rapidly detects,
accurately identifies and promptly responds to emerging infectious
diseases such as Zika virus. The GDD Operations Center has been
monitoring the spread of the epidemic from Brazil to other countries in
the Americas since Brazil first reported Zika transmission in May of
2015. CDC's Central American office has facilitated the verification of
Zika cases in several countries throughout Latin America, including
Colombia, Venezuela, and Nicaragua. The GDD program has also been
working to ensure that new information regarding Zika virus and its
possible link to birth defects is communicated to U.S. Mission Health
Unit staff throughout the Americas.
Investing in global health is not just the right thing to do to
save lives, it is the right thing to do to protect Americans. The
global health security agenda, with critical support from Congress, is
collaborating with countries around the world so that we can prevent,
detect, and respond to health threats when and where they first emerge.
Zika has been present in Africa for decades, and it's possible that it
causes microcephaly there as well. The sooner we detect a problem,
wherever it occurs, the more rapidly we can respond to it and prevent
it from spreading. It is in all of our best interests to work with
others to improve public health capacity around the world.
research activities
More research is critical to addressing several gaps in our ability
to respond to Zika as outlined in the Zika Emergency Request. We need a
better understanding of the epidemiology of Zika and potential Zika-
associated birth defects and other adverse health outcomes. We need
better diagnostic methods that can quickly and clearly differentiate
between similar viruses to detect evidence of past Zika infection.
Diagnosis of Zika is complicated by the fact that about 80 percent of
infected people appear not to have symptoms. The virus can be reliably
detected by current diagnostic methods only in the first 7 days of
illness onset.
Currently, a Reverse Transcription-Polymerase Chain Reaction (RT-
PCR) test can provide a definitive diagnosis of Zika, but only if it is
performed within about a week of symptom onset. The tests we have
available for Zika in persons who are no longer ill may have cross-
reactivity with similar flaviviruses, particularly dengue, which can
lead to false-positive or inconclusive results. Diagnosis is
particularly challenging with Zika virus since most people will not
experience symptoms and therefore will not go to their healthcare
provider in time for PCR-testing to be utilized. We also need to
determine the length of time a man who has been infected by a mosquito
may continue to shed virus in semen.
Additional research is also needed to develop methods of mosquito
control. Control of the particular mosquito that spreads Zika is very
challenging. We need to both implement the best tools we have today,
and conduct more work and research to develop better tools and
strategies for mosquito control. Existing methods for mosquito control
all have shortcomings, especially in areas where the population of
Aedes vector mosquitoes is rampant. Vector control is particularly
challenging with this specific type of mosquito because of its
preference to live in and around houses, the fact that it bites during
the day, the fact that it preferentially bites humans, and its ability
to breed in very little water. Better mosquito surveillance is also
vital to determine the location of mosquitoes and areas with mosquito
resistance to insecticides which would inform the implementation of new
mosquito control techniques.
Finally, a vaccine is needed to protect people at risk of Zika
virus infections, particularly women of childbearing age. NIH, in
collaboration with ASPR/BARDA, will address the possibility of
developing such a vaccine based on vaccines for dengue and West Nile
virus are under development as outlined in the Emergency Request. NIH
also is exploring other vaccine development strategies. At CDC, our
scientists developed both a West Nile virus vaccine which is currently
in use for animal protection in the United States, and a dengue
vaccine, which is currently in clinical trials.
conclusion
Nature is a formidable adversary. To protect Americans, the Zika
Emergency Request invests in the laboratories, disease detectives,
disease tracking systems, mosquito control, and investigations needed
to continue to improve these essential tools. Investment in both the
practice and research on new means of mosquito control is particularly
important, as is work on a vaccine. As the Nation's health protection
agency, CDC is focused on responding quickly to new and emerging health
threats such as the Zika virus.
In addition, of the more than $1.8 billion in the President's
emergency funding request to prepare for and respond to the Zika virus,
$828 million is for activities at CDC. This includes funding to support
prevention and response strategies through:
--Supporting Zika virus readiness and response capacity in States and
territories with mosquito populations that are known to
transmit Zika virus, with a priority focus on areas with
ongoing Zika transmission;
--Enhancing mosquito control programs through enhanced laboratory,
epidemiology and surveillance capacity in at-risk areas to
reduce the opportunities for Zika transmission;
--Establishing rapid response teams to limit potential clusters of
Zika virus in the United States;
--Improving laboratory capacity and infrastructure to test for Zika
virus and other infectious diseases;
--Implementing surveillance efforts to track Zika virus in
communities and in mosquitoes;
--Deploying targeted prevention and education strategies with key
populations, including pregnant women, their partners, and
healthcare professionals;
--Expanding the CDC Pregnancy Risk Assessment Monitoring System,
improve Guillain-Barre syndrome tracking, and ensure the
ability of birth defect registries across the country to detect
risks related to Zika;
--Increasing research into the link between Zika virus infections and
the birth defect microcephaly and measure changes in incidence
rates over time;
--Enhancing international capacity for virus surveillance, expand the
Field Epidemiology Training program, laboratory testing,
healthcare provider training, and vector surveillance and
control in countries at highest risk of Zika virus outbreaks;
and
--Improving diagnostics for Zika virus, including advanced methods to
refine tests, and support advanced developments for vector
control.
We look forward to working with the Congress on the implementation
of the President's emergency funding request.
CDC's current response to the Zika outbreak in the Americas again
demonstrates our commitment to global health security and why
implementation of the Global Health Security Agenda (GHSA) is needed.
Global health security is a shared responsibility that cannot be
achieved by a single actor or sector of government. In partnership with
other nations and international organizations, the CDC is committed to
mounting a prompt, coordinated response to the emerging threat of Zika
virus in order to protect the people both in the United States and
around the world.
Thank you again for the opportunity to appear before you today. I
appreciate your attention to this concerning outbreak and I look
forward to answering your questions.
Senator Blunt. Thank you.
Dr. Fauci.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS
DISEASES, NATIONAL INSTITUTES OF HEALTH,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Fauci. Mr. Chairman, Ranking Member Murray, Senator
Mikulski, and members of the committee, I want to first express
my appreciation for your calling this very important hearing
and giving me the opportunity to discuss with you the research
that is conducted and supported by the National Institutes of
Health in addressing all emerging and reemerging infections,
including Zika.
I show this slide because it tells a little bit about the
uniqueness of the mandate of the National Institute of Allergy
and Infectious Diseases. Like every other institute at the NIH
(National Institutes of Health), we are responsible for
maintaining a robust basic and clinical research portfolio in
the disciplines of our mandate. In our case, it is infectious
diseases and immune-mediated diseases.
However, unique among the institutes, we have the
responsibility of responding rapidly to new and emerging
diseases. This is really quite unique, because we can wake up
in the morning the way we did 7 months ago and realize all of a
sudden we have a new, very serious issue with Zika.
I show this slide, which is an empty map of the world, and
I show it from a historical standpoint, because before this
committee, probably in this room, 31 years ago, when I first
presented the situation with HIV, I brought up the concept of
new and reemerging infections, and I put this particular arrow
of HIV on the map. And every year that I have testified before
this committee, we always seem to add one, sometimes two, and
maybe three, new diseases or reemerging diseases.
Some of them are only really curiosities. Others are very
serious.
So if you take the sum of the 31 years that I have been
doing this, this is what the map looks like now, which are all
diseases that have cropped up, some of which have caused
serious problems, others of which have been just curiosities.
Some of them are newly emerging infections. HIV/AIDS was
one of the newly emerging infections. It was brand new. We
hadn't seen it before. And it has had and still does have an
extraordinary impact globally. There are others like MERS,
SARS, and others.
As important as a newly emerging disease is a reemerging or
resurging disease. Let me give you some examples, because it is
relevant to what we are talking about today.
West Nile virus, which was never in the Western Hemisphere,
for centuries was in Africa and the Middle East. All of a
sudden, about a decade and half ago, it arrived in New York
City and now is prevalent in the United States at a low level.
Ebola virus disease, which was discovered in 1976, resurged in
2014 and 2015 in West Africa. We all know about that.
Chikungunya, which was never in the Western Hemisphere,
appeared there in 2013 and is now highly prevalent in the
Caribbean and South America.
Now we are dealing with Zika virus, which essentially,
since its discovery in 1947, was something that was under the
radar. We didn't fully realize its impact until the explosion
of cases that we have now seen.
In fact, in this article which I wrote just a few weeks ago
in the New England Journal of Medicine, I underscored that Zika
virus was yet again another arbovirus virus, or mosquito-borne
virus, that has inflicted itself on our Western Hemisphere and
the Americas. I mentioned the other ones, West Nile, dengue,
now Zika, chikungunya.
What is NIH doing? What is our responsibility? As I told
this committee many times in the past in previous hearings, we
have the responsibility of conducting basic and clinical
research, but also providing resources for researchers both in
academia and industry to be able to do the kinds of research
needed, be it in medical centers in Washington or New York or
in California or where have you.
The endgame is ultimately to develop interventions in the
form of diagnostics, therapeutics, and vaccines. Rather than go
through all of the issues that we are going to address--and we
will understand the virus better, work with the CDC in
developing better diagnostics, understand better vector
control--the issue that is of immediate importance right now is
to be able to develop a safe and effective vaccine against
Zika.
I want to remind you, and I think you all remember that in
the United States decades ago, we had a similar problem in our
country, and that was the congenital rubella syndrome. In the
1960s, there were 20,000 babies a year born in the United
States with congenital rubella syndrome, which has varying
degrees of severity of visual impairment leading to blindness,
deafness, heart disease, and mental retardation.
When the rubella vaccine was developed, congenital rubella
syndrome essentially disappeared. So although it was a vaccine
that was targeted for all the population and is a required
vaccine now, its real target was women of child-bearing age,
because the concern is protecting pregnant women, as Dr.
Frieden has emphasized in his presentation.
The advantage that we have is that Zika is a flavivirus.
Fortunately, thanks to the support of this committee, we've had
the opportunity to work for decades on other flaviviruses. We
developed a successful vaccine for yellow fever, a successful
vaccine for dengue, as well as another dengue vaccine, an
improved vaccine, which is in a phase 3 clinical trial in
Brazil, as well as a West Nile virus vaccine.
But unfortunately, we didn't have a pharmaceutical company
to partner with us on the West Nile virus vaccine, because it
wasn't felt to be something that would be profitable for them,
because West Nile virus wasn't a major disease in the United
States. I don't think we are going to have that problem now,
because we have a number of companies that are very interested
in developing Zika virus vaccines with us.
This is just an example of how you can use previous
knowledge to make a vaccine that can go into clinical trial
quickly.
So on the left-hand side, that little bit of DNA is called
a plasmid. When we did the West Nile virus vaccine, we inserted
the gene of the West Nile protein in that plasmid. We injected
it into people and made virus-like particles. And it was a good
vaccine. It was safe, and it induced a good immune response.
We have already taken that same plasmid, removed the West
Nile gene, placed in the Zika gene, and now you have the
beginning of a Zika vaccine.
It really is a testimony to having the experience of
continued years of support in trying to respond to Zika.
We will likely go into phase 1 clinical trial with this
vaccine sometime in late summer, and I hope, after several
months, we will know if it is safe, and we will know if it
induces a good immune response. If it does, then we will move
to more advanced stages of testing. I can't guarantee when we
will have the vaccine available, but I can tell you we have a
very good head start because of years of prior work.
So I want to close on this last slide by, again,
reiterating the mandate of what we do and why it is so
important not only to do the fundamental basic research with
established diseases, but also be able to respond rapidly to
newly emerging and reemerging diseases.
I want to close by thanking the committee for the support
you have given us, and telling you how important it is for us
to get that supplement to our budget to be able to continue
this degree of activity. Thank you.
[The statement follows:]
Prepared Statement of Anthony S. Fauci, M.D.
Mr. Chairman, Ranking Member Murray, and Members of the
Subcommittee: Thank you for the opportunity to discuss the research
response of the National Institutes of Health (NIH) to emerging
infectious diseases threats to our Nation and the world. The current
case in point is our response to the outbreak of Zika virus disease in
the Americas. I direct the National Institute of Allergy and Infectious
Diseases (NIAID), the lead NIH institute for conducting and supporting
research on emerging and re-emerging infectious diseases, including
those caused by flaviviruses such as Zika virus.
The Administration is taking appropriate action to protect the
American people and, as you know, on February 8 it announced a request
to Congress for more than $1.8 billion in emergency funding to enhance
ongoing efforts to prepare for and respond to the Zika virus, both
domestically and internationally. This includes funding for work on the
development of vaccines and diagnostics and to improve scientific
understanding of the disease.
The overarching NIAID mission is to conduct and support research to
better understand, treat, and prevent infectious and immunologic
diseases. This is accomplished through a spectrum of research, from
basic studies of the mechanisms of disease to applied research focused
on developing diagnostics, therapeutics, and vaccines. As part of this
mission, NIAID has a dual mandate encompassing both research on ongoing
public health issues and the capability to respond rapidly to newly
emerging and re-emerging infectious diseases such as those caused by
Zika virus.
These emerging and re-emerging disease threats, whether man-made or
naturally occurring, are perpetual challenges, in part due to the
capacity of microbial pathogens to evolve rapidly and adapt to new
ecological niches that most often result from human activity. To
address the challenges posed by emergent infectious diseases, NIAID
employs both targeted, disease-specific research as well as broad-
spectrum approaches. NIAID maximizes its efforts by prioritizing the
development of drugs effective against multiple bacteria or viruses,
and ``platform'' technologies to facilitate rapid development vaccines
and diagnostics for multiple infections.
NIAID is well-positioned to rapidly respond to infectious disease
threats as they emerge by leveraging fundamental, basic research
efforts; domestic and international research infrastructure that can be
quickly mobilized; and productive partnerships with industry. NIAID
maintains a program that provides preclinical research resources for
use by scientists in academia and private industry worldwide to advance
translational research against emerging and reemerging infectious
diseases. These resources are designed to bridge gaps in the product
development pipeline and lower the scientific, technical, and financial
risks incurred by industry in order to incentivize them to partner with
us in the development of effective countermeasures against these
emerging infectious disease threats. NIAID also supports the Vaccine
and Treatment Evaluation Units (VTEUs), a research network for
conducting clinical trials to quickly investigate promising therapies
and vaccine candidates when public health needs arise. NIAID
collaborations with other Federal agencies, including those undertaken
within the Department of Health and Human Services (HHS) Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE), help advance
progress against newly emerging public health threats. In addition,
partnerships with academia, the biotechnology and pharmaceutical
industries, and international researchers and organizations such as the
World Health Organization (WHO) and WHO's regional office, the Pan
American Health Organization (PAHO), are integral to these efforts.
overview of zika virus
Zika virus is a flavivirus. These viruses typically are transmitted
by mosquitoes and often have the ability to spread quickly to new
geographic locations because of the widespread prevalence of these
vectors. Other well-known flaviviruses include dengue virus and yellow
fever virus; like Zika virus they are transmitted by mosquitoes of the
Aedes species. Zika virus was discovered in monkeys in Uganda in 1947
and is now endemic to Africa and Southeast Asia. During the past decade
it has emerged in other areas of the world, including Oceania, the
Caribbean, and Central and South America, where countries, notably
Brazil, are currently experiencing unprecedented Zika transmission.
Infections caused by Zika virus are usually asymptomatic. About 20
percent of infected individuals experience clinical symptoms such as
fever, rash, joint pain, and conjunctivitis (red eyes). Symptoms of
Zika virus infection in humans are typically mild and brief, with very
low hospitalization and fatality rates. The recent outbreak of Zika
virus disease in Brazil has coincided with a reported increase in the
number of infants born with microcephaly, a birth defect characterized
by an abnormally small head resulting from an underdeveloped and/or
damaged brain. In addition, increases in suspected cases of Guillain-
Barre syndrome (GBS), a rare, acute, immune-mediated peripheral nerve
disease that leads to weakness, sometimes paralysis, and infrequently,
respiratory failure and death, have been noted in Brazil and other
countries in the Americas.
Further research is needed to better understand the effect of Zika
virus infection on the body, particularly during pregnancy; to
investigate the potential relationship between Zika infection and
microcephaly, as well as explore the potential relationship between
Zika infection and GBS; and to develop better diagnostics, vaccines and
treatments, and new methods of vector control. Currently, no vaccines
or specific therapeutics are available to prevent or treat Zika virus
disease. Improved diagnostic tests also are needed because Zika virus
infection causes nonspecific symptoms and can be difficult to
distinguish from other mosquito-borne infections such as dengue,
malaria, and chikungunya in antibody screening tests. Moreover, current
antibody screening tests can be falsely positive or inconclusive if the
individual was previously infected with related viruses such as dengue,
which is prevalent in South America and the Caribbean. Therefore, a
positive result with the antibody screening test requires an additional
test to confirm the diagnosis.
nih research on zika virus
NIAID has a longstanding commitment to flavivirus research,
including extensive efforts to combat diseases such as dengue, West
Nile virus, and yellow fever. This research has informed our
understanding of the viral genetics, vector biology, and pathogenesis
of flaviviruses and provides a strong foundation for our efforts to
learn more about Zika virus. NIAID has responded to the newly emerging
Zika virus disease outbreak by expanding our portfolio of basic
research on Zika virus and other flaviviruses. NIAID also is
accelerating efforts to develop improved diagnostics and candidate
therapies for Zika virus as well as prioritizing the development of
Zika virus vaccines. In addition, screening tests and pathogen
reduction technologies are critically important to assure safety of the
U.S. blood supply.
The emergency funding request for NIH would support development of
vaccines to prevent Zika virus infection, from the discovery phase
through preclinical and eventually clinical testing. In addition, the
request would support basic research to understand the natural history
and pathogenesis of the virus, including potential links to
microcephaly; establishment of animal models to test candidate
countermeasures; development of rapid, sensitive, and specific
diagnostic tests; and discovery and preclinical development of new
therapeutics to treat disease caused by Zika virus. This research is
necessary to better understand this emerging infection and uncover the
best ways to diagnose, treat, and prevent Zika virus disease.
In January 2016, NIAID issued a notice to researchers highlighting
NIH's interest in supporting research and product development to combat
Zika virus. Areas of high priority include basic research to understand
viral replication, pathogenesis, and transmission, as well as the
biology of the mosquito vectors; potential interactions with co-
infections such as dengue and yellow fever viruses; animal models of
Zika virus infection; and novel vector control methods. In addition,
the notice indicates that NIH will pursue Zika virus research to
develop sensitive, specific, and rapid clinical diagnostic tests; drugs
against Zika virus as well as broad spectrum therapeutics against
multiple flaviviruses; and effective vaccines and vaccination
strategies.
NIAID also is partnering with other NIH institutes, the Eunice
Kennedy Shriver National Institute of Child Health and Human
Development, the National Institute of Neurological Disorders and
Stroke, and the National Institute of Dental and Craniofacial Research,
to accelerate Zika virus research as it relates to the mother-infant
pair. The Institutes issued a notice that indicates NIH's interest in
supporting research to understand transmission, optimal screening and
management in pregnancy, and the mechanisms by which Zika virus affects
the developing nervous system, including potential links to
microcephaly.
developing tools to combat zika virus
In response to public health concerns about Zika virus, NIAID has
accelerated ongoing flavivirus research efforts to speed the
development of tools that could help control current and future
outbreaks of Zika virus. A safe and effective Zika vaccine would be a
very valuable tool to help stop the spread of infection and prevent
future outbreaks. NIAID is investigating multiple Zika virus vaccine
candidates, including vaccines based on technologies that have shown
promise in targeting other flaviviruses. The NIAID Vaccine Research
Center (VRC) is pursuing a DNA-based vaccine for Zika virus that is
similar to a West Nile virus vaccine previously developed by NIAID. In
Phase 1 testing, the West Nile vaccine candidate was shown to be safe
and generated a strong immune response in humans, offering a model for
Zika vaccine development. NIAID scientists also are designing a live,
attenuated vaccine, using an approach similar to that used for making a
vaccine against the closely related dengue virus. The dengue vaccine
candidate showed an excellent safety profile and generated strong
immune responses in early-phase clinical trials. In January, a large
Phase 3 trial assessing the dengue vaccine candidate was launched in
Brazil in collaboration with the Butantan Institute. In addition, NIAID
grantees are in the early stages of developing a Zika virus vaccine
based on a recombinant vesicular stomatitis virus--the same animal
virus used successfully to create an investigational Ebola vaccine
candidate--that expresses the Zika E glycoprotein. Plans are underway
to evaluate this potential vaccine construct in tissue culture and
animal models.
While these approaches are promising, it is important to realize
that the development of investigational vaccines and the clinical
testing to establish whether they are safe and effective takes time.
Although a safe and effective, fully licensed Zika vaccine will likely
not be available for a few years, we hope to begin early-stage clinical
testing of one or more NIAID-supported vaccine candidates in 2016.
developing vaccines to prevent chikungunya virus
Chikungunya virus is transmitted to humans primarily via the bite
of infected Aedes mosquitoes, the same mosquitoes that transmit Zika
virus. Chikungunya virus causes a sometime-serious illness
characterized by fever and severe joint pain, which can last for months
and be disabling. Since 2013, chikungunya virus has spread rapidly in
the Caribbean, as well as Central and South America. No licensed
vaccines or therapeutics are available to prevent or treat chikungunya
virus infections. NIAID has responded to the emergence of chikungunya
virus by accelerating research on diagnostics, therapeutics, and
vaccines to combat the disease.
The emergency funding request for NIH would support efforts to
develop a safe and effective chikungunya vaccine to prevent this
debilitating mosquito-borne disease. Additional funds would enable
animal model and human clinical tests of promising vaccine candidates.
This research will build upon efforts of scientists at the NIAID VRC,
who have developed a candidate chikungunya vaccine based on a DNA
vaccine that leads to the production of virus-like particles. The NIAID
VRC vaccine candidate was safe and generated an immune response in a
Phase 1 clinical trial. The vaccine is currently in Phase 2 clinical
testing at six study sites in the Caribbean. NIAID also is planning a
Phase 1 trial of a live, attenuated measles virus-vectored vaccine
candidate to be conducted through the NIAID VTEUs. Several additional
chikungunya vaccine candidates will be evaluated for safety, ability to
generate immune responses, and efficacy in preclinical and animal model
studies; if promising, these candidates will advance to clinical
testing.
conclusion
NIH is committed to continued collaboration with HHS agencies and
other partners across the U.S. government in advancing research to
address Zika virus infection, and we look forward to working with the
Congress to implement the President's emergency funding request. As
part of its mission to respond rapidly to emerging and re-emerging
infectious diseases throughout the world, NIAID is expanding our
efforts to elucidate the biology of Zika virus and employ this
knowledge to develop needed tools to diagnose, treat, and prevent
disease caused by this virus. In particular, NIAID will pursue the
development of safe, effective vaccines to prevent disease caused by
chikungunya and Zika viruses.
FUNDING FOR PUERTO RICO
Senator Blunt. Thank you, Dr. Frieden and Dr. Fauci.
Dr. Frieden, of the $1.8 billion request, based on the
breakdown, that looks like about $228 million would go
specifically through CDC to efforts in Puerto Rico and other
territories, and then CMS (Centers for Medicare & Medicaid
Services) has $250 million to supplement Medicaid in Puerto
Rico. So about half a billion of that $1.8 billion is focused
largely on Puerto Rico.
Do you want to talk about that a little bit?
Dr. Frieden. We are most concerned about Puerto Rico
because it is an area, because of its natural environment and
human environment, where viruses spread by this particular
mosquito spread very widely.
Dengue first arrived in Puerto Rico about a decade ago. Our
studies in Puerto Rico show that 80 percent to 90 percent of
adults have been infected in the past with dengue. And
chikungunya, which just arrived a year and half, less than 2
years ago, studies sometime back showed that about a quarter of
all adults have already been infected by this virus spread by
the same mosquito.
So we think there is a real possibility that, at some point
in the coming months--and we can't predict with certainty when.
It could happen very soon. It could happen months later. But at
some point, we may well see tens or hundreds of thousands of
Zika infections in Puerto Rico.
There are approximately 34,000 births per year in Puerto
Rico, so we are concerned with 3,000 deliveries per month,
roughly, with the risk of microcephaly there.
So our priority would be to reduce the risk to pregnant
women. That can be done by two broad means. First, personal and
household protection, where you provide to pregnant women
mosquito repellent, clothing that repels mosquitoes; encourage
use of long sleeves, long pants; encourage people to stay
indoors if possible in air-conditioning, or at least in
screened space; provide screens and possibly insecticide-
treated screens, which are effective.
Those are personal measures that we can support through
programs in Puerto Rico, and we are already moving as quickly
as we can to try to do that, sometimes with support from
foundations, and sometimes with support that we can find within
our resources.
The second area is vector control. That means control of
the mosquito. That is very challenging. That means getting rid
of standing water everywhere, eliminating tires, puddles,
anywhere that this mosquito can breed. It can breed in the top
of a bottlecap, if there's some water in it. So there's a real
challenge in reducing breeding sites.
We also apply larvicides--these are natural materials or
chemicals that can reduce mosquito larvae--to any water
surfaces, drains, or other areas where mosquitoes can breed.
There may be a role for spraying of insecticides in some
outdoor places, but even possibly in some indoor places.
TIMELINE FOR VECTOR CONTROL
Senator Blunt. I'm going to run out of time so I will be
brief.
With the mosquito effort in Puerto Rico and the Virgin
Islands and American Samoa, and then as you move into the
Southern United States, including Texas and Florida, is that a
1-year effort? Is the Zika virus likely to spread beyond the
lifecycle of the individual mosquito? How long does this effort
need to be made?
Dr. Frieden. We think this is something that we need to
scale up as rapidly as possible and will likely be needed for
the longer term. Zika is likely going to continue to spread, if
it acts as dengue and chikungunya have for years. But sometimes
it spreads explosively and then comes down to a more low level
of transmission.
But we can't predict it. We will just have to see what
happens with time and what we can prevent.
ZIKA TRANSMISSION
Senator Blunt. And, Dr. Fauci, when it does spread, is
there a possibility that you have it wherever you are, or you
come back from Brazil or Puerto Rico and you have it and don't
know it? Talk a little bit about the way this virus shows
itself.
Dr. Fauci. About 80 percent of people who get infected have
no symptoms and would likely not realize they have been
infected. Of the other 20 percent, it is a relatively mild
illness, generally fever, some muscle and joint aches, a rash,
and some conjunctivitis, or pinkeye.
We know that when you are infected, the virus stays in your
blood for a week or so, 10 days. After that when you do test
for the presence of the virus, it is not there.
The issue that we are following closely, and that the CDC
is very heavily involved in, is that we know that it can be
transmitted sexually, but we don't know how long it stays in
the seminal fluid. Is it only during the acute phase of
infection? Is it a week, a month, or what have you?
We have experience with Ebola, which taught us that we
should be circumspect before we make any firm conclusions. In
studies of survivors of Ebola, we find that a certain
percentage have continued presence of Ebola virus in the semen
for several months following infection. Now that may not be the
case with Zika, but it's something we want to keep an eye on.
That is why you do natural history follow-up studies.
With regard to the blood, Zika virus essentially leaves
after a period of about 10 days.
Senator Blunt. Okay. Thank you.
There will be time for multiple rounds of questions, but
the order will be Senator Murray, Senator Cochran, Senator
Mikulski, Senator Moran, Senator Schatz, Senator Capito,
Senator Merkley, Senator Shaheen, and then others as they come
in. We will go back and forth, based on order of arrival.
If these floor votes do start, I would just ask the
members, if you have time to go vote and come back, we will
just continue the hearing and let other people do their 5
minutes or so of questioning while others are going over to
vote and coming back.
Senator Murray.
ZIKA DIAGNOSTICS
Senator Murray. Thank you very much.
Dr. Frieden, last week, the CDC updated its testing
recommendations for pregnant women. They are now recommending
that all pregnant women be offered Zika testing after they have
traveled to an area where the virus is spreading, regardless of
whether they have experienced symptoms or not. I think that is
a really good recommendation, to include the asymptomatic
women, because we do know that four out of five people don't
know they have had the virus, because they don't have any
reaction.
That means a lot of women will need to be screened. How
readily available are these diagnostic tests?
Dr. Frieden. There are, broadly speaking, two types of
tests.
One is to find the virus when it is in your blood, when
you're acutely ill. That test is amply available through or
becoming available. We have produced enough materials for it,
and we are shipping them out and training State laboratories
and city laboratories through the public health systems. So
that test for someone acutely ill, I think we won't have a
supply problem.
The bigger challenge is diagnosing prior infection. First
off, it is an imperfect science. The virus is very similar
genetically to other flaviviruses, and, therefore, people who
have had dengue or yellow fever vaccine or even West Nile virus
may have a falsely positive test. So there are two different
tests that are done for prior infection.
We are literally working around the clock to produce enough
of those. We produced an initial batch of 32,000, a second
batch of 30,000 this week. We hope to have a third batch of
30,000 by the end of the month. And we are working with four or
five different companies to try to encourage them, on a
nonexclusive licensing agreement, to produce more.
But we do think that, for a few weeks and potentially
couple months, there could be people who want to be tested and
the test is not available. It hasn't happened yet, but we will
see spot shortages of some States that are ready and others
aren't. If that initial test is positive, there is a much more
complex secondary test, which is little more accurate but still
can have false positive results. And that takes up to a week,
and our scientists are now working over the next couple months
to reduce the time from a week to 3 or 4 days by splicing the
antigens into a faster growing virus, because that second test
requires growth of the virus.
MICROCEPHALY AND OTHER BIRTH DEFECTS
Senator Murray. Okay. There have been about 4,000 cases of
children with microcephaly at this point reported in Brazil.
And we have all seen the heartbreaking pictures of the children
born with that really devastating birth defect.
I understand that the link between Zika and microcephaly
has not been determined conclusively. But regardless, that is a
lot of children and families who have been dealing with this
condition for a long time. What is long-term prognosis for
those children and their families?
Dr. Frieden. At CDC, one of the characteristics that we
have to help protect Americans is a broad range of expertise,
including what Congress has funded as the National Center for
Birth Defects and Developmental Disabilities. So we have some
of the world's leading experts in congenital abnormalities, and
they are part of our emergency response.
They tell us that the lifetime additional cost of caring
for a child with a severe birth defect may range from $1
million to $10 million per child in this country. There's going
to be range of disabilities associated with microcephaly. We
just won't know until more time has gone.
We've already seen cases that were so severe they resulted
in early death. We have seen cases that resulted in blindness
or deafness or severe problems with eyesight or hearing. We
have seen other cases where infants appear to be normal, from a
morphological standpoint.
So these are all things that we need to understand further
so we can give information to people so they can decide what
they want to do with their health.
FUNDING FOR VECTOR CONTROL
Senator Murray. Okay. There has been a rise of mosquito-
borne illnesses--you both talked about it--affecting the United
States at the same time CDC's budget for mosquito control has
declined. There has been a 60 percent decrease from 2004 to
2015 in the epidemiology and laboratory capacity grant funding
for vector-borne disease surveillance. According to a recent
assessment, as a result of these funding decreases, human
surveillance has become more passive, laboratory capacity has
declined, and mosquito-surveillance activity has diminished now
to the point where some State and key local health departments
no longer even do it.
That is a trend that obviously needs to change. What do we
know about the effectiveness of existing mosquito-control
interventions?
Dr. Frieden. To control mosquitoes, you first need to
monitor them. So mosquito surveillance, as we call it, is quite
important. Unfortunately, it is not done as well as we would
like across the United States. It is done in a patchwork. Some
areas do a superb job. Other areas don't do it at all. When we
show you maps of where these two mosquito vectors are present,
those are our best estimates of where those mosquitoes are.
They may be partial, out of date, no longer correct.
So we need, first, to improve our tracking for where
mosquitoes are, and then our means to control them. And we can
do that through controlling outdoors baby mosquitoes, larvae,
and adult mosquitoes.
But with this particular mosquito, because it is an indoor-
biting mosquito, it's very difficult to control.
ZIKA SUPPLEMENTAL REQUEST
Senator Murray. Okay. The supplemental request from the
President, how much did they ask for, for mosquito abatement
strategies?
Dr. Frieden. So the CDC component of that is $828 million.
Of that, all three of the components include mosquito control.
The three components meaning Puerto Rico and the territories,
at-risk States, and our international work.
Senator Murray. Which is clearly important for Zika but for
a number of the other mosquito-borne illnesses.
Dr. Frieden. Yes. Anything that controls the Zika-spreading
mosquitoes will also reduce the risk of both dengue and
chikungunya.
Senator Murray. Okay. Thank you.
Senator Blunt. Senator Cochran.
Senator Cochran. Thank you, Mr. Chair, for convening this
hearing.
We appreciate the witnesses coming in and helping us
understand the nature of the challenge that we face dealing
with infectious diseases and other challenges in the public
health arena. Thank you for the excellent job you are doing in
helping target funds where they are needed most.
I understand that we have already received $1.8 billion in
funding to enhance Zika virus programs. Is this enough? Are we
in need of an additional request for the Senate and House to
approve?
Dr. Frieden. Thank you very much.
For the Zika virus emergency supplemental request, we have
provided our best estimate of what we think we need at this
point. We think that will cover for the next 1 to 2 years.
But there is a lot that we don't know. We are literally
learning more every day. But based on what we know now, I can
say that the funding that CDC has asked for, we have a clear
plan for. We don't know that we will be able to absolutely
prevent every infection and every adverse health outcome, but
it will allow us to flex up; to robustly respond in areas at
risk; and, most importantly, to support the States,
territories, and localities that are potentially at risk, as
well as provide information to patients and doctors and those
who need to know.
Senator Cochran. Dr. Fauci, is there any further
appropriation needed beyond that which we have already approved
by Congress?
Dr. Fauci. Similar to what Dr. Frieden said for the CDC,
when the NIH was asked for justification for what we would be
able to do to respond to Zika, the money that is in the
President's request, of the total $1.8 billion, the portion for
the NIH is adequate to do what we need to do right now. Thank
you.
Senator Cochran. Thank you for your good efforts and your
leadership, and cooperating with our committee in discharging
our responsibilities, too. Thank you very much.
Senator Blunt. Senator Mikulski.
EBOLA FUNDING FOR ZIKA
Senator Mikulski. Thank you very much, Mr. Chairman. In the
interest of time, I ask that my entire statement be put in the
record. And I want to thank you and Senator Murray for holding
this hearing, and Senator Cochran for being here.
I am going to get right to my question, but I think what
this shows is, once again, the defense of the Nation does not
only rely in DOD (Department of Defense). We might be fighting
ISIL (Islamic State of Iraq and the Levant) with airstrikes,
but we could be protecting America with mosquito eradication.
We need to be able to be prepared, and we need a reliable
infrastructure along the way.
Dr. Frieden, I am going to go right to you. The President
is asking for an urgent supplemental. The numbers have been
explained and so on. There are others who say, ``Hey, Tom, you
have the Ebola money. Why don't we just reprogram that? You
helped the world contain that. America has acted once again.''
And yet when I spoke to you, you were on the edge of your chair
about the possibility of reprogramming and also that we would
be very dithering in the way we proceed, and you had a sense of
urgency, particularly over the next couple weeks.
So could you say why you need a supplemental, according to
the definition of urgent, sudden, and unforeseen? Or should we
reprogram the money?
Dr. Frieden. First, the situation is urgent, because we are
learning more every day. We have already seen more than two
dozen locally acquired cases in Puerto Rico. We may see rapid
spread through the island, and we need to respond urgently.
It is, certainly, sudden. This is something which, until
late last year, no one had any idea that a mosquito bite could
result in a serious fetal malformation.
And it is unforeseen. We have actually never before had a
mosquito-borne cause of malformations, as far as we know, on a
major scale.
Our Ebola supplemental, we are deeply grateful that
Congress provided that and allows us to continue to respond to
the Ebola outbreak in West Africa. We continue to have about
100 CDC staff on the ground. Last month alone, we did 10,000
tests for Ebola, to identify a new case of Ebola and a new
cluster. We then responded to that cluster of cases with
intensive contact investigation of more than 100 high-risk
contacts. It's a very challenging environment still. So first
off, Ebola is not over.
Second, if you look at the dollars for Ebola, those dollars
are fully committed. Within the United States, the budget was
about $600 million. By the end of this year, more than 95
percent of that will be gone.
In the three affected countries, we budgeted $300 million.
By the end of this year, we will spend at least $300 million in
those areas.
For the rest of the Ebola supplemental, it is about the
Global Health Security work. And for Global Health Security,
this is about finding things like Zika before they become
problems like this. It is finding threats when they first
emerge.
Senator Mikulski. Doctor, what you are saying is that the
Ebola money is actually committed, that it is not a pot of
money we can turn to and move around in a fungible way to deal
with Zika, that we have to deal with Zika on its own--that is
number one--to immediately be able to respond, because in
Puerto Rico, as you said, 40 million people are traveling back
and forth.
We do not know the full extent of the disease. Dr. Fauci
has also spoken to that. We do not know about the impact on
people over 65. We have talked about pregnant women, really
quite an eye-popper in and of itself. We do not know about the
impact on people with compromised immune systems. We do not
know that. We do not know a lot. And we do not know about the
long-term consequences.
You mentioned chikungunya, a new thing to me. But the
effects of this last 10 months simulate like arthritic
conditions. It could leave long-lasting consequences.
So we need to get over that there are pots of money sitting
around--am I right?--that you can move around. We have to deal
with this now. Also the same for CDC and NIH, we need reliable
infrastructure ongoing.
Am I right in this?
Dr. Frieden. Absolutely.
Senator Mikulski. I don't want to put words in your mouth.
Dr. Frieden. Yes, absolutely.
Senator Mikulski. You conveyed a pretty good sense of
urgency to me.
Dr. Frieden. Yes. Absolutely correct, Senator. Thank you
very much for those remarks.
We do need urgently to not let down our guard against the
threats we know and strengthen the system so we don't always
have to address things that we might have been able to find
earlier.
Senator Mikulski. Well, my time is up.
Dr. Fauci, I could ask you so many questions, but I
remember 30 years ago, you and I kind of began together. We
have been on a very long journey together. And when men began
to die, particularly on the West Coast, and we didn't know what
was going on, we turned to CDC because you are our bio-
detectives. And then we turn to NIH.
The rest is history. It is a history we can be proud of. We
need to be proud of that fact now. We need a reliable
infrastructure that you are turning to do the basic research.
From our conversations, you will be looking at the
institute that does research on the brain. You'll be looking at
the institute that looks out for maternity and child health.
You are going to be cutting across NIH, and you can't just keep
moving it around.
Research dollars are committed for the long-term. Am I
correct?
Dr. Fauci. You are correct.
Senator Moran [presiding]. Thank you very much, Senator.
In order to accommodate Senator Schatz's ability to vote,
Senator Schatz is recognized.
DENGUE VIRUS
Senator Schatz. Thank you very much.
Dr. Frieden, I first of all want to say thank you on behalf
of the people of the State of Hawaii for your aggressive
response and your assistance with State and local government on
Hawaii Island in terms of the dengue fever outbreak. As you
know, this is a public health crisis in its own right, and we
now have the emerging threat of a possible Zika crisis.
I don't think there is really any doubt that we ought to
fund the supplemental as quickly as we can.
Like Zika, dengue is a virus that can be transmitted by
mosquitoes, namely the yellow fever mosquito and the Asian
tiger mosquito. Both of these mosquito types are in Hawaii and
both could transmit Zika.
Our State has now had about 250 confirmed cases of dengue
since September 2015, most on the west side of the Big Island.
Your response has been robust and particularly helpful.
So my question for you is whether or not I can count on
your continued commitment to address Zika and dengue. It seems
to me some of this at this point ought to be simultaneous,
where we both have a current crisis and a potential new crisis.
Dr. Frieden. Thank you very much. You are absolutely
correct that the measures that will protect against one of the
viruses will also protect against the other. I have to be frank
that the unit that deals with these viruses is relatively small
at CDC and is now fully taken up with the Zika response. But we
won't turn our back on any part of the country where this is a
risk and spreading.
We are stretched because of that, and there aren't a large
number of experts in control. So Dr. Lyle Petersen, who has
traveled to Hawaii, is now the incident manager for the Zika
response.
But if we have the supplemental dollars in hand, one of the
key components will be providing funding, technical assistance,
and materials to areas, including Hawaii and the Southern
States that have the other mosquito aegypti presence, so they
can strengthen mosquito-control activities.
TELEMEDICINE
Senator Schatz. In terms of public health education,
obviously, a fair amount of the public health education has to
happen in rural areas, which by definition are going to have
difficulty getting the latest information on the best
practices. I am wondering how much you've used or are
considering using teleconferencing technology and other means
to push out the information as efficiently as possible?
Dr. Frieden. We use extensive teleconferencing, Internet,
other actions. We had during the first week of the response a
call with clinicians throughout the United States, with more
than 3,000 groups or individuals calling in. We push out
information very actively through Twitter, through our social
media, and also through the clinical networks. We have been
working really very closely with the American College of
Obstetrics and Gynecologists to get information out as well.
VECTOR CONTROL
Senator Schatz. I want to talk a little bit about vector
control. One of the problems that we have in the State of
Hawaii is that in 2009, we decimated the vector-control branch
within the Hawaii State Department of Health. I wouldn't be
surprised if other States and local governments decimated their
respective vector-control branches under budget pressure.
I'm wondering whether you would be in a position, not over
the table, but over time, to work with the committee to provide
recommendations to each State and county and local government
on what you think the resource requirements would be. I think
even if we are able to fund this supplemental, and I anticipate
that we will be, the vector-control piece has to be at least
partly funded by State and local governments. And I anticipate
that the experts in local areas are going to know what they
need, but this going to be a political decision. This is going
to be an appropriations decision. So what we need from CDC is
for you to communicate through our U.S. Senators, our Members
of Congress, our Governors, what it is that is required,
because the reason a vector-control branch gets cut when the
budget is tight is that it is such an abstract reason to spend
taxpayer dollars. It is very difficult to justify to somebody
who is walking down the street wondering why their taxes just
went up.
Now we have an urgent public health crisis, and I would
like for you to provide recommendations so that States and
counties can actually resource this appropriately.
Dr. Frieden. We can certainly do that. I would add that you
are absolutely correct. This is quite variable around the
United States and underinvested in many places.
There are really several areas to work on. The first is
surveillance, so we understand where the mosquitoes are. That
is not simple. It is a labor-intensive, year-round or much of
the year-round process. The second is implementing what we know
now to reduce mosquito populations. The third is optimizing our
current intervention. And fourth is coming up with some new
strategies; new chemicals; safer, more effective insecticides;
new means of stopping mosquitoes.
We need to do all four of those things. We could get a good
start on that with the emergency supplemental.
Senator Schatz. Thank you.
ZIKA OUTBREAK IN PUERTO RICO
Senator Moran. Senator, thank you.
Dr. Fauci, Dr. Frieden, welcome. I heard your testimony. I
didn't hear any of the questions or answers to questions, so I
perhaps will be repeating. But in order to accommodate Senator
Blunt's ability to vote, I was unable to be here to hear those
things.
Let me first ask, is Puerto Rico different because the
outbreak is occurring there as compared to one of the 50
States, something we ought to be aware of different in their
public health capabilities or structure?
Dr. Frieden. There are a series of differences in Puerto
Rico. In order to get a big outbreak of a disease like Zika,
you need the virus present, the mosquito present, and the human
conditions present. In Puerto Rico, we have all three.
So these particular mosquitoes, the aegypti mosquitoes, are
present in large numbers throughout the island. Second, the
prevalence of air-conditioning and screens is less than it is
in some other locations. Third, the ability to reduce mosquito
populations is less than elsewhere, both for natural and for
human reasons.
If we look at other parts of the United States, parts of
Florida and Texas have had clusters of dengue infections.
Wherever dengue goes, Zika can follow. So in those areas, we
have a lower risk of widespread transmission.
We don't know what will happen. We don't have a crystal
ball. But if it behaves as the other infections have behaved in
the past, we don't expect to see a widespread transmission
because of several things. First, there tend to be lower
numbers of mosquitoes. Second, people tend to be inside air-
conditioning in a greater proportion of the day, and less
crowded together. So crowding means that a mosquito can bite
many people at once and result in an explosive spread.
Travelers are likely to come back throughout the United
States from Zika-affected areas.
Senator Moran. Is the public health infrastructure
different from Puerto Rico to the 50 States?
Dr. Frieden. I think it is safe to say that there are real
challenges with the public health infrastructure. States and
territories are variable in their capacities, and Puerto Rico
is challenged in this, as it is in some other areas.
EBOLA FUNDING FOR ZIKA
Senator Moran. I heard a bit of the questioning by the
former chairman of the full committee, who was attempting not
to elicit an answer from you different from the one she wanted,
and I'm sure that didn't happen. But I want to make sure I
understand the relationship between Ebola funding and the
potential use of that funding to combat this or other incidents
of outbreaks.
So tell me what has transpired since the supplemental Ebola
funding occurred? And is there any opportunity for those funds
to be used in fighting other outbreaks?
Dr. Frieden. The bottom line for the Ebola supplemental
funds that were provided to CDC is that they are all planned
for and committed. If we were to reprogram those funds, we
would be either risking letting down our guard in the fight
against Ebola, which is not yet over, or risking letting down
our partners in parts of the world where we have committed to
doing a better job finding things like Zika when they first
emerge, and doing a better job stopping them and preventing
them.
LESSONS LEARNED FROM EBOLA RESPONSE
Senator Moran. Ebola and Zika, I assume, are significantly
different in their presentation to the world, their ability to
do significant damage. But you are telling us we are better
able to respond now as a result of things that have transpired
from the response to Ebola?
Dr. Frieden. Yes, that is correct. But we still have a lot
of gaps around the world, where we are tracking new health
threats when they first emerge.
The Ebola supplemental fundamentally did two broad things.
One was give us the wherewithal to stop Ebola. That is a fight
that we are still on. We still have around 100 people in West
Africa fighting Ebola. We did 10,000 tests for Ebola last month
from partners around the world. And we're making the world
safer from future health threats through the Global Health
Security Agenda.
Senator Moran. In that regard, let me thank you, Doctor,
and the folks at CDC for their tremendous response and effort,
particularly in Africa and globally in regard to Ebola.
You are reminding me of something that shouldn't need to be
reminded of: Crises still occur even when they are not on the
front pages or on the nightly news. So, just because we don't
see or read doesn't mean that the problem doesn't continue to
exist.
ROLE OF FDA IN ZIKA RESPONSE
Let me ask a final question. My responsibilities have
shifted a bit, with a greater focus now on the FDA. Is there
anything in particular that you would tell me on the role that
FDA can, should, and will play in this regard? A significant
portion of the money of the supplemental is intended for FDA. I
would be delighted to hear, Dr. Fauci, if there's something
that you would like me to know about that.
Dr. Fauci. It's a very good question. I have to tell you
that our experience, both with the Ebola situation and
currently now as we are gearing up for the development of
countermeasures for Zika, that our interactions with the FDA
have really been as good or better than they have ever been.
We get them involved and they get us involved right from
the beginning, when we are developing a clinical trial
protocol. For example, the phase 1 study that we will hopefully
get going by late summer for the first early look at a Zika
vaccine involves very heavily the FDA right from the beginning.
That is really much better than going ahead and doing it and
then having the FDA figure out if you've done the right thing
or not. They are with us right from the beginning.
So the FDA's part of the supplemental and the things they
need to do to gear up to be able to meet this challenge with us
is very well justified. You will see part of that request is
for the FDA.
Senator Moran. Thank you.
Thank you both.
FLAVIVIRUS
Senator Blunt [presiding]. Mr. Merkley.
Senator Merkley. Thank you very much.
I wanted to express appreciation for both of your
organizations and the great work that they do, and then turn to
a couple pieces of this puzzle. One is that I think you both
alluded to the similarity between West Nile, dengue fever, and
the Zika virus. Do we have any initial sense of whether there
is any immunity created by previous exposure to West Nile or
dengue?
Dr. Frieden. We think not. We have seen lots of this virus
in people who have been exposed and been affected with both of
those viruses before. But we are still learning a lot about
this virus.
Senator Merkley. This may be another question that we will
learn more about, but as we look at the DNA comparison, do we
have a sense of whether the differences between these three
viruses are recent in terms of hundreds or thousands of years,
or ancient, distinct diseases?
Dr. Frieden. The genome of Zika is about 30 percent
different from the genome of dengue, according to what our
science has shown. Of course, there are four different strains
of dengue.
But I would have to get back to you with more details on
the evolutionary history.
[The information follows:]
history of zika
Zika virus was first discovered in 1947 and is named after the Zika
Forest in Uganda. In 1952, the first human cases of Zika were detected
and since then, outbreaks of Zika have been reported in tropical
Africa, Southeast Asia, and the Pacific Islands. Zika outbreaks have
probably occurred in many locations. Before 2007, at least 14 cases of
Zika had been documented, although other cases were likely to have
occurred and were not reported. Because the symptoms of Zika are
similar to those of many other diseases, many cases may not have been
recognized.
Source: https://www.cdc.gov/zika/about/overview.html.
Senator Merkley. One you mentioned that it virtually
disappears from the blood after 10 days. Does that mean that at
that point of a mosquito biting you, after 10 days, it would be
very unlikely to transmit the disease?
Dr. Frieden. It would not be able to, correct.
Senator Merkley. And once I have had it, if I am 10 years
old and I have had Zika, and now I am 18, would there be
immunity from having had the disease previously?
Dr. Frieden. We don't know, but we think and we hope that
would be the case. That is one of the reasons we are so
optimistic about NIH work with the vaccine.
Senator Merkley. So in that case, when you have an initial
population with no immunity, you would expect the virus to run
very rapidly through the population. But at that point, if
there is immunity from previous illnesses, now you have a
population that has been partly immunized by the spread of the
disease previously, and the risk of infection might drop
substantially in that type of situation. Is that an accurate
picture of how it would work?
Dr. Frieden. Yes.
DISEASE MODELING
Senator Merkley. In addition to the medical research teams,
do we have a modeling team working on demographics of this to
understand how the natural immunization of populations might
slow the spread and reduce the risk?
Dr. Frieden. Yes, although, given the large confidence
intervals and the large number of unknowns, that type of
exercise is perhaps less productive in this situation.
Senator Merkley. Do we believe, at this point--I realize we
will learn a lot more--that women who have had Zika say in
childhood would be very unlikely to have the virus at a level
that would cause concern in their childbearing years?
Dr. Frieden. If this behaves as other viruses, infection
with Zika before pregnancy would not have an impact on
subsequent pregnancies. But we have to caveat everything we
say. This is a new, unexpected phenomenon, and we are still
learning more. But if it behaves the way most viruses behave,
we would be very surprised to see an effect on subsequent
pregnancies.
CYTOMEGALOVIRUS
Senator Merkley. Can either of you say a little bit about
CMV (Cytomegalovirus) and the type of birth defects that come
from that?
Dr. Frieden. CMV was identified as a cause of birth
defects, including microcephaly, around 1962. It primarily
affects in the first trimester of pregnancy, although it can
have effects later in pregnancy. According to information
provided by our scientists, it may affect only about 10 percent
of the women who are infected. We are not really sure why that
is the case.
Senator Merkley. Is that also a cousin to the Zika virus?
Or is that something entirely different?
Dr. Frieden. No, it is totally different.
Senator Merkley. Do we understand the disease mechanism by
which it produces this impact on the brain as a result of
exposure?
Dr. Frieden. I would have to get back to you on that.
[The information follows:]
Both cytomegalovirus (CMV) and Zika are viral infections. There are
no FDA-approved vaccines to prevent either Zika or CMV. It is not known
whether there is a connection between the two viruses, or whether prior
or co-infection with CMV increases the likelihood of infection with
Zika.
The Zika virus is a flavivirus, a group of infections that also
includes dengue, West Nile, and yellow fever. The Zika virus is
neurotropic, meaning that it primarily affects the brain. Research is
unclear at this point whether these effects are a direct result of the
virus itself or due to an immunologic response to Zika infection. The
Zika virus is transmitted by the Aedes aegypti mosquito, common in
warmer climates; recent studies have also suggested that it can be
transmitted sexually. In early March 2016, researchers showed that the
Zika virus could infect nerve cells. Another new study of 88 pregnant
women with rash in Brazil found that many who were infected with the
Zika virus demonstrated a range of health concerns, including pregnancy
loss, central nervous system abnormalities, growth restriction, low
amniotic fluid, and abnormal blood flow to the baby, along with babies
born with microcephaly.
CMV is one of the herpes viruses, from a group of infections that
also include chickenpox. A common infection that is usually harmless or
causes mild symptoms, it can be transmitted through contact with bodily
fluids (such as saliva or blood), can be sexually transmitted, or, if a
pregnant woman has an active infection, it can be transmitted to her
fetus. CMV can cause serious disease in babies infected prior to birth
(congenital CMV). According to the CDC, about 1 in 5 children born with
congenital CMV infection will develop permanent problems, such as
hearing loss or developmental disabilities, and a small number may die.
At this time, there are no FDA-approved vaccines to prevent either Zika
or CMV.
MICROCEPHALY AND OTHER BIRTH DEFECTS
Senator Merkley. Okay. Listen, thank you all very much.
Is there anything else you would like to add?
Dr. Frieden. No, just that, as you indicate, this is a
really unprecedented phenomenon. With each passing day, the
evidence that Zika is causally related to microcephaly gets
stronger, though it is not yet proven.
As I mentioned, just yesterday, we published data showing
the Zika virus genome in the brain tissue of infants who had
died from Zika infection, or with Zika infection with
microcephaly. That is really the strongest direct evidence to
date that this, at least in the course of the pregnancy, is a
neurotropic virus. It grows in and only in the brain tissue for
the infected infants.
Senator Merkley. I want to clarify a point. You said it
grows only in the brain tissue?
Dr. Frieden. In the situation where our scientists examined
two infants who had died in the first 24 hours, they were able
to identify the Zika virus only in the brain tissue.
Senator Merkley. Yes, okay. I was aware of that. When you
said it grows in the brain tissue, do we have a sense that it
inhabits cells in the brain and replicates itself within the
brain?
Dr. Frieden. We do not know the answer to that question
yet.
Senator Merkley. Thank you all very much.
Senator Blunt. Senator Capito.
ZIKA TRANSMISSION
Senator Capito. Thank you, Mr. Chairman.
I thank both of the gentlemen. This has been a very
interesting hearing, and I think very timely, too.
I also would like to say that the further out front that
both of you are on this issue I think will help alleviate some
of the massive questions we are going to be getting.
One technical question, I guess. Can the mosquitoes be
transmitted? Say you are traveling in an area where they are
heavily populated and you come back to the United States. Can
you transmit the mosquitoes with you? Is that a danger,
bringing the actual transmitter of the virus into the country?
Dr. Frieden. That generally is not how the disease is
spread. It is generally spread within the body, where somebody
is infected, they have it in their blood, and then the mosquito
bites them and then bites someone else.
Senator Capito. Okay. So actually having the mosquitoes in
the United States is not our biggest concern?
Dr. Frieden. The parts of the United States that have the
mosquitoes that can spread this are at risk of having some
locally acquired cases.
Senator Capito. So if a person is infected, if that
mosquito were to happen to bite that person, they could pick
the virus up from the person and then transmit?
Dr. Frieden. Exactly.
Senator Capito. That's pretty interesting.
PUBLIC OUTREACH AND EDUCATION
I would say, in looking at what happened with the Ebola
virus and the news and a lot of reaction, and some might have
said overreaction or underreaction, but in any way, anyway, in
a public way, I'm thinking man on the street kind of thing, the
best that we can do to avoid that kind of--it wasn't hysteria,
but high, high alarm that maybe wasn't based on facts, in this
case, I think the better.
So I guess what I would say to you is, you are dealing with
the science, you are dealing with the vaccine, possible
vaccine, mosquito eradication. What kind of outreach are you
doing to public health departments and others to make sure that
we tamp down any kind of stampeding kind of reaction, because
it is frightening for young women thinking about having
children?
Dr. Frieden. We do extensive outreach to health
departments, to doctors and other clinicians, and to the
public. What we have done is to emphasize that there is
something that everyone can do, because when people understand
there is something they can do, I think that helps focus their
attention.
The key here is to reduce the risk that pregnant women will
be bitten by an infected mosquito. The way to do that is, first
and foremost, advise pregnant women in the continental U.S.
that it would be better not to travel to a place where Zika is
spreading while they are pregnant. For women who are pregnant
in an area like Puerto Rico where Zika is already present, the
key is to reduce the risk of mosquito bites.
For communities, there are things that they can do to
understand and control mosquito populations. For us in public
health and at NIH, the goal is to learn more quickly and inform
people what we are learning and take whatever steps we can to
reduce the risk to pregnant women.
Dr. Fauci. It's really important, too, and we are trying
our best to do this, to gain as much knowledge as we can, and
to communicate the knowledge. When we have something that is
firmly evidence-based, we want to be able to say this is what
you can expect or not. When we don't know the answer, we must
not be afraid to say we don't know the answer, but we are
trying to get it.
I think when the public gets confused is if you give half
answers. If we don't know, we don't know. If we do know, we
will tell you as often as we possibly can.
VACCINE DEVELOPMENT
Senator Capito. I think that is a good response, and,
certainly, as I said, for the man on the street and the woman
on the street, that is extremely important.
You mentioned a bit about a vaccine where the goal of the
vaccine was to protect pregnant women. But it ended up being,
and it is now, widely distributed to infants and children and
even those of us who are over a certain period of years.
Do you envision that this could become something like that.
You're trying to protect pregnant women--I guess you can't
really tell, but----
Dr. Fauci. That is the reason why when you develop the
vaccine, you target it for everyone. Even though there may be a
greater at-risk group, you target it for everyone.
Envisioning how it will be used is really going to depend
on how the Zika outbreak evolves. Let me give you an example.
If it turns out that the outbreak is still raging 2 years from
now, 1.5 years from now, at a time when we actually have shown
that a vaccine works and that it is safe and that it is
effective, even if it is on an emergency basis, you would want
to widely distribute that vaccine. If you are in a country
where the risk is always there of an outbreak of Zika, you
might want to make that part of the normal vaccination program.
If you are in a country where you haven't had any outbreaks of
Zika and it is unlikely that you would, I wouldn't foresee that
the Zika vaccine would be part of a required vaccination
schedule.
So you really have to take a look at where you are and what
the risk is.
MICROCEPHALY AND OTHER BIRTH DEFECTS
Senator Capito. Okay, can I just ask one quick question? If
a pregnant woman has Zika and has a child with no microcephaly,
are there other issues associated with that? That is my
question.
Dr. Frieden. We don't know.
Senator Capito. We don't know. Thank you.
Dr. Fauci. I totally agree with Dr. Frieden that we don't
know. There are other things besides just classic microcephaly
or small brain. Like recently, there has been a report,
yesterday and the day before, about ocular issues, real
problems with vision that don't necessarily involve
underdevelopment of the brain, but where the virus actually can
attack the retina. There are some very striking pictures in a
recent publication of the retina of some children who have been
affected by Zika that are really quite concerning.
Senator Blunt. Senator Shaheen.
INTER-AGENCY COORDINATION
Senator Shaheen. Thank you, Mr. Chairman.
And thank you both for being here and for all of the work
that the CDC and NIH are doing to address this challenge.
I know that Senator Moran asked about the FDA, but
obviously there are other Federal agencies--Homeland Security,
the State Department, the Department of Agriculture, Customs
and Border Protection--that have a role to play as we think
about how to respond to this kind of outbreak.
Can you talk about how you are coordinating with other
agencies within the Federal Government to address this?
Dr. Frieden. HHS (Health and Human Services) is the lead
dealing with this response and coordinates across many
different components across HHS that have to respond. The State
Department, for example, uses the CDC travel advice for their
advice not only for travelers but also for our mission
personnel under chief of mission authority at post, including
the CDC staff who were there. And we work closely across the
U.S. Government with coordination, wherever necessary, by the
National Security Council.
INTERNATIONAL COOPERATION
Senator Shaheen. With respect to other countries around the
world, the European Medicines Agency, for example, has
established a task force of European experts with knowledge in
vaccines and other infectious diseases.
How are we working with them? Are we part of what they are
doing? What other international efforts are we involved in?
Dr. Frieden. We work very closely with countries around the
world. CDC has teams of our doctors and other epidemiologists
today in both Brazil and Colombia. We also work very closely
with the Pan-American Health Organization of the World Health
Organization here and the World Health Organization in Geneva
as a good way of having a ground where everyone can collaborate
together.
CLIMATE CHANGE
Senator Shaheen. Now, New Hampshire, in the last 15 years
or so, had cases of West Nile virus that never used to exist
that far north. To what do we attribute the spreading of these
kinds of mosquitoes? Is it just globalization? Is it also the
warming of the climate that is affecting that? Do we have any
analysis that tells us it is going to get worse? Is it going to
retreat? What do we think the future is going to be?
Dr. Frieden. As Dr. Fauci showed in his opening
presentation, we do think the continued emergence and
reemergence of health threats, including those spread by
mosquitoes and ticks and other vectors, is the new normal. It
is going to continue for the foreseeable future.
For the mosquito population specifically, and these viruses
specifically, our scientists tell us that the key drivers have
been the movement of people from one part of the world to
another, because the virus basically hitchhikes inside of
someone's blood. And then a mosquito that can spread that virus
spreads it elsewhere.
And urbanization, having lots of people close together
makes it ideal for mosquitoes to be able to spread this quite
explosively.
The mosquitoes that spread Zika, as far as we know, are not
present as far north as New Hampshire. But as there are changes
in the climate, it may change some of the environments in ways
that are very difficult to predict the implications of.
HEALTH REGISTRY
Senator Shaheen. Can you talk about how important
registries are, as we think about how we figure out where this
is affecting populations?
Dr. Frieden. Registries are a key tool to identify affected
individuals and enable us to get population-based information
and deeper information about individual cases and about the
range of illness that can be present.
Senator Shaheen. Someone was explaining to me that one of
the reasons this suddenly popped and got the world's attention
was because there was a large enough population in Brazil, and
enough babies born, to suddenly see a pattern. We had seen it
in other islands and other places where we did not have enough
of a population to really be able track what might be
happening.
So you talked about the virus being identified in 1947--was
that the year? So can we track back? And do we have any idea
what may have happened in some of these other places before we
saw a large enough population to be able to identify this as a
problem?
Dr. Frieden. Some of that work will be very difficult to do
because the blood test cross-reacts with other viruses. There
was a relatively large outbreak in French Polynesia. In
retrospect, what we have heard from various reports is that
they have identified children with microcephaly born following
that outbreak. But we haven't yet seen definitive information
on that.
Dr. Fauci. The point you made is a very good point,
Senator, because when you are dealing with a disease, even if
it is difficult to track for the reasons that Dr. Frieden
mentioned, when you are dealing with a disease that is
smoldering at a low level, and there is a complication that is
relatively uncommon, you may completely miss it.
Once you see a disease in which it explodes in a
population, and then all of a sudden you have so many cases of
what would be otherwise an unusual complication, then you start
to see it. We saw that with Ebola when, prior to the outbreak
of Ebola in 2014 and 2015, there were mini outbreaks, affecting
as few as two, and as many as 100 people. When you get 28,000
cases, the way we did in West Africa, we started seeing things
with Ebola that we didn't realize that were associated with
Ebola.
I think the point that you made is a good one, and that is
why we are keeping a close eye on what is happening with Zika,
because literally every week or month, we learn something new
and important about this.
Senator Shaheen. Thank you.
Thank you, Mr. Chairman.
Senator Blunt. Senator Alexander.
PREGNANT WOMEN
Senator Alexander. Thank you.
Thanks to both of you for your remarkable work and for
being here.
You said, Dr. Frieden, that our focus should be on
reminding pregnant women that they should try to avoid being
bitten by a certain type of mosquito. That is really the focus
of what we are talking about, right?
Dr. Frieden. Well, first, to avoid going to a place that
has Zika spreading. And for those who are----
Senator Alexander. But the goal is, for pregnant women to
avoid, a certain type of mosquito. If you are not a pregnant
woman, and if there are none of those types of mosquitoes, this
is not a concern. Is that correct or is that not correct?
Dr. Frieden. That is generally correct. There might be a
small exception for men who may be infected and whose partners
may be pregnant.
TRAVEL ADVISORIES
Senator Alexander. I go fishing in Minnesota and Canada.
There are lots mosquitoes up there. But I gather those are not
the mosquitoes likely to carry this virus. If you were about to
travel, where would you go to get the best list today of the
places where you could go where you are not likely to be
infected by this type of mosquito?
Dr. Frieden. The CDC Web site will have that information
updated on a regular basis.
Senator Alexander. If a pregnant woman's husband has
traveled to an affected country, what precautions should that
couple take?
Dr. Frieden. We recommend, at this point, until we know
more, that if they have sex, they use a condom.
Senator Alexander. If a woman is planning on becoming
pregnant, and if she has traveled to an affected country, how
long should she wait before she becomes pregnant?
Dr. Frieden. There is still a lot we don't know, and so we
are giving information to the public and to the obstetricians
about situations like that.
We believe that if someone has been infected on the last
day that they were somewhere, they could get sick for about 2,
maybe 3 weeks. After that, the virus would be out of their
blood. If this behaves as other viruses behave, there would be
no increased risk to the next pregnancy after some period of a
month or so.
But we don't know that for sure.
Senator Alexander. So while you don't know for sure, 4 to 6
weeks after returning from an affected area would probably mean
the virus is gone?
Dr. Frieden. I don't know what Dr. Fauci would say, but----
Dr. Fauci. I think that would be a reasonable assumption.
But then, just as I said in answer to one of the other
questions, we really want to do a natural history study and
study a lot of people and understand really how long it is
until that virus is gone.
I would think 4 weeks would be reasonable, but before you
say definitively, we really want to do the studies that we are
now undertaking.
HEALTH EFFECTS ON CHILDREN
Senator Alexander. Does this virus have an effect on a
newborn or a toddler whose brain is not yet fully developed?
Dr. Frieden. We don't know the answer to that. We have not
seen reports of adverse effects.
ZIKA DIAGNOSTICS
Senator Alexander. You may have answered this, but on
diagnostic tests and vaccines, if I'm a pregnant woman and I
want to know if I have the virus, who do I call?
Dr. Frieden. Your doctor should get in touch with your
local health department.
Senator Alexander. And what will your local health
department do?
Dr. Frieden. If you are actively ill, they will use the CDC
tests that accurately can say whether the virus is in your
blood. If you weren't ill, or it has been a few months since
you traveled, your local health department will do a CDC-
developed test that may be able to determine whether you have
been infected.
Senator Alexander. But you are likely not to feel ill, did
you not say?
Dr. Frieden. That's correct.
Senator Alexander. Eighty percent of the time, there are no
symptoms.
Dr. Frieden. That's correct.
Senator Alexander. So you might return from an affected
area. You may feel good. But you may worry that you might have
contracted the virus. The chances are four out of five that you
don't have any symptoms. So you still call your local health
department.
Do you have enough diagnostic tests to meet the need?
Dr. Frieden. We are working around the clock to scale that
up. We are already in the process of sending out 62,000 tests
developed at the CDC lab, working with private companies to try
to do more.
But there may be a period of weeks or a couple months where
there aren't enough tests for the people who want to have them
done.
ZIKA VACCINE DEVELOPMENT
Senator Alexander. Dr. Fauci, it sounded yesterday in our
discussions that you felt pretty confident that there would be
a vaccine, and it sounded like the amount of time it could take
might be as quickly as 12 or 15 months. Is there anything we
should do to help you speed that up?
Dr. Fauci. The answer is that I don't think we can speed it
up, but I want to clarify for the committee exactly what I
meant when I said 12 to 15 months.
If you look at the natural way that you would get a vaccine
approved with all of the i's dotted and t's crossed through the
FDA, in which you did a trial where you definitively showed
that it worked, that generally would take, for a vaccine like
this, anywhere from 3 to 5 years. The point that I made about
an accelerated approach was that we know we can start early
trials, probably by the end of the summer in phase 1 just to
ask the questions, is it safe, and does it induce an immune
response that you would predict would be protective?
Once we get finished with the phase 1 trials, which would
likely be by the end of 2016, if the epidemic is still raging,
let's say in Brazil, and you have enough people who are at risk
for infection, you could go into an accelerated phase 2 trial
there. And probably within a period of 6 to 8 months, you will
be able to definitively say whether the vaccine works.
If that circumstance exists, then you could ask for an
accelerated approval from the FDA or from whatever regulatory
authority is involved, which would truncate that 3- to 5-year
period to much shorter.
However, if there are no infections around, which is
exactly what we saw when we got to that point with the Ebola
vaccine, just as we were getting ready to do the definitive
trial, because of the public health capabilities and what CDC
and others had done in West Africa, there were no new cases of
Ebola. So we were unable to definitively show the Ebola vaccine
works.
Senator Alexander. Mr. Chairman, my time is up. You have
taken me toward the end of 2017, assuming there is a raging
epidemic. Then you still have a period of time for manufacture.
Or does that go pretty fast?
Dr. Fauci. For the product that we are talking about,
manufacturing goes pretty fast, Senator. That is the reason we
are engaging the pharmaceutical companies right now, in
anticipation of that.
Senator Alexander. Thank you, Mr. Chairman.
Senator Blunt. Senator Reed.
INTERAGENCY COORDINATION
Senator Reed. Thank you very much, Mr. Chairman.
Thank you, gentlemen, for your service.
I know Senator Shaheen touched on the interagency
coordination, but I was at Fort Dietrich on Monday at the NIH
laboratory, the DHS laboratory, and the DOD laboratory, and
there are many pictures of you there, Dr. Fauci, and deservedly
so. Just a report from the front.
Anything you might want to add about coordination between
departments? And one aspect that I particularly find intriguing
is sort of identifying the problem at the earliest possible
stage.
We know the Zika virus, mosquito-borne virus, is a current
issue, but we can all sort of expect there will be another wave
of mosquito-borne viruses. What are we doing in terms of
coordination efforts between departments to try to identify the
next threat, as well as deal with this one?
Dr. Fauci. I think, Senator, you picked up on something
that is quite true. Our cooperation and collaboration with a
number of agencies, particularly the Department of Defense and
the interactions that we have had now for some time up in
Frederick at Fort Detrick, has really been very important. I
think it showed itself wonderfully during the Ebola outbreak
when we had an extraordinary amount of interaction that
hastened things.
With regard to the surveillance, Dr. Frieden and the CDC
are very much involved as part of an international health
security network to try to surveil and find outbreaks before
they get out of hand. That is the goal of this global health
security agenda that we have.
Senator Reed. Dr. Frieden.
Dr. Frieden. I just would reiterate what you have said and
what Dr. Fauci said. The Department of Defense played an
extremely important role in the Ebola response. We are already
in conversations with them on diagnostics. We provided them
with our kits and materials, and also on mosquito control,
where they have a high degree of excellence and some
significant capacity in mosquito control. So they are fully
integrated into the response here.
And in a broader sense, the Global Health Security Agenda
is our way of cross-governmental collaboration to find threats
when they first emerge, stop them as quickly as possible, and
prevent them wherever that is possible.
COORDINATION WITH STATE PUBLIC HEALTH DEPARTMENTS
Senator Reed. Let me follow up on that question in terms of
surveillance and preemption, if you will, in terms of the State
and local level.
Are you coordinating with the State public health
departments and other agencies for spraying mosquitoes? You
mentioned how, in response to Senator Alexander, the State
health departments are really the point of contact for
particularly pregnant women who have concerns. Can you
elaborate on your coordination with State and local?
Dr. Frieden. We work very closely with State, tribal,
territorial, and local health departments, and mosquito-control
districts, which can sometimes be separate areas. In fact, one
of the key components of the emergency supplemental request is
to provide funding to do better at tracking and stopping the
growth of mosquito populations.
VECTOR CONTROL
Senator Reed. Do you anticipate that there will be
widespread preemptive spraying beginning very soon when the
weather changes? And how far north, essentially, will that go?
Do you have an idea?
Dr. Frieden. Well, as spring and summer approach, we will
see an increase in mosquito populations, and we will see areas
particularly. There are two types of mosquitoes that spread
this virus. One of them, Aedes aegypti, spreads it in primarily
the Southern States. That is the mosquito that spreads this
virus more effectively.
So those are the areas that are at the greatest risk of
having clusters or local transmission of this virus. We have
already seen some of those States scaling up their activities.
We would like to have the resources to provide them to do that
as rapidly and effectively as possible.
There is a secondary mosquito vector called albopictus, or
the tiger mosquito, that is much more widely distributed, and
that will somewhat depend on the local populations of
mosquitoes and the capacities. But we have another component of
the supplemental request, which would also strengthen activity
there.
Senator Reed. Thank you very much.
Thank you, Mr. Chairman.
Senator Blunt. Senator Lankford.
Senator Lankford. Thank you.
I want to pick up on what Senator Reed was talking about
there.
Walk me through the balance between a mosquito-borne virus
and our aggressive pursuit of bringing down the population of
that mosquito versus getting a vaccine ready, done, produced,
and out. Walk me through the balance there of how you are
trying to attack that.
Dr. Frieden. It is all of the above. A vaccine is not going
to be here for some time, and so right now we need to do as
well as we can to reduce mosquito populations and reduce the
risk to pregnant women.
If a vaccine that is safe and effective becomes available,
that will greatly simplify our effort, and then it will be a
different type of approach.
But the mosquito-control activities will benefit not just
Zika but also dengue, chikungunya. And if we do them better, in
areas where malaria is spreading, it will help our malaria-
control activities as well.
Senator Lankford. So is the assumption, both domestically
and internationally, step one of this is not only development
of a vaccine, but aggressive population control of that
mosquito?
Dr. Frieden. Correct.
Dr. Fauci. They really go hand-in-hand. We get asked this
all the time. The thing that you could do immediately now is to
accelerate vector control. It's not going to be easy, because
this is a very wily mosquito, the Aedes aegypti. But that is
the thing that could be immediately done now, as we are working
our way toward developing a vaccine.
VACCINE DEVELOPMENT
Senator Lankford. Okay, then walk me through when we get
the vaccine. Because it sounded like you anticipate having a
vaccine at least done that works in the laboratory by the end
of this year. Is that correct?
Dr. Fauci. What I said is that, by the end of 2016, we will
have a Zika vaccine trial that will have been completed that
will ask, is it safe, and does it induce a response that you
would predict would be protective?
There is a far leap from that to having an effective
vaccine. But that first stage is one that we are accelerating,
and we will likely have the trial finished by the end of 2016.
Senator Lankford. So at this point, as far as dealing with
the virus that we have, is it harder or easier or about the
same--talk me through the complications of this versus a flu
vaccine.
Dr. Fauci. Well, flu is entirely different, but I will try
to be brief and explain.
We have made successful vaccines against other
flaviviruses. Zika is a flavivirus. We have a successful
vaccine against yellow fever. We have a successful vaccine--we
can do a little better, but is reasonably successful--against
dengue. And we would've had a successful vaccine against West
Nile, but we couldn't advance it because companies did not want
to partner with us.
Influenza is an entirely different situation because
influenza changes from season to season. We have influenza
vaccines, and sometimes they are not as effective as we would
like them to be.
Senator Lankford. Last year, not so much.
Dr. Fauci. Not so much, last year, correct. This year,
better.
Senator Lankford. Okay, so then the hope is to have this
and then try to distribute this internationally first?
Domestically? Let's take this out 2 years from now. Let's say
it is still moving at some point. Obviously, we have to deal
with the source area in South America, but we are also dealing
with Americans here.
Dr. Fauci. Again, just to give you a potential scenario,
you want to target the areas where you have an outbreak. In the
United States, we don't anticipate----although we are ready for
everything and we never say never, and never say always--we
don't anticipate a massive outbreak like we are seeing in
Brazil. We do anticipate that it is likely we will see a small
number of local transmissions of Zika, just as we did see with
dengue and that we did see with chikungunya in the Southeast
part of the country.
Unless something radically changes, I don't see broad Zika
vaccination of the entire U.S. population.
Senator Lankford. Would that include Puerto Rico?
Dr. Fauci. Puerto Rico is a different story, as Dr. Frieden
said very clearly. Puerto Rico is a much different story than
the continental United States, because of the special
conditions there. And to see how rapidly chikungunya spread
throughout Puerto Rico, that is the thing that we are concerned
about with regard to Zika in Puerto Rico.
TRAVEL RESTRICTIONS
Senator Lankford. Any talk about limiting movement of
people or travel from South America or Puerto Rico into the
continental United States where you are seeing outbreaks start?
Is there conversation about that? Or is there a threshold where
you would say, when it reaches this point, we may want to do
more than just say, be aware there's a travel advisory, but to
say no?
Dr. Frieden. There are more than 40 million trips a year.
Senator Lankford. Correct. A lot.
Dr. Frieden. So our focus now is to broaden the emphasis on
reducing risk to pregnant women by advising them to defer
travel, if possible.
PUBLIC HEALTH EMERGENCY FUND
Senator Lankford. Okay. Just a quick question on this. We
are talking about emergency appropriations at this point,
having a conversation about that. At what point do you think
that you would make a request to say, ``We are the United
States of America. We deal with emergencies worldwide all the
time. We should have a fund set aside that is appropriated
dollars.'' We know we are going to have hurricanes and
tornadoes and earthquakes. We also know that we are going to
have global issues like this with health, and we would have a
part of an appropriations request dealing with an emergency
fund.
Dr. Frieden. We would, certainly, be eager to follow up
with you on that concept.
Dr. Fauci. Agreed.
Senator Blunt. Senator Durbin.
Senator Durbin. Thanks, Mr. Chairman.
Thank you, both, for being here.
Let me say at the outset a special thanks to the chairman
and ranking member, Senator Blunt and Senator Murray. I believe
that our appropriation this year for both of your agencies
reflects the importance of your work, and this hearing reminds
us that we never know where the next challenge is going to
come.
VACCINE DEVELOPMENT
Dr. Fauci, from the NIH perspective, if NIH did not engage
in these clinical trials and this research to develop this
vaccine, would the private sector do it?
Dr. Fauci. The private sector would be less enthusiastic
about going from A to Z on Zika vaccine development, because
that is a major investment in a vaccine that likely would not
have worldwide general use. So what we have done and continue
to do at the NIH is try to de-risk it for the company. If you
look at how much money it would cost in getting from the
concept all the way through to a product, the numbers they give
vary, but it is somewhere between $750 million and $1 billion.
What NIH does to de-risk is to develop the concept, do the
preclinical testing, provide the research resources, and go at
least into phase 1 trial. And then generally, we like to hand
it off to a company that will then take it into advanced
development.
If they don't do that, what we do then is we then push into
phase 2. We have a part of HHS called BARDA, the Biomedical
Advanced Research and Development Authority, which actually
helps us in that advanced development and partners with
industry. So if you look at a spectrum from the concept to the
vaccine, the further we push it toward the product, the more
enthusiastic the company is about getting involved, because we
have taken away from them a lot of the risk and much of the
expense.
So if NIH just backed out completely, I don't think that
you are going to have the enthusiasm from companies for
developing these types of vaccines.
Vaccines and products that everyone will use, you don't
need an incentive for them. But when it is a public health
issue that isn't immediately profitable, not every company, but
many, would not want to go near that.
SURVEILLANCE
Senator Durbin. I have a whole line of questions about then
pricing the product, but I'm going to save those for another
day and perhaps another hearing. But I'm glad you made the
point that you did about the necessity of your work when it
comes to such public health challenges.
Dr. Frieden, it was an honor to visit your headquarters 10
days ago, or 11, in Atlanta and see the amazing array of talent
that America has and you have, and to hear what was done there
when Brazil was struggling with uncertainty about this
challenge and went to the one place in the world that they
could trust to help them find the answers, and that was the
Centers for Disease Control in Atlanta, Georgia. And to meet
the doctors and researchers there was a great day for me and a
real eye-opener.
We went into your, for lack of a better word, war room, and
you showed me the charts with Zika. I looked up and saw that
one of the key areas of concern was in the Caribbean, Puerto
Rico and the Virgin Islands, if I recall. And then I think you
gave us numbers, or I have heard numbers subsequently, that
they have identified some 20 indigenous cases in Puerto Rico
and some 30 in the United States that were likely people who
traveled to areas where the Zika virus could be borne by
mosquitoes. Have those numbers changed since I visited?
Dr. Frieden. We have continued to see the advancement of
two things--first, travelers returning to the U.S. We are now
at more than 50 who have come back to the U.S. We expect that
there could be hundreds or thousands in the months to come. And
Puerto Rico, we continue to identify new cases of Zika spread
locally.
Senator Durbin. You are America's first line of defense
when it comes to public health attacks. And I thank you and the
people who work at CDC.
PUERTO RICO
I want to zero in, again, as others have, on Puerto Rico,
because, as you described to me before the arrival of a
vaccine, which we pray will be soon, if needed, but before
that, it sounded to me like the way we address this challenge
and danger from a public health perspective is pretty basic, in
terms of standing water, bug repellents, screened homes, air-
conditioning, and gathering in crowds.
So it seems like it is a basic public health issue. I came
away from there concerned, because you and I both know the
status of the economy in Puerto Rico. They are flat on their
back. They are bankrupt. They don't have local resources to
deal with customary public health challenges, let alone this
new challenge.
How do we resolve that? Will the President's $1.8 million
request take into consideration the need to supplement what
would otherwise be available if this were the continental
United States fighting this challenge?
Dr. Frieden. Yes, we would surge in, and we are now doing
what we can in Puerto Rico to reduce the risk to pregnant women
by encouraging personal, household, and community activities to
reduce the risk of mosquito bites.
What you outlined is exactly what we need to do, and what
we are moving forward to do. There are some other measures of
controlling mosquitoes that we are going to try to implement
there, working with the communities in Puerto Rico that are
affected.
EVOLUTION OF ZIKA VIRUS
Senator Reed. How long has the Zika virus been around?
Dr. Frieden. It was first discovered in 1947, but not until
the past few months has there been this association with
microcephaly recognized.
Senator Reed. And the carrier in this case, the aegypti
mosquito, it also carries dengue and chikungunya?
Dr. Frieden. Yes.
Senator Reed. So this is an aberration of the original Zika
virus, or an evolution of it that is causing this challenge
today?
Dr. Frieden. We don't know if this Zika virus changed. What
has changed is the population it is affecting. It is affecting
large numbers of people that had not been recognized
previously.
It is possible that Zika was causing something like this in
Africa for decades, but because we didn't have the monitoring
systems, we didn't know. We just don't know that at this point.
Senator Reed. Thanks for your good work.
Thank you, Doctor.
VACCINE FUNDING
Senator Blunt. Senator Durbin, Senator Alexander, I
mentioned before you got here, we would have time for more
questions. I think both Senator Murray and I have a couple. If
you would like to ask anything else, that would be good.
Dr. Fauci, you mentioned in your testimony, and it's
possible while I went to vote maybe some of these topics may
have been discussed, but you mentioned that we want to continue
the studies that we are doing right now on Zika. How are you
funding those studies right now?
Dr. Fauci. Right now, in the absence of the implementation
of the supplemental funding, we are using money that was
allocated to other flaviviruses. So I am moving money out of
certain areas to pay for the things that we are doing right
now.
So we have some time-limited flexibility to move money from
one area to another to, for example, get the early production
of that vaccine candidate, so we can start this trial by the
end of the summer.
We have essentially taken several millions of dollars from
one area to another. It is almost all by providing funds to our
grantees that have existing grants for other flaviviruses, both
in the United States and to our Brazilian collaborators. These
are scientists who have been working on dengue, who have been
working on West Nile, people who are, essentially, ready to hit
the ground running. Those are the ones that we are funding
right now.
We are trying to get new people involved, because we can't
get to where we want to go just with the people who are,
essentially, dividing their time between two goals.
PUERTO RICO ACTIVITIES
Senator Blunt. Dr. Frieden, you just said, regarding
actions in Puerto Rico, we would surge in and we are doing so
now. The same question, how are you funding that effort?
Dr. Frieden. So our division of vector-borne disease
control usually deals with dengue outbreaks of yellow fever
around the world, as well as West Nile disease in this country,
and new viruses such as two that we have identified in the past
year that are tick-borne, Heartland and Bourbon viruses, in the
past few years.
We have taken the staff off those programs and put them
into the response to Zika. We currently have about 300 people
working in this response.
Our dengue branch is in Puerto Rico and has been there for
many decades, so basically, we rededicated the staff to do
that.
And we have activated our emergency operations center,
which allows us to coordinate more effectively and ask for
people from throughout the agency, in the case of Puerto Rico,
who speak Spanish to go and help with the response there.
Senator Blunt. I am reassured by both of those answers. It
creates a sense for us that this is, in your view, an emergency
that has to be dealt with like an emergency, and appreciates
the fact that Congress, even in an emergency often, the House
and Senate working together is not going to happen in the next
couple days or the next couple weeks, in all likelihood. That
is reassuring to me.
EBOLA SUPPLEMENTAL FUNDING
I think, Dr. Frieden, you said that you don't want to use
Ebola funds to meet this crisis. Does that mean that you
wouldn't even be using Ebola funds that aren't scheduled to be
spent yet in the infectious disease area, if we need to in the
next 3 weeks? Or is there plenty of money for the next 3 weeks?
Dr. Frieden. So for our part of the emergency supplemental
request, to me it would make a big difference to understand
whether we are talking about reprogramming dollars. That would
be a big concern, because the Ebola dollars that are not spent
are all planned for activities that we believe are critical of
the dollars that are allocated to CDC.
We are looking throughout our entire agency to see how we
can scrape together funds to function effectively in the next
few weeks. The challenge are mechanisms like sending money out
to States for strengthening vector control, sending more
diagnostic kits out, enhancing our ability to protect pregnant
women, improving vector-control activities in different places,
and doing more extensive surveillance for microcephaly.
But we will do whatever we can to respond as effectively as
we can, because it is an emergency.
Senator Blunt. So your big concern there, if I understood
that answer right, would be if we actually reprogrammed dollars
in a way that could become permanent as opposed to access to
dollars that arguably could be used in the short term, with the
definition that you are pursuing.
Dr. Frieden. Yes.
ZIKA DIAGNOSTICS
Senator Blunt. When you mentioned vaccine--you weren't
talking about vaccine. That was actually a note I made, just to
be clear. When you talk about the testing material not
available yet, but possible, you are not talking about the
long-term vaccine challenge that Dr. Fauci is talking about.
You are talking about a test that you believe adequately works?
Dr. Frieden. We have two different tests. The test for
early infection works not as well as we would like, but it can
rule out infection. And we are scaling up production of that
and working with the private sector to try to have them share
some of the burden of getting those tests out.
Senator Blunt. And the fact that you said you were scaling
up production on that would indicate you are actually spending
money and creating effort to do that right now.
Dr. Frieden. Yes, absolutely.
Senator Blunt. I don't want to be difficult about this, but
actually, for me as a member of this committee, knowing that
you are changing other priorities to meet this one helps us
make the case that, clearly, this is something that is an
immediate priority, as opposed to some long-term thing that
would be wonderful to do, but doesn't have the same immediacy.
Senator Murray.
U.S. BLOOD SUPPLY
Senator Murray. Thank you, Mr. Chairman.
I don't think anybody touched on this, but can you talk a
little bit about what the implications of Zika are for our
blood supply? And should people who have returned from
traveling overseas give blood?
Dr. Frieden. Yes, as of February 1, the American
Association of Blood Banks has advised that individuals who
have traveled to Zika-affected areas not donate blood for 28
days. We think that is reasonable. The FDA will follow up on
that, which is already in effect, with more formal guidance.
The more challenging situation is in Puerto Rico, and we
are in active discussions now. There are logistic and financial
implications of not collecting blood from Puerto Rico, so that
is something that needs to be worked through.
Over the next 6 to 12 months, we hope that FDA, CDC, and
NIH will be able to develop a screening test for Zika in blood
and/or a way of inactivating Zika in blood.
Senator Murray. How long will that take?
Dr. Frieden. Six to 12 months, if things go well. So we
don't currently have that type of test, and that is one of the
things that the FDA ask in this supplemental request would help
to cover.
PUBLIC HEALTH EMERGENCY FUND
Senator Murray. Okay. Finally, we spent a lot of time
talking about Zika today. We talked about Ebola before. Mother
Nature has a way of providing us with surprises. There will be
more in the future.
Do you have gaps in your funding that concern you in your
preparation for whatever future hearing we're going to have on
a name of something that we never said before?
Dr. Frieden. To me, the biggest concern is, both within the
United States and globally, our ability to find, stop, and
prevent health threats. And for the global work, that is what
the Global Health Security Agenda addresses. We have been able
to get good commitments from other countries, so we don't have
to go it alone.
But our commitment is very important there. That is a
multiyear effort to close those gaps in our knowledge, because
the weakest link, the blind spot anywhere in the world, is
really a risk to all of us.
Also, within the United States, our core public health
capacity is not as strong as it needs to be for detect and
response. In this case, we are seeing the weaknesses in
mosquito control around the United States. But there are other
weaknesses as well in our ability to find threats rapidly and
stop them.
And I just want to take a moment to thank the members of
the committee for their support in the 2016 budget. Our highest
priority program to protect Americans better on combating
antibiotic resistance was funded at a significant increase, and
we are moving that out quickly. That is an example of an area
where we weren't doing enough testing; we weren't doing enough
tracking; we aren't stopping outbreaks that are happening. That
is the kind of threat that we need to continue to scale up our
response to.
Senator Murray. That is the basic public health, right?
Dr. Frieden. Absolutely.
Senator Murray. Okay.
Dr. Fauci, from your end?
Dr. Fauci. I agree. The kind of support we got in the 2016
budget was really very much appreciated. I want to thank you
very much for that. It was very important.
Senator Murray. Okay.
Thank you, Mr. Chairman.
Senator Blunt. Senator Cochran.
Senator Cochran. Thank you very much for being here today
and helping us understand the challenges that you are facing in
carrying out your responsibilities. We appreciate the
determined effort that obviously exists to do the best job we
possibly can to protect the public health of citizens of the
United States.
I know, as taxpayers, people are going to be willing to
share in the burden of spending and finding the money that we
need to have to devote to these very important research
projects and programs to help protect the public health of our
citizens.
I don't know of any higher calling than that engaged in by
capable and creative scientists, doctors, researchers. So thank
you for what you do. We appreciate it.
MICROCEPHALY AND OTHER BIRTH DEFECTS
Senator Blunt. I have three more quick things, one on
microcephaly.
Do you have a sense of how long it will be before you have
a firmer determination of absolute connection?
Dr. Frieden. I will comment first, and Dr. Fauci can say
more.
I think, with each passing day, we have an increasing level
of suspicion or confidence that it is a causal relationship.
Some of the time we will wait for two studies that are
currently getting underway.
One is in Brazil that is called a case-control study where
we look retrospectively at women whose infants were infected
and those whose infants weren't, to understand the differences
with infection rates and other risk factors.
And the second is a cohort study, which is the more
definitive type of study, which we are getting underway in
Colombia now with our team that is down there now. That will
follow hundreds of women who were infected in different stages
of pregnancy and do meticulous examination of them and their
infants to see what the rates are.
So those are two things where we will learn more. But I
will say, even in this week, the data that has come out through
the scientific publications makes it look very much like this
is a virus that is what we call neurotrophic. It targets the
nerve cells, the central nervous system, and it is looking
increasingly certain, although not yet proven, that it is
causal.
Senator Blunt. Dr. Fauci.
Dr. Fauci. I totally agree. The definitive report when it
gets out in the literature is the case control cohort study. We
are really getting much more evidence now. Just yesterday, the
publication came out reporting four cases that the CDC looked
at, in two babies that were stillborn and two babies that died
within 20 days of birth. The presence of Zika virus in the
neural tissue of those babies make it really quite convincing.
It is starting to look, as Dr. Frieden said correctly,
literally every week that goes by, there is more compelling
evidence.
Senator Blunt. And is there any more evidence of
association with short-term or long-term paralysis?
Dr. Frieden. So the Guillain-Barre syndrome, there is, I
would say, fairly strong evidence and suspicion of correlation.
We see Guillain-Barre following a range of infections. A
diarrheal disease caused by a bacteria, Campylobacter
influenza, can cause Guillain-Barre as a post-infectious
complication. It is a system where the body's immune system
attacks our nerves, and it can be quite severe, although it
usually does resolve in a period of weeks to months.
We have done two types of studies on this. One is to look
at the epidemiology with a pattern of the disease in the
population. That really does look suggestive, because Zika
comes and then you see a bump in Guillain-Barre after that.
The second kind of study, which we have already completed
the field work on, was a case-control study in Brazil. I will
say the Brazilians have been very collegial, very open, very
transparent about this. So we did a case-control study of
people with Guillain-Barre and controls. We have done the
initial work on that. The field work is complete. The
laboratory work we hope to finish in the next couple of weeks.
That will give us some more definitive information as well.
GLOBAL HEALTH SECURITY FUND
Senator Blunt. My last question, on the Global Health
Security fund, I believe, to this point, there have been no
agreements made with South American countries. Am I correct on
that?
Dr. Frieden. So the Global Health Security Agenda in the
first phase of it, phase 1, there were 17 countries. In phase
2, there were 13 countries. In addition, that included Peru and
Haiti, as well as partnering with the Caribbean community, an
organization called CARICOM. But in phase 2, we have not yet
identified funds for the phase 2 countries.
Senator Blunt. So there are identified countries but no
funds for those countries in South America yet?
Dr. Frieden. At this point, that is correct.
Senator Blunt. Anything else either of you would like to
add?
Senator Murray.
Senator Murray. No, thank you very much, both of you.
Dr. Frieden. Just to thank you for holding this hearing and
for your interest and support for public health.
Dr. Fauci. Thank you very much.
Senator Blunt. Thank you, both, for being here.
ADDITIONAL COMMITTEE QUESTIONS
The record will stay open for 1 week for any additional
questions.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Roy Blunt
Question. It appears that much of the supplemental request is for
activities that CDC's annual budget already supports or to programs
that were further increased through the Ebola Supplemental. Why is our
foundational public health system not able to deal with infectious
disease outbreaks?
And if the public health system is not prepared, why does CDC's
annual budget request not reflect an increase for preparedness
programs?
Should we be concerned that CDC needs an influx of money every time
there is an epidemic?
$666 million was provided in the Ebola supplemental for domestic
preparedness activities. Now, you are asking for $453 million more, on
top of the discretionary dollars already provided to these same
preparedness programs in the fiscal year 2016 Labor/HHS bill. If
hospitals are prepared to respond to Ebola, why aren't they prepared to
respond to Zika? And if the public health system cannot respond to
Zika, can it adequately respond to any infectious disease?
Answer. The Nation has significantly enhanced its preparedness in
the years following the September 11th attacks, when funds were
provided for enhancing public health preparedness. State and local
health departments have greatly increased their capacity to respond to
an array of hazards, which is evidenced through States' proven success
in responding to critical events without requesting direct Federal
support (such as the 2011 Joplin, Missouri tornado and the 2013
explosions in West, Texas). Zika virus response requires additional
equipment, facilities, and specialized training beyond what is
typically required for all-hazards preparedness. The unique nature of
this disease requires additional steps to enhance our response measures
to ensure whole community preparedness. Fundamentally, Ebola prevention
in the United States is about hospital infection control and tracking
of returning travelers, and Zika prevention and control is about
mosquito surveillance and control and rapid response to cases through
mosquito control and other interventions. These are largely unrelated
activities, except for the common denominator of the need for a strong
public health system.
Mosquito-borne disease prevention and control requires specialized
activities not typically included in all-hazards preparedness, such as
entomology, mosquito surveillance, and specialized laboratory capacity.
While all-hazard preparedness has improved, critical funding for
response to mosquito-borne illness has waned in recent years. According
to an analysis by the Council of State and Territorial Epidemiologists,
Epidemiology and Laboratory Capacity grant funding decreased by 61
percent between 2004 and 2012:
--Only 62 percent of jurisdictions had a formal plan for killing
adult mosquitos in the event of an outbreak.
--67 percent of jurisdictions decreased mosquito trap sites.
--70 percent of jurisdictions decreased testing of mosquito pools.
--45 percent of jurisdictions decreased tests on human, mostly the
result of inadequate laboratory staffing.
In addition to the unique needs for mosquito-borne disease
response, the association between Zika virus and microcephaly is
unexpected and unprecedented. A new infectious cause of fetal
malformations has not been identified in decades and never has a
mosquito-borne virus been connected with birth defects. Specialized
prevention and response activities also are needed to prevent birth
defects, support families affected by them, monitor the outcomes of
potentially affected infants, and better identify risks.
Question. The Department of Health and Human Services has confirmed
with my staff that they have the legal flexibility to use all but $35.2
million of the remaining $1.5 billion Ebola supplemental for other
infectious disease outbreaks. Have you asked Secretary Burwell to use
this funding for Zika response and preparedness?
When HHS briefed Senators on February 9, 2016 with Secretary
Burwell and Drs. Fauci and Frieden, both Directors stated this was an
``emergency'' and that both the CDC and NIH could begin obligating
funding ``today.'' If this is a true emergency, why are you not trying
to use any funds currently available to you?
Answer. CDC is using funds currently available for immediate Zika
response needs. However, current funding will not support all efforts
needed to respond to Zika, and we are drawing funds from activities
directed by Congress. The $50 million in reprogrammed CDC funds used in
the initial stages of the Zika emergency response were taken from the
preparedness account, including the Strategic National Stockpile (SNS)
and the Public Health Emergency Preparedness (PHEP) Cooperative
Agreements. Without reimbursement, the $5.75 million reduction of SNS
will result in decreased acquisition of 20,000 vials of anthrax vaccine
that would be used to treat and/or prophylax 67,000 individuals exposed
to anthrax. Reimbursement will allow for purchase later in the fiscal
year. The $44.25 million reduction of PHEP will result in reduced
preparedness awards to States and cities. Reimbursement by June will
allow for full planned awards to each State in fiscal year 2016.
While Zika is an emergency, Ebola and emerging health threats
continue to endanger the health of Americans here and around the globe.
CDC is still working to ensure prevention and control of Ebola in West
Africa. CDC still has 100 staff on the ground, and has continued to
test more than 10,000 samples per month in Liberia, Sierra Leone, and
Guinea. There is a possibility that small clusters of Ebola could
emerge in the future, or other diseases could emerge that will test the
public health infrastructure we are strengthening. In January, 68 days
after the WHO declared the end of Ebola transmission in Sierra Leone, a
new case was found, sparking the need for rapid response. As we
continue to learn about Ebola and how it can be transmitted, it is
essential that Ebola funding remain in place to rapidly address needs,
such as:
--Deploying new countermeasures and diagnostics for Ebola; and
--Accelerating development of Ebola therapeutics and vaccines to more
rapidly and effectively respond to the next outbreak.
In addition to Ebola, other infectious disease outbreaks like Lassa
fever continue to pose threats to Americans health and safety. For
example, CDC has been actively consulting on a suspected case of Lassa
fever in an American healthcare worker. Transmitted by rats, Lassa
virus causes large, seasonal outbreaks in West Africa. An outbreak is
currently ongoing in Benin, which neighbors Togo. CDC is sending a team
to Benin and a staff member to Togo to assist in responding to Lassa
fever. Human-to-human transmission is possible through contact with
blood, tissue, or excretions of a person who has Lassa fever. This case
reminds us that our Global Health Security work is critically important
to protecting Americans abroad and here at home. And it shows us the
importance of continuing to use our remaining Ebola funds not just to
address the possibility of small Ebola clusters but to strengthen the
public health infrastructure of countries so they are prepared for
other existing and emerging diseases.
Rebuilding the infrastructure that was lost and strengthening it
for the future is essential. These investments are crucial to keeping
Americans safe from emerging threats, here and abroad. Congress
appropriated Global Health Security funds with the expectation that
they would be spent over 5 years, and we have plans in place to spend
the unobligated funds through fiscal year 2019 as intended by Congress.
The Global Health Security agenda (GHSA) is a multi-year effort between
the Federal Government, other nations, international organizations, and
public and private stakeholders, to accelerate progress toward a world
safe and secure from infectious disease threats and to promote global
health security as an international security priority to:
--Prevent and reduce the likelihood of outbreaks--natural,
accidental, or intentional;
--Detect threats early to save lives; and
--Respond rapidly and effectively using multi-sectorial,
international coordination and communication.
In July 2015, the United States and 17 partner countries announced
5-year plans to meet GHSA goals. Many of these plans have been
published online and are part of the Presidential- or Prime Minister-
level commitments with recipient countries. The countries are already
using GHSA funds to respond to ongoing public health emergencies within
their borders. At least 8 of these 17 countries are responding to
disease outbreaks right now, and are applying the GHSA tools and
approaches to respond more effectively. Building these systems and even
more importantly using these systems to respond takes some time, but we
know that these investments pay off. GHSA pilot projects delivered
tangible results in just over 1 year, but sustained investment over 5
years will have a transformative effect to the entire health system.
GHSA is a synergistic effort to our current response to Zika and
our ongoing response to Ebola. The need to respond to the Zika virus
urgently does not diminish our need to continue to implement GHSA,
which is a long-term effort to keep Americans safe from emerging
threats, here and abroad. Building this capacity takes planning and
implementation over time, and we have 5-year plans in place to spend
these funds and build the capacity of countries to prevent, detect and
respond to emerging threats.
Ebola supplemental funding provided to the National Institute for
Allergy and Infectious Diseases (NIAID) has already been committed to
ongoing activities as part of NIAID's research response to Ebola virus
disease. NIAID-supported Ebola research has and will continue to
provide important information about the disease. The ongoing NIAID-
funded study of Ebola survivors has revealed eye, musculoskeletal, and
neurological complications of the disease. It also detailed the risk of
sexual transmission, demonstrating that viral material could persist in
semen up to 18 months after experiencing Ebola symptoms, and that
individuals could have intermittent detection of virus (after testing
negative). In addition, NIAID conducted a randomized controlled trial
that found two Ebola vaccine candidates were safe and immunogenic.
Finally, NIAID conducted a randomized controlled trial of the
monoclonal antibody cocktail ZMapp in the midst of the West African
outbreak.
With respect to the Zika virus, NIAID has realigned some available
funds from its fiscal year 2016 appropriation to respond rapidly to the
current Zika outbreak. NIAID is accelerating research to understand the
Zika virus and develop diagnostics, vaccines, and therapeutics against
the virus, and the Administration has requested emergency funding to
enhance and expand our ongoing efforts to prepare for and respond to
the Zika virus.
Question. According to a recent article, the Zika virus might cause
permanent blindness for babies born with microcephaly. Can you discuss
this latest finding?
Answer. Findings show that infants with possible Zika virus
infection have had abnormal eye development. It is not known if Zika
virus infection caused any of these abnormalities. In a recent study of
29 infants in Brazil born with microcephaly (abnormally small head),
presumed to be caused by Zika virus infection, approximately one third
demonstrated eye abnormalities. Most of those affected (70 percent) had
abnormalities in both eyes. Changes affected different tissues in the
eye including the light-sensitive retina, iris, lens, and the optic
nerve, which transmits signals from the eye to the brain. In the
retina, the abnormalities involved disruption of the pigmented layer of
cells that help keep the neurons alive. In the optic nerve, affected
infants had fewer neurons, and the nerve exhibited incomplete
development or malformation. The more severe cases could result in
permanent vision loss or blindness.
For infants with possible congenital Zika virus infection, CDC
recommends that an ophthalmologic evaluation be conducted either before
discharge from the hospital or within 1 month after birth. Infants with
abnormal initial eye evaluation should be referred to a pediatric
ophthalmologist for further evaluation. CDC will continue to work with
our partners to conduct studies to more fully understand the magnitude
of risk and the range of outcomes associated with Zika virus infection
during pregnancy.
Question. The CDC and our States' public health systems have been
successful in limiting the effects of other mosquito-borne diseases
such as dengue fever and West Nile virus. If we are able to control
those diseases and limit the affected areas to Southern States, why do
you think Zika is different?
Answer. While we have had some success in responding to dengue and
West Nile outbreaks in the past, mosquito-borne threats remain an
issue, as evidenced by the 2015 dengue outbreak in Hawaii. In addition,
while there is some overlap with mosquito control measures for dengue,
West Nile Virus, and Zika virus, different prevention and control
strategies are required. West Nile Virus is primarily spread by Culex
mosquitos. These mosquitoes are found throughout the continental United
States while Aedes aegypti, the principal vector for Zika and dengue,
has been identified across the southern half of the United States,
primarily in the Southeast. Culex mosquitos have been historically
easier to control than aedes aegypti, in part because they bite at
night. The other important difference that would impact mosquito
control approaches is that West Nile Virus is maintained in nature
through a cycle involving transmission between birds and mosquitos.
Zika virus, on the other hand, is believed to circulate in humans and
mosquitos and does not have a non-primate reservoir.
Unlike the West Nile virus and dengue fever, we are seeing
unexpected and unprecedented clinical outcomes with Zika virus.
Evidence suggests that the Zika virus is linked to adverse pregnancy
and newborn health outcomes. However, there are a number of unknowns
with Zika. We do not know the full spectrum of possible health affects
to pregnant women and the fetus. Additionally, the Zika virus also can
be spread by a man to his sex partners. We do not know how long the
virus is present in semen in men who have had Zika or if infected men
who never develop symptoms can have the Zika virus in their semen.
While we have not yet seen transmission of the Zika virus by
mosquitos within the continental United States, we expect many
returning travelers will have Zika infection. There are about 40
million people travelling between the continental United States and
Zika-affected areas each year. Therefore, all U.S. jurisdictions must
be prepared to evaluate, test, and manage patients with potential Zika
virus infection, particularly pregnant women.
Question. What lessons were learned from the Ebola outbreak and how
have those lessons influenced the response so far?
Answer. CDC is using the tried and true methods to manage
emergencies within the Department, and interagency coordination has
been a focus from the beginning. Through our response to Ebola we've
learned several lessons that we are employing now:
--First, communication with the public is critical, and we plan to be
aggressive in sharing information as we have it.
--Second, we want to be up front with the public that this is an
evolving situation and we are learning new things as we go. We
will update the public as new information becomes available,
and our guidance will change as we learn more.
--Third, our core mechanisms for getting information out to
clinicians, public health officials, and the public at large--
like health alerts and clinician outreach calls--have been
strengthened.
--Fourth, as it was for Ebola, the entire countermeasure enterprise
is engaged in developing tests for early diagnosis and
vaccines.
--And finally, just like with Ebola, our core strategies are to
prevent, detect and respond.
While CDC and our State and local partners are building upon the
lessons learned and the collaborations established during the Ebola
response, many of the particular precautions and considerations
relevant to the current Zika response will require different strategies
and techniques.
The Zika request builds on the Ebola investments and provides for
technical expertise at the State and local level to prevent, diagnose,
and track Zika virus infections in all populations, but specifically
focusing on pregnant women, the most vulnerable population. Arboviral
disease expertise comprises a unique knowledge base that combines
laboratory, human, and mosquito surveillance. Currently, this expertise
does not exist in all State health departments. In order to adequately
track the anticipated volume of travel-associated cases and possible
local transmission cases, laboratory and surveillance expertise is
urgently needed at the State/local level. We are learning more about
Zika every day, and we are sharing information--and adjusting our
guidelines and recommendations--as we learn more.
When new public health threats emerge, the specialized
epidemiology, laboratory, and public health response surge capacity
needs are not met within Federal, State, and local public health
budgets. This is clearly true with Zika response, which requires
extensive entomology, mosquito surveillance and control, tailored risk
communications and prevention efforts, and pregnancy and birth outcomes
monitoring. We know that such threats will emerge each year, and we do
extensive surveillance to predict those threats and detect them early,
but we do not know in advance when and where these threats will
ultimately appear. CDC's budget does not include resources for these
surges. As the urgent and emerging Zika virus progresses during summer
months, it is necessary to have maximum flexibility to respond in a
manner that is most appropriate. As the Zika response and the Ebola
response have demonstrated, CDC needs the ability to respond quickly at
the beginning of an outbreak, even before Congress has time to provide
additional resources. The Administration's supplemental request
provides resources to support emerging needs related to Zika and other
infectious diseases. The transfer authority associated with the funds
for emerging needs allows transfers of resources within the Department
of Health and Human Services, which could support CDC's response to
Zika and future infectious disease threats.
Based on our Ebola response experience, the Zika supplemental
includes several authorities for CDC to aid in flexible, timely
response:
--Adding to Strategic National Stockpile: The proposed funding
specifically authorizes that ``products purchased with these
Zika funds may... be deposited in the Strategic National
Stockpile.''
--Overseas auto purchase and insurance authority was added to allow
supplemental funds to be used overseas for car purchase and
usage (global health funding already has this authority).
--Flexibility on Sec. 317S of the PHS Act was added to avoid
burdensome matching requirements on grantees related to
mosquito control.
--Construction authority for grantees was added to allow State and
local health departments and other grantees to use funds for
facilities that may be necessary to Zika response and
prevention, for example, laboratory facilities.
--Acquisition and construction authority for CDC was added to allow
CDC to use funds to expand vector-born disease laboratory
capacity in San Juan, Puerto Rico and Ft. Collins, Colorado.
--Funding transfer authority: Transfer authority would allow CDC to
move these funds across CDC accounts to be able to more quickly
respond to health security issues.
In addition, several General Provisions also support CDC's
response:
--Expanded overseas facilities authority: This proposal would allow
CDC to ``acquire, lease, construct, alter, renovate, equip,
furnish, or manage facilities'' overseas without having to send
payments through the Department of State.
--Hiring authorities:
--Personal service contracts: This authority would authorize CDC to
use personal service contracts for response staffing.
Although this authority has already existed globally, it
does not currently exist domestically. People working under
personal service contracts would NOT be Federal Government
workers.
--Direct hire authority: This authority would allow expedited
hiring authority for emergency positions.
--Reimbursement authority: This authority will allow CDC to use
emergency funds to backfill transfers and reprogramming used
before supplemental funds were available.
In responding to the Zika virus outbreak, NIAID draws on past
experience and lessons learned from other emerging infectious diseases
such as the HIV/AIDS pandemic and the recent Ebola outbreak. These
prior public health emergencies have outlined a core set of clinical
research principles that can help ensure studies conducted during such
emergencies meet the highest scientific standards and mitigate any
potential harm to participants. The core clinical research principles
include collaborating with local partners, prioritizing candidate
treatments and vaccines with plausible benefit, employing
scientifically sound clinical trial designs, and promoting transparency
through prompt dissemination of results. As research on potential
medical countermeasures progresses to the point of clinical evaluation,
NIAID intends to employ these principles in addressing the current Zika
virus outbreak.
Question. Zika is the second significant infectious disease
outbreak threatening the United States in recent years. Given that we
live in a global society where diseases are only a plane ride away,
should we change the way we react to disease outbreaks? Specifically,
how does the research community pivot research efforts to address the
outbreaks?
In recent years, why does it seem that the U.S. response is
reactive rather than proactive?
Answer. The Zika outbreak is validating the Global Health Security
Agenda's (GHSA's) core concepts, priorities and necessity--investments
in the public health workforce, surveillance, laboratory and public
health emergency management that help us respond better to public
health crises, from MERS to Ebola to Zika and more. On any given day,
there are disease outbreaks around that world that have the potential
to impact the United States.
GHSA outlines the way forward toward a world more secure from
infectious disease threats. Every country around the world needs to be
able to prevent, detect and effectively respond to infectious disease
threats, including emerging zoonotic diseases, such as Zika virus.
Preventing the emergence and spread of health threats will help reduce
the number and magnitude of disease outbreaks. The Zika outbreak shows
that threats came come from anywhere in the world, and we are all
connected by the air we breathe, the water we drink, and the planes we
ride on.
The research community can pivot its efforts to address outbreaks
by supporting, when applicable, the twelve identified GHSA activities,
called ``Action Packages'' in the areas of prevent, detect, and
respond. These activities facilitate regional and global collaboration
toward specific GHSA objectives and targets that fall under Prevent,
Detect, and Respond goals. More information on these action packages
can be found at: https://ghsagenda.org/packages.html.
NIAID and its Federal partners can respond rapidly when infectious
diseases emerge because we are able to build upon our broad and
flexible research foundation and efforts of the Public Health Emergency
Medical Countermeasures Enterprise. In the case of Ebola, NIAID
investments in biodefense research provided basic knowledge and
research capacity to address this urgent public health threat.
Similarly with Zika virus, NIAID is utilizing its long-term research
portfolio in related flaviviruses to accelerate research on Zika virus.
NIAID maximizes its research resources by pursuing development of
medical countermeasures with wide impact, such as broad-spectrum
antibiotics and antiviral drugs effective against multiple bacteria or
viruses. NIAID also seeks to establish and validate efficient platform
technologies to more rapidly develop vaccines and diagnostics for a
variety of threat agents. NIAID's migration from a ``one bug, one
drug'' approach toward a broader, more flexible research paradigm is
yielding scientific advances that will facilitate our ability to
respond to emerging public health threats. In the case of Zika virus,
antivirals developed for other flaviviruses, along with broad-spectrum
antivirals with activity against a range of pathogens, are being tested
for activity against Zika, potentially expediting identification of
effective therapies. For example, NIAID supported mouse model testing
of the broad-spectrum antiviral drug BCX4430 that found that the drug
has activity against Zika virus. NIAID had previously supported the
initial development of BCX4430 as a drug for filoviruses including
Ebola. In addition, vaccine platforms developed for other viruses are
being rapidly adapted for Zika, allowing NIAID to accelerate
preclinical work.
Question. The National Institutes of Health is requesting $80
million in the supplemental request. This is one-third the amount of
NIH's funding request during the Ebola outbreak. How was this funding
level developed and what research efforts will it be focused on?
It is my understanding that while NIH has spent money researching
similar diseases, currently the NIH spends $0 on the Zika virus. Why
did the fiscal year 2017 budget request not include funding for Zika
research?
Answer. The breadth, scope, method of transmission, pathogenesis,
disease complications, and lethality of the Ebola and Zika virus
outbreaks are very different. Additionally, the pipeline of
countermeasures, such as vaccines, and the stage of their development
are also dissimilar. For example, while the NIH funding request for
Zika includes funds for early-stage (Phase I) clinical trials of Zika
vaccine candidates, the NIH funding request for Ebola included funds
for larger, advanced (Phase II and III) clinical trials of Ebola
vaccine candidates that had already completed Phase I clinical trials.
Similar to the rapid response to Ebola, NIAID has and continues to
rapidly respond to the current Zika outbreak by accelerating research
on Zika and related flaviviruses. It is important to note that prior to
the large-scale emergence of Zika virus in the Americas, Zika virus
disease was thought to be a relatively benign illness. As we have
learned more about its potential ramifications, we are now focused on
rapid early-stage discovery and development of candidate vaccines,
diagnostics, and therapeutics, and the Administration has requested
emergency funding to enhance and expand our ongoing efforts to prepare
for and respond to the Zika virus.
Within the Administration's Zika emergency funding request, $130
million would support NIH research to immediately address the outbreak
in fiscal year 2016. We did not include costs that would be incurred in
fiscal years 2017-2019 to fund pivotal Phase IIb and Phase III vaccine
clinical trials in endemic areas, nor the funds required to continue
ongoing research initiated in fiscal year 2016. This fiscal year 2016
request was based on the scientific assessments of NIH program staff
who are familiar with the size and scope of the current Zika outbreak,
the current state of the Zika research field, and the capabilities of
extramural and intramural scientists to pivot to focus their research
on this public health issue. The requested funding would support
research to gain fundamental knowledge about Zika virus and the disease
it causes, including potential links to microcephaly and Guillain-Barre
syndrome. The emergency funding for NIH also would support the
development of rapid, point-of-care diagnostics; therapeutics effective
against Zika and other flaviviruses; and vaccines for Zika.
As of March 1, 2016, NIAID has stretched to commit $10 million of
its existing resources to combat the Zika health emergency. NIAID's
fiscal year 2017 budget proposal provides some limited flexibility to
fund research on Zika virus and other emerging and re-emerging
infectious diseases.
Question. Is any of the fiscal year 2016 increase ($212.4 million)
for the National Institute of Allergy and Infectious Diseases being
used for Zika research?
Answer. NIAID appreciates the Committee's support in the fiscal
year 2016 budget, which provided an increase to NIAID's budget,
including $100 million dedicated to research to address the urgent
challenge of combating antibiotic-resistant bacteria.
Question. The supplemental requests $190 million for research and
development efforts for a vaccine. Is this a one-time funding request
or will NIH and BARDA need continued investments related to a vaccine
for the Zika virus?
Answer. NIAID plans to obligate in fiscal year 2016 all of its
proposed $130 million funding, which, as described earlier, would
support research to gain fundamental knowledge about Zika virus as well
as the development of rapid, point-of-care diagnostics; therapeutics
effective against Zika and other flaviviruses; and vaccines for Zika.
The funding would support several leading Zika vaccine candidates in
preclinical evaluation, and promising candidates would be taken through
Phase I clinical trials in endemic areas. The proposed $130 million
would not fund advanced clinical evaluation such as Phase IIb trials.
Question. How have research efforts related to other mosquito-borne
viruses such as dengue fever or West Nile virus helped us towards
developing a treatment for the Zika virus?
Answer. NIAID is utilizing its existing flavivirus research program
to help develop needed countermeasures for Zika virus. For example,
NIAID has developed resources to screen for antiviral drugs active
against viruses in the flavivirus family, including dengue, West Nile,
and yellow fever viruses. Building on these efforts, NIAID has
developed a specific assay to test drug candidates for activity against
Zika virus. NIAID is making this assay available to the research
community and is currently testing drug candidates that have activity
against other flaviviruses (including broad-spectrum antivirals) to
determine if they are effective against Zika virus. Successful
candidates would be evaluated for further development as Zika virus
treatments. In addition, NIAID research on vaccines for other
flaviviruses has accelerated the development of candidate Zika virus
vaccines. NIAID scientists are modifying candidate vaccines they
developed for West Nile virus and for dengue virus to quickly generate
candidate Zika virus vaccines for further evaluation.
Question. The Zika virus does not have a rapid diagnostic test,
effective treatment, or a vaccine. How do you prioritize the
development of these three necessary components to stopping the
epidemic?
Answer. CDC recognizes the expertise and authorities that exist
across the Federal Government and is collaborating with many agencies
in order to effectively detect, prevent, and respond to Zika virus. CDC
has prioritized access to diagnostic tests in its Zika efforts and
continues to work with FDA to obtain Emergency Use Authorization (EUA)
for Zika diagnostic assays. These assays will have the potential to
diagnose Zika virus disease during the first week of illness, and can
be used on serum samples from people with a history of symptoms
associated with Zika and/or people who have recently traveled to an
area during a time of active Zika transmission. CDC is also partnering
with the Biomedical Advanced Research and Development Authority (BARDA)
to expand lab diagnostics manufacturing in the short-term and in the
longterm, to encourage commercial production of diagnostic assays. CDC
and NIH work collaboratively to facilitate the transfer of research
efforts into products and services that will effectively combat Zika
virus and other mosquito borne diseases.
NIAID is working to develop all three of these needed
countermeasures for Zika virus by building on existing scientific
knowledge about flaviviruses. It is critical to have rapid, sensitive,
and specific diagnostic tests for Zika virus to identify currently and
previously infected individuals, particularly pregnant women who may be
concerned about potential congenital defects. In addition, drugs to
treat Zika virus infection would be important tools to address the
ongoing Zika outbreak. The top priority of NIAID is the development of
a Zika virus vaccine that could prevent infection and thereby avert
congenital defects potentially linked to Zika virus infection,
including microcephaly.
To stimulate other Zika-related research, several NIH ICs have
issued notices to alert the research community about NIH's interest in
supporting Zika-related research and product development. High-priority
research areas include assessing the impact of infection during
pregnancy, developing rapid, specific, and sensitive clinical
diagnostic tests; and broad-spectrum therapeutics effective against a
range of flaviviruses, such as Zika. NIH also is encouraging research
applications aimed at understanding how Zika is transmitted, as well as
how the immune system responds when people are infected by Zika and
other flaviviruses. These notices may be accessed by going to: https://
grants.nih.gov/grants/guide/notice-files/NOT-AI-16-026.html, http://
grants.nih.gov/grants/guide/notice-files/NOT-HD-16-004.html, and http:/
/grants.nih.gov/grants/guide/notice-files/NOT-HL-16-307.html.
Question. How much concern should there be that Zika will become
wide-spread in the United States with an infected mosquito biting
multiple people?
Answer. While we have not yet seen local mosquito-borne
transmission of the Zika virus within the continental United States, we
expect that the number of cases of Zika infection among returning
travelers will increase. Zika virus is transmitted to people primarily
through the bite of an infected Aedes species mosquito (A. aegypti and
A. albopictus). These are the same mosquitos that spread dengue and
chikungunya viruses. In addition, CDC and State health departments are
now investigating reports of sexual transmission of Zika virus, several
involving pregnant women. These reports suggest sexual transmission may
be a more likely means of transmission for Zika virus than previously
considered.
Recent chikungunya and dengue clusters in the United States suggest
that Zika outbreaks in the U.S. mainland may be relatively small and
localized. Better housing construction, less crowding, regular use of
air conditioning, use of window screens and door screens, and State and
local mosquito-control efforts have helped to contain transmission of
these mosquito-borne viruses. For the Commonwealth of Puerto Rico as
well as the U.S. Virgin Islands and American Samoa, the situation is
different; all three areas have already reported local Zika
transmission.
Chikungunya provides a basis for estimating spread of Zika in the
United States and territories. Chikungunya and Zika viruses have
similar transmission cycles during outbreaks, using the same mosquito
species to infect humans who amplify and typically spread the virus
from one location to another. The number of cases of Zika transmission
in Puerto Rico is doubling every week, and based on our experience with
dengue and chikungunya, we believe this number will continue to rise.
As a point of comparison, a quarter of the population in Puerto Rico
has been infected with chikungunya, which arrived on the island less
than 2 years ago, which would indicate that at least 600,000 infections
of Zika are likely to occur there.
Question. In an attempt to end the spread of the Zika virus, Brazil
is conducting trials releasing genetically modified male mosquitoes
that do not produce offspring into the wild. Are you familiar with this
project and what are your thoughts on this approach?
Answer. Oxitec, the company developing this technology, has briefed
NIAID on the use of its self-limiting mosquito technology and the
status of the controlled release studies in Brazil. This is one of
several approaches currently under investigation for control of Aedes
aegypti-borne infectious agents. NIAID is in contact with Oxitec and
other investigators pursuing a variety of novel approaches to mosquito
control.
While a promising technique, mass release of genetically modified
males is not suitable for emergency use. Reduction in Aedes aegypti
populations was observed in small scale field trials in areas of
Brazil, but these observed populations may or may not reduce
transmission of Zika or dengue viruses. To be effective, massive
numbers of genetically modified male mosquitos would need to be mass
reared on an industrial scale, with excellent quality control.
Furthermore, multiple release points would be needed, as Aedes aegypti
has a short flight range. Releases would need to be sustained, due to
high reproductive rate of Aedes aegypti. Finally, to date, the largest
trial is a 4.5 hectare area in suburban Rio de Janeiro; covering the
island of Puerto Rico (which is over 900,000 hectares) is not feasible
in near term. Release of genetically modified male mosquitos may hold
potential for use in concert with current mosquito control methods to
suppress mosquito populations and to reduce the spread of diseases like
Zika virus.
Question. Can you discuss the guidance that has gone out to State
and local health departments about how to test for and treat Zika?
Is there a requirement that a local lab inform the State before
sending samples to CDC?
Answer. Zika virus is a nationally notifiable condition. Healthcare
providers are encouraged to report suspected Zika cases to their State
or local health department to facilitate diagnosis and mitigate the
risk of local transmission. Local laboratories should make sure the
State or local health department and CDC have been notified and have
approved of the receipt of all specimens before they are collected and
shipped. Working closely with the State or local health departments
ensure that the appropriate test is ordered and results are interpreted
correctly. CDC provides State and local health departments with
instructions on collection and submission of body fluids for Zika virus
testing. This can be found at: http://www.cdc.gov/zika/hc-providers/
body-fluids-collection-submission.html. CDC has developed interim
guidelines for pregnant women and women of reproductive age with
possible Zika virus exposure (http://www.cdc.gov/mmwr/volumes/65/wr/
mm6505e2er.htm?s_cid=mm6505e2e
r.htm_w). Because there are limited data and experience with Zika virus
in pregnancy, CDC continually evaluates any new or emerging data that
may inform future recommendations. As more information becomes
available, we will update the CDC Zika website (http://www.cdc.gov/
zika/). CDC also has developed guidance and recommendations on Zika for
travelers, healthcare workers, and other groups. As new guidance and
recommendations are developed and updated, they are posted on CDC's
Zika website (http://www.cdc.gov/zika/). CDC also has developed interim
guidelines for healthcare providers caring for infants and children
with possible Zika virus exposure (http://www.cdc.gov/mmwr/volumes/65/
wr/mm6507e1er.htm?s cid=mm6507e1.htm w). Q&As on these guidelines also
are available (http://www.cdc.gov/zika/hc-providers/qa-
pediatrician.html). Information on CDC's interim Zika guidelines can be
found on CDC's Zika website at: http://www.cdc.gov/zika.
Question. Do you know how many States have labs that have the
capacity to test for Zika?
If tests have to be sent to the CDC for testing, what is the lag-
time before a physician will receive testing confirmation?
Answer. Testing capacity varies from State to State. As of February
11th, nine jurisdictions have the capacity to perform reverse
transcription polymerase chain reaction (RT-PCR) testing for Zika. CDC
has prioritized access to diagnostic tests in its Zika efforts and
continues to work with FDA to obtain Emergency Use Authorization (EUA)
for Zika diagnostic assays. These assays will have the potential to
diagnose Zika virus disease during the first week of illness, and can
be used on serum samples from people with a history of symptoms
associated with Zika and/or people who have recently traveled to an
area during a time of active Zika transmission.
Question. I was contacted by a constituent in Missouri who has a
son that was born with congenital cytomegalovirus (CMV) which can also
cause microcephaly in babies.
Is there any connection between CMV and Zika?
Answer. Both cytomegalovirus (CMV) and Zika are viral infections.
There are no FDA-approved vaccines to prevent either Zika or CMV. It is
not known whether there is a connection between the two viruses, or
whether prior or co-infection with CMV increases the likelihood of
infection with Zika.
The Zika virus is a flavivirus, a group of infections that also
includes dengue, West Nile, and yellow fever. The Zika virus is
neurotropic, meaning that it primarily affects the brain. Research is
unclear at this point whether these effects are a direct result of the
virus itself or due to an immunologic response to Zika infection. The
Zika virus is transmitted by the Aedes aegypti mosquito, common in
warmer climates; recent studies have also suggested that it can be
transmitted sexually. In early March 2016, researchers showed that the
Zika virus could infect nerve cells. Another new study of 88 pregnant
women with rash in Brazil found that many who were infected with the
Zika virus demonstrated a range of health concerns, including pregnancy
loss, central nervous system abnormalities, growth restriction, low
amniotic fluid, and abnormal blood flow to the baby, along with babies
born with microcephaly.
CMV is one of the herpes viruses, from a group of infections that
also include chickenpox. A common infection that is usually harmless or
causes mild symptoms, it can be transmitted through contact with bodily
fluids (such as saliva or blood), can be sexually transmitted, or, if a
pregnant woman has an active infection, it can be transmitted to her
fetus. CMV can cause serious disease in babies infected prior to birth
(congenital CMV). According to the CDC, about 1 in 5 children born with
congenital CMV infection will develop permanent problems, such as
hearing loss or developmental disabilities, and a small number may die.
At this time, there are no FDA-approved vaccines to prevent either Zika
or CMV.
There are many unanswered questions about the Zika virus and its
effects on health. Specifically, we need to establish whether Zika
virus causes fetal abnormalities and/or other pregnancy complications,
such as fetal loss, stillbirth, or ocular abnormalities, and if any
other factors may be contributing to these effects (e.g., prior CMV or
dengue exposure in the pregnant woman). Case-control studies will help
to generate hypotheses for potential co-factors, and longer term
prospective studies will provide more definitive evidence. To stimulate
research on Zika, NIH issued notices for the research community to
highlight the interest in supporting Zika-related research and product
development. High-priority research areas include assessing the impact
of infection during pregnancy, developing rapid, specific, and
sensitive clinical diagnostic tests; broad-spectrum therapeutics
effective against a range of flaviviruses, such as Zika; and vaccines.
NIH also is encouraging research applications aimed at understanding
how Zika is transmitted, as well as how the immune system responds when
people are infected by Zika and other flaviviruses.
Question. What are the NIH and CDC doing related to research,
generally, on microcephaly and how does this intersect with research
related to CMV?
Answer. The Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD) has ongoing studies on CMV
infection. NICHD is funding a large study of CMV transmission in
pregnancy in Brazil (R01HD061959). This is a prospective study of
congenital CMV of 10,000 women enrolling during pregnancy with a 2-year
follow-up. In addition, the NICHD's Maternal Fetal Medicine Network is
conducting a Phase III clinical trial on treatment for prevention of
congenital CMV (https://clinicaltrials.gov/ct2/show/NCT01376778). NICHD
is supporting other CMV studies to evaluate treatments to improve
neonatal outcomes and on CMV vaccines. These studies may be able to
incorporate Zika-related research, and the new funding opportunities
(http://grants.nih.gov/grants/guide/pa-files/PAR-16-106.html) should
stimulate further research on Zika and its impact on children's health.
CDC is conducting research to:
--Examine long-term health problems that infants born with CMV
infection may suffer. These health problems include
microcephaly, mental disabilities, and hearing loss;
--Improve laboratory and newborn screening tests to identify infants
with congenital CMV infection, about 1 percent of whom may be
born with microcephaly; and
--Identify the burden of congenital CMV infection and CMV-related
birth defects, such as microcephaly, among infants in
populations where a large proportion of mothers are already
infected with CMV.
______
Questions Submitted by Senator Thad Cochran
Question. Dr. Frieden, much of the funding requested for the
Centers for Disease Control and Prevention is for domestic response
activities like mosquito control programs. Such programs have long been
a staple in Southern states like Mississippi with warmer climates. How
would any new funding be used differently by State and local agencies
that already conduct important mosquito control activities?
Answer. CDC's supplemental request includes direct funding for
States and territories, prioritized based on risk of Zika transmission,
primarily through two of CDC's existing cooperative agreements. CDC's
Public Health Preparedness Emergency (PHEP) and Epidemiology and
Laboratory Capacity for Infectious Diseases (ELC) cooperative
agreements provide support to public health departments across the
nation to enhance their ability to effectively respond to emerging
public health threats, such as the Zika virus disease. These funds will
provide critically needed flexible and adaptable funds to enable select
health departments to effectively respond to this emergent need.
Funding for jurisdictions through the ELC cooperative agreement
supports prevention and control activities including maintenance and
expansion of arboviral disease diagnostic capacity, human and
environmental surveillance activities, and prevention and communication
activities to prevent mosquito-borne disease.
In addition, much of the funding requested to support the CDC
response will provide scientific, technical and logistical support to
State and local efforts to respond to Zika virus. CDC staff continue to
provide direct technical assistance, working with public health
partners and State health departments to alert healthcare providers and
the public about Zika, post travel notices and other travel-related
guidance, provide State health laboratories with diagnostic tests,
detect and report cases, publish and disseminate guidelines to inform
testing and treatment of people with suspected or confirmed Zika, and
study what might be responsible for the reported rise in microcephaly
and Guillain-Barre Syndrome, as well as studying the dynamics of sexual
transmission.
Other key CDC work that supports State and local response includes:
--Providing reference and surge laboratory capacity for the Nation.
CDC is building laboratory capacity and infrastructure to test
for Zika virus and other infectious diseases across the United
States by providing critical laboratory supplies, reagents,
equipment, and training for diagnostic testing and surveillance
activities in States and territories. CDC resources are
supporting diagnostic test manufacturing and CDC laboratory
surge capacity, both of which help meet State testing needs,
especially in Puerto Rico. In addition, CDC continues to work
on improving diagnostics for Zika.
--Providing a framework for tracking Zika-affected pregnancies and
births. CDC-supported expansion of systems for maternal and
child and birth defect surveillance improves the ability of
State-run registries across the country to detect risks related
to Zika.
--Helping States deploy and target effective mosquito control. CDC-
supported investments in mosquito control will help States and
cities identify and address areas where mosquitoes breed to
drive down mosquito populations. Continued CDC work on
development of innovative mosquito control tools, such as
promising new products that may be safer and more effective
than today's methods, will eventually help States reduce the
population of mosquitoes that can spread Zika and other
diseases.
--Supporting timely, accurate and effective communications to the
public and healthcare providers. CDC development of targeted
prevention and education strategies and supporting materials
for key populations (including pregnant women, their partners,
and healthcare professionals) are widely disseminated for use
by State health departments and partners.
Question. Dr. Frieden, in my home State of Mississippi, we have
more mosquitoes than people. For years, people have been concerned
about the possibility of an outbreak of a mosquito-transmitted disease
like West Nile virus. Why do you think Zika is more likely to develop
into an outbreak than some other dangerous mosquito-transmitted
disease?
Answer. Mosquito-borne diseases are among the most complex of all
infectious diseases to prevent and control. Of particular concern,
States throughout the southern United States are home to Aedes aeypti
mosquitos that spread Zika virus most efficiently. Recent chikungunya
and dengue clusters in the United States suggest that Zika outbreaks in
the U.S. mainland may be relatively small and localized due to
protective factors like window use screens and less dense living
conditions; however, any local outbreaks will be of deep concern to the
people living there. Furthermore, unlike other mosquito-borne diseases,
evidence suggests that Zika is linked to fetal malformations such as
microcephaly. The potential harm Zika has on the developing baby makes
even small outbreaks particularly concerning. Furthermore, in
territories, particularly Puerto Rico, Aedes mosquitos are abundant and
local transmission has already been reported. The speed at which the
outbreak is spreading in Puerto Rico is particularly concerning. As a
point of comparison, a quarter of the population in Puerto Rico has
been infected with chikungunya, which arrived on the island less than 2
years ago, which would indicate that at least 600,000 infections of
Zika are likely to occur there.
______
Question Submitted by Senator Brian Schatz
Question. The Vector Control Branch at the Hawaii State Department
of Health was decimated in 2009 due to budget cuts. Can you provide
specific recommendations on vector control resource requirements for
State and local governments? We would like to be able to get back to
each member, governor, and State with these recommendations.
Answer. Vector-borne diseases are among the most complex of all
infectious diseases to prevent and control and requires unique
capabilities of State and local public health departments. Public
health departments need the laboratory surveillance, and
epidemiological ability to track disease prevalence in people and
mosquitos. States and localities also must be able to conduct sentinel
surveillance and to implement scalable pesticide and non-pesticide
based vector control to respond to emerging arboviral threats like
Zika. Some areas have these capacities already in place but many State
and local health departments do not have the laboratory, mosquito
surveillance or human surveillance capacity to respond to a mosquito-
borne outbreak as complex as Zika virus.
______
Questions Submitted by Senator Tammy Baldwin
Question. I am encouraged that both the NIH and the CDC have joined
the more than two dozen government organizations, medical journals, and
global health organizations in pledging to share scientific and
research data related to Zika to speed the fight against the spread of
this virus. This is an important step to help ensure that our global
response to this and other outbreaks is coordinated and that impacted
areas can benefit from the most up-to-date scientific advances.
But, what challenges remain in this area to improve sharing with
our partners--such as physical sample sharing--and what have NIH and
CDC learned from the recent Ebola crisis to improve scientific
exchange?
Answer. HHS is coordinating a single process to obtain samples from
endemic countries, including Brazil, and direct them to highest
priority research needs (inside and outside of the government). To help
in this effort, NIAID is supporting two biorepositories which make
virus and other clinical specimens (e.g., plasma from infected
individuals) available to researchers and commercial developers.
NIH has a longstanding commitment to make scientific data publicly
available in a timely manner. Publicly-released data, including
datasets generated and released by NIAID, serve as critical resources
for scientists around the world, and are essential to enable the
advancement of research and surveillance of infectious diseases. For
example, in the recent Ebola outbreak in West Africa, NIAID genome
sequencing efforts and resources provided additional information about
the circulating Ebola virus strain. This genomic information, shared in
real-time in publicly accessible international data repositories at the
NIH's GenBank, helped researchers to understand how the virus is
transmitted and causes disease, as well as guide strategies for
developing new therapeutics, vaccines, and diagnostics. Similar
activities are already underway for Zika virus. Rapid data sharing is
an increasingly important aspect of collaborative research, and NIH is
committed to sharing research results in the current Zika outbreak in
order to facilitate better understanding of disease caused by the virus
and to help develop safe and effective countermeasures.
Within the Global Health Sample Sharing Initiative (GHSI), CDC is
collaborating to mount coordinated responses to the Zika virus to
enhance information sharing about a) public health practices and
policies in our countries, and b) a list of scientific and public
health studies done in our institutions and in collaboration with Latin
American and Caribbean countries to unify our efforts to expedite
knowledge about the link between Zika, microcephaly and Guillain-Barre
syndrome, as well as on the development of medical countermeasures. CDC
is also sharing samples among GHSI countries to rapidly to expedite
research and development of diagnostics and life-saving vaccines and
therapeutics by implementing a GHSI Operational Framework for the Rapid
Sharing of Biological Materials.
Question. Is there a centralized resource or list of CDC and NIH-
funded studies related to Zika virus that researchers can use to avoid
designing duplicate studies and to help facilitate partnerships with
existing studies?
Answer. CDC has a centralized repository of currently funded
studies related to Zika virus in its IMPAC (Information for Management,
Planning, Analysis and Coordination) II system. This system allows
staff to track and manage research grants and contracts, making
information to the public more accessible.
Centralized information regarding CDC funded Zika activities can
also be found through the Tracking Accountability in Government Grants
System (TAGGS). The department-wide TAGGS database is a central
repository for grants awarded by the eleven HHS Operating Divisions
(OPDIVs). TAGGS tracks obligated grant funds at the transaction level.
TAGGS data can be searched by the public at: https://taggs.hhs.gov/.
Grants.gov provides a centralized location for grant seekers to
find and apply Federal funding opportunities, including those related
to Zika supported by CDC. Grants.gov data can be searched by the public
at: http://www.grants.gov/.
NIH's Research Portfolio Online Reporting Tools (RePORT) website
(https://report.nih.gov/index.aspx) provides access to reports, data,
and analyses of NIH research activities, including information on NIH
expenditures and the results of NIH-supported research. This includes
the Report Expenditures and Results (RePORTER; https://
projectreporter.nih.gov/) tool, which allows users to search a
repository of NIH-funded research projects. Information about NIH-
funded studies related to Zika virus can be found using this tool, as
well as on the NIAID website at: http://www.niaid.nih.gov/topics/Zika/
Pages/default.aspx. Scientists interested in pursuing research on Zika
virus can contact their NIH program official or search the NIH Guide
for Grants and Contracts (http://grants.nih.gov/grants/guide/
index.html) for NIH Funding Opportunities and Notices related to Zika
virus.
SUBCOMMITTEE RECESS
Senator Blunt. The subcommittee will stand in recess until
10 a.m. on Thursday, March 3.
The hearing is adjourned.
[Whereupon, at 11:54 a.m., Thursday, February 11, the
subcommittee was recessed, to reconvene at 10 a.m., Thursday,
March 3.]