[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
       
       
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                    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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