[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
FIGHTING FLU, SAVING LIVES:
VACCINE INNOVATION AND SCIENCE
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON SCIENCE, SPACE,
AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
__________
NOVEMBER 20, 2019
__________
Serial No. 116-56
__________
Printed for the use of the Committee on Science, Space, and Technology
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://science.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
38-331 PDF WASHINGTON : 2021
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COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HON. EDDIE BERNICE JOHNSON, Texas, Chairwoman
ZOE LOFGREN, California FRANK D. LUCAS, Oklahoma,
DANIEL LIPINSKI, Illinois Ranking Member
SUZANNE BONAMICI, Oregon MO BROOKS, Alabama
AMI BERA, California, BILL POSEY, Florida
Vice Chair RANDY WEBER, Texas
LIZZIE FLETCHER, Texas BRIAN BABIN, Texas
HALEY STEVENS, Michigan ANDY BIGGS, Arizona
KENDRA HORN, Oklahoma ROGER MARSHALL, Kansas
MIKIE SHERRILL, New Jersey RALPH NORMAN, South Carolina
BRAD SHERMAN, California MICHAEL CLOUD, Texas
STEVE COHEN, Tennessee TROY BALDERSON, Ohio
JERRY McNERNEY, California PETE OLSON, Texas
ED PERLMUTTER, Colorado ANTHONY GONZALEZ, Ohio
PAUL TONKO, New York MICHAEL WALTZ, Florida
BILL FOSTER, Illinois JIM BAIRD, Indiana
DON BEYER, Virginia JAIME HERRERA BEUTLER, Washington
CHARLIE CRIST, Florida FRANCIS ROONEY, Florida
SEAN CASTEN, Illinois GREGORY F. MURPHY, North Carolina
BEN McADAMS, Utah
JENNIFER WEXTON, Virginia
CONOR LAMB, Pennsylvania
VACANCY
C O N T E N T S
November 20, 2019
Page
Hearing Charter.................................................. 2
Opening Statements
Statement by Representative Eddie Bernice Johnson, Chairwoman,
Committee on Science, Space, and Technology, U.S. House of
Representatives................................................ 9
Written statement............................................ 10
Statement by Representative Frank Lucas, Ranking Member,
Committee on Science, Space, and Technology, U.S. House of
Representatives................................................ 10
Written statement............................................ 12
Witnesses:
Panel 1:
Dr. Daniel B. Jernigan, MD, MPH, Director, Influenza Division,
National Center for Immunization and Respiratory Diseases,
Centers for Disease Control and Prevention
Oral Statement............................................... 13
Written Statement............................................ 16
Dr. Anthony S. Fauci, MD, Director, National Institute for
Allergy and Infectious Disease, National Institutes of Health
Oral Statement............................................... 24
Written Statement............................................ 26
Discussion....................................................... 36
Panel 2:
Dr. Sharon Watkins, Ph.D., State Epidemiologist, Director, Bureau
of Epidemiology, Pennsylvania Department of Health and
President, Council of State and Territorial Epidemiologists
Oral Statement............................................... 60
Written Statement............................................ 62
Dr. Robin Robinson, Ph.D., Vice-President for Scientific Affairs,
RenovaCare and former Director, Biomedical Advanced Research
and Development Authority, U.S. Department of Health and Human
Services
Oral Statement............................................... 82
Written Statement............................................ 84
Discussion....................................................... 98
Appendix I: Answers to Post-Hearing Questions
Dr. Daniel B. Jernigan, MD, MPH, Director, Influenza Division,
National Center for Immunization and Respiratory Diseases,
Centers for Disease Control and Prevention..................... 110
Dr. Anthony S. Fauci, MD, Director, National Institute for
Allergy and Infectious Disease, National Institutes of Health.. 115
Dr. Robin Robinson, Ph.D., Vice-President for Scientific Affairs,
RenovaCare and former Director, Biomedical Advanced Research
and Development Authority, U.S. Department of Health and Human
Services....................................................... 124
Appendix II: Additional Material for the Record
Articles submitted by Representative Bill Posey, Committee on
Science, Space, and Technology, U.S. House of Representatives.. 128
Documents submitted by Representative Bill Posey, Committee on
Science, Space, and Technology, U.S. House of Representatives.. 137
``VICP Settlements Chart'' submitted by Representative Bill
Posey, Committee on Science, Space, and Technology, U.S. House
of Representatives............................................. 144
Presentation submitted by Dr. Anthony S. Fauci, MD, Director,
National Institute for Allergy and Infectious Disease, National
Institutes of Health........................................... 145
FIGHTING FLU, SAVING LIVES:
VACCINE INNOVATION AND SCIENCE
----------
WEDNESDAY, NOVEMBER 20, 2019
House of Representatives,
Committee on Science, Space, and Technology,
Washington, D.C.
The Committee met, pursuant to notice, at 10 a.m., in room
2318 of the Rayburn House Office Building, Hon. Eddie Bernice
Johnson [Chairwoman of the Committee] presiding.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Johnson. This hearing will come to order. And
without objection, the Chair is authorized to declare a recess
at any time.
Let me say good morning and welcome our witnesses to
today's hearing on vaccine science and innovation. Smallpox
once plagued the world's population, killing approximately 300
million people in the 20th century alone. Smallpox is the only
human disease to be eradicated, thanks to the development of
the vaccine. Another devastating disease, polio, had just 33
cases reported worldwide in 2018, compared to 350,000 cases in
1988. Every day, vaccines are saving lives, especially the
lives of children and other vulnerable populations. There is no
such thing as healthy skepticism when it comes to vaccines.
Unfortunately, there is a well-funded, disinformation
campaign targeting the public and weakening public health laws.
School vaccination requirements have been commonplace in the
U.S. for generations, and exemptions were granted only for
legitimate medical reasons. However, in my home State of Texas,
the number of unvaccinated children has spiked since 2003 when
the Texas legislature expanded the exemptions to include
nonmedical reasons. The number of exemptions rose from 2,000 in
the year 2003 to 57,000 last year. We are seeing this replayed
across the country, and innocent children are falling ill.
Health officials have confirmed 21 measles cases in Texas this
year and 1,261 nationwide, 61 of which led to serious
complications.
As the first nurse elected to Congress, I have been
dedicated to the improvement of public health my entire career.
The Science Committee may not have jurisdiction over the Health
and Human Services agencies, but we have long had a role in
supporting improved public health through good science.
This morning, we will explore the science and innovation
challenges for vaccine development through the lens of
influenza. For the healthiest among us, the flu just lays us
out for several days, with no lasting side effects. However,
for the very young, the elderly, pregnant women, and other
vulnerable groups, the flu can be deadly. The Centers for
Disease Control and Prevention (CDC) recorded an estimated 48.8
million illnesses and 79,000 deaths during the 2017-2018 flu
season. Approximately 600 of those deaths were children.
Each year, influenza vaccine production begins with the
collection and analysis of data many months before the
beginning of the flu season. The challenge with influenza is
that the viruses change constantly, and by the time flu season
begins, the vaccine may not fully match the circulating
viruses. Scientists are working to develop viable and more
effective alternatives to the current egg-based vaccine, as
well as a universal vaccine that will not require annual
update.
Yet another scientific challenge for influenza and many
other infectious diseases is incomplete data and antiquated
data systems. Through modernization of data systems and data
analytic tools across the Federal and State levels, we will be
able to accelerate vaccine research and development for many
diseases.
We have two expert panels that will help us understand the
full cycle from basic research to vaccine development,
production and deployment and surveillance. The witnesses will
also describe the role of Federal agencies, State agencies, and
the private sector, including the partnerships among all of the
stakeholders. I want to extend my warm welcome to all of you
this morning. And I want to thank the Vice Chair, Dr. Bera, for
his leadership on this issue. I look forward to today's
discussion.
[The prepared statement of Chairwoman Johnson follows:]
Good morning and welcome to today's hearing on vaccine
science and innovation.
Smallpox once plagued the world's population, killing
approximately 300 million people in the 20th century alone.
Smallpox is the only human disease to be eradicated, thanks to
the development of the vaccine. Another devastating disease,
polio, had just 33 cases reported worldwide in 2018, compared
to 350,000 cases in 1988. Every day, vaccines are saving lives,
especially the lives of children and other vulnerable
populations. There is no such thing as healthy skepticism when
it comes to vaccines.
Unfortunately, there is a well-funded disinformation
campaign targeting the public and weakening public health laws.
School vaccination requirements have been commonplace in the
U.S. for generations, and exemptions were granted only for
legitimate medical reasons. However, in my home state of Texas,
the number of unvaccinated children has spiked since 2003, when
the Texas Legislature expanded the exemptions to include non-
medical reasons. The number of exemptions rose from 2,000 in
the year 2003 to 57,000 last year. We are seeing this replayed
across the country, and innocent children are falling ill.
Health officials have confirmed 21 measles cases in Texas this
year, and 1,261 nationwide, 61 of which led to serious
complications.
As the first nurse elected to Congress, I have been
dedicated to the improvement of public health my entire career.
The Science Committee may not have jurisdiction over the Health
and Human Services agencies, but we have long had a role in
supporting improved public health through good science.
This morning, we will explore the science and innovation
challenges for vaccine development through the lens of
influenza. For the healthiest among us, the flu just lays us
out for several days, with no lasting side effects. However,
for the very young, the elderly, pregnant women, and other
vulnerable groups, the flu can be deadly. The Centers for
Disease Control recorded an estimated 48.8 million illnesses
and 79,000 deaths during the 2017-2018 flu season.
Approximately 600 of those deaths were children.
Each year, influenza vaccine production begins with the
collection and analysis of data many months before the
beginning of the flu season. The challenge with influenza is
that the viruses change constantly, and by the time flu season
begins, the vaccine may not fully match the circulating
viruses. Scientists are working to develop viable and more
effective alternatives to the current egg-based vaccine, as
well as a universal vaccine that will not require annual
update. Yet another scientific challenge for influenza and many
other infectious diseases is incomplete data and antiquated
data systems. Through modernization of data systems and data
analytic tools across the federal and state levels, we will be
able to accelerate vaccine research and development for many
diseases.
We have two expert panels that will help us understand the
full cycle from basic research to vaccine development,
production, deployment, and surveillance. The witnesses will
also describe the role of federal agencies, state agencies, and
the private sector, including the partnerships among all of the
stakeholders.
I want to extend a warm welcome to all of you this morning.
And I want to thank the Vice-Chair Dr. Bera for his leadership
on this issue. I look forward to today's important discussion.
Chairwoman Johnson. I might say that I have a markup in
another Committee, so I will have to leave before we get
through all of the deliberations.
The Chair now will recognize Mr. Lucas for an opening
statement.
Mr. Lucas. Good morning, Chairwoman Johnson. I would like
to thank you and Vice Chairman Bera for holding this hearing,
especially given that we are in the middle of flu season.
In the United States, nearly a million individuals are
hospitalized for the flu every year, including more than 48,000
children. In Oklahoma, since the 2019 flu season began on
September 1, there has been one death and 73 hospitalizations
from the flu. However, these numbers would be far worse if we
did not have vaccines. Vaccination is, by far, the best flu
prevention measure we can have today.
It's easy to forget that a little over 100 years ago the
world faced one of the deadliest pandemics in history: The 1918
H1N1 pandemic, also known as Spanish flu. It killed an
estimated 50 million people worldwide, including roughly
675,000 people in the United States. Medical technology and
countermeasures at the time were limited to isolation and
quarantine. Influenza vaccines did not exist, and antibiotics
had not been fully developed yet.
Thankfully, due to basic research, advancements were made
both in treatment and prevention of the flu. The development of
vaccines has played an important role in reducing and
eliminating deadly disease. I can still recall my father's
stories about how late summer and fall were a terrifying time
as a child because of the threat of polio during those seasons.
Lucky for me, I did not have to experience this fear because of
the first polio vaccine being available in the United States in
1955.
And thanks to widespread vaccination, polio has been nearly
eradicated in the United States with just 33 cases reported in
2018. However, polio remains a threat in some countries. With
the world becoming more connected through modern
transportation, it only takes one traveler with polio to bring
the disease into the United States. And as I'm sure we'll hear
this morning from our witnesses, the best way to keep the
United States polio-free is to maintain high immunity through
vaccination.
Considerable advancements have been made in health
technology, disease surveillance, medical care, medicines,
drugs, vaccines, and pandemic planning. While significant
progress has been made, gaps remain, and a severe pandemic
could still be devastating to the global population.
As the human population has grown, so has the livestock,
swine, and poultry populations to feed them. This expanded
number of hosts provides increased opportunities for unique
viruses from birds, cattle, and pigs to spread, evolve, and
infect people.
As a Member of the House Agriculture Committee, I supported
the creation of the National Animal Vaccine and Veterinary
Countermeasures Bank, which was included in the last farm bill.
This vaccine bank will maintain a sufficient quantity of animal
vaccines and other countermeasures to provide a rapid response
to an animal disease outbreak. If an outbreak were to occur and
we were not prepared, our entire agricultural sector would
suffer immense losses, causing long-term harm to the economic
viability of the United States livestock, poultry, and swine
production, not to mention the damaging to human health.
I look forward to hearing from our witnesses today about
the current state of our stockpiles of human health vaccines to
provide the capacity for rapid responses to emergency
situations. I particularly look forward to hearing how BARDA
(Biomedical Advanced Research and Development Authority)
Influenza Vaccine Manufacturing Infrastructure is supporting
the public-private partnerships with domestic vaccine
manufacturers to increase preparedness levels and response
capacities for potential pandemic flu events in the United
States.
Last, I would just like to say how pleased I was to see the
President's recent executive order to address modernizing flu
vaccines. The executive order recognizes influenza as a public
health and national security priority with the potential to
inflict harm on the United States through large-scale illness
and death. Most importantly, it establishes a national task
force to explore alternative vaccine production methods and new
technologies, including a plan to accelerate the development of
a universal flu vaccine. I look forward to seeing what
recommendations come from the task force.
I would again like to thank Chairwoman Johnson and Vice
Chair Bera for holding this hearing. I would also like to thank
both witness panels for taking the time to share your
expertise, your insights with us this morning.
And I yield back the balance of my time, Madam Chair.
[The prepared statement of Mr. Lucas follows:]
Good morning Chairwoman Johnson. I would like to thank you
and Vice Chairman Bera for holding this hearing, especially
given we are in the middle of flu season.
In the United States, nearly a million individuals are
hospitalized for the flu every year, including more than 48,000
children. In Oklahoma, since the 2019 flu season began on
September 1st, there has been one death and 73 hospitalizations
from the flu. However, these numbers would be far worse if we
did not have vaccines. Vaccination is, by far, the best flu
prevention measure we have today.
It is easy to forget that a little over a hundred years ago
the world faced one of the deadliest pandemics in history - the
1918 H1N1 pandemic, also known as the ``Spanish flu.'' It
killed an estimated 50 million people worldwide, including
roughly 675,000 people in the United States. Medical technology
and countermeasures at the time were limited to isolation and
quarantine. Influenza vaccines did not exist, and antibiotics
had not been fully developed yet.
Thankfully, due to basic research, advancements were made
both in treatment and prevention of the flu. The development of
vaccines has played an important role in reducing or
eliminating deadly disease. I can still recall my father's old
stories about how late summer and fall was a terrifying time as
a child because of the threat of polio during those seasons.
Lucky for me, I did not have to experience living with this
fear because the first polio vaccine became available in the
United States in 1955.
And thanks to widespread vaccination, polio has been nearly
eradicated in the United States, with just 33 cases reported in
2018. However, polio remains a threat in some countries. With
the world becoming more connected through modern
transportation, it only takes one traveler with polio to bring
the disease into the United States. As I'm sure we will hear
this morning from our witnesses, the best way to keep the
United States polio-free is to maintain high immunity through
vaccination.
Considerable advancements have been made in health
technology, disease surveillance, medical care, medicines and
drugs, vaccines and pandemic planning. While significant
progress has been made, gaps remain, and a severe pandemic
could still be devastating to the global population.
As the human population has grown, so has the livestock,
swine and poultry populations to feed them. This expanded
number of hosts provides increased opportunities for unique
viruses from birds, cattle, and pigs to spread, evolve and
infect people.
As a Member of the House Agriculture Committee, I supported
the creation of the National Animal Vaccine and Veterinary
Countermeasures Bank, which was included in the last Farm Bill.
This vaccine bank will maintain sufficient quantities of animal
vaccines and other countermeasures to provide a rapid response
to an animal disease outbreak. If an outbreak were to occur and
we were not prepared, our entire agricultural sector would
suffer immense losses, causing long-term harm to the economic
viability of U.S. livestock, poultry and swine production - not
to mention the damaging effect on human health.
I look forward to hearing from our witnesses today about
the current state of our stockpiles of human health vaccines to
provide the capacity for rapid response in emergency
situations. I particularly look forward to hearing how BARDA's
Influenza Vaccine Manufacturing Infrastructure is supporting
public-private partnerships with domestic vaccine manufacturers
to increase preparedness levels and response capabilities for
potential pandemic flu events in the United States.
Lastly, I would just like to say how pleased I was to see
the President's recent Executive Order to address modernizing
flu vaccines. The Executive Order recognizes influenza as a
public health and national security priority with the potential
to inflict harm on the United States through large-scale
illness and death.
Most importantly, it establishes a national task force to
explore alternative vaccine production methods and new
technologies - including a plan for accelerating the
development of a universal flu vaccine. I look forward to
seeing what recommendations come from the task force.
I would again like to thank Chairwoman Johnson and Vice-
Chairman Bera for holding this hearing. I would also like to
thank both witness panels for taking the time to be here to
share your expertise and insights with us this morning.
I yield back the balance of my time.
Chairwoman Johnson. Thank you very much.
If there are Members who wish to submit additional opening
statements, your statements will be added to the record at this
point.
At this time I will introduce our witnesses. Our first
witness on the panel is Dr. Daniel Jernigan. Dr. Jernigan is
the Director of Influenza Division for the National Center for
Immunization and Respiratory Diseases at CDC. Dr. Jernigan is
responsible for oversight and direction of a broad scientific
program to improve detection, prevention, treatment, and
response to seasonal, novel, and pandemic influenza. The
Influenza Division is responsible for national and global
surveillance of influenza and serves as a World Health
Organization collaborating center for the surveillance,
epidemiology, and control of influenza. Dr. Jernigan entered
the CDC in 1994 and is a retired Captain of the U.S. Public
Health Service and was the recipient of the 2019 Service to
America Medal.
The next witness on this panel is Dr. Anthony Fauci. Dr.
Fauci is the Director of the National Institute of Allergy and
Infectious Diseases (NIAID), a position he's held since 1984.
He oversees an extensive research portfolio of basic and
applied research to prevent, diagnose, and treat established
infectious diseases such as HIV/AIDS, respiratory infections,
diarrhea diseases, tuberculosis, and malaria, as well as
emerging diseases such as Ebola and Zika. He also supports
research on the transplantation and immune-related illnesses,
including the anti-immune disorders, asthma, and allergies. He
has advised six Presidents on HIV/AIDS and many other domestic
and global health issues. He was one of the principal
architects of the President's Emergency Plan for AIDS Relief, a
program that has saved millions of lives throughout the
developing world.
As our witnesses should know, you will each have 5 minutes
for your spoken testimony. Your written testimony will be
included in the record for the hearing. When you've completed
your spoken testimony, we will begin with questions. Each
Member will have 5 minutes to question the panel. We will start
with Dr. Jernigan.
TESTIMONY OF DR. DANIEL B. JERNIGAN, M.D., MPH,
DIRECTOR, INFLUENZA DIVISION, NATIONAL CENTER FOR
IMMUNIZATION AND RESPIRATORY DISEASES,
CENTERS FOR DISEASE CONTROL AND PREVENTION
Dr. Jernigan. Well, thank you very much. Good morning,
Chairwoman Johnson, Ranking Member Lucas, and distinguished
Members of the Committee. I am Dr. Dan Jernigan, Director of
the Influenza Division of the Centers for Disease Control and
Prevention. I want to thank the Committee for the opportunity
to discuss CDC's work supporting vaccine innovations to improve
prevention of influenza.
Each year, influenza causes a significant health burden in
the United States with many millions of Americans becoming ill,
hundreds of thousands requiring hospitalization, and tens of
thousands dying. Influenza viruses are constantly changing,
requiring us to update the vaccine components every year.
Sometimes, these changes can be sudden and significant,
resulting in flu strains that can lead to devastating
pandemics. Hospitalization and death can happen in any flu
season, and each year, flu vaccination prevents millions of
illnesses and thousands of severe and sometimes tragic
outcomes.
Influenza vaccines are very safe, and they remain the
single best way for people to fight the flu. Despite the
significant benefits, the effectiveness of the flu vaccine, and
the numbers of Americans being vaccinated are not optimal. We
at CDC are working with NIH (National Institutes of Health) and
other Federal and State government partners and with the
private sector to use cutting-edge science to make influenza
vaccines better.
The long-lasting broadly protective universal vaccines that
Dr. Fauci will talk about are the ultimate goal for flu
prevention. However, these vaccines are still years away. In
the near term, we can save millions of Americans from the flu
by making incremental improvements to vaccines that can be
produced using already available production platforms and by
getting more Americans vaccinated each flu season.
CDC has a central role in every part of the seasonal
influenza vaccine development and administration cycle,
including continuous virus tracking around the globe,
preparation of vaccine viruses, purchasing 10 percent of flu
vaccines used in the United States, and monitoring vaccine
coverage, safety, and effectiveness.
To improve flu vaccines, CDC has implemented innovations
throughout the vaccine lifecycle. CDC has invested in and
collaborated with every State public health department on flu
surveillance. This investment has resulted in automated real-
time electronic laboratory reporting of influenza test results
to CDC using cloud-based messaging.
CDC has transformed flu virus surveillance by using next-
generation genomic sequencing to characterize all influenza
specimens received at CDC. This means we can identify and track
viruses much more quickly and accurately, leading to more
timely selection of candidate vaccine viruses and earlier
detection of viruses with pandemic potential.
Genomic sequencing equipment, which once filled a room, now
fits in the palm of your hand. We now have a mobile mini lab
that can be taken on the plane as a carry-on and set up almost
anywhere in the world, including rural resource-constrained
settings.
CDC has implemented innovations for supporting newer
vaccines by developing candidate vaccine viruses for the cell-
based vaccine and by providing genomic sequences used to make
the recombinant protein vaccine. Both of these newer vaccines
have the potential to be manufactured more quickly and may be
more effective than traditional vaccines that are grown in
eggs.
CDC now also routinely generates vaccine viruses using a
technique called reverse genetics. This allows us to build a
vaccine in a matter of days or weeks, much faster than
traditional methods, making the U.S. more prepared to respond
quickly to a pandemic.
CDC was the first to establish a national system for the
routine monitoring of influenza vaccine effectiveness, and that
vaccine effectiveness network provides critical information for
manufacturers and researchers in developing enhanced vaccines
by collecting more specific data about how well the vaccine
works each season. Recently, we have expanded the network and
are planning to add new immunity testing and conduct more
studies to better evaluate vaccine effectiveness.
Finally, a major component of improving influenza vaccine
impact is getting more people vaccinated. Fewer than half of
adults in the U.S. receive their influenza vaccines. And
despite all of our successes and our global leadership in
influenza detection and prevention, there is still more we need
to be able to do. Each of the topics I mentioned today from
working with domestic public health partners to track and
characterize viruses to developing vaccine candidates and
studying vaccine effectiveness will benefit from investments in
generating more precise and timely data. I believe we can
harness this data to make vaccines work better.
I want to close today by reminding you all to make sure
that you and your families are vaccinated before the holiday
travel begins. And thank you for the opportunity to talk about
CDC's influenza work, and I look forward to your questions.
Thanks.
[The prepared statement of Dr. Jernigan follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Johnson. Thank you, Dr. Jernigan. Dr. Fauci.
TESTIMONY OF DR. ANTHONY S. FAUCI, M.D.,
DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND
INFECTION DISEASE, NATIONAL INSTITUTES OF HEALTH
Dr. Fauci. Thank you very much, Madam Chairwoman, Members
of the Committee. Thank you for giving me the opportunity to
testify before you today. I am Dr. Anthony Fauci, the Director
of the National Institute of Allergy and Infectious Diseases at
the NIH, and I'm going to talk to you over the next couple of
minutes about the NIH's efforts to improve the influenza
vaccines and to ultimately develop a universal flu vaccine.
As shown on this slide, although, as Dr. Jernigan had
mentioned, it's very important to get vaccinated because even
if a vaccine is not 100 percent effective or even 50 percent
effective, the benefit to the individual to get vaccinated and
to the community is profound. However, we can do better because
seasonal influenza vaccines are not consistently optimally
effective. In addition, we know through history that pandemics
occur, but we usually are too late in our response, as we were
in the 2009 H1N1.
And finally, we spend considerable time what I call chasing
after pandemics, as we had with the H5N1 and H7N1, in which we
made significant investments. We needed to do that, but those
pandemics never occurred.
This slide shows a journal, the Journal of Infectious
Diseases, containing a number of papers in which my colleague
and I gave the introduction emphasizing the point that I just
made that although influenza vaccines are good and important
and should be utilized, we can do better. By doing better, we
need to improve the seasonal influenza vaccines, which would
lead to a better capability to respond to pandemic influenza,
which ultimately will get us to the goal that we'll speak about
over the next minute or 2, and that is the development of a
universal influenza vaccine.
In the summer of 2017, we brought a group together to
develop a plan, which we published in 2018, for the strategic
plan and the research agenda to mobilize scientists throughout
the country and the world to develop a universal flu vaccine.
So let me explain what we mean by a universal flu vaccine.
This is somewhat of a complicated slide, but it really does
make the point. We will not get a universal flu vaccine
overnight. I use the word iterative, which means it will be a
step-wise process in which we go from improvement, the broad
capability of responding to a particular type of a strain,
versus the ability to respond to all strains. Note on the lower
left-hand part of the slide it is divided into two major groups
of influenza: Group 1 and group 2.
On the right-hand part of the slide, the tip of that
triangle is what we do today. We make a vaccine for this season
that's highly specific to the strains that are circulating this
season. However, those strains change. They mutate. They drift.
What we want to do is go to the next step, is to make a vaccine
that would cover all the H3N2's or all the H1N1's, and then
next step would be to get one that would do all the group 1's
and all the groups 2's until ultimately we have a universal
vaccine that essentially covers all of these.
We're going to do that with new technologies, as you are
well aware. We currently have a technique of growing the virus
in eggs to develop a vaccine. Although that's tried and true
and time-honored, it's inefficient and has many areas of going
wrong. So we're using new platforms, as shown here on the
slide, such as recombinant proteins, viral vectors,
nanoparticles, and others.
This is a blowup of the influenza virus. And to the right
is an important protein called the hemagglutinin. It is
important to note that the hemagglutinin has two components,
what we call a head and the stem. The head is the part that the
body makes an immune response against. However, it mutates
often, changes leading to the ineffectiveness. However, the
dark blue is the stem, which doesn't change much at all.
So the strategy now, one of several strategies is to
develop a vaccine in which you cut off that head, as shown
there, take the stem, and put it on a nanoparticle, which is
highly immunogenic, which will ultimately serve as the vaccine.
So if I could show you this, this is a 4-million-times
blowup of what the first universal flu vaccine would look like,
and these dark blue areas are the stems.
We have started a phase 1 trial, as shown here, in the
spring of this year. It will end at the end of this year, and
then next year, we will do a group 2 universal flu vaccine.
So as the President said in the executive order, the
purpose of what we're doing is to go ahead and improve little
by little until we get vaccines to protect us in the most
efficient way possible. Thank you.
[The prepared statement of Dr. Fauci follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Chairwoman Johnson. Thank you, Dr. Fauci.
At this point we will begin our first round of questions,
and the Chair will recognize herself for 5 minutes.
Dr. Jernigan, as you well know, there is a well-funded
disinformation campaign sowing confusion and fear in the
public. This campaign carefully targets and preys on different
populations with different belief systems. Innocent children
are falling ill today with diseases we once thought were
eradicated in the U.S. Young women are unnecessarily being put
at increased risk for cancer. And these anti-science forces are
creating a major challenge in future vaccination efforts.
How big of a role does social media play in this
resurgence, and how can we overcome these tactics? And what is
CDC doing specifically to combat these efforts?
Dr. Jernigan. Yes, so certainly at CDC we want to do
everything we can to get more people vaccinated. We know with
influenza that only about half of Americans actually get a
vaccine. Another half still need to get vaccinated. A lot of
the reasons why they don't get that vaccinated for influenza is
because they're worried about the effectiveness of the vaccine.
So with regard to our discussion here, improving the
effectiveness of the flu vaccine certainly would actually I
think get more people to be vaccinated.
Your question is really around the role of misinformation
and social media participating in that. We do think that there
is a lot of information out there. Parents have lots of
different places that they can get information, and a lot of
times they don't know which of it is science-based, which of it
is evidence-based, et cetera.
So I think at CDC our plan is really to try and strengthen
public trust in vaccines by truly trying to get people to be
more confident in the vaccines, getting the information out
there about how effective they are. And that really comes down
to three things: Protecting the community; helping to
understand the differences in these different pockets, these
different communities, what makes them not have as much
confidence in vaccine as they should; and to identify and
develop materials that we can use for those specific
communities, reaching out to key opinion leaders within those
communities.
A second thing would be to empower the parents, that is,
get with the very young parents when they first have children
or with pregnant women. Get them the right information that
they could understand better about the benefits of vaccine and
understand why it is so important to get vaccinated and work
with clinicians so that they have the tools to talk with those
family members as well.
And then finally to stop the myths as much as possible, and
so we do that I think by providing the scientific-based,
evidence-based information that's out there, that's on our
website, and then working to make sure that that can be reused
on multiple different platforms so that people can get that
science-based or evidence-based information.
Chairwoman Johnson. Thank you very much. Dr. Fauci, would
you like to comment on that?
Dr. Fauci. Yes, just to underscore what Dr. Jernigan said.
You know, if you do a survey and find out what is the most
important reason why people don't get vaccinated for influenza,
and it's because of the so-called misperception that it--it
really doesn't work. And I think we need to emphasize that even
though it isn't 100-percent effective, even a modestly
effective vaccine will prevent you from getting infected, will
prevent individuals, particularly those who are susceptible to
complications, will prevent them from getting hospitalized and
may ultimately save their lives. So this perception that the
vaccine doesn't work, really we need to put that aside because
everyone, as Dr. Jernigan said, should get vaccinated.
Chairwoman Johnson. Thank you very much. I'm going to ask
Mr. Lucas to ask his questions.
Mr. Lucas. Thank you, Madam Chair.
Dr. Jernigan, in Oklahoma the State Department of Health
has reported that influenza has already claimed one life and
hospitalized 70 others. Continuing on the comments that you and
Dr. Fauci have made, when I look my constituents in the eye
back home to stress the importance of getting vaccinated and to
prevent the hospitalizations and deaths, can you expand on
that? You're in a town meeting with me, you're looking my
neighbors in the eye, this is rural Oklahoma, you're talking
about things that are to the point.
Dr. Jernigan. Well, certainly we know the burden of
influenza is very high. That is the illnesses and deaths that
occur because of influenza. There are tens of millions of cases
every year, hundreds of thousands of hospitalizations, and tens
of thousands of deaths that occur every year. We know that with
the vaccine that we have you can prevent thousands of deaths
every year and tens of thousands of hospitalizations. It's
important to get vaccinated and not just for yourself because
it also helps protect the community around you.
There are a number of benefits that the vaccine has. It
prevents you from getting sick. It reduces you from having to
be hospitalized with flu. For people with underlying chronic
diseases, it's actually like a prevention tool. It's like
something you should take every year because it can keep you
from getting a second heart attack. So people with underlying
conditions, it helps them as well. It protects pregnant women
and their babies so that those that are born but not 6 months,
ineligible for vaccine, getting the pregnant mother vaccinated
actually helps the baby during that period of time before they
can get vaccinated.
There's data that shows that it's lifesaving in children.
You can actually reduce the chance of death with influenza by
65 percent. So there are a number of things that are important
about it.
Even if it's not 100-percent effective like Dr. Fauci
mentioned, it can reduce the severity of illness that you have
during the flu season if you were to get infected.
Mr. Lucas. Dr. Fauci, my background is in agriculture, and
in that world of course we have the robust National Veterinary
Stockpile, which is prepared to provide farmers and ranchers
with countermeasures against damaging animal diseases such as
avian influenza and swine flu within 24 hours. Could you speak
to the current state of the human vaccine stockpile management
and what we could do to better prepare to address potential
pandemic emergencies?
Dr. Fauci. I would love to do that except that the CDC is
the one who's responsible for the stockpile, so I'll pass that
to Dr. Jernigan.
Mr. Lucas. I flip over to you then, Doc.
Dr. Jernigan. Not to keep passing this, but actually BARDA
is the one that manages the vaccine stockpile----
Mr. Lucas. With the great insight that both of you have----
Dr. Jernigan. Yes.
Mr. Lucas [continuing]. Enlighten us as to what's going on
so we can reassure the folks back home----
Dr. Jernigan. Sure.
Mr. Lucas [continuing]. We're paying attention, that is,
you and your entities are taking care of their best interest.
Dr. Jernigan. Absolutely. So I think in terms of what we do
at CDC, we monitor influenza around the globe, especially the
avian influenza and the swine influenza viruses that are
emerging around the globe. We do that through 143 laboratories
where we detect those. We take that information and use it in a
thing called the influenza risk assessment tool or the IRAT.
You can actually get on your browser and put in IRAT CDC and
see a graph of where we have ranked these different concerning
potential pandemic viruses in that graph.
With that information, we work with the rest of the
interagency to determine which of those should be made into
vaccine candidates, which of them should actually be made into
vaccines and stockpiled, which ones should undergo trials. And
so with that we have made decisions about things to put into
that stockpile so that the U.S. is prepared.
Many of those vaccines, say, for instance, the H5N1
vaccine, it's in the vaccine stockpile. It may be enough to
vaccinate first responders and a few small risk groups.
However, these viruses continue to change, and so it's actually
very important for us to find new vaccine technologies so that
the vaccine stockpile isn't something that just has to keep
getting more and more vaccines put into it but rather upstream
we have fast technologies and be able to make vaccines quickly.
And then ultimately, once there is a universal vaccine, that
may be the best thing for us to prevent pandemics is to have
that available.
Mr. Lucas. In my final moments before I yield back I eluded
in my opening statement to my father's observations in the
1940s and 1950s prior to the development of the polio vaccine
in 1955 how the outbreaks kept seemingly getting worse and
worse and the sheer terror that it brought in the communities
in that late summer season and early fall. My generation was
not alive for that, did not experience that, but it was truly
terrifying.
My first off-farm job when I was 14 was mowing a little
country cemetery, and I had a great-aunt who was the family
historian. And I remember asking her why in one section of the
cemetery, why are all these babies buried? Why are all these
young women buried? She said look at the tombstones. They say
1918 and 1919. The Spanish flu took them all, took them all and
brought, even in rural Oklahoma, society to a grinding halt for
weeks and weeks as this passed through.
My generation, having not experienced any of that,
sometimes doesn't necessarily understand what the potential
downside is and why you gentlemen and all of your colleagues
work so hard.
And thank you, Dr. Bera, for giving us this opportunity to
focus on these issues. And with that, I yield back.
Mr. Bera [presiding]. Yes, thank you to the Ranking Member.
Also thank you to Chairwoman Johnson for allowing me to be a
doctor today.
And, yes, there are a couple hearings happening on the Hill
today. I think this is the most important hearing that's taking
place actually today, and I think that's why all the cameras
are out in Longworth.
You know, just thinking about it, to both Dr. Fauci and Dr.
Jernigan, you know, my home district and my home State senator
is Dr. Richard Pan, a colleague of mine and, you know, we're on
the frontlines of trying to combat some of the disinformation
that is out there.
And I just want to run through a couple quick yes/no
questions. Is there any scientific evidence that vaccines lead
to increased risk of autism, Dr. Fauci?
Dr. Fauci. Absolutely not.
Mr. Bera. Dr. Jernigan?
Dr. Jernigan. No.
Mr. Bera. You know, when I was practicing, I would talk to
some of my patients. They would often come back at me and say,
well, I don't want to get the flu vaccine because I had it
before and it caused the flu. Dr. Fauci, is there any evidence
that the flu vaccine causes the flu?
Dr. Fauci. The flu vaccine does not cause the flu.
Mr. Bera. Dr. Jernigan?
Dr. Jernigan. I agree the flu vaccine does not cause the
flu.
Mr. Bera. Great. And, you know, the whole point of science
is to pursue the truth, and I think it's important for us to
dispel some of these myths. There are legitimate reasons for a
small cohort of individuals, you know, if they have allergies
to eggs, et cetera, to opt out of the vaccine.
But, you know, one of the most important things about why
it is important--let's use measles as an example to vaccinate a
large population of folks--is the concept of herd immunity. And
I think it's important for the public to understand that
particular concept. Dr. Fauci or Dr. Jernigan, whoever--would
you, you know----
Dr. Fauci. It's a very important concept not only for flu
but, I mean, our recent unfortunate experience that we had in
this country particularly in New York City in the Williamsburg
section was a classic example of what happens when the umbrella
of herd immunity goes down below a certain level because you
had a community in which the level of vaccination was somewhere
between 70 and 80 percent. For measles you need somewhere
between 91 and 93 or more percent of the community so that when
someone inevitably comes in from the outside or someone travels
and brings back measles, if the community isn't protected by
that herd immunity, you get the very unfortunate situation
which we saw in the Williamsburg section of Brooklyn.
Mr. Bera. What are current measles vaccination rates in
America?
Dr. Fauci. It's over 90 percent.
Mr. Bera. OK. So we want to keep that. And measles was a
disease that, you know, for the most part we had eradicated in
America, and now we're starting to see the incidence starting
to pop up again.
I guess for Dr. Jernigan, you know, I'll often hear
individuals say, well, you know, we don't really need these
vaccines or the flu vaccine because we haven't had a pandemic
like the Spanish flu for 100 years. Can you talk a little bit
about why we've been so lucky?
Dr. Jernigan. Yes. So I think with the pandemic influenza,
this is a situation where the flu viruses that are actually
circulating in animals can actually mix with those flu viruses
that are in humans. And when they do that, they share their
genes and can create a flu virus that has not been seen before.
That means that it can spread very quickly through the
community, and often it can cause severe deaths and illnesses
and hospitalizations. The 1918, like was mentioned, was one of
the worst. That one clearly caused at least probably 675,000
deaths in the United States.
We've had three other pandemics in the last 100 years.
Those were with changes in the vaccine that were not as bad. We
at CDC have looked at the 1918 virus and found that there are
particular changes in that virus that really made it severe. So
there's nothing preventing that from happening again, so for us
it's important to maintain the vigilance so that we can see
what's happening, maintain the ability to have vaccine
available quickly so that we can get it and be able to prevent
influenza and severe influenza if we were to have another
pandemic.
Mr. Bera. And in today's interconnected world where people
move across boundaries, having two big oceans are not
necessarily protective for us.
Dr. Fauci, you and I had the opportunity to work together
around the 2014 Ebola outbreak in West Africa. Can you talk a
little bit about the evolution and development of an Ebola
vaccine and how that's helped us, you know, in the 2017
outbreak in Western Congo and, you know, and giving us an
ability to better manage Ebola?
Dr. Fauci. Well, back in the 2014 to 2016 outbreak in West
Africa of Ebola, during that period of time we, together with a
variety of other agencies, including the CDC and other
international agencies, began the testing of a vaccine called
VSV, which now is ultimately made by the company Merck. So at
that time we did phase 1 studies right here in the United
States. We did it at the NIH in our campus. Some were done in
Europe, and then we did it in West Africa. We advanced to phase
2. The CDC did a study in Sierra Leone. We did one in Liberia,
and then ultimately it was shown in a ring vaccination study in
Guinea to actually be effective in preventing infection,
particularly those who were exposed. That vaccine has now been
used in the Democratic Republic of the Congo (DRC), and over
245,000 doses have been given in a contact ring vaccination
approach.
It is very clear that if in fact we didn't have that
vaccine, we would be in a much worse situation than we found
ourselves in in the Democratic Republic of the Congo. And, as
you well know from the reports coming out from the CDC, the
number of cases per week of Ebola have gone down and down and
down. We're not through with it yet. It's still there, but the
vaccine has played a major role in being able to prevent the
explosion that we saw in West Africa.
Mr. Bera. Well, Dr. Fauci, Dr. Jernigan, thank you for your
service to our country. And just in closing, vaccines are safe,
vaccines are effective, and vaccines save lives.
So with that, Mr. Posey.
Mr. Posey. Thank you. And I'm grateful to the Chair for
holding this hearing.
Flu shots can play a very important role in protecting the
public from the flu and reducing its spread. I want to focus my
comments on a 90-year-old policy which should have ended
decades ago. Why do we still have mercury in millions of flu
vaccines that are given to infants, toddlers, and pregnant
women?
In July 1999 the Public Health Service, the American
Academy of Pediatrics, and vaccine manufacturers issued a joint
statement agreeing that thimerosal-containing vaccines should
be removed as soon as possible.
And at this point I have a number of documents that I would
like to include in the record by unanimous consent. First is a
bibliography of studies raising safety concerns about
thimerosal, which is vaccine mercury; second, a report from the
Children's Health Defense outlining some of the misconceptions
about mercury in vaccines, clearing up some misconceptions;
third, a 1999 joint statement of the American Academy of
Pediatrics and the U.S. Public Health Service calling for the
immediate removal of mercury from all vaccines.
In 2004 the Institute of Medicine recommended removing
mercury from all vaccines administered to pregnant women and
children. By 2003 mercury was removed from vaccines in the
United States. Yet a year later the CDC recommended the flu
vaccine for children 6 months to 36 months of age but refused
to state a preference for mercury-free vaccines, thus
reintroducing mercury to the childhood vaccine schedule.
In 2006 California passed a law banning mercury-containing
flu vaccines for pregnant women and children under 3. In 2009,
much to the credit of Chairwoman Johnson, a bill was introduced
banning mercury from power plants, and I think what she said
then is even more pertinent to vaccinations, that mercury is a
neurotoxin. Even at low levels, mercury can have an adverse
health effect, particularly on women of childbearing age and on
developing fetuses.
Dr. Fauci, you worked with my predecessor Dr. Dave Weldon,
and I reviewed your testimony from October 5, 2004. That
hearing was on removing mercury from flu vaccines. During that
hearing, CDC Director Gerberding, the FDA's (Food and Drug
Administration's) Dr. Egan, and you all agreed and you stated
repeatedly, ``We are moving rapidly to thimerosal-free
vaccines.'' And you also said, ``The better part of it is that
if you can move to a vaccine preparation that is absolutely
risk-free with regard to mercury, then you should do it.''
The public concerns are still there. Mercury is in fact a
neurotoxin. Babies, unborn and newborn, are at a critical stage
of neurodevelopment. The one change is when the flu vaccine
became a recommended shot. Manufacturers were automatically
protected from all liability and accountability by lawsuits.
Now they have no incentive to remove mercury.
I read over the flu vaccine package insert for flu vaccine,
and each one says it has not been tested for safety in pregnant
women. Common sense said that we should err on the side of
safety.
Dr. Fauci, you testified to that 15 years ago. The failure
to completely remove mercury feeds the fear and takes a
backseat to saving a few bucks each shot. What steps are being
taken by you as a leader in the public health community to
move, quote, ``rapidly to mercury-free vaccines,'' close quote?
Or is it no longer a priority? And when can we expect it to be
completed?
Dr. Fauci. I don't think I can answer directly the question
of when it will be completed. Just getting back to the
discussions that we had years ago in the Committee, I said then
and I would say it again that the optimal situation would be to
have thimerosal-free vaccines, mostly as I mentioned at that
hearing, which you didn't say, was that was mostly for the
peace of mind of people, but the scientific evidence that that
is a harmful amount of this material in the vaccine does not
indicate that.
The issue with the thimerosal--and I'll let Dr. Jernigan
also comment on that with regard to the CDC--is that it is in
very, very few vaccines and only in multidose components. In
the multidose component, the balance of the risk of getting a
contamination of a bacteria, which we know can occur if you
don't put something like thimerosal into the vaccine, versus
the risk of a deleterious effect of thimerosal, which is really
ethylmercury and not methylmercury, clearly balances the favor
of making sure you protect from infection the multidose vials.
Dan, maybe you can amplify that a bit.
Dr. Jernigan. Yes, I think it's important to know that CDC
is committed to assuring that vaccines in the United States are
safe. Currently, this year there's projected to be 169 million
doses of influenza vaccine, and we understand that only about
15 percent of that is the thimerosal-containing multidose
vials. So those that would like to have a thimerosal-free
vaccine, actually the vast majority of vaccine that is
available are the prefilled syringes, the single-dose vials.
Mr. Posey. My time is expired. Thank you.
Mr. Bera. Thank you. Before I recognize Mr. McNerney, just
a quick question.
Mr. Posey raised a couple issues and maybe just yes/no
answers. Is the flu vaccine safe for pregnant women?
Dr. Fauci. Yes.
Dr. Jernigan. Yes, absolutely.
Mr. Bera. Is the flu vaccine safe for infants and children?
Dr. Fauci. Yes.
Dr. Jernigan. Yes.
Mr. Bera. Great. With that, I'd like to recognize the
gentleman from California, Mr. McNerney.
Mr. McNerney. The neighbor from California. Thank you,
Chairman. I thank the witnesses this morning.
Dr. Fauci, how can computational data scientists partner
better with microbiologists to accelerate the research?
Dr. Fauci. Well, I mean, computational biology is a
discipline that essentially impacts on virtually all of the
biological issues we do, so we can do computational biology
when we do the sequencing of various strains of virus that come
in and that you want to make a vaccine for. In fact, I think in
his opening statement Dr. Jernigan had mentioned the fact that
the capability both of the CDC and the NIH to do mass
sequencing of a variety of quasi-species of any virus,
including influenza, relies on computational biology to be able
to get to the next step in developing a vaccine.
Mr. McNerney. Is the symmetry pattern of this nanoparticle
significant in any way?
Dr. Fauci. Yes, I mean, actually what it is is that the
display of multiple components of that stem create the ability
to engage what we call the B cell repertoire of the immune
system so that the chances of it hitting the B cells that will
ultimately respond to give you the kind of an antibody response
you want, that's a highly immunogenic approach. And
nanoparticle approaches to any vaccine is really the wave of
the future.
And that's what we're trying to do to get away from the
situation of having to grow a complete virus and use that as
the vaccine the way we're doing in eggs. Here, you use
recombinant DNA technology, and you show the immune system only
that part of the virus that you want it to respond to and you
avoid all of the other distracting immune responses. That's why
the scientific community is so excited about those new
technologies.
Mr. McNerney. Thank you. Dr. Jernigan, following up on Dr.
Bera's question, if we find ourselves in a pandemic outbreak,
how quickly with existing technology can vaccines be produced
to catch up with the outbreak?
Dr. Jernigan. An example I think is in 2017 when there was
the identification of a very bad H7N9 influenza virus that
started to circulate among poultry in China. It ended up having
almost 2,000 human cases that were exposed to them. We were
able to receive the virus sequence directly from colleagues in
China. And with that, we were able to use reverse genetics like
I mentioned before to actually build the vaccine virus. CDC has
the capability to do that under good laboratory practices
conditions at CDC and then be able to hand that vaccine virus
to the manufacturers. We can do that very quickly, within a
matter of days to weeks.
However, once we hand it off to the manufacturers, they are
bound by the existing manufacturing capabilities that they
have. About 18 percent of all manufacturing right now is in
non-egg-based manufacturing. The rest is egg-based
manufacturing, which takes at least 6 months. And so getting
things to be quicker is going to be an important national
security thing for us to be able to respond more quickly.
Mr. McNerney. Thank you. Can you address the autoimmune
reaction to influenza vaccines--and forgive my pronunciation--
such as Guillain-Barre syndrome?
Dr. Jernigan. I'll let you do that if you want.
Dr. Fauci. So there has been a rare association of cross-
reactivity between some of the antigenic components of a
vaccine and certain tissues in the body. Again, and this has
not been clearly proven yet, but in one of the vaccines that
were available for the H1N1 flu of 2009, there was the
suggestion that one of the peptides that's associated, which is
part of a protein that was associated with the vaccine, induced
the response that cross-react with a substance--I hate to use
these big words for you--we use a substance called hypocretin,
which is one of the neuropeptides that's involved in
narcolepsy. So the autoimmune phenomenon of that has been
discussed, disputed, but not really definitively proven. So
what it is is that when you expose the body to a protein, it
recognizes it as something that's similar to what's in your
body and makes an autoimmune response against it.
Mr. McNerney. Well, my son had a pretty scary reaction to
his second DPT injection. Can you speak to that? It was a
seizure that was pretty scary, maybe not dangerous but scared
the hell out of us.
Dr. Jernigan. Certainly. I mean, febrile seizures is a
known reaction just to a number of different vaccines, and I
don't know the particulars, but that is something that is
possible.
Mr. McNerney. Is it dangerous?
Dr. Jernigan. No. For the most part it's something that
does not have a lasting impact.
Mr. McNerney. OK. Thank you. I yield back.
Mr. Bera. I recognize Mr. Baird.
Mr. Baird. Thank you, Mr. Chairman. And we appreciate you
witnesses being here and sharing your expertise.
So my first question, Dr. Jernigan, deals with, in your
testimony you mentioned the development of a mobile mini lab
cloud-based platform that can be set in a remote resource-
limited settings to process test virus specimens and to send
that genomic data up to a cloud for further analysis and
action. So could you elaborate on how this cloud-based platform
would allow public health officials to address outbreaks
quicker and more effectively in a largely rural area like my
4th congressional District in Indiana?
Dr. Jernigan. So, yes, I think we were referring to the use
of these micro-technologies like this one here, which actually
is a sequencer. And so you actually take the specimen, prepare
it in some little boxes that we take that fit into a carry-on
on a plane. You prepare them, and then you just simply inject
it in you. There's a way that you can actually do what's called
barcoding of the specimens and do multiple specimens at one
time. And with that, you get a sequence. And the sequence just
tells you the genes of the influenza viruses.
So this is something that we have demonstrated in various
different settings. We actually did take it to Iowa to a swine
fair where we actually swabbed a number of the show pigs and
that we were able to quickly determine if they had influenza,
the swine influenza that was circulating among that group.
That data plugs into a laptop through this little USB port,
and then on the laptop it runs a lot of the information and
prepares the signal that gets sent up to the cloud where we
have a process called IRMA. IRMA is a tool, a pipeline tool
that actually takes the data and uses machine learning and
artificial intelligence to try and determine which of the flu
viruses are actually in the sequences. That information then
gets pulled down by our bioinformatics staff at CDC where they
can then, if needed, generate a vaccine virus. And so this
allows us to take the tool to the place where the problem is
occurring rather than having to try and figure out how to get
viruses to the CDC.
Mr. Baird. So to take that one step farther, you could
regionalize or wherever you collected your data, then you could
develop a vaccine specific for that area is what----
Dr. Jernigan. It's possible.
Mr. Baird [continuing]. More quickly----
Dr. Jernigan. The manufacturing process would let you
probably not be able to do that, but yes, you can tailor what
you know about in certain regions. I think Dr. Watkins will
probably get into some of the data issues in the subsequent
testimony.
Mr. Baird. So you mentioned pigs, and I have a background
in agriculture, so when you were swabbing those pigs, any
thoughts on the African swine fever?
Dr. Jernigan. Yes, so African swine fever is something
that's different than the swine influenza, and so I'm not an
expert in the swine fever, but certainly these same kinds of
technologies could be used anywhere in the world to do that
kind of detection.
Mr. Baird. Thank you. Dr. Fauci, do you have any thoughts
on that area?
Dr. Fauci. Yes. The point that Dr. Jernigan made, it's
interesting. I'm in some respects glad you brought that up
because we constantly get people confused between African swine
fever and influenza that's in pigs that could recombine with an
influenza to give us a pandemic. It has absolutely nothing to
do with that, but sometimes people get confused when they hear
the word African swine fever, which is really completely
unrelated to influenza.
Mr. Baird. And I appreciate that. That's part of the reason
I mentioned that. So I thank you. I yield back.
Mr. Bera. Thank you. Let me recognize Mr. Foster.
Mr. Foster. Thank you, Mr. Chairman. And thank you to our
witnesses.
Let's see. Back to the nanoparticle universal influenza--
can you, I guess, Dr. Fauci, say a little bit about the nature
of the nanoparticle and how you actually bond the stem sections
to the nanoparticle?
Dr. Fauci. Yes, it's very interesting. It's a beauty of
nature. It's a self-assembling ferritin particle, the ferritin
protein from a bacteria. And what it does is that when you
combine the genes of both, when they express themselves, they
express themselves as the nanoparticle, which symmetrically has
the----
Mr. Foster. Bonding site, so----
Dr. Fauci [continuing]. Stem of the hemagglutinin----
Mr. Foster. So they just fit properly?
Dr. Fauci. They just fit properly.
Mr. Foster. They fit in the--OK.
Dr. Fauci. You know, it's--I hate to use this word, but
it's almost like a miracle of the natural selection----
Mr. Foster. All right.
Dr. Fauci [continuing]. Becoming----
Mr. Foster. So the nanoparticle is actually just a larger
protein----
Dr. Fauci. Exactly.
Mr. Foster [continuing]. Folded in the specific----
Dr. Fauci. Precisely.
Mr. Foster [continuing]. Geometry.
Dr. Fauci. Right.
Mr. Foster. OK. And now, if I was reading your slides
correctly, the stem section is highly preserved but not
absolutely preserved?
Dr. Fauci. Right.
Mr. Foster. And so are you then going to need several
versions of this or are there dozens of versions or--just in
terms of the stem variability?
Dr. Fauci. We don't know, but we believe that we will not
need very much because even though it's not completely
preserved, we don't believe that the mutations that occur in
the stem have a functional relevance in making it different
from one to the other. So everything we've done so far where
we've looked at the stem and we just recently completed a
series of experiments where you made antibody against multiple
components of the stem, and then you uses antibodies to screen
the entire group of the group 1, which contains 10 of those
H's, and it just neutralized every one of them. So we think--
not 100-percent sure--that if we get a series of antibodies
against multiple components of the stem, we could probably
knock out an entire group. And there are two major groups. So I
think we're going to need at least two, but I don't think we're
going to need 10.
Mr. Foster. OK. Fascinating. And you mentioned--this is in
phase 1 clinical trials at NIAID Vaccine Research Center, which
is----
Dr. Fauci. Yes.
Mr. Foster [continuing]. And that's human safety?
Dr. Fauci. Yes.
Mr. Foster. And has it proven effective in animals?
Dr. Fauci. Yes. Yes. Yes.
Mr. Foster. OK. And so it's all the way through safety and
effectiveness in animals and is at safety in humans right now?
Dr. Fauci. Right. What we showed in animals is that when
you injected it into the animal, you got a complete array of
antibodies against the whole panel of the flu. You don't
challenge them with every single one, but you know you have a
protective level of antibody.
Mr. Foster. Fascinating. OK. Changing the subject a little
bit, Dr. Jernigan, can you say a little bit about the unique
challenge of achieving high rates of immunization in immigrant
populations where they very often have a lot of reticence to
connect to anything official because of the demonization of
immigrant communities?
Dr. Jernigan. Relative to my earlier comments about ways to
protect the community as a form of increasing vaccine
confidence, certainly there are communities that don't value
the vaccine, and so I think the better way to get at those
groups is to really identify what are the factors that are
leading them not to get vaccinated.
Mr. Foster. In the case of immigrant communities, you know,
frankly, following the 2016 election, I talked to principals in
minority communities in my district who were turning kids away
from school because they were not being immunized because they
were terrified that ICE (Immigration and Customs Enforcement)
was going to come get them if they got their kids immunized.
And these are kids that are U.S. citizens, but they have
someone in their family who might be undocumented. And is that
something you see? Do you monitor the rates of non-immunization
in different populations, and do you see an effect?
Dr. Jernigan. I don't know if we have that information. We
do look at immunization coverage and look at it by race and
ethnicity. But in terms of the specifics around immigrant
communities, I don't know that we have that information.
Mr. Foster. OK. Yes, if you could do a little----
Dr. Jernigan. I can get back to you on that.
Mr. Foster [continuing]. And get back to us, I'd appreciate
it.
Let's see. Finally, you had mentioned that it was the meat
industry in various forms that was a major player in the
spreading pandemics and having the viruses. Now, in a world
where you had artificial vegetable-based meat, which is one
that a lot of people dream about, is that something where you'd
be intrinsically less prone to pandemics?
Dr. Jernigan. So influenza viruses are in reservoirs, and
so humans are one of those reservoirs, and there's, you know,
human-specific influenzas that circulate among humans. The
biggest reservoir is among birds, and the biggest reservoir
among birds is migratory waterfowl, and so ducks and geese----
Mr. Foster. OK. So we're without----
Dr. Jernigan. So----
Mr. Foster [continuing]. Migratory----
Dr. Jernigan. Yes.
Mr. Foster. That's not something anyone really wants.
Dr. Jernigan. That would be very difficult to try and get
rid of, yes.
Mr. Foster. OK. Thank you. I yield back.
Mr. Lucas. Would the gentleman yield?
Mr. Foster. Absolutely, I'll yield my negative 2 seconds.
Mr. Lucas. That's wonderful. One of the great challenges
those of us in the agriculture industry deal with are migratory
birds and migratory animals who move around from Canada to
Central and South America. They are the thing that we're most
frightened about because in their overflights they deposit
little presents as they go along.
Which then are subject to consumption by other forms of
livestock that have similar characteristics to the rest of us.
So that's an issue that causes us great angst not--maybe that's
just the best place to leave it.
Mr. Bera. Great. Let me recognize Mr. Gonzalez.
Mr. Gonzalez. Thank you. Thank you for calling this
hearing, and thank you to our panel for all your work. I'm a
somewhat new father, 19-month-old son, and obviously the flu
with respect to our children is something that's near and dear
to my heart and many hearts in this room and across the
country.
According to a Wall Street Journal article, CDC estimated
that over 27,000 children ages 4 and younger were hospitalized
with the virus and 118 died in the 2017 to 2018 flu season.
Clearly, these are troubling for any parent, I think the
uncertainty maybe more than anything. And while immunization
levels in the U.S. are relatively high, gaps still do exist.
And providers can do more to increase immunization rates among
their patients and their colleagues.
According to the CDC, fewer than 70 percent of healthcare
providers receive the influenza vaccine each year. How does the
CDC engage with healthcare providers to promote vaccination?
Dr. Jernigan. So certainly through a number of different
studies CDC has identified that the one way to get patients
vaccinated is to make sure that the healthcare providers are
promoting the vaccine as well. If you look at the coverage
among healthcare providers, it falls into different kinds of
categories. The more you are at an academic hospital, the more
likely you're to be vaccinated as a healthcare provider. The
more training you have--physicians have upwards of 90 percent.
The farther you get away from a hospital and the lower the
training like an aide at a long-term care facility----
Mr. Gonzalez. Got it.
Dr. Jernigan [continuing]. Those are the ones that are not
being vaccinated. We clearly want to get the message out that
those folks really need to get vaccinated.
Mr. Gonzalez. Great. And then additionally, in the last
decade it's predicted that fewer than 50 percent of Americans
actually get the shot. What research has been done or are you
all doing just to get a sense of why folks aren't actually
getting vaccinated?
Dr. Jernigan. So----
Mr. Gonzalez. I'm trying to identify root causes here.
Dr. Jernigan. Yes, so there are periodically focus-group
testing that gets done on different groups to try and find out
what the reasons are. The main reason that we've identified in
the last few years is the effectiveness of the vaccine. People
don't think it's as effective as it should be, and that's
keeping them from getting vaccinated.
We know now that there are more places to get vaccinated
than ever, so access is one of those things that may have been
a problem but certainly we're getting over with now.
Mr. Gonzalez. OK. And then NIAID has prioritized the
development of universal influenza vaccines and has highlighted
its research strategy toward this goal in the Strategic Plan
For a Universal Influenza Vaccine. In your testimony you
highlight that one of the main challenges facing the goal of
producing universal vaccines is improving vaccine production
strategies. Could you tell us about plans to address this
challenge and keep working toward a universal vaccine?
Dr. Fauci. Yes. Thank you for that question, Mr. Gonzalez.
Yes, that was the point I was trying to make, that we really
need to switch into different what I call vaccine platforms. In
other words----
Mr. Gonzalez. Yes.
Dr. Fauci [continuing]. Not to require to having to decide
on a strain in February and then take 6-1/2 to 7 months to get
it grown and processed to be able to put it in a vaccine,
whereas if you do the kind of platform such as the
nanoparticle, which is one of several platforms.
So as part of our strategic plan that I articulated in that
document that you mentioned is to try and develop and perfect
various platforms so that we can get away from the burden of
having to grow the virus.
Mr. Gonzalez. Thank you. And I will yield my remaining
time.
Mr. Bera. Let me recognize Ms. Stevens.
Ms. Stevens. Thank you so much for this insightful panel,
and thank you, Dr. Bera, as well for bringing us all here
together.
We heard a little bit today that despite strong efforts in
both the public and private sector that a universal flu vaccine
remains elusive. What scientific advances do you see on the
horizon to improve the flu vaccine?
Dr. Fauci. Yes. I believe the scientific advances will be
what I was showing on one of the slides of ultimately being
able to develop a vaccine that would induce a response that
would have broader coverage. You know, I was just actually
speaking to one of the scientists who made a breakthrough
discovery yesterday when he visited the NIH, Dr. Ian Wilson
from the Scripps Clinic. And in 2009 he developed an antibody
from a person who was infected with flu, and it bound very,
very clearly to a particular component of the stem antibody,
which was interesting. And then he found out that not only did
it neutralize the virus that the person was infected with, it
neutralized all of the viruses in that particular group, which
is the group 1, 10 viruses. That was the scientific
breakthrough that allowed us to go to the next step of a
universal flu vaccine. So it's breakthroughs like that that I
predict over the next few years will make it easier and easier
to get to the ultimate goal of a universal flu vaccine.
Ms. Stevens. Dr. Jernigan, did you have any----
Dr. Jernigan. Yes, I think in terms of the near-term kinds
of things, I think what we've been looking at, the main problem
in the influenza vaccine right now is one of the virus
components. We can only put four different components in the
vaccine and one of them called H3N2, that's the problem child
of the vaccine. And so that one we know that when you put it
into eggs to manufacture, which is 85 percent of all
manufacturing, it ends up changing that influenza virus so that
it no longer looks as much like the circulating viruses that
are infecting people. So the use of the egg-based manufacturing
is introducing some changes that may be having an effect on the
effectiveness of the vaccine itself. So moving to cell-based
vaccines, moving to recombinant vaccines may be quicker and may
actually make the vaccine to be looking more like the H3N2
viruses that are actually circulating.
Ms. Stevens. Can the Federal Government play a role
particularly in terms of the tools that are being developed to
monitor the effectiveness and safety of our vaccines?
Dr. Jernigan. Absolutely. I think at CDC we have a vaccine
effectiveness network that we manage. And that one we've been
able to expand some, but I think expanding that much greater
would allow us to be able to get information about how the
vaccine is working better or worse in certain age groups,
certain parts of the country, certain types of individuals. It
would give us a lot more information to know how to make the
current vaccines better.
Ms. Stevens. Yes. And then in your testimony, Dr. Watkins,
you mentioned that public health data infrastructure is a
little outdated and it hinders our ability to prevent outbreaks
before they occur and it hinders our ability to respond rapidly
when they do occur. And it also hinders, you know, just our
overall ability around surveillance data. Could you just speak
a little bit about--or tell us a little bit about the--and Dr.
Watkins isn't here--sorry. I'm so eager for Dr. Watkins, and
you're both looking at me like Dr. Watkins isn't here. But one
of you could talk about data infrastructure and, you know, we
will also pay note to Dr. Watkins when she arrives.
Dr. Jernigan. I think that over time we have seen that
there's been an improvement in the use of data at healthcare
facilities through electronic health records, et cetera, but
the public health establishment has to receive information from
multiple different sources. And right now there's not a really
standardized or common way that that information can come in.
Plus, it's hard for a State health department to be able to
quickly get the information they need to know, is this a case
of whatever particular reportable disease? Do I need to
intervene quickly? Has this person been vaccinated?
From a flu perspective, we currently get real-time
information about influenza-like illness from a number of
different sources, but only about half of that is real-time.
The other is doctors filling out forms and things. If we were
able to get real-time information from all of those providers
regularly, we would be able to know exactly what's happening
with flu at a much more local level, more precise data, more
actionable data for decisionmaking.
Ms. Stevens. Thank you, Dr. Jernigan. And, yes, it is the
race for information and data in this modern age. Thank you,
Mr. Chairman. I yield back the remainder of my time.
Mr. Bera. Thank you. Let me recognize Dr. Babin.
Mr. Babin. Thank you. Dr. Chairman. I appreciate you.
And thank you two gentlemen for being here, your expert
testimony.
I just wanted to ask you, Dr. Jernigan, first, what are
some of the emerging technologies and practices being developed
to identify different pathogens, targets, and modernize the
delivery of vaccines? And pardon me if you've already answered
questions like this, but I have a markup on a different floor
in the same building, so I just came in.
I'm a dentist, and one of my colleagues down here asked me
if there were vaccines to eliminate cavities and would I be
against those. He said that in jest, of course, but we
encourage Halloween and things like that for.
Dr. Jernigan. So with regard to the diagnostics--I'm not
going to address the cavity issue, but in terms of diagnostics,
so CDC currently maintains a thing called the International
Reagent Resource, which is an online storefront that all of the
public health departments in the United States and 143
laboratories around the globe are able to go on and order
standard reagents that CDC makes so that we know that the globe
is actually doing the same kind of testing for influenza so
that we can use that information quickly. That uses a process
called PCR or polymerase chain reaction, which is a common way.
We're currently updating that to get to some newer kinds of PCR
devices. But what's really been game-changing is the ability of
genomic sequencing.
Mr. Babin. Right.
Dr. Jernigan. And so CDC has established three national
influenza reference centers at three public health labs in the
United States where they do all of that genomic testing so that
we can pick up emerging antiviral resistance, viruses that
might be a pandemic, a virus that's emerging, those kinds of
things so that we can act more quickly.
Mr. Babin. Thank you very much. That's very fascinating.
And what are the main scientific and technological hurdles
that stand in the way of the development of a universal
influenza vaccine? I caught the tail end of somebody's question
that had a similar one like that. And how are you working to
overcome these, Dr. Jernigan, if you would. I'm going to ask
him one here in just a second.
Dr. Jernigan. Well, certainly. I'll let Dr. Fauci talk
about all the various different hurdles that are out there. For
us the influenza virus has been able to evade human immunity
forever, and so you can get influenza every year. So the task
we have at hand is a very difficult one in that the body itself
is not able to have long-lasting immunity. So we're trying to
find something that the body itself is not very good at.
Mr. Babin. All right. Now, Dr. Fauci, if you would just go
ahead and elaborate on that as well then.
Dr. Fauci. Yes. Well, there's one hurdle that I think is
really a serious hurdle. Even if we get a universal vaccine
that would induce a response against a wide array of
influenzas, and that is a phenomenon that's really very
interesting. It's called imprinting. And what it is is that
your body tends to make a response against the first influenza
or the first antigen that it was exposed to when you were a
youngster so that even later on in life when you get exposed to
that organism, that microorganism again from an evolutionary
standpoint, that was a good thing because that means that your
immune system is primed so that if you see that micro begin,
you make a really good response.
That's great for something like measles or mumps or
rubella, which doesn't change. It stays the same. With
influenza it works against you----
Mr. Babin. Yes.
Dr. Fauci [continuing]. So that what you will do is that if
the first--I'm an H1N1 person in the sense that I was born at a
time when H1N1 was around. So my immune system is primed to
make a response against H1N1. So if I get exposed to an H3N2 or
even get vaccinated with that, even though I'll make a
reasonable response, my body will revert to wanting to make a
response to H1N1. It's referred to sometimes as original
antigenic sin.
So the real problem is how do you get around that so that
you can vaccinate somebody and overcome that tendency to make a
response against something that you were originally exposed to?
That's going to be an important obstacle.
Mr. Babin. Well, and that was the question I was saving for
you, and you've actually mostly answered it because this is why
measles, mumps, and rubella vaccines have a 97-percent
effectiveness where influenza is only, what is it, 10 percent
up to 60?
Dr. Fauci. No, no, that was a very bad year.
Mr. Babin. Up to 60 percent, though, right, 10 to 60
percent.
Dr. Fauci. Yes, 40 to 60 percent is----
Mr. Babin. Yes.
Dr. Fauci [continuing]. What it is, yes.
Mr. Babin. So that's the biggest hurdle we have.
Dr. Fauci. Exactly.
Mr. Babin. Yes. OK.
Dr. Fauci. You hit the nail on the head exactly.
Mr. Babin. All right. Thank you very much, and I yield
back.
Mr. Bera. Let me recognize Mr. Casten.
Mr. Casten. Thank you, Mr. Chair. Thank you both so much. I
am just totally intrigued by this universal vaccine idea, and I
want to start if you'll just humor me as a biology nerd.
I want to just follow on Congressman Foster's question. So
the fact that the stem has been so preserved, how confident are
you that that's because there is something fundamentally that
the bug just can't change that protein versus the fact that
statistically the antigens were on the surface and so, as we
start developing antibodies to go after the stem, are you
confident that the stem won't start evolving into something
else?
Dr. Fauci. You know, it could. It could evolve under
immunological pressure, but from the standpoint of conserved
components--we call them epitopes, parts of proteins--when
something is conserved throughout evolution, it's usually
because it's critical for that particular thing to survive
whether it's a species, an animal, or a protein, so there must
be something about that stem that's absolutely critical to the
function of the virus. So we think it's not going to change,
but we better be careful. We don't want to make an assumption
that is going to turn out to be wrong.
Mr. Casten. And have the animal studies been of a long
enough duration to give you some confidence that there is no--I
forgot what the word that you used was, that immunological----
Dr. Fauci. Yes, no, to be honest with you, no. We haven't
done it for a decade and shown that over a period of time if
you keep vaccinating an animal and making a response against
stem and then years later it's going to evolve, we haven't
proven that yet. So, I mean, obviously, it needs to be done.
Mr. Casten. OK. So what if anything can we do to
accelerate--we on, you know, this side of the room to
accelerate the development of these universal vaccines? Is it
the time to just get through phase 2 trials at this point or is
there something else that you need?
Dr. Fauci. No, actually, what it is that--we thankfully
have gotten very good support from the Congress to do the kind
of work that we're doing for the universal flu vaccine. In
fact, in our last appropriation there was a set-aside that was
put in order to stimulate the research in that area. So we are
very appreciative of the Congress for what you already are
doing.
Mr. Casten. OK. I want to pivot--and this is--I'm going to
take a chance here just because I get the sense, Dr. Fauci,
that you and I may share a sense of humor. Do you know what you
call alternative medicine when it works? Medicine.
I raise that because we are in a moment where there's this
rise in anti-scientific thinking from climate science denial to
the anti-vax movement to, you know, I think The New Yorker last
week had this article about the rise in people who think that
the--where the stars were when they were born has an impact on
their future.
As you think about the concerns to public health, there's
one set of concerns that is, you know, the anti-vax movement,
people consciously choosing not to take proven medicine.
There's a separate risk of people who are consciously choosing
to take bogus medicine. Which of those--and maybe I'm phrasing
this the wrong way, but are those comparable concerns, and are
we doing enough to combat both?
Dr. Fauci. I think they are comparable. I think there's
danger in both of those. I think you brought up two very
important points. There really is an obvious concern about
people who are anti-science and don't want to believe the
clear-cut science facts, and there is a danger to actually
having deleterious effects of assuming the efficacy of things
that are bogus and going ahead and doing that.
We have, several years ago, established first a center and
now an institute for an alternative and complementary medicine
to be able to look at some of these things that society and
people in the community are convinced work to prove whether
they either do or do not work, so we are doing something about
trying to put some scientific rigor to some of these things
that are potentially bogus. So that's what we're trying to do
on that end.
On the anti-science end, the only thing that we can do is
to continue to do what Dr. Jernigan and his colleagues at the
CDC and what we do at the NIH is to continue to try and get out
the message and the evidence-based proof of what works. There's
nothing like evidence to be able to convince someone that
something works, and you have to keep coming in with evidence
over and over again.
Mr. Casten. So are we doing enough to keep bogus science
off the shelves? Because when I go to Walmart and I look down
the flu medicine, there's some homeopathy up there as well, and
I don't know that the average person knows the difference. So
should we be doing more to make sure that we----
Dr. Fauci. Yes, I think as a society we should be. I'm not
sure that there's much that we at the NIH or that--with Dan at
the CDC can do, but clearly there's stuff out there that really
doesn't really do anything except potentially harm people.
Mr. Casten. Thank you. I yield back my time.
Mr. Bera. Let me recognize Mr. Murphy.
Mr. Murphy. Thank you, Mr. Chairman. I just want to say
thank you actually professionally to both of you gentlemen. Dr.
Fauci, I followed your career since the early 1980s when you
made such fantastic and landmark discoveries with HIV, and it's
really put forward something today now that's manageable, so
thank you from our community.
Being the last one to speak, I always have to figure out
which questions that folks have already asked, but let me go
back to one of the things that my colleague pointed out, the
anti-scientific movement these days, and I actually think
that's a major problem. I saw last week that people are now
starting back on the flat Earth agenda.
And I want to go back to the anti-vaccine movement that's
going back in our country. I wonder if you could really speak
to that, what it's done as far as populations at risk, and
where do you see that going in the future? Because it is a
major issue these days.
Dr. Jernigan. Well, certainly, I think there are pockets
where individuals are talking with one another, some schools,
that kind of a setting where folks are actually hearing from
each other rather than looking to see what the science space is
or listening to physicians. And so those pockets I think can
lead to more and more children, for instance, not getting
vaccinated, to get into school.
I think it's important for us also to recognize that people
get their information multiple different ways now, and so for
us to be nimble on how it is that we get the science-based
information, the evidence-based information to those folks,
identify what their needs are, and then provide them the
information that they need. But until you address those
specific groups, I think with information that is valid to
them, I think it's going to be actually very difficult.
Mr. Murphy. Thank you. One other issue I'd like us to
revisit is Ebola. I don't think people in the United States
really understood the gravity of what would have happened if
that had gotten into Lagos or any of the other places in the
future. And I was wondering if you could talk a little bit more
just about the vaccine with Ebola. Does it mutate on the level
that the other ones do? And can you, just for edification, just
explain to folks the infectivity rate of the Ebola virus versus
the HIV virus, for example? I know it's a multitude-scale more
infective, but I think giving an example would be helpful.
Dr. Fauci. Well, Ebola, unlike influenza, which drifts and
mutates, is pretty stable. It's an RNA virus, so there's always
mutations. But the mutations have not proven to be functionally
relevant. So if you do a sequence of Ebola in a strain in West
Africa, which was Ebola Zaire, the Ebola that's now in DRC is
still Ebola Zaire. There are different types of Ebola. There's
Ebola Sudan, Ebola Zaire, and others. But within Ebola Zaire,
which is the one we're dealing with right now, it really has
not been a problem that it has mutated to the point of being
functionally relevant. So you can measure point mutations, but
they don't change anything about it.
I think the question you ask is, what is the relationship
with the vaccine. The relationship with the vaccine is that the
vaccine has worked, and any change in the virus has not had any
impact on the vaccine, so it looks pretty good. So as I
mentioned a little bit earlier in the testimony, we've now
distributed over 250,000 vaccinations in the outbreak in the
DRC.
The second part of your question is the issue of how it's
transmitted. In an untreated, unvaccinated arena such as what's
going on in the DRC right now, the mortality of that is about
67, 70 percent. It's transmitted only by direct contact with a
contaminated bodily fluid.
Mr. Murphy. Right.
Dr. Fauci. And that was really important, so if someone
gets Ebola and they're incubating it and they get a fever but
they're not having diarrhea, they're not having bleeding,
they're not vomiting, that person is really quite
noncontagious. And that's the reason why there wasn't a concern
of people back when the patients in Texas got infected. There
was a concern that those two nurses were infecting people, and
they were not.
Whereas when you get something like influenza, influenza is
transmitted by the respiratory route, and there's a window of
when you're actually not really very sick when you can actually
transmit it because you're shedding virus for a period of time
before you get sick and after. So there really is a rather
substantial difference in transmissibility. It is tough to get
infected with Ebola unless you have direct contact with a
really sick person, whereas you can get influenza on an
elevator when the person next to you sneezes----
Mr. Murphy. Right.
Dr. Fauci [continuing]. So there's a big difference.
Mr. Murphy. Thank you. I thank you, Mr. Chairman. I'm going
to yield back the remainder of my time to Mr. Posey.
Mr. Posey. I thank the gentleman for yielding.
Mr. Chairman, I'd like to add one more document to the
documents.
It clearly indicates that while these vaccinations are safe
for most people, there are some for whom it's not safe. The
Vaccine Injury Trust Fund has paid out over $4 billion, with a
B, which they did not mention. Forty-six percent of those were
for influenza-based vaccinations. So I didn't want to ruin the
love in here, but I think we should not be cavalier about those
for whom it's inappropriate and that we do try and identify who
it might not be appropriate to receive those shots for public
safety in the future. Thank you very much.
Mr. Bera. Great. Let me recognize Ms. Bonamici.
Ms. Bonamici. Thank you, Dr. Chairman. And thank you, Dr.
Fauci, for reminding us that we can get flu in elevators, which
we ride in all the time in this building, and I'm really glad I
got my flu shot.
And thank you to the witnesses for being here today. You
know, when we reflect over what happened last century, we made
such astounding success developing vaccines to eradicate
pernicious diseases. In the United States we essentially
eliminated polio and smallpox and diphtheria and in the rest of
the world largely defeated those. The World Health Organization
(WHO) estimates that vaccines have prevented at least 10
million deaths between 2010 and 2015. That's pretty remarkable.
But in this hearing today we're acknowledging that there's
still a great deal of work to do, especially with influenza,
one of the most pervasive infectious diseases globally, yet,
despite all the efforts, we're still struggling to effectively
predict or respond to those annual epidemics because of the
rapidly changing nature of the flu, as you both discussed.
The good news, as our witnesses indicated, is this exciting
cutting-edge research that's being conducted throughout the
country to develop new approaches. Thank you, Dr. Fauci, for
bringing your model. Thank you, Dr. Jernigan, for bringing your
mobile lab.
And a lot of that work is federally funded or supported,
which is why I'm glad we're having this hearing today. Some of
that innovative research is happening at the Oregon Health
Sciences University in Portland. Dr. Jonah Sacha and his team
are working on a novel method of long-term flu vaccination that
inserts pieces of target pathogens into cytomegalovirus, or
CMV, to trigger a response by the immune system's T cells when
the body encounters flu virus. I don't understand what that
means, and I'm hoping you will explain it.
Dr. Fauci, are you familiar with this approach? Can you
briefly explain how it functionally differs from the one you
described in your testimony or more traditional efforts that
rely on antibodies, as well as comment on the importance of
pursuing varied methods in search of a breakthrough? And, Dr.
Jernigan, if you're familiar as well.
Dr. Fauci. Right. So the person you're referring to is
named Dr. Louis Picker, and he has established the vaccine
platform, which uses a cytomegalovirus, which is highly
immunogenic. And what that platform is, it's called a vector
platform. So he takes a virus that we know and have experience
with, cytomegalovirus. He inserts into the virus the gene of a
particular protein that he wants to make. He's done it with
tuberculosis, he's done it with HIV, and he's doing it with
other pathogens.
So what happens is that if you wanted to make a vaccine,
which he's trying to do, against HIV, he takes the gene that
codes for the outer protein of the HIV called the envelope. He
sticks it into the cytomegalovirus, and he injects it first
into an animal. He hasn't done it into a human yet because
there were some safety issues there. Cytomegalovirus is not a
benign virus, so it needs to get big scrutiny from the FDA. But
in the animals, it's been very effective. He injects it into
the animals. It starts to replicate, and it starts pumping out
this protein, which is the HIV protein, and he's created in the
animals at least a pretty good HIV vaccine.
Ms. Bonamici. Fascinating. The project I was mentioning was
at the Oregon Health Sciences University Vaccine and Gene
Therapy Institute.
Dr. Fauci. Correct.
Ms. Bonamici [continuing]. In Oregon. So also I wanted to
ask about Dr. Jernigan, about the FluSight website. Since 2013
the CDC has engaged in efforts to use its predictive data
analytics. How's that working and, you know, the public-facing
website? What are you learning from that?
Dr. Jernigan. Yes, so this is a network where we have over
25 different academic modelers. These are individuals that use
various different sources of information--social media,
weather, all kinds of different information. We provide them
some inputs each week, and then they have to tell us what they
think is going to happen in terms of, is the flu going to peak
this week--when's it going to start, et cetera, so it's a way
that we are trying to get not what's happening with flu now but
what is flu going to do. We think that's important so that when
we have a pandemic, we can use that information to inform
folks. But during regular seasons, that information can be
quite helpful for an outpatient clinic, knowing when they need
to increase the amount of staff, for a hospital in knowing if
they need to have more beds in the ICU, even for pharmacies to
know when they move things around----
Ms. Bonamici. Right. Right.
Dr. Jernigan [continuing]. At the pharmacy.
Ms. Bonamici. And some places run out of flu vaccines.
Dr. Jernigan, data from more than 100 countries is used to
determine which viruses--and influence the viruses that are
recommended for inclusion in the annual vaccine. What
challenges exist for collaborating with so many countries to
share data and make sure that that's usable by everyone? What
can be done to improve the international disease surveillance
and data sharing so that we can better prepare?
Dr. Jernigan. Right. So in the United States we have a very
good view of what's happening with influenza with thousands of
viruses that we characterize here. We work with 143 other
laboratories, receive viruses from them, but there are blank
spots on the globe where we don't know what's going on. So the
more we can get improved surveillance, better genomic
surveillance in that setting, more timely information from
them, that helps that country, but also helps the rest of us to
know what's going on with flu, know if pandemics are showing
up, and to make better vaccines.
Ms. Bonamici. Thank you. I see my time is expired. I yield
back.
Mr. Bera. Thank you. Let me recognize Ms. Wexton.
Ms. Wexton. Thank you, Mr. Chairman. And thank you, Dr.
Jernigan and Dr. Fauci, for joining us here today.
In October the CDC released some new statistics about
maternal vaccinations. And I was kind of surprised to see that
only one in three pregnant women receive both flu and whooping
cough vaccines because women with the flu are more than twice
as likely to be hospitalized if they're pregnant and nearly 70
percent of whipping cough deaths occur in children who are
younger than 2 months of age.
However, flu vaccinations during pregnancy reduce
hospitalization of babies less than 6 months old by an average
of 72 percent, and whooping cough vaccinations will lower the
hospitalization of babies by 91 percent. I hope we can agree
that vaccinations are a critical part of prenatal care for
expectant mothers.
And I understand that, Dr. Jernigan, you mentioned in your
testimony that fewer than half of adults in the United States
will get their flu shot because they have a perception that the
flu vaccine is not effective. And I know that you've already
talked a little bit about misperceptions and false information
that's out there, but how can we more effectively communicate
the benefits of flu vaccine?
Dr. Jernigan. With regard to pregnant women, I think it's
currently around half are getting vaccinated for flu, and so
that's a real success story. Over the last several years we've
seen it really rise to that level. Clearly, we need to do more,
and clearly we need to do more with the other vaccines that are
for pregnant women.
If you look at who's getting vaccinated, while only half of
Americans are getting vaccinated, you can actually see that the
most vaccinations are happening among the old and the very
young. And so trying to get at those groups that are late in
their teens, 18 to 49 years of age, that's the group that we
really need to get at to start increasing the amount of
vaccinations. So that's going to take targeted efforts, really
using social media and other approaches to get to them.
Ms. Wexton. And just get them used to getting a vaccine
every year----
Dr. Jernigan. Yes, and----
Ms. Wexton [continuing]. Just make it an annual thing.
Dr. Jernigan. Part of the problem is that you have to get a
vaccine to flu every year, plus that's a group of people that
probably don't avail themselves of a lot of preventative health
care and don't go to the doctor a lot, so I think getting that
group in is a challenge but one that we need to work on.
Ms. Wexton. And I'm glad you brought up social media
because, you know, we have seen a lot of how social media can
impact lives in a good way or a bad way. And one of the issues
with social media is that information spreads so quickly. The
viral nature of it allows people to communicate in a bubble
without external sources that point out when something is just
plain false or something is true, has withstood peer review and
all that. So it's something that we've seen across Committees
in other contexts as well, but here in this issue we're talking
about lives are at stake.
And earlier this year, the American Academy of Pediatrics
sent letters to the CEOs of major social media platforms,
including Google, Facebook, and Pinterest, and highlighted the
growing harm to children from vaccine misinformation that's
spread across their sites. And I understand that you have
already spoken in some of your testimony about the
misinformation and how it spreads, but can you--do you--and
this is for both witnesses. Do you think that these platforms
are doing enough, given that lives are on the line?
Dr. Jernigan. I certainly think people access their
information multiple different ways than they used to, and so
making sure that we get our information that is scientific-
based, evidence-based in the format that is going to be reused,
reusable in that setting I think is an important thing. I don't
know if you want to talk on that.
Dr. Fauci. I agree. I think we can do more, and we can do
better, but I think that the platforms that we have now to get
the message out I think are having some positive effect. But
clearly it's a challenge that's not going to go away. We're
going to have to keep on it. It's not going to be a problem
you'll solve and it's over. We have to keep at it over and over
again.
Ms. Wexton. Very good. Thank you so much. I'll yield back.
Mr. Bera. Well, in closing, just two other questions that
come up repeatedly. Folks will say it's almost the end of
November, I've already made it this far, I don't need the flu
shot this year. Is that correct?
Dr. Jernigan. So our recommendation from the Advisory
Committee on the Immunization Practices and CDC is that we
recommend you get your vaccine if possible by the end of
October, but as long as influenza virus is circulating, we
recommend you get a vaccine. So it is not too late to get a
vaccine. Our goal is to try and get people vaccinated prior to
the season start so that there's 2 weeks of time before--allow
their immune systems to build up so that if they get exposed,
but clearly we recommend that you continue to get vaccinated
now.
Mr. Bera. So since I know most of America is watching this
hearing and not another hearing, it is not too late to get the
flu shot?
Dr. Jernigan. It is not too late to get vaccinated.
Mr. Bera. And then another question that comes up
occasionally is nasal flu vaccine versus flu shot, any
recommendations or equally effective?
Dr. Jernigan. So currently CDC does not have any preference
for any one vaccine over another. There are personal
preferences and parental preferences with regard to the live
attenuated influenza vaccine, the nasal vaccine, so there's no
preference for one over the other. They're all listed as
effective as each other.
Mr. Bera. Great. Well, I once again want to thank both of
you for your service to this country and service to medicine.
And again for those watching at home, vaccines are safe,
vaccines are effective, and vaccines save lives. Thank you.
And we'll recess for a few moments and allow the second
panel to get seated. Thank you.
Dr. Jernigan. Thank you.
Dr. Fauci. Thank you.
[Recess.]
Mr. Bera. Welcome back. At this time I would like to
introduce our second panel of witnesses. The first witness in
our second panel is Dr. Sharon Watkins. Dr. Watkins is the
Director for the Bureau of Epidemiology and the State
Epidemiologist for the Pennsylvania Department of Health. She
is also the President of the Council of State and Territorial
Epidemiologists. Dr. Watkins is responsible for management and
oversight of the Bureau of Epidemiology, which includes the
Division of Infectious Disease, Environmental Health, and
Community Health. Dr. Watkins has led disease surveillance and
outbreak response efforts, including those related to Zika,
healthcare-associated infections, measles, and hepatitis A. Dr.
Watkins has over 40 peer-reviewed publications and over 20
years of experience in applied public health and epidemiology.
Thank you for being here, Dr. Watkins.
Our second witness is Dr. Robin Robinson. Dr. Robinson is
currently Vice President of Scientific Affairs for RenovaCare,
Incorporated, directing development of cellular therapies for
wound healing. Previously, he served as the first Director of
the Biomedical Advanced Research and Development Authority,
BARDA, and Deputy Assistant Secretary for Preparedness and
Response from 2008 to 2016. He also served as BARDA's Influenza
and Emerging Disease Program Director from 2004 to 2008. Dr.
Robinson was the recipient of the Department of Defense Clay
Dalrymple Award in 2008, the HHS (Department of Health and
Human Services) Distinguished Service Award 3 times, and a
finalist for the Service to America Medal in 2009. Thank you
for being here, Dr. Robinson.
As our witnesses should know, you will each have 5 minutes
for your spoken testimony. Your written testimony will be
included in the record for the hearing. When you have completed
your spoken testimony, we will begin with questions. Each
Member will have 5 minutes to question the panel. We'll start
with Dr. Watkins.
TESTIMONY OF DR. SHARON M. WATKINS, PH.D.,
STATE EPIDEMIOLOGIST, DIRECTOR,
BUREAU OF EPIDEMIOLOGY, PENNSYLVANIA DEPARTMENT OF HEALTH, AND
PRESIDENT,
COUNCIL OF STATE AND TERRITORIAL EPIDEMIOLOGISTS
Dr. Watkins. Dr. Bera, Ranking Member Lucas, and Members of
the Committee, thank you for the privilege to appear before you
today. My name is Dr. Sharon Watkins, President of the Council
of State and Territorial Epidemiologists, CSTE, and State
Epidemiologist for the Pennsylvania Department of Health.
CSTE is an organization of 56 member States and territories
representing applied public health epidemiologists or disease
detectives. We work every day in partnership with CDC to detect
and respond to influenza outbreaks, gain an understanding of
potential changes in the virus, and deliver lifesaving
vaccines. I have witnessed the devastating impact of seasonal
influenza, the 2009 H1N1 pandemic, measles, and many other
vaccine-preventable diseases in the communities I serve.
Public health threats require efficient, timely responses
that rely on a network of public health agencies at all levels
of government in coordination with healthcare providers.
Response to outbreaks happens at the local level. Data on the
age group affected, vaccination status, underlying illness,
pregnancy status, and whether the outbreak is in a school or a
long-term care facility, for example, are all needed to be able
to rapidly identify where to respond and what is needed.
Unfortunately, this public health network is choked by
antiquated data systems that rely on obsolete and sluggish
data-sharing methods. Faxes and phone calls are still in
widespread use. The system is in dire need of security
upgrades. Lack of interoperability, reporting consistency, and
data standards lead to errors in quality and completeness,
timeliness, and communication.
I have stood before communities in crisis who are
justifiably bewildered and angered that public health cannot
access disease data or access it faster. ``How is it that I can
simply log into a portal and get my medical test results in a
matter of minutes and you, who are charged with protecting
public health don't have access to today's health data?''
It shocks people to learn that we do not have national
coverage connecting hospital emergency departments (EDs) with
public health surveillance systems. About 40 percent of all ED
visits are not submitted to public health departments, leaving
us flat-footed in identifying and responding to severe flu
infections among high-risk groups, including pregnant women,
children, and the elderly.
We are now entering flu season and are challenged by the
concurrent outbreak of lung illness associated with e-
cigarettes. Public health is urgently deciphering faxed medical
records to distinguish e-cigarette-related cases from flu
cases. This information arrives piecemeal at different times
through different channels. Try to decipher addendum 1 in my
written testimony. It's a 4-page sample of a 350-page faxed
medical record received by the Pennsylvania Department of
Health on one of our e-cigarette cases. Providers already have
this data shared and collected in electronic health records but
cannot rapidly share these data with public health, who have no
way to receive them electronically.
Death certificates are still filed on paper in some states,
and only 63 percent of all death certificates are submitted to
CDC for national aggregation within 10 days. Regrettably, most
influenza-associated deaths occur in unvaccinated children, and
it takes weeks to uncover and link the flu death with
vaccination history, causing lags in communication to
stakeholders who need answers to these questions.
CSTE and our partners, the Association for Public Health
Laboratories, NAPHSIS (National Association for Public Health
Statistics and Information Systems), and HIMSS (Healthcare
Information and Management Systems Society), together with more
than 90 other institutions, believe the time is now to step up
and take a coordinated approach to building a 21st century
public health data superhighway. The superhighway will collect
health data from healthcare providers and report it
automatically to public health departments and link it to other
key data, including birth and death records and immunization
registries and share that data seamlessly and securely with
CDC.
The technology is here. What we really need are resources.
That is why the proposed funding of $100 million that was
included in the House Labor, Health, and Human Services
appropriation bill to support data infrastructure at the CDC is
urgently needed. During your ongoing deliberations, CSTE hopes
you will consider the need for a modernized electronic
interoperable public health data system and skilled public data
health scientists to strengthen public health's best prevention
strategy--vaccination. We recognize this effort must be funded
with new money rather than cut already-underfunded public
health. Without Federal support, public health surveillance
modernization will remain unattainable, and the Nation will
suffer.
We look forward to working with you, and I thank you for
the opportunity to testify before you today.
[The prepared statement of Dr. Watkins follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Bera. Thank you. Dr. Robinson.
TESTIMONY OF DR. ROBIN ROBINSON, PH.D.,
VICE PRESIDENT OF SCIENTIFIC AFFAIRS, RENOVACARE, AND
FORMER DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND
DEVELOPMENT AUTHORITY, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Robinson. Good morning. Thank you, acting Chairman and
Ranking Member Lucas and distinguished Members of the
Committee. Thank you for the opportunity to speak with you
today. I'm Dr. Robin Robinson, currently the Vice President of
Scientific Affairs at RenovaCare, the former Director of BARDA,
and the DAS (Deputy Assistant Secretary) at ASPR (Assistant
Secretary for Preparedness and Response), and a developer of
influenza vaccines in industry.
Four years ago I testified as the BARDA Director before the
House on the state of affairs for seasonal influenza during a
harsh season and what we could do to remedy mismatched flu
vaccines. Since that time, seasonal influenza has returned each
year and brought illness and death despite our medicine cabinet
full of vaccines and antivirals.
New influenza vaccines with adjuvants and a fourth strain
of influenza vaccines and a new class of antivirals were added
since 2015. Yet we still have not solved the chief issue with
influenza vaccines--poor effectiveness.
Our domestic capacity to produce pandemic influenza
vaccines has quadrupled since 2005 thanks to our investments in
new cell and recombinant-based production technologies.
However, our ability to manufacture and make available pandemic
influenza vaccines are not fast enough to preempt pandemic peak
effects.
Last, many universal influenza vaccine candidates have
emerged over the past 40 years but none have crossed the finish
line. Today, I wish to address poor vaccine effectiveness, slow
vaccine production, and elusiveness of universal influenza
vaccines.
Vaccine effectiveness and universal influenza vaccines are
both dependent on the selection of viral antigens that can
elicit long-lasting, broad, and strong immuno-protective
responses across many different influenza virus subtypes. An
ideal universal influenza vaccine would elicit strong and
lasting immunity against currently circulating and drifted
strains of seasonal influenza viruses to obviate the need for
annual immunization against seasonal influenza and serve as a
vaccine primer for pandemics.
The story of universal influenza vaccine development is
long and woeful. For the past 40 years, multiple ways of
innovation have driven universal influenza vaccine development.
One of the earliest and most expensive efforts was by Merck in
the 1980s and 1990s focusing on vaccines comprised of the
highly conserved influenza M2 matrix protein. However, the M2
vaccine candidates were poorly immunogenic. Next, vaccine
candidates targeted the highly conserved MP, and NS2 proteins
were developed and shown to be poorly immunogenic as well.
The story changed with two discoveries, one of which Dr.
Fauci mentioned earlier, made this decade. Antibodies were
discovered in 2011 to specific epitopes on the conserved stem
portion of the viral hemagglutinin protein and shown to bind
and neutralize widely diverse influenza viruses. This discovery
has led to a new development wave of chimeric hemagglutinin and
hemagglutinin stem vaccine candidates that are undergoing
clinical evaluation presently.
The other discovery, which occurred this year, was the
finding of antibodies to conserve epitopes on the viral
neuraminidase protein, which has been a target for antivirals
for many years. These antibodies bind and neutralize widely
diverse influenza viruses. This discovery will likely initiate
another wave of vaccines that scientists will likely include
this specific neuraminidase protein in their next generation of
flu vaccine candidates.
On the issue of more rapid production of influenza
vaccines, new synthetic messenger RNA (mRNA) vaccine technology
may expedite vaccine production. Since mRNA vaccines do not
require the isolation, adaption, and production of viral
vaccine stocks like the current egg and cell-based influenza
vaccines, weeks to months may be saved in vaccine production.
This time savings may allow the late production of seasonal
influenza vaccine strains when a mismatch occurs between
circulating influenza viruses and seasonal influenza vaccines.
Similarly, the production time for 600 million doses of
pandemic influenza vaccine may be reduced from 6 months to 3
months and become available before the pandemic peaks. As added
value of messenger RNA vaccines may be a faster and easier way
to distribute and administer these vaccines. Many messenger RNA
vaccines are encapsulated in liposomes or nanoparticles, as Dr.
Fauci stated, and which may intrinsically have adjuvant
properties and the ability to administer vaccines
transdermally, hence trading a syringe and needle for a self-
administered patch.
None of these innovations and discoveries will make it into
the influenza vaccines of the 2020s without immediate and
sustained multiyear funding and authorities to NIH, BARDA, FDA,
and CDC to execute with industry partners the pandemic plans of
yesterday and today. Your continued wisdom, generosity, and
support have carried us this far. Help us finish the journey.
Thank you.
[The prepared statement of Dr. Robinson follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Bera. Thank you, Dr. Robinson.
At this point we'll begin our first round of questions. The
Chair recognizes himself for 5 minutes.
Dr. Robinson, thank you for your service at BARDA. I've had
the chance to meet with the top folks at BARDA, but another
international organization that I've also had the chance to
meet with is CEPI (Coalition for Epidemic Preparedness
Innovations) and, you know, it is an organization that is
looking at bringing the international community together, along
with the private sector to look at vaccines for emerging
diseases and so forth.
If you could elaborate a little bit more on the mission of
CEPI. And, you know, one of the big disappointments for me is
that the United States currently doesn't participate in CEPI,
and I'd be curious about your opinion as to whether the U.S.
should participate and, you know, if you want to elaborate on
that.
Dr. Robinson. Thank you for the question. I always smile
when CEPI is brought up because my former deputy at BARDA was
Richard Hatchett, and he is the current CEO of CEPI.
Should the U.S. participate in the activities of CEPI
against emerging infectious diseases and the development of
vaccines? And the answer is that we already are. The inception
of CEPI occurred back around 2014, and it actually became a
reality in 2017, and that the NIH and BARDA specifically had
investments in emerging infectious disease and specifically on
vaccines such as Ebola, Zika, and others, and that that was
part of our contribution and we will continue as the U.S.
Government's efforts in these specific areas. So we do actually
support what they do. In many cases we have contracts and
grants that actually are supporting these same projects that
they're working on but not on--so--but without duplication of
exactly what they're doing.
Mr. Bera. You know, if we play off of that for a moment--
and, again, my interest in pandemic preparedness and some of
the threats, if we look at emerging diseases and some of those
pandemic threats, what is our capacity to, you know--within the
private sector to quickly ramp if we see an emerging pathogen,
quickly identify it, identify a potential vaccine to mitigate
that pathogen, you know, just from your perspective as an
expert in the field?
Dr. Robinson. So I'll give it in the context of when I
started my public service in 2004 in which it would take months
to years to be able to respond to a new emerging pathogen. My
first assignment was on H5N1, avian influenza viruses, and how
we could actually make a vaccine toward that.
Since that time, we actually had a real live test in 2013
with the emergence of H7N1 viruses. What normally would take
about 6 months to actually produce those vaccines, we actually
brought that down to closer to 3 months. There was a specific
reason why. First, as you heard from Dr. Fauci and Dr.
Jernigan, we were able to get the sequence of that virus
immediately. And actually it was on April Fools' Day of 2015 it
actually moved forward within weeks to actually have that
sequence distributed not only to the vaccine manufacturers of
egg and cell-based producers but also for recombinant products.
By the summer we actually had those vaccines in clinical
trials. And so in record time we were able to do that. Many of
the innovations that we are talking about today would even
expedite that further. And our goal of course is to actually
have pandemic vaccine not only produced but available within 12
weeks.
Mr. Bera. Great. And, Dr. Watkins, you know, in a prior
life I was Chief Medical Officer for Sacramento County, so did
a lot of public health work and, you know, it makes me chuckle
because we would get information faxed to us and, you know,
most of the public wouldn't believe that in this day and age in
2019 a lot of public health records and information is faxed-
based.
So you talk about interoperability. You talk about
collecting data and creating big data sets. Could you just
elaborate a little bit more on what that would allow you to do
in terms of more rapidly identifying potential outbreaks, et
cetera, and why a more robust interoperable electronic public
health record would allow you to do your job better?
Dr. Watkins. Sure. You know, when I think about medical
delivery of the healthcare system today, I mean, it's amazing
the advancements that have been made, but I think public health
has been left behind a little bit. And we are still dealing
with faxes, and we are still dealing with phone calls and
spreadsheets, handwritten spreadsheets. And it really does
impact our ability to quickly respond to a situation.
So if immunization records were able to be quickly linked
to our disease reporting system, if we were able to get
electronic case reports and see data as it's coming in and
digest that in the health department, we would really be able
to respond much faster.
Much of what we do in many of the pandemics or the emerging
threats that we have today is scratch our heads, and we're
really struggling with the data sharing and the data management
of so much big data. Public health needs to have our systems
renewed and reinvested in.
And CSTE has produced this book in conjunction with
stakeholders. There are a lot of stakeholder stories in this
that talk about why public health is important and the time is
now to invest money in our data systems.
Mr. Bera. Great. The Chair now recognizes Ranking Member,
Mr. Lucas, for 5 minutes.
Mr. Lucas. Thank you, Mr. Chair.
Dr. Robinson, in your testimony you highlight that clinical
trials have shown that vaccines that are stockpiled remain
highly effective even after 10 years in storage. How has BARDA
worked with the industry to improve the shelf life of
stockpiled vaccines and other countermeasures in the event of a
pandemic emergency?
Dr. Robinson. Thank you for the question, sir. We started
in 2005 building our stockpiles for pandemic influenza. These
would be to treat those individuals that are highly vulnerable,
at high risk, and our critical workforce to make sure the
country still operates in a severe pandemic, so around 27
million doses. And that was actually for all the different
strains that have been shown to have pandemic potential from
the H5N1 viruses to the H7N1 I just described a moment ago to
the new waves of H7N9 viruses. Through the IRAT (Influenza Risk
Assessment Tool) process that the CDC has with BARDA, FDA, and
NIH, we actually meet twice a year, go over these strains to
see which ones are available.
But in 2015 we said that--and it was a question that
actually came up from the Members here. Is the vaccine that you
have stockpiled in these companies, is it still good? And the
answer was, well, we know that the potency assays look really
good, but we said that's not enough. So we went and actually
did a clinical study using newly made H5N1 virus vaccine
against a vaccine that had been made 10 years before. And the
results of that in the Bright study, which have been published,
show that they were equal and they were still highly
immunogenic and could be used without or with an adjuvant to
protect those individuals.
Mr. Lucas. Thank you, Doctor.
Dr. Watkins, you suggest that the use of artificial
intelligence or machine learning could be useful to identify
outbreaks early and encourage individuals to get vaccinated.
Can you elaborate further on how this technology can be
utilized?
Dr. Watkins. Sure. Thank you for that question. Public
health does have a lot of data. It's not interconnected, and I
think that the ability to look at birth and death certificates
and immunization rates and existing comorbidities and combine
that with census-tracked information and behavior information
and information on poverty and immigration status, all of those
other data sets helps us better understand at the community
level what are the hesitations or what are the limitations to
vaccination or access to health care or maybe language
barriers. And when we're able to use all the data that Google
has at their hands and we don't, I think we're better able to
target where efforts should go.
As an example, during the opioid crisis, we and other
states funded by CDC have been looking at vulnerability
assessments. So we're looking at where are our deaths happening
due to overdose. Where are babies being born with neonatal
abstinence syndrome? Where are rates of hepatitis C and HIV
increasing? And where does that overlay with poverty and some
other statistics? That's use of big data in a state to really
look at vulnerabilities and target where we should be working.
We could be doing that with many more things had we the
technology and interconnection.
Mr. Lucas. Thank you, Doctor. I yield back.
Mr. Bera. Let me recognize Dr. Murphy.
Mr. Murphy. Thank you, Mr. Chairman. Thank you guys for
coming this afternoon, and I appreciate your expertise.
The first question I'm going to have is for Dr. Watkins
because I was looking through some of the copies that you have
of medical records and everything and having experienced the
explosion of the electronic medical record just in my own
practice in the last 25 years I see the challenges for it. If
you could wave a magic wand, you know, there is a way to pull
data out of these reports and quantify it, what would it look
like? Because I preface it by saying we have so many different
medical record systems in our country, most of which don't talk
to one another. And unless we have literally a single system,
I'm not sure of what this would look like. So I'm just
interested in your thoughts about reality of this, how we do
this because I think the purpose is altogether a great one, but
the devil's in the details. What does that look like?
Dr. Watkins. Thank you for that question. I would also
refer you to this report that has been done. And we can get you
a copy of that. But what we're talking about is modernizing
systems we already have, so our laboratory system, which is
called LIMS (laboratory information management system), and its
ability to rapidly transmit data between us and the provider
and CDC, and handle those results needs to be modernized and
made more interoperable.
Our death and birth certificate registries need to be more
rapid. I mean, we shouldn't be having paper records of these
important documents. Our immunization registries should be
interconnected with our other disease reports. And our
electronic disease collection system should be able to know if
you've gotten influenza when a death certificate comes in. I
shouldn't have to wait weeks. I should be able to see that
within real time.
So looking at being able to bring those and CDC is doing a
lot of work on electronic case records and modernizing all of
these systems. What we're talking about is bringing all states
up to a better level. Some states are really far behind, and
some states are behind in some things but not in others.
And when I think about a pandemic or the next emerging
issue, I mean, we don't want public health to be the weak link
in the chain. We want public health to protect your family, my
family, and the public's health with the same tools that
private medicine has and the same speed. So that's what we're
talking about.
Mr. Murphy. All right. Thank you for the question. It's a
daunting task. I think it's a good idea. I will tell you just
it adds an entirely additional level of just data entry, but
then again, that's what we do. We work on data.
Dr. Watkins. We'd like to get out of the data entry. You
know, I have some analogies for you if I may, I'm sure we all
have private physicians. We have healthcare providers. And, you
know, they're not sharing information handwritten on you.
They're not walking your lab test results in a spreadsheet. I
mean, they're working in a modern world with modern technology
and modern informatics. And public health is the frontline for
pandemics. We should be working with that same speed. It's like
building a space probe and forgetting to put in the advanced
communication and data-sharing aspect of it.
And I feel like in this modernization of health care and
we're talking about vaccine innovation, we're thinking about
all that, but we need to think about modernization of public
health data sharing so that we can be the frontline of public
health and not be the weak link in the chain.
Mr. Murphy. Great, thank you. Because I agree. Those are
the issues. It's not cancer, it's not other things that you
need the connectivity.
Just one other quick question just, Dr. Robinson. I was
wondering if you could speak to--we've talked a little bit
about the vaccines that come primarily from eggs versus the
cell-based and the recombinant. Can you speak to really why you
don't believe that the technology of the latter really is
taking up or are we making good progress toward moving away
from the egg-based vaccines?
Dr. Robinson. So because of the efforts we had at HHS and
primarily through BARDA we actually made a paradigm shift where
we were 100 percent egg-based to, as Dan Jernigan said today,
85 percent.
Now, how are we going to move to at least having greater
adoption of recombinant cell-based when we don't have some of
the problems with mismatches? First of all, we have to realize
that the influenza vaccine industry is a commodity-driven
industry, and that the way that we were able to move the needle
to begin with, it was interacting with them as public-private
partnerships. That has to be revived and continue to go forward
with these new discoveries to make it worthwhile for them to
have a product so they can get out of the egg-based vaccine
business.
I will say that there's promising progress that companies
that are solely egg-based have actually either bought
recombinant vaccine candidates and that are actually licensed
now or they're internally developing new influenza vaccine
candidates. So we need to expedite that and facilitate it with
the continued efforts that we've had with a good formula
before.
Mr. Murphy. I have just one follow-up. Do you think that
the recalcitrance to doing that really is regulatory or is it
the economies of the cost?
Dr. Robinson. It's regulatory. I mean, they--industry and
that--I am now part of that industry--will--may say, well, we
don't want to do that because the--we have to go through the
entire process of getting a new vaccine license from the FDA,
but that's the normal course of vaccine development.
The real problem is, why spend money and we don't have to?
Mr. Murphy. Right. Sure.
Dr. Robinson. And that's a reality.
Mr. Murphy. Sure. Thank you very much. I yield back my
time.
Mr. Bera. All right. Let me recognize Mr. Cohen.
Mr. Cohen. Thank you, Mr. Chair.
Dr. Robinson--and you may have--this probably have been--
may have been touched on in the first panel, but the whole
public media, social media conspiracy theories about
vaccinations causing autism, how much of an effect has this had
on people getting vaccinated? And how much of an effect of
people not getting vaccinated have on public health?
Dr. Robinson. So there's two parts to that question. The
first part is, what was the effect of anti-vaccine groups for
autism? And we fought this battle during the last decade, and I
will say that to a great extent that battle has been won, and
so scientific data was actually shown that there's no link
between vaccination and autism.
The second part of that----
Mr. Cohen. Let me ask you a follow-up on that.
Dr. Robinson. Yes.
Mr. Cohen. You say it's been won.
Dr. Robinson. I'm going to answer that because we have a
new wave of anti-vaccination, and I'm very concerned about this
because they don't have as their true agenda vaccination. They
could care less whether it works or doesn't work because they
have a hidden agenda for other things of anarchy and other
things. And the tactics that they're using are ones that cyber
terrorists have been using over the past several years, and I'm
very alarmed by that because, again, the vaccination is not
their real issue here.
Mr. Cohen. Well, there are some that I think--you know, for
instance, my friend Robert Kennedy, Jr., he's a major anti-
vaxer, and he's not for anarchy.
Dr. Robinson. No.
Mr. Cohen. I think his issue was thinking that mercury as a
preservative was the cause. Is that correct?
Dr. Robinson. That is one of the platforms that they have
espoused.
Mr. Cohen. Has there been studies to show that that is
wrong?
Dr. Robinson. So that was said by Dr. Fauci earlier, one is
it's not methylmercury, it's ethylmercury that is in some
multidose vials of some vaccines. I will say that we made a
pointed effort in 2008 with influenza vaccines to remove that,
and the manufacturers did this without being mandated to do so
and so that there are single-dose syringes without the mercury
in those vaccines and those are primarily given to children and
to pregnant women. And so there has been major progress on
this. And as Dr. Jernigan said in his testimony earlier that
CDC and FDA are mounting efforts to be able to minimize that.
But again, the amounts that are there and the kind of mercury
there are not the kind that Mr. Kennedy has been talking about.
Mr. Cohen. Dr. Watkins, do you have any perspective on this
as well, anything you can add?
Dr. Watkins. Thank you. I mean, I think public health is
clearly worried about these sentiments and that we need to do a
better job in communicating the efficacy of the vaccine and the
benefits that it does. In addition to preventing disease, it
also lessens the severity and complications and particularly
for those most at risk, so it prevents death and
hospitalization.
I think, you know, public health thinks a lot about where
people get their health information and how do they communicate
with each other? And we need to do a better job of producing
convincing messages that are shared on different platforms.
Mr. Cohen. How many people do you know--or if you can give
us a round figure--die annually from the flu?
Dr. Watkins. I don't have the figure in my head, but we can
get it for you.
Mr. Cohen. Well, Dr. Robinson, do you have a clue?
Dr. Robinson. Yes, sir. At the low end, 10,000, upwards to
48,000 a year, sir.
Mr. Cohen. So those people more likely than not, if they
had the flu vaccine--and you don't know that some of them might
not have gotten the flu vaccine and not been that particular
strain--but more likely than not, that would have and reduced
greatly if all those people had been inoculated?
Dr. Robinson. That's correct.
Mr. Cohen. Yes. Thank you. I'm a big proponent of
vaccinations. My father was a pediatrician. He gave vaccines.
In 1954 he gave the Salk vaccine to second-grade students in
the test trials. I had a brother that was in second grade. He
gave him the Salk vaccine. I was in kindergarten. He brought it
home to give to me, and he had second thoughts because it was
outside of his charge. Within 2 months I got polio. Vaccines
are good.
I yield back the balance of my time.
Mr. Bera. Thank you. We'll open it up to additional
questions from the Members, and I'll start by recognizing
myself.
And my interests are in pandemic preparedness, Dr. Watkins.
You know, we've been having conversations with companies like
Google. And I know Google has been doing some work in
identifying particular search words that may pop up that would
then allow us to rapidly say, you know, people are searching
the term fever or, et cetera, to try to quickly go into, let's
say, a country in Africa or someplace else. Are you familiar
with any of those trials and, you know, have they been
successful, not successful, et cetera?
Dr. Watkins. Well, public health is aware of those kind of
crowdsourcing tools that look at G.I. symptoms or they look at
fever, but we've not been using them in public health, most
jurisdictions. I think some may have. What we are interested in
because we are system that uses case-based surveillance--I
mean, we know your name if you're sick. We're counting you as
an individual. But we have expanded a little past that into
syndromic surveillance where we are looking at deidentified
emergency department visits and really gaining a lot of
information that way.
So I can't say whether Google has been validated through
public health methods, that is crowdsourcing. I can say that
looking at emergency departments, just, you know, are you
seeing a spike in this, that, or the other, has been incredibly
effective, not just in identifying the uptick of flu, but of
many other diseases, including being able to identify clusters
of illnesses.
Mr. Bera. Dr. Robinson, would you want to add anything?
Dr. Robinson. No, I think Dr. Watkins----
Mr. Bera. Yes.
Dr. Robinson [continuing]. Has said it.
Mr. Bera. And yet I still think it's worth--as we're
looking at global health and, you know, pandemic preparedness,
to continue to work with these technology companies that, you
know--because part of rapidly responding and getting ahead of
pandemics is quickly saying, hey, let's get someone out there,
let's identify what that pathogen is, and let's see if we can't
mitigate it at the source. Is that correct?
Dr. Watkins. Absolutely. But with all due respect, I think
public health is under-sourced and under-resourced in the
informatics world. So our ability to really be doing that is
contingent on us being able to modernize.
Mr. Bera. Do public health information systems speak across
State lines?
Dr. Watkins. No, not necessarily. No.
Mr. Bera. OK. And that's not because of any regulatory
issues that we've placed as Congress? That's just under-
resourcing or----
Dr. Watkins. Well, it's both. I mean, Ohio doesn't have the
jurisdiction to see that John Smith in Pennsylvania has
influenza. It's my jurisdiction. But we could do a better job
of sharing, not identified data, across State lines.
Mr. Bera. Right.
Dr. Watkins. And when there is an outbreak and we need to
share that information, we do so securely.
Mr. Bera. OK.
Dr. Watkins. But, no, for example, in my state,
Philadelphia is on a different surveillance system than the
state is, and it does really matter. We have to really work
hard to share data. And when CDC wants to see Statewide data,
we have to work with Philadelphia to harmonize it. It's
inefficient.
Mr. Bera. You know, as a public health expert, let me ask
another question about vaccination rates and--I guess let me
put it this--when I was a child, I got a lot of my vaccines at
school. And it's how--I'm an internist by training, not a
pediatrician, but it's always occurred to me that, you know,
for efficiency's sake, especially for multidose vaccines,
you've got a captive audience in that school. The kids are
going there. But the overhead if you had school-based nurses or
public health nurses that were able to go into those schools to
vaccinate their kids, it would be more effective, more
efficient, and I'd just be curious from your perspective, Dr.
Watkins, if that's something that we made a mistake of moving
away from?
Dr. Watkins. Well, we certainly do school-based
vaccinations in outbreak settings. That's a perfect setting,
and we do use that venue. I think school-based nurses are a
resource that is shrinking, and so not all schools have access
to that. I think that looping schools into immunization and
other kinds of issues is always a goal of public health, and I
do think that we've done it broader but have shrunk that
footprint, yes.
Mr. Bera. I mean, I understand that there's probably
concerns about liability issues----
Dr. Watkins. There are.
Mr. Bera [continuing]. And, et cetera, that have moved us
away from that, but just from a pure cost perspective and
efficacy perspective, I think those investments in public
health nurses or school-based nurses, the overhead and, et
cetera, and again the efficiency, particularly with multidose
vaccines because you lose a lot of kids. They don't come in for
a month later for that second vaccine. And, again, I believe
you could rapidly boost the number of children that are getting
vaccinated, you know, if we were to utilize tools like that.
And I guess I'd ask one last question with regards to
measles, et cetera. Just I'd be curious from your perspective
as a public health professional, how Pennsylvania and others
around the country are trying to address the periodic
outbreaks.
Dr. Watkins. Sure. I mean, we're exhausted. I'll just be
honest. I was just at a conference in New York, and I can't
even imagine what they've had to go through to be able to
address those thousands of cases.
You know, in Pennsylvania, I think we're at 17 cases. What
I think you don't realize is that for every case, hundreds of
people are likely exposed. And if it's been close-contact
exposure, if you were infectious with measles right now,
everyone in this room and everyone in this room for the 2 hours
after you have left it would have been exposed.
Public health notifies you. We track you down when we can.
We assess your immunity. We work to make sure that not only are
you taken care of but everyone you've exposed is notified and
properly treated. Either you're immune or you're not, and if
you're not and we can't get--we can't get you prophylaxis in
time, you may be quarantined. There are a lot of steps that go
into measles. And it's an enormous resource drain. It's been
difficult for New York and for any of us who have had cases of
measles.
Mr. Bera. Well, Dr. Watkins, thank you for your work and
all those public health professionals. And, Dr. Murphy, if you
have any additional questions.
Mr. Murphy. Thank you, Mr. Chairman. Again, thank you guys
for coming.
Dr. Watkins, let me ask a question just because we're
looking at this in one level of the problems that you face with
interconnectivity and challenges by all means. My question is
what have you done in the State of Pennsylvania to talk to the
other counties because public health departments at least in
North Carolina are run by counties? What have you guys done on
a State level to develop interconnectivity?
And just on a corollary, I did a lot of work in the North
Carolina legislature with the opioid epidemic. And we had
people on the border of North Carolina going into Virginia
getting prescriptions, vice versa. So we worked close by with
our State neighbors to develop a system that somebody in
Virginia could know if somebody's jumping across a line and
getting prescriptions in North Carolina.
It's the same thing. It's State interconnectivity, not
necessarily a Federal pushdown approach. When we look at the
Nation as a whole of pandemics that are going on, by all means
we need to know that information. But these tend to be
localized. And so what have you guys done on the State level to
address this problem?
Dr. Watkins. So let me just say that Pennsylvania is
structured differently than North Carolina. I mean, we have 10
county and municipal jurisdictions. We're home rule,
commonwealth, so they are on our same system of disease
surveillance, and so we are able to share that. So what happens
are lab reports come in or a report from a physician comes into
the State health office, and we push it to the jurisdiction or
to the district office.
Mostly if you're in a home rule system, if you're in
Pittsburgh, for example, Pittsburgh is seeing their own
records. But we do collect it all in the same data system.
Philadelphia is large, and they're able to have their own data
in a different system. So we work with them. We work with them
both from a disease perspective. We share outbreak information
all the time. We work with them from an IT perspective to try
to harmonize what we do.
And of course we're always working with our neighbors,
whether it be on hepatitis A outbreaks or measles or sharing
of--I mean, patients don't have borders. I mean, you could be
hospitalized in New Jersey and go into a long-term care
facility in Pennsylvania. It happens all the time. So we keep
in touch, but we could do it better, faster, and without loss
of information or misinformation if we were better
electronically suited.
Mr. Murphy. All right. Well, let me just follow up then.
Are you not electronically suited in these different counties?
And why would you not appeal to your State rather than the
Federal Government to make that happen?
Dr. Watkins. So what I'm talking about is the sharing of
laboratory information with disease surveillance, and that is
happening at the State level, but it's not an easy connection.
We've really not invested money in this in a long time. For
example, our immunization record is not connected to our
disease surveillance record. And I'm speaking from the national
perspective, CSTE. You've asked me a Pennsylvania question, but
I could be answering for many states. I don't know if your
immunization record in North Carolina is connected to your
disease registry. For many states it's not. So those are the
kind of things that would help us get data and respond faster.
You know, in a measles exposure situation, who's been
immunized? You know, that's a hard question. It shouldn't be a
hard question, but it is a hard question. And we've resorted to
actually going to high schools, the old high school who's
stored records who've looked them up for us because the
physician had gone out of practice or--you know, I mean, public
health is a make-it-work kind of a system, and we just do what
we need to do. But we're getting further and further behind.
Mr. Murphy. I see. Thank you. Thank you. And one other
quick question just with Dr. Robinson. In the success that
we've seen with the cervical cancer vaccine against the HPV
virus--here I am a physician trying to put myself out of
business. Where are we and where do you see us as far as other
malignancy vaccines? I'm going to give you prostate cancer, for
example, because I've seen literature for that for 15 years. I
just don't see the door being knocked down. So can you just
speak to that briefly and what your experience is and thoughts?
Dr. Robinson. Yes. Twenty years ago when I was in industry
we actually worked on a prostate cancer vaccine and a melanoma
vaccine. What has driven the oncology vaccine has been
supplanted by the monoclonal antibodies that have been
developed with great, great success over the last 15 years. So
that has somewhat moved the vaccine programs and especially in
companies to a lesser degree.
Some of those vaccines were extremely promising as we and
others were evaluating those in the clinic, and I would suspect
that once we reach the peak of the monoclonal antibodies for
oncology purposes, that we will actually see a resurgence of
vaccines for different types of cancer reappear probably in the
next decade in fact.
Mr. Murphy. Thank you.
Mr. Bera. Great. Before we bring the hearing to a close, I
want to thank both of our witnesses for testifying before the
Committee today.
The record will remain open for 2 weeks for additional
statements from the Members and for any additional questions
the Committee may ask of the witnesses. The witnesses are
excused, and the hearing is now adjourned.
[Whereupon, at 12:31 p.m., the Committee was adjourned.]
Appendix I
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Answers to Post-Hearing Questions
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Appendix II
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Additional Material for the Record
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