[Senate Hearing 114-554]
[From the U.S. Government Publishing Office]
S. Hrg. 114-554
THE REEMERGENCE OF VACCINE-PREVENTABLE DISEASES: EXPLORING THE PUBLIC
HEALTH SUCCESSES AND CHALLENGES
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING THE REEMERGENCE OF VACCINE-PREVENTABLE DISEASES; FOCUSING ON
EXPLORING THE PUBLIC HEALTH SUCCESSES AND CHALLENGES
__________
FEBRUARY 10, 2015
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia BERNARD SANDERS (I), Vermont
RAND PAUL, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN COLLINS, Maine AL FRANKEN, Minnesota
LISA MURKOWSKI, Alaska MICHAEL F. BENNET, Colorado
MARK KIRK, Illinois SHELDON WHITEHOUSE, Rhode Island
TIM SCOTT, South Carolina TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
BILL CASSIDY, M.D., Louisiana
David P. Cleary, Republican Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
(ii)
C O N T E N T S
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STATEMENTS
TUESDAY, FEBRUARY 10, 2015
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 1
Murray, Hon. Patty, a U.S. Senator from the State of Washington,
opening statement.............................................. 3
Collins, Hon. Susan M., a U.S. Senator from the State of Maine... 13
Mikulski, Hon. Barbara A., a U.S. Senator from the State of
Maryland....................................................... 14
Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana... 16
Warren, Hon. Elizabeth, a U.S. Senator from the State of
Massachusetts.................................................. 18
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas....... 19
Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin.. 20
Franken, Hon. Al, a U.S. Senator from the State of Minnesota..... 22
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania................................................... 43
Prepared statement........................................... 45
Murphy, Hon. Christopher, a U.S. Senator from the State of
Connecticut.................................................... 45
Bennet, Hon. Michael F., a U.S. Senator from the State of
Colorado....................................................... 47
Witness--Panel I
Schuchat, Anne, M.D. (RADM, USPHS), Director, National Center for
Immunization and Respiratory Diseases, Centers for Disease
Control and Prevention, Atlanta, GA............................ 4
Prepared statement........................................... 6
Witnesses--Panel II
Moore, Kelly L., M.D., MPH, Director, Immunization Program,
Tennessee Department of Health, Nashville, TN.................. 24
Prepared statement........................................... 25
Sawyer, Mark H., M.D., FAAP, Professor of Clinical Pediatrics,
Division of Infectious Diseases, University of California San
Diego and Rady Children's Hospital, San Diego, CA.............. 29
Prepared statement........................................... 31
Jacks, Tim, M.D., DO, FAAP, Parent, Pediatrician, and Every Child
By Two Immunization Champion, Gilbert, AZ...................... 38
Prepared statement........................................... 39
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
March of Dimes Foundation.................................... 56
Response by Anne Schuchat, M.D. (RADM, USPHS), to questions
of:
Senator Roberts.......................................... 58
Senator Cassidy.......................................... 59
Senator Casey............................................ 61
Senator Baldwin.......................................... 62
Senator Warren........................................... 62
(III)
Response to questions of Senator Casey by:
Tim Jacks, M.D., DO, FAAP................................ 63
Mark H. Sawyer, M.D., FAAP............................... 63
Kelly L. Moore, M.D., MPH................................ 65
Response to questions of Senator Roberts by Mark H. Sawyer,
M.D., FAAP................................................. 65
Response to questions of Senator Warren by:
Tim Jacks, M.D., DO, FAAP................................ 66
Mark H. Sawyer, M.D., FAAP............................... 66
Kelly L. Moore, M.D., MPH................................ 67
THE REEMERGENCE OF VACCINE-PREVENTABLE DISEASES: EXPLORING THE PUBLIC
HEALTH SUCCESSES AND CHALLENGES
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TUESDAY, FEBRUARY 10, 2015
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10 a.m., in room
SD-106, Dirksen Senate Office Building, Hon. Lamar Alexander,
chairman of the committee, presiding.
Present: Senators Alexander, Collins, Kirk, Roberts,
Cassidy, Murray, Mikulski, Sanders, Casey, Franken, Bennet,
Baldwin, Murphy, and Warren.
Opening Statement of Senator Alexander
The Chairman. The Senate Committee on Health, Education,
Labor, and Pensions will please come to order.
This morning, we're holding a hearing about the reemergence
of vaccine-preventable diseases. Senator Murray and I will each
have an opening statement. Then we'll introduce our panel of
witnesses. After our witness testimony, Senators will each have
5 minutes of questions.
We have two panels today and 2 hours for the hearing. We're
going to end about noon. We'll have an hour for each panel, and
I will end the first panel at 11 o'clock.
From smallpox to polio, we have learned in the United
States that vaccines save lives. Yet a troubling number of
parents are not vaccinating their children. Last September,
this committee held a hearing about the Ebola virus. Our
witnesses included a brave physician, Dr. Kent Brantly, who
worked in Liberia and who contracted Ebola, and a brave father
in Sierra Leone who came to warn us about how rapidly the virus
was spreading there.
The number of people being infected with Ebola was doubling
every 3 weeks, and many of those infected were dying, because
for Ebola there was and is no cure, and there was and is no
vaccine. This produced a near panic in the United States. It
changed procedures in nearly every hospital and clinic. I
remember one Chattanooga public health officer saying it's all
Ebola all the time every day.
In response, Congress appropriated more than $5 billion to
fight the spread of the virus. The impact of efforts to fight
Ebola is that the number of Ebola cases is declining. At the
same time, here in the United States we are now experiencing a
large outbreak of a disease for which we do have a vaccine.
Measles used to sicken up to 4 million Americans each year.
Many believed that it was an unpreventable childhood illness.
But the introduction of a vaccine in 1963 changed everything.
Measles was declared eliminated, meaning absence of continuous
disease transmission for greater than 12 months from the United
States in 2000.
Then from 2001 to 2012, the median yearly number of measles
cases reported in all of our country was 60. Today is February
10, 2015. It is the 41st day of the year, and already we have
seen more cases of measles than we would in a typical year.
One measles outbreak in Palatine, IL, a suburb about a half
hour from Chicago, has affected at least five babies, all less
than 1 year old. Infants and individuals who are
immunocompromised are traditionally protected by what is called
herd immunity, meaning when more than 9 out of 10 of the people
around them are vaccinated, so they don't get sick, and that
keeps the babies and others who can't get vaccinated from
getting sick. That herd immunity is incredibly important.
Measles can cause life threatening complications in children,
such as pneumonia or swelling of the brain.
Our witnesses today will talk more not just about what is
causing this outbreak, but why some parents are choosing not to
vaccinate their children. Measles is only one example. This
hearing, which was planned before the measles outbreak, reminds
us of the importance of vaccines.
An analysis of immunization rates across 13 States
performed by USA Today found the following: Hundreds of
thousands of students attend schools, ranging from small
private academies in New York City to large public elementary
schools outside Boston to Native American reservation schools
in Idaho, where vaccination rates have dropped precipitously
low, sometimes under 50 percent.
California is 1 of the 20 States that allow parents to
claim personal belief exemptions from vaccination requirements.
In some areas of Los Angeles, 60 percent to 70 percent of
parents at certain schools have filed a personal belief
exemption. In those elementary schools, vaccination rates are
as low as those in Chad or in South Sudan.
The purpose of this hearing is to examine what is standing
between healthy children and deadly diseases. It ought to be
vaccinations. Too many parents are turning away from sound
science. Sound science is this: Vaccines save lives.
They save the lives of the people who are vaccinated. They
protect the lives of the vulnerable around them, like infants
and those who are ill. Vaccines save lives.
They protect us from the ravages of awful diseases like
polio, which invades the nervous system and can cause
paralysis. I can remember as a child how parents were
frightened by the prospect of polio for their child. I had
classmates who lived in iron lungs. Our majority leader,
Senator McConnell, contracted polio as a child.
Whooping cough is another example, which causes thick mucus
to accumulate in the airways and can make it difficult for
babies to breathe; or diphtheria, a bacterial infection that
affects the mucous membranes of your nose and throat and can,
in advanced stages, damage your heart, kidneys, and nervous
system.
We have learned that vaccines save lives. They take deadly,
awful, ravaging diseases from horror to history.
It is troubling to hear that before we've even reached
Valentine's Day this year, 121 Americans are sick with measles,
a disease eliminated in the United States 15 years ago. It is
troubling that a growing number of parents are not following
the recommendations of doctors and public health professionals
who have been making those recommendations for decades.
At a time when we are standing on the cusp of medical
breakthroughs never imagined--cutting-edge personalized
medicine tailored to an individual's genome, for example--we
find ourselves retreading old ground.
I now turn to Senator Murray for her opening statement.
Opening Statement of Senator Murray
Senator Murray. Thank you very much, Chairman Alexander.
Thanks to all of our witnesses for coming and sharing your
expertise with us today.
Keeping our children and families healthy could not be more
important. I'm glad to have the opportunity to hear from all of
you about the threat vaccine-preventable diseases still pose in
the United States and to discuss what we should be doing to
take these threats off the table.
There's no question we have come a long way when it comes
to what were once widespread and extremely dangerous illnesses.
Vaccines are truly one of our country's greatest public health
successes. Thanks to them, we know how to prevent illnesses
that struck so many children as recently as a generation or two
ago, like polio and whooping cough and measles.
Recent news about the measles outbreak in many States,
including my home State of Washington, made clear that vaccine-
preventable diseases are still a threat and that we can't
afford to become complacent about protecting the progress that
we've made.
Bottom line, this means children across the country need to
be vaccinated. It also means we need to be vigilant about
breaking down any barriers that families may face when it comes
to accessing certain vaccines. We need to ensure that in any
cases where take-up rates are low, we're providing information
and spreading awareness so that more people can be protected.
The HPV vaccine is a great example. It prevents life
threatening cancers, including cervical cancer, which impact
thousands of lives in the United States each year.
Despite that, CDC reports that take-up rates for the
vaccine are still unacceptably low, meaning people continue to
be exposed to deeply harmful illnesses that could have been
prevented.
I know several of our witnesses have done a lot of work on
this issue. I will certainly have questions about what we can
do to encourage broader use of vaccines. We're looking forward
to an update from Dr. Schuchat about the recent measles
outbreaks and the work the CDC is doing to continue to
encourage vaccination.
I'm very eager to hear from Dr. Kelly Moore about the role
of States in preventing and responding to outbreaks like this
one. I know that Dr. Sawyer and Dr. Jacks will also be able to
provide valuable insight into ongoing, nationwide efforts to
increase immunizations rates and keep children and families
healthy.
I want to thank again all of our witnesses for the
important work you are doing and for taking the time to be here
with us today.
Thank you very much, Mr. Chairman.
The Chairman. Thank you, Senator Murray, and thank you to
you and your staff for working with us to jointly invite the
witnesses today. That always produces a better hearing and a
good variety of views.
Each witness will have up to 5 minutes.
We'll ask you, Dr. Schuchat, if you'll summarize your views
in 5 minutes so Senators can have a chance to ask questions.
Then we'll take an hour. I said before some of the Senators
came in that we'll have to end the first panel at 11 so we can
get to the second panel, which will go on to 12. I hope all of
us can get questions in to the first panel. If not, you'll be
first in line on the second panel.
Dr. Schuchat is the Director of the National Center for
Immunization and Respiratory Diseases at the Centers for
Disease Control and Prevention. She has worked at CDC since
1998 on immunization, respiratory, and other infectious
diseases. She is a Rear Admiral in the U.S. Public Health
Service Commissioned Corps and was named Assistant Surgeon
General of the U.S. Public Health Service in 2006.
Dr. Schuchat, welcome.
STATEMENT OF ANNE SCHUCHAT, M.D., (RADM, USPHS),
DIRECTOR, NATIONAL CENTER FOR IMMUNIZATION AND
RESPIRATORY DISEASES, CENTERS FOR DISEASE CONTROL
AND PREVENTION, ATLANTA, GA
Dr. Schuchat. Good morning, Mr. Chairman and members of the
committee. Thank you for the opportunity to speak with you
today.
Our nation's immunization system is strong, protecting the
health of Americans, saving lives and money. This year's
outbreak of measles demonstrates how interconnected we are.
Many threats, including measles, are just an airplane ride
away.
Despite high national immunization coverage against
measles, last year, we had more cases of measles in the United
States than we've had since 1994. Since January 1, we've
already had more measles cases this year than we've had in most
full years since 2000, when home-grown measles was eliminated
in the United States.
From January to February 6 this year, 121 people from 17
States have been reported to have measles. Most are linked to
an ongoing outbreak that originated at Disney parks in
California during December. Most cases were not vaccinated or
didn't know if they had been vaccinated.
Recent patients with measles have exposed others in a
variety of settings, including at school, childcare, emergency
departments, outpatient clinics, and airplanes. These episodes
require a rapid response coordinated across local, State, and
Federal jurisdictions. The backbone for such a response comes
from the public health immunization infrastructure, the systems
and people that protect our communities from vaccine-
preventable diseases.
Today, we're talking about measles, but we could just as
easily be talking about a resurgence of whooping cough, a
meningitis outbreak in college, or adapting to a shortage of a
popular combination vaccine. We need a strong immunization
system that takes care of the everyday prevention and assures
the quality of clinical practice but is also robust enough to
respond to emergencies and ready to launch mass vaccination for
the next pandemic.
Whether a vaccine is given in a private doctor's office or
at a community clinic, the public health system plays a
critical role in making sure vaccination is accessible, safe,
and effective and used in the best way to protect all
Americans, and that our immunization policies are based on a
strong scientific foundation continually reviewed.
Our priorities for maintaining a strong program include
preserving core public health infrastructure at the local,
State, and Federal levels; maintaining adequate vaccine
purchase to provide a safety net for uninsured adults and for
responding to outbreaks and other urgent vaccine needs; and
making strategic investments to enhance the immunization
infrastructure and evidence base and improve efficiency.
Coverage for many childhood vaccines is above 90 percent,
and reported cases for most vaccine-preventable diseases are
down by more than 90 percent. Most parents are vaccinating
their children with most of the recommended vaccines. Less than
1 percent of toddlers have received no vaccines at all.
Immunization continues to be one of the most cost-effective
public health interventions. For each dollar invested in the
childhood program, there are $10 of societal savings and $3 of
direct medical savings. The past 20 years of U.S. childhood
immunization has prevented over 300 million illnesses, 732,000
deaths, and resulted in $1.4 trillion in cost savings.
In many ways, though, we are victims of our own success.
Because of our success, fewer and fewer doctors, nurses, and
parents have witnessed the serious and sometimes life
threatening consequences of these diseases. Because of our
success, parents may wonder if vaccines are necessary, and they
may worry that the risk or temporary discomfort of vaccinating
may outweigh the benefits of protecting their families from
vaccine-preventable diseases.
The increase in measles cases should be seen as a wake-up
call. Measles is very contagious and quickly uncovers pockets
of under-vaccination. In the 1980s and early 1990s, measles
outbreaks uncovered systemic problems with poor children having
access to vaccines, leading to the creation of the Vaccines for
Children Program.
Today, measles in the United States is an indicator of how
globally interconnected we are. When we see outbreaks
associated with importations, measles uncovers those people in
areas in the United States that are opting out of immunization.
We have indications that some of those unvaccinated micro
communities may be getting larger.
Our immunization system has risen to challenges in the
past, and CDC will work with partners to keep measles from
regaining a foothold in our country again. Working together, we
can keep these numbers down, keep measles from returning and
threatening the health of our communities, and sustain the
enormous health and societal benefits that our immunization
partnership has achieved.
Thank you.
[The prepared statement of Dr. Schuchat follows:]
Prepared Statement of Anne Schuchat, M.D. (RADM, USPHS)
Introduction
Good morning Chairman Alexander, Ranking Member Murray, and members
of the committee. I am Dr. Anne Schuchat, Director of the National
Center for Immunization and Respiratory Diseases at the Centers for
Disease Control and Prevention (CDC). Thank you for the opportunity to
speak with you today.
It has been said many times that vaccines are one of public
health's greatest achievements. The immunization of children in the
United States has saved millions of lives, contributed to longer life
expectancy, reduced health disparities, improved quality of life, and
saved trillions of dollars in societal costs. Immunizations have become
a routine part of how we care for our children. Less than 1 percent of
children in the United States receive no vaccines at all.
However, the success of vaccination means fewer and fewer doctors,
other healthcare providers, and parents have witnessed the serious and
sometimes life-threatening consequences of vaccine-preventable diseases
(VPDs). Illness from vaccine-preventable disease is no longer common,
and parents may wonder if vaccines are really necessary or believe that
the risks of vaccinating infants or temporary discomfort a vaccine may
cause outweigh the benefits of protecting them from infection with
VPDs. Yet even small numbers of cases can lead to the re-emergence of
VPDs if we have increasing numbers of unvaccinated people.
measles
The recent measles outbreaks in the United States provide an
excellent example of our continued vulnerability to VPDs. Measles is a
highly contagious respiratory disease caused by a virus. It spreads
through the air through coughing and sneezing. After an infected person
leaves a location, the virus remains viable for up to 2 hours on
surfaces and in the air. It spreads so easily that if one person has
it, 90 percent of the people close to that person who are not
vaccinated or otherwise immune will also become infected. The good news
is that since the 1960s, there has been a highly effective vaccine to
prevent measles. One dose is about 93-percent effective at preventing
measles; two doses are about 97-percent effective. Before the U.S.
measles vaccination program started in 1963, about three to four
million people in the United States got measles each year; 400-500 of
them died, 48,000 were hospitalized, and 4,000 developed encephalitis
because of measles. In the United States, widespread use of the vaccine
has led to a 99-percent reduction in measles cases compared with the
pre-vaccine era.
Because of a highly effective vaccination program and a strong
public health system for detecting and responding to measles cases and
outbreaks, measles was declared eliminated from the United States in
2000. However, the story does not end with elimination. While the
western hemisphere has eliminated measles, the disease is still endemic
in many parts of the world, with 20 million cases occurring worldwide
annually. Outbreaks can occur in the United States when unvaccinated
groups are exposed to imported measles virus. Between 2000 and 2013, a
range of 37 to 220 measles cases per year were reported in the United
States with most of these originating outside the country. Importations
of measles remain a significant challenge. Unvaccinated U.S. residents
traveling overseas are at risk for measles, and returning unvaccinated
U.S. residents and foreign visitors to the United States may develop
measles and expose unvaccinated people in the United States. When
measles gets into communities of unvaccinated people in the United
States, such as people who refuse vaccines for religious, philosophical
or personal reasons, outbreaks are more likely to occur. New research
recently published in the journal Pediatrics has found that people who
seek personal belief exemptions for their children often live near one
another. We think these micro-communities are making it difficult to
control the spread of measles and are making us vulnerable to having
the virus re-establish itself in our country again. In addition, they
put others at risk who cannot get vaccinated because they are too young
or they have specific health conditions. CDC works with its partners,
such as the American Academy of Pediatrics and the American Association
of Family Physicians, to develop and disseminate evidence-based tools
to help health care providers and parents understand the science
recommending vaccination.
High measles vaccine coverage and rapid public health response are
critical for preventing and controlling measles cases and outbreaks.
While overall measles vaccination coverage rates are high at 92
percent, one in 12 children in the United States is not receiving his
first dose of measles-mumps-rubella (MMR) vaccine on time, underscoring
considerable measles susceptibility across the country. In addition, we
see considerable variability in coverage across States. In 2013, there
were 17 States where less than 90 percent of toddlers had received at
least one dose of MMR. Within States, some counties or communities have
much lower vaccination rates than the State average.
From January 1, 2015, until January 30, 2015, a total of 102 people
in 14 States have been reported as having measles. Most of these cases
are part of an ongoing, large multistate outbreak linked to the
Disneyland theme parks in California. CDC is working with State and
local health departments to control this outbreak which started in late
December. Many of you know that in 2014, the United States experienced
the highest number of measles cases we had reported in 20 years, over
600 driven in large part by one large outbreak of 383 cases, occurring
primarily among unvaccinated Amish communities in Ohio. Although we
aren't sure exactly how this year's outbreak began, we assume that
someone got infected overseas, visited the parks and spread the disease
to others. Infected people in this outbreak here in the United States
this year have exposed others in a variety of settings including
school, daycares, emergency departments, outpatient clinics and
airplanes. Frontline public health workers and clinicians across the
country are following up on suspected measles cases in light of the
recent outbreak. They are part of an enormous public-private
partnership that protects health and saves lives through the Nation's
immunization system.
In response to the current outbreak, CDC issued a Health Advisory
on January 23, 2015, to notify public health departments and healthcare
facilities about the multi-State outbreak and to provide guidance for
healthcare providers nationwide. On January 29, 2015, CDC held a press
briefing to inform the public about the outbreak and the importance of
appropriate prevention and treatment measures. CDC updates its web page
weekly to prominently include information about measles including
direct links to fact sheets and continuing education webinars aimed at
clinicians regarding measles. CDC also works with many partner
organizations including clinician organizations, public health
associations, and patient groups to share information, develop tools,
and explore new partnership activities to reach the public and health
care providers about immunization. In addition, CDC supports State and
local health departments in their outbreak investigations by providing
technical support for measles prevention and control; testing specimens
from patients with suspected measles infection; and, providing rapid
assistance on the ground through formal requests from State health
departments.
overview of u.s. immunization policies and programs
CDC's national immunization recommendations currently provide
guidance for the prevention of 17 VPDs across the lifespan. CDC's
immunization program plays a fundamental role in achieving national
immunization goals and sustaining high vaccination coverage rates to
prevent death and disability from VPDs. CDC's Immunization program
includes the Vaccines for Children (VFC) entitlement program, and CDC's
317 Immunization program.
VFC is one of the largest and most successful public-private
partnerships. Created by the Omnibus Budget Reconciliation Act of 1993
and implemented in 1994 as a new entitlement program, the VFC program
allows eligible children to receive recommended vaccinations free of
charge as part of routine care, supporting the reintegration of
vaccination and primary care. The VFC program serves children through
18 years of age without insurance, those eligible for Medicaid,
American Indian/Alaska Native children, and underinsured children who
receive care through federally qualified health centers or rural health
clinics. CDC purchases vaccines to distribute to VFC-enrolled providers
by funding 61 eligible grantees for VFC-related operations activities.
Currently, there are more than 44,000 public and private providers in
the VFC program, and VFC distributes over 50 percent of all routinely
recommended vaccines for those 18 years and younger. VFC has been
instrumental to achieving high vaccination coverage rates and reducing
disparities.
In addition, a discretionary immunization program was enacted in
1962 through the Vaccine Assistance Act, or section 317 of the Public
Health Service Act. Over its 50-year history, the Program has played a
role in helping to achieve national immunization goals by supporting
the public health workforce and systems at the national, State, and
local levels as well as supporting vaccine purchase. These include
systems to ensure quality assurance, such as proper vaccine storage,
manage vaccine shortages, and educate and promote immunization
recommendations across the life span. To implement the discretionary
program, CDC works collaboratively with the 64 grantees, including the
50 States, six large cities (including the District of Columbia), five
territories, and three Pacific Freely Associated States.
In addition, the discretionary program is responsible for
investments that strengthen the evidence base for our immunization
policies and practices. It supports disease surveillance, laboratory
capacity, and scientific studies to evaluate vaccine effectiveness,
safety, and program. The program allows us to maintain public health
preparedness for a response to a vaccine-preventable national
emergency, such as a pandemic or biologic attack.
Scientifically based vaccine policies are a foundation of the U.S.
immunization system. In the United States, the Advisory Committee for
Immunization Practices (ACIP) advises the CDC on national vaccine
policy for preventing infectious diseases in the civilian population.
The immunization systems and expertise that are supported by the
national immunization program make substantial contributions to the
evidence base upon which the ACIP deliberates in making its
recommendations by providing data about the burden of disease, safety
and efficacy of the vaccine, economic analyses, including cost-
effectiveness data, and information about other factors such as how the
recommendation can be implemented by the health care system in
conjunction with other recommended vaccines.
Once adopted by CDC, the committee's recommendations establish the
standard of practice for preventing VPDs. The Affordable Care Act
requires that, as of September 2010, vaccines recommended by ACIP
(along with other recommended preventive services) be covered by non-
grandfathered private health plans without cost-sharing. In addition to
post-market surveillance conducted by the CDC and the Food and Drug
Administration (FDA) for FDA-approved vaccines, ACIP continues to
review the safety and effectiveness of vaccines even after they are
recommended, and updates recommendations as more data become available.
New data are reviewed in the context of the risks of adverse effects
and the benefits provided by the vaccine.
Coverage for many childhood vaccinations are at, near, or above 90
percent, and reported cases for most VPDs have decreased by 90 percent
or more in the United States. Immunization continues to be one of the
most cost-effective public health interventions. For each dollar
invested in the U.S. childhood immunization program, there are $10 of
societal savings and $3 in direct medical savings.\1\ The past 20 years
of childhood immunization has prevented 322 million illnesses, 732,000
deaths, and nearly $1.4 trillion in societal costs.\2\ Our investments
have supported national, State and local programs that have
dramatically improved access to vaccination for all children and put
systems in place to detect and respond to outbreaks of VPDs and to
monitor vaccine effectiveness and safety.
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\1\ Zhou F, Shefer A, Wenger J, et al. Economic evaluation of the
routine childhood immunization program in the U.S., 2009. Pediatrics
2014;133:577-85
\2\ CDC. Benefits from Immunization During the Vaccines for
Children Program Era--United States, 1994-2013. MMWR 2014;63(16):352-55
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challenges
While overall vaccination rates remain high, we still face several
challenges in preventing VPDs. The majority of parents have their
children vaccinated, however, we know that some parents delay or refuse
vaccinations. CDC has conducted research to better understand why some
parents choose not to vaccinate their children. There are many reasons
parents give for their vaccine hesitancy despite overwhelming and
consistent scientific evidence that vaccines are safe and effective.
For some, many VPDs don't have the visibility they once had, and many
parents tell researchers that they question whether the vaccines are
more dangerous for their child than the disease they prevent. Parents
also have access to conflicting and often inaccurate information about
vaccines via the internet, and others express concern that there are
too many vaccines.
CDC knows that maintaining public confidence in immunizations is
critical to preventing declines in vaccination coverage rates and
outbreaks of VPDs. CDC supports science-based communication campaigns
and other efforts to convey the benefits of vaccines to the public to
aid individuals in making informed vaccine decisions to protect
themselves and their loved ones. CDC also conducts outreach to educate
healthcare providers about current immunization policy and clinical
best practices to help them protect their patients and communities from
VPDs. CDC developed and will maintain a dynamic provider toolkit for
conversations with parents about vaccination that includes evidence-
based strategies, print materials, and web-based tools.
Another challenge we currently face is a low adult vaccination
coverage rate. Last week, CDC released the latest non-influenza
vaccination coverage rates for adults, and the results were not
encouraging. Findings show most coverage rates continue to be below
Healthy People 2020 targets with persistent racial and ethnic gaps. We
know that to reach adults we will need different strategies than we
have used with the childhood program. Unlike children who have
scheduled routine visits with their pediatrician, adults may see
multiple physicians for specialty care, many of whom do not offer
vaccination services. CDC is working to increase awareness of the need
for vaccines for adults among the general population and the provider
community. We also are looking at increasing access through non-
traditional venues, including pharmacies and retail clinics.
Outbreaks of VPDs continue to be an ongoing challenge for the
public health system. Measles elimination was declared in the United
States in 2000, but we still contend with importations of measles
viruses. In addition, there have been recent outbreaks of meningitis
and mumps in university settings and other tight knit communities.
Measles, however, is a particularly sensitive indicator of the strength
of our public health systems as it is very contagious and quickly
uncovers pockets of under vaccination. In the 1980s and early 1990s,
measles outbreaks uncovered a weakness in access to vaccines, resulting
in the creation of the VFC program. Today, it is an indicator of how
globally interconnected we are, with measles importations uncovering
those communities opting out of immunization, and indicating those
communities may be getting larger. Ongoing surveillance is critical to
detecting and responding to outbreaks quickly to prevent further spread
of the disease and to understanding vaccine effectiveness and safety
over time. CDC is committed to a strong evidence base to assure that
immunization programs are protecting Americans and based on the best
available data, continuously reviewed and updated.
looking forward
The U.S. immunization system has been very successful in reaching
high coverage levels and low incidence of most VPDs. As the current
outbreak demonstrates, we cannot become complacent to the threat of
VPDs as the current increase in measles cases has shown us. CDC's
priorities for the coming year focus on keeping the American public
prepared to respond to such threats. These include: educating and
engaging health care providers and the American public on the science
about vaccine safety and effectiveness, preserving core public health
immunization infrastructure at the local, State, and Federal levels;
maintaining an adequate amount of vaccine purchase to provide a
vaccination safety net for uninsured adults and for response to VPD
outbreaks and other vaccine urgent needs while recognizing the expanded
access to vaccine coverage through the Affordable Care Act; and, making
strategic investments to enhance the immunization infrastructure and
evidence base and improve efficiency.
The increase in measles cases should be seen as a wake-up call. Our
immunization system has risen to challenges in the past, and CDC is
committed to keeping measles and other VPDs from regaining a foothold
in the United States again. The very large outbreaks we have seen
around the world often started with a small number of cases. Working
together, we can keep these numbers down, keep measles from returning
and threatening the health of our communities, and sustain the enormous
health and societal benefits that our immunization partnership has
achieved.
The Chairman. Thanks, Dr. Schuchat. About 10 years ago,
Senator Frist, our Senate majority leader, who was also a
physician, led a group of us to South Africa, where we found
the president of South Africa had rejected the science on HIV/
AIDS. He decided it wasn't caused by a virus, and that the cure
was the elimination of poverty, setting back South Africa for
years in terms of its ability to deal with HIV/AIDS.
Now, today, there's information that's on the internet,
which is where we were told the South African president had
found his information some years ago, that says there was a
study published in The Lancet in 1998 by Andrew Wakefield
alleging a connection between the measles, mumps, and rubella
vaccine, MMR, and autism.
Let's say you're a physician or pediatrician, and a parent
comes in and says, ``I've been on the internet, and I'm
concerned, because I found that according to this medical
journal, there is a relationship between the measles and mumps
vaccine and autism.'' What would you say to that parent?
Dr. Schuchat. Autism is a terrible condition. That paper
that you're mentioning has been totally discredited. It was
found to be fraudulent and is not the case. There have been
dozens of studies of vaccines and the question of autism.
Vaccines don't cause autism. They are highly effective and safe
and are a good way to protect your children from vaccine-
preventable diseases.
The Chairman. When you say totally discredited, what do you
mean by that?
Dr. Schuchat. The information in that particular report was
found to be fraudulent by a British investigator. Some of the
information wasn't correct in terms of the notes that were
submitted.
There have been dozens of studies that were better to try
to understand whether there is a link between vaccines and
autism. It was sort of a natural question some parents had
because of the onset age for autism. Those studies have been
incredibly reassuring.
When I talk to the public or I talk to parents, I like to
explain that as a physician and as a public health expert, I
can tell you that vaccines are very safe and effective. While
autism is a terrible condition, one thing we know is that
vaccines don't cause autism.
The Chairman. You would say to the parent that that article
was just flat wrong.
Dr. Schuchat. That's right.
The Chairman. And that numerous studies have shown that it
was wrong.
Dr. Schuchat. That's right.
The Chairman. What happened to the author of the article?
Dr. Schuchat. He lost his medical license.
The Chairman. Why?
Dr. Schuchat. Because of the fraudulent behavior.
The Chairman. Because of the fraudulent behavior. We've
been talking about a variety of vaccines. It struck me, as we
were so worried about Ebola last fall--and we're still worried
about it--that many of the public health people from Tennessee
would point out to me that we had the flu season coming up. How
many Americans die each year from the flu?
Dr. Schuchat. Flu is very variable, but it can be between
3,000 in a really good year to about 50,000 in a severe year.
This is a quite severe year for flu.
The Chairman. Three-thousand to fifty-thousand could die
from flu. Is there a vaccine for flu?
Dr. Schuchat. That's right. There are several different
vaccines for influenza. Right now, about 46 percent of
Americans get a flu vaccine each year. We'd like that to be
much higher. We do recommend everybody 6 months and over get a
flu vaccine every year.
The Chairman. Let's go back to measles for a minute.
Measles is not just a runny nose, is it? It is a serious
disease. What would you say to a parent who comes in and says,
``I'm going to opt not to get the measles vaccine?'' What are
the risks of that? How many children who contract measles die?
Dr. Schuchat. Before there was a measles vaccine in the
United States, 400 to 500 children in this country died. The
risk of dying is much higher in countries that are poor, where
malnutrition is a problem. We have about 150,000 deaths from
measles around the world each year. It used to be millions, and
that's actually an improvement because of high uptake of
measles vaccine.
The Chairman. Would it be accurate to say that if your
child contracted measles in the United States, the chances of a
death would be about 1 in 1,000?
Dr. Schuchat. That's right. But remember there are other
problems with measles, not just that rare risk of dying. Even a
mild case of measles is a really scary thing for a parent.
My mom was telling me about when I had measles. She was
scared to take my temperature because I looked so horrible and
it had been so high and she was worried it wasn't coming down.
Measles can be pretty scary for parents, even the mild cases.
There are other complications besides death. Children can
get pneumonia. They can get dehydration. They can also get a
neurologic problem, encephalitis, which can be quite scary and
severe.
The Chairman. Thank you.
Senator Murray.
Senator Murray. Dr. Schuchat, thank you so much for being
here, and I really thank you for all the work you do to protect
our families and children across the country. There is no doubt
that challenges remain with regards to immunization rates, and
American families' broad access to no-cost vaccines is clearly
a key factor in maintaining and improving our vaccination
rates.
In my home State of Washington, we have a universal
childhood vaccine program which provides recommended vaccines
for all children. I know there are a number of important
Federal programs that ensure access to free vaccines in our
country.
Can you describe CDC's effort to ensure all Americans do
have access to the vaccines they need without cost sharing,
including through the Vaccines for Children Program, and,
particularly why that's so important?
Dr. Schuchat. The CDC administers the Vaccines for Children
Program, and we just celebrated 20 years of that program. It's
been extraordinarily effective. It provides free vaccines to
children who are uninsured, Medicaid eligible, American Indian,
Alaskan Native, truly to financially vulnerable children in the
country. It actually provides vaccines for almost 50 percent of
children in the United States.
This program has greatly overcome racial, ethnic, and
financial barriers to vaccination, and we see much higher
coverage now in the era of the VFC Program. As I mentioned, we
think it has saved over 300 million illnesses--prevented those
illnesses in the past 20 years and saved $1.4 trillion.
CDC also supports the States in a discretionary
immunization program to try to bridge some of the gaps that are
not addressed through the VFC Program, in particular,
supporting the public health infrastructure for immunization.
State and local health departments have immunization programs
that work with the clinicians in those areas.
They don't just investigate outbreaks like the measles
outbreak, but they work day in and day out in supporting
provider education, in dealing with vaccine shortages, in
distributing vaccines so that they get to the providers'
offices. Your own State of Washington has an absolutely
fantastic program.
Senator Murray. Thank you. For me and for a lot of my
colleagues, disease prevention was a key priority when we wrote
the Affordable Care Act, and I'm very proud of the fact that
health plans now do have to cover recommended vaccines without
cost sharing.
As health insurance coverage now is increasing, can you
tell me what CDC is doing to help health departments bill
insurance providers for vaccines provided to cover individuals?
Dr. Schuchat. That's right. The Affordable Care Act means
that more people have insurance, and more insurance is
excellent for vaccines, because the ACA requires that insurers
provide all recommended vaccines with no co-pays or deductibles
when they're given in that work provider.
CDC has been supporting, I believe, 35 States to set up
billing practices so that if insured people need to get
vaccinated, for instance, in a public health clinic, that
health clinic will be able to bill the insurer and recoup the
money. We're really trying to make sure that the scarce Federal
dollars that are discretionary really go to protect the
infrastructure and that the insurers pay their way.
Senator Murray. OK. Good. I just wanted to mention I'm
really proud of the number of organizations in my home State
where they're really truly global leaders in promoting
vaccination worldwide. We have the Gates Foundation and PATH,
and the reality is we're incredibly lucky in this country to
have people who have witnessed deaths by diseases like measles
or polio or whooping cough.
I know that you've worked with these issues across the
globe. Can you tell us what you perceive as the key challenges
to achieving optimal immunization rates here as opposed to
developing countries?
Dr. Schuchat. We are so fortunate here to have a strong
health system and access to vaccines. In many countries, even
with the GAVI Alliance that provides vaccines for free for some
of the poorest countries, the infrastructure is very weak.
Strengthening health systems overseas so that they really can
deliver vaccines is vitally important.
There are a number of public-private partnerships that have
been helping in that arena, and I want to just mention the
Measles-Rubella Initiative. They're responsible for more than a
billion children getting measles vaccines through campaigns and
other areas. We think that about 15 million children have been
prevented from dying from measles in the last 15 years through
the Measles-Rubella Initiative working with governments around
the world.
Senator Murray. The public health infrastructure that we
have here is critical for issues like this.
Dr. Schuchat. Absolutely. Even if every single American was
insured, we still need public health to make sure that we are
addressing the needs of the communities.
Senator Murray. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thanks, Senator Murray.
We'll now move to 5-minute rounds of questions. Senator
Collins, Senator Mikulski, Senator Cassidy, Senator Warren will
be the first four. For the Senators who just arrived, at 11,
we're going to move to the second panel even if we haven't
finished the Senators' questions. That will take 15 minutes,
and then we'll pick right up where we left off with the
Senators who are next in line.
Senator Collins.
Statement of Senator Collins
Senator Collins. Thank you, Mr. Chairman.
Dr. Schuchat, the president's budget request includes a $50
million cut to the Centers for Disease Control and Prevention
Section 317 immunization program. You just responded to a
question from Senator Murray about the importance of the State
and local public health infrastructure.
More than just paying for vaccines, the section 317
immunization program supports outreach, awareness, surveillance
efforts by the State and local public health agencies. It's
puzzling to me that the administration would propose to cut
this program when we're in the midst of a measles outbreak,
when you would think that you would want increased public
outreach, awareness, and surveillance.
You've just talked about the importance of the State and
local roles. Could you explain to us why this cut has been
proposed?
Dr. Schuchat. The public health infrastructure at the
State, local, and Federal level is vitally important to
protecting Americans. As I mentioned earlier, these threats
like measles are an airplane ride away.
The reduction in resources requested through the
President's budget will be accounted for through a reduction in
vaccine purchase, and the idea is that instead of paying for
vaccines for insured people, the health departments will be
able to bill the insurer so that they will pay their way.
Absolutely, protecting the public health infrastructure at that
State and local level is critically important, as is the
communication outreach and the provider work that we do.
Senator Collins. Well, it just seems to me that this is
exactly the wrong time for us to be reducing funding in this
area, given the importance that you've just outlined.
Historically, access to healthcare and the cost of vaccines
had been the major barriers to achieving high vaccination
rates. Increasingly, it's clear that other factors have come to
bear as we're seeing declining vaccination rates in some
extremely wealthy areas of our country. For example, there was
a recent article in The Atlantic magazine that recently
compared unfavorably the vaccination rates in wealthy areas of
Los Angeles to the higher rates in the South Sudan.
How should our public health strategy change to reach those
parents? You would not think that that would be the area, since
they obviously can afford the cost of the vaccines and have
ample access to healthcare, certainly better than those in the
South Sudan.
Dr. Schuchat. Twenty-five years ago, we were dealing with a
problem of children not having access to vaccines. What we're
seeing more and more these days are parents opting out of the
system and not wanting their kids to be vaccinated. I like to
start with the premise that every parent wants their child to
be healthy and safe, and that's No. 1.
For a number of parents, especially in some of these
communities where opting out is common, they really don't
realize that the diseases are still around. As we're seeing
this year, when measles virus comes into a community, it's
those communities where lots of people aren't vaccinated that
are at higher risk. I hope parents in those communities are
recognizing that the threat is actually real.
Another factor is misinformation, and, of course, in
today's world, it's really easy to get information of all
types. Much of it isn't very good. We at the CDC try to have
the best information possible available and to make sure people
see the sources of the information and can really check the
facts themselves. We also work closely with clinician groups
like the American Academy of Pediatrics, because what our
research suggests is that parents want to hear about these
things from their own doctor who knows them and their family
and their unique circumstances.
A lot of the attitudes out there may be from complacency
that these diseases haven't been visible. Unfortunately, this
year, the disease is getting more visible.
Senator Collins. Thank you. I think that The Lancet study
also played a huge role. Unfortunately, there are a lot of
people who still mistakenly believe there is a link to autism
and are unaware that that study has been thoroughly
discredited.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Collins.
Senator Mikulski.
Statement of Senator Mikulski
Senator Mikulski. Thank you, Mr. Chairman.
Doctor, my question was going to be fairly identical to
Senator Collins' question on the reduction of $50 million in
the 317 grant program, which is to take care of the uninsured
as well as vaccine safety outreach and education. Now, you're
saying that that reduction of $50 million will have no impact
on those services related to vaccine safety outreach and
education?
Dr. Schuchat. No, I can't say that those reductions will
have no impact. What I actually tried to say is that the way
that we would address those changes would be to reduce the
discretionary vaccine purchase and try to really increase the
billing of insurance. It's, of course, vital that the public
health infrastructure be protected.
Senator Mikulski. Well, we feel the same way and,
particularly, on the issues related to outreach and education.
I'd like to join with the gentlelady from Maine, because this
is not an appropriations hearing, but when we do move to Labor
HHS, this is a valid area of inquiry and bipartisan
cooperation.
This then takes me to science and the misinformation. Does
CDC track the correlation between vaccine compliance and rates
of autism? Specifically, Mississippi, that has almost virtually
a 100 percent compliance rate--what is the autism rate in
Mississippi?
Dr. Schuchat. I don't have that information. There are a
number of ways that we've tried to understand trends in autism
and vaccine exposures, and a number of different study designs
have really discredited any link between autism and vaccines.
Senator Mikulski. Here's my question. See, I believe that
the solution to misinformation is more information and that it
be science and evidence-based, exactly your whole professional
career, Doctor. My question, though, is do you track that? Do
you track the correlation?
Dr. Schuchat. We track the trends going on in autism and
the trends going on in vaccination around the country. The
trends in vaccination are that almost everybody is getting
vaccinated with most of the vaccines. State by State, there are
differences in particular vaccines.
Mississippi does not allow personal belief exemptions, and
many people feel that the only exemptions that ought to be
allowed are medical ones, because, of course, some children
can't get vaccines because of health reasons.
Senator Mikulski. I'm not here trying to get into it. What
I'm trying to get into is the epidemiology.
Dr. Schuchat. Right.
Senator Mikulski. That where there are high rates of
compliance, how does that correlate?
Dr. Schuchat. There's no correlation between vaccination
uptake and autism.
Senator Mikulski. And you have the epidemiology to support
that?
Dr. Schuchat. Right.
Senator Mikulski. Which then goes exactly to outreach and
education. I want to go to a different--the committee ought to
really think about our efforts in the area of autism. I know
we've been very focused on issues related to Alzheimer's and
others. It really is an epidemic in our country.
Mothers would do anything, and fathers as well, to protect
their children. They need good information, they need real
science, and for families facing these challenges, they need to
have answers. It's another area we should take a look at on a
bipartisan basis.
I want to shift gears to immigrant children and their
vaccinations, and I know this can get controversial. What are
the outreach efforts and how do we deal with this? Because, for
example, 60,000 children came to America last year. Many of
them are in Maryland, and, hopefully, they're in the sunshine,
going to schools and so on.
Has CDC made an effort with States where there are high
rates of new immigrants, both legal and not legal, where the
immunizations of the children are addressed? Because there's
this whole attitude--they shouldn't be in our schools, they
shouldn't get our public health infrastructure, and this is
exactly what we're talking about.
In my own hometown of America, Central American kids are
going to school side by side with the gentry kids. How do we
ensure that the needs of those children are addressed and,
therefore, the needs of American children to be protected are
also addressed?
Dr. Schuchat. Vaccine-preventable diseases don't respect
borders, and it's critically important for individuals to be
vaccinated for their own health but also to protect the people
around them. The State and local health departments work very
hard to make sure that people are immunized, regardless of
their country of origin.
It's very important in an era where measles has been
eliminated from North and South America for us to continue to
make sure that there are strong immunization efforts in other
parts of the world where measles is still circulating. For
vaccine-preventable diseases, it is important to make sure that
people have access to vaccines, regardless of where they're
from.
Senator Mikulski. Thank you.
The Chairman. Thank you, Senator Mikulski.
Senator Cassidy.
Statement of Senator Cassidy
Senator Cassidy. Dr. Schuchat, tell me, of those folks
infected in the California epidemic, how many were native-born
Americans and how many had immigrated here?
Dr. Schuchat. I don't have that information. What I can say
is that most of the importations that we have of measles each
year are in Americans who are traveling abroad.
Senator Cassidy. Now, when you say American, though, an
American----
Dr. Schuchat. U.S.-born.
Senator Cassidy. A U.S.-born American.
Dr. Schuchat. Right.
Senator Cassidy. We've heard a lot about how the families
from the wealthy communities of Santa Monica and the west side
of Los Angeles are not vaccinating their children, but is that
where we're seeing these cases? Do you follow what I'm saying?
I did my residency in Los Angeles, and there are a lot of
immigrants, and a lot of those immigrants may have fallen
between the cracks. Again, do we have any sense of who is
contracting this?
Dr. Schuchat. Right. For the measles outbreak, we are
seeing spread in some of the wealthier communities in
California, for instance. Years ago, we had a lot of
importations of measles from Latin America, which is where we
have a lot of immigrants. The Americas really took on the
elimination of measles and did major campaigns around all of
the countries and had great success.
Senator Cassidy. Can I ask then--I'm sorry--just because
time is limited--when someone immigrates, what is their
requirement in terms of immunization? If somebody is coming
from the Philippines, what is the requirement now?
Dr. Schuchat. There's a requirement for documentation of
vaccination against the vaccine-preventable diseases. For
children, the Vaccines for Children Program actually makes sure
that the refugees, for instance, would have access to vaccines.
Senator Cassidy. Now, that would be for VFC. That's for
children, by definition, less than 18. What if an adult
immigrates from a country like the Philippines?
Dr. Schuchat. Right. That's not the case there, but most of
the spread is coming from--most of the risk is in children. If
you survive to adulthood in most countries, you've actually
already been exposed to measles.
Senator Cassidy. Of those adults going to the Philippines
and coming back, and they are the ones bringing the cases, is
there any--I assume there's a travel advisory--if you go to the
Philippines, get immunized. Is there any effort in the
Philippines? You've mentioned how the Americas have kind of
bucked up their immunization efforts. What about the
Philippines?
Dr. Schuchat. Yes, there are efforts there. Unfortunately,
the Philippines suffered that horrible hurricane, and after the
weather problem, much of their immunization infrastructure was
destroyed. They have had a really bad measles outbreak in
response and are really--actually CDC and others have helped
respond to help them work on their immunization campaigns.
The biggest outbreak we had last year of measles was in
travelers--a couple of Amish adults who traveled to the
Philippines who had never been vaccinated and brought the virus
back to Ohio. It turned out the Amish community really stepped
up to be vaccinated, but that was a large community where very
few people had been immunized.
Fortunately, in the United States, most communities have
high immunization rates, and it's just these newer communities
where parents are opting out that we're quite worried about.
Senator Cassidy. When we travel overseas, oftentimes we
need an immunization record. A fellow from my church just went
to a mission conference in the Philippines. I should ask him.
Was he required to show his vaccination record, et cetera, to
go, and is it required--MMR?
Dr. Schuchat. He wasn't, but we hope that we're reaching
him through our outreach efforts. We were concerned that with
the Ohio outbreak we hadn't reached those travelers. They
hadn't realized they should have been immunized. In fact, they
were misdiagnosed----
Senator Cassidy. That seems like an easy thing to do, if
you apply for a visa, to put in a note saying, ``Listen, you're
traveling to a place with endemic measles.''
Dr. Schuchat. Yes, there are a lot of electronic prompts
and so forth now that do alert you. With our alerts, they're
not 100 percent in terms of people following them.
Senator Cassidy. Is that something that we, when we approve
a visa--somehow, it seems like there should be some process by
which when somebody is traveling to an endemic country that we
would remind them of the risk.
Dr. Schuchat. Yes. Definitely, we could look into that.
Senator Cassidy. What about immunization rates since 2009?
Have they risen or stayed the same?
Dr. Schuchat. They have risen for some of the newer
vaccines, and they're stable for the others. As I mentioned, we
track very closely the percent of children who receive no
vaccines at all by age 2, and that's low.
Senator Cassidy. Some of it's stable. I just am wondering
about Senator Murray's statement--and you seemed to concur--
that the Affordable Care Act may have improved immunization
rates. We know with the CHIP Program and the Vaccines for
Children Program--I have done a lot of immunization work among
children--that, really, cost has not been a barrier for
immunization for children for some time, again, because of VFC
as well as for public health units. Would you accept that?
Dr. Schuchat. That's right. It's adults where the
vaccination record rates are very low, and then we have some
lagging coverage in teenagers, particularly with the HPV
vaccine.
Senator Cassidy. But VFC would not, for example, require
hepatitis B coverage in an adult, I presume.
Dr. Schuchat. No, the VFC just covers people through age
18.
Senator Cassidy. The ACA would not, either?
Dr. Schuchat. No, the ACA would cover vaccination of an
adult with hepatitis B if they were in a recommended----
Senator Cassidy. If they're at risk.
Dr. Schuchat. Yes.
Senator Cassidy. A gay man or something like that.
Dr. Schuchat. Well----
Senator Cassidy. I do think it's important for the record
that for childhood immunization, the Affordable Care Act has
really, not hurt, but it has certainly not augmented that which
was previously there.
Dr. Schuchat. The Vaccines for Children Program has had
huge impact, and it's really been a wonderful----
Senator Cassidy. Huge impact, yes, the VFC but not the ACA.
The Chairman. We need to keep moving.
Senator Cassidy. I yield back. I'm sorry.
The Chairman. Thank you, Senator Cassidy.
Senator Warren.
Statement of Senator Warren
Senator Warren. Thank you, Mr. Chairman.
When the polio and measles vaccine became available for the
first time, parents lined up to make sure their kids would be
protected. They lived in a world of infectious diseases that
destroyed children's futures, and they desperately wanted to
leave that world behind.
These vaccines worked so well that the memory of these
diseases has faded and the importance of vaccination has become
less obvious. Last month, the Pew Research Center Report found
that while nearly 80 percent of baby boomers and seniors
believe vaccines should be mandatory, only 59 percent of people
under 30 hold that belief, and now measles is back.
Dr. Schuchat, you are the top immunization official in the
United States. I just want to walk through the science on this
with you. Is there any scientific evidence that vaccines cause
autism?
Dr. Schuchat. No.
Senator Warren. Is there any scientific evidence that
vaccines cause profound mental disorders?
Dr. Schuchat. No, but some of the diseases we vaccinate
against can.
Senator Warren. The diseases can, but not the vaccines. Is
there any scientific evidence that vaccines have contributed to
the rise in allergies or autoimmune disorders among kids?
Dr. Schuchat. No.
Senator Warren. Are there additives or preservatives in
vaccines that can be toxic to kids?
Dr. Schuchat. Not in the amounts that are in vaccines.
Senator Warren. Is there any scientific evidence that
giving kids their vaccines further apart or spacing them
differently is healthier for kids?
Dr. Schuchat. No, it actually increases the risk period for
children.
Senator Warren. So it adds to the danger.
Dr. Schuchat. Right.
Senator Warren. Is there any scientific evidence that kids
can develop immunity to these diseases on their own simply by
eating nutritious foods or being active?
Dr. Schuchat. No.
Senator Warren. How do the risks of a child responding
negatively to a vaccination compare with the risks of skipping
vaccinations and risking exposure to a deadly disease?
Dr. Schuchat. Vaccines are safe and highly effective, and
it's important for parents to know they're the best way to
protect their kids.
Senator Warren. Every parent wants to protect their
children. Parents should know that all of the credible
scientific evidence suggests that modern vaccines are safe,
modern vaccines are effective, and modern vaccines are our best
chance of protecting our children from diseases that can kill
them. Is that right?
Dr. Schuchat. That's right.
Senator Warren. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warren.
Senator Roberts.
Statement of Senator Roberts
Senator Roberts. Thank you, Mr. Chairman. I appreciate you
holding this hearing.
In Kansas, we had 19 cases of vaccine-preventable diseases
last year. The most prevalent was measles. We have not had any
new measles cases reported yet this year. However, our public
health workers are concerned, our parents are concerned, and I
am concerned. The problem is that our immunization rates are
down. For the 2013 year to the 2014 school year, the percentage
of youngsters that have received the necessary vaccinations is
now below 90. That's not good.
For the record, I had measles and chicken pox and mumps and
everything else that people had back in the day.
What I'm asking, if I can get to it here very quickly--if
immunization rates continue to decline, what advice do you give
to these youngsters' parents who have to rely on others in
their community to choose vaccination to help protect their
own?
Dr. Schuchat. The lower the rates are, the more your
children are at risk. You want to be making sure your own
children are vaccinated, but also it's important to have those
around them vaccinated. Some kids can't get vaccines because
they have leukemia, for instance. They can't get live viral
vaccines. Our best protection is that community level of
vaccination.
Senator Roberts. Well, you highlight three reasons parents
don't vaccinate--the fear of side effects, religious or
philosophical objections--and there's a whole bunch of
paragraphs here in the background information on which States
are easier to get a religious exemption and which are easier to
get a philosophical objection--a simple letter signed by a
doctor.
How often, however, about the mistrust of the recommended
vaccine schedule--how often would you say that is the reason
that the vaccine schedule is too rigorous, and what
reassurances could you provide to parents on this concern?
Dr. Schuchat. Many parents do mention the number of shots
the children get at a particular visit as something that
concerns them. We like to let people know that the vaccines are
recommended at the times they're recommended because of the way
they work and because of the disease risk.
Our advisory committee on immunization practices reviews
the science of the vaccines and diseases and updates the
schedule every year based on the best information available. I
strongly recommend parents get their children vaccinated on
time and according to the schedule.
Senator Roberts. In answer to the chairman's question,
which really nailed the issue right off the bat, there was a
major Danish study published in 2002--540,000 children showed
definitely there was no relationship between MMR, i.e., measles
vaccination, and any kind of problem with autism. An Institute
of Medicine report in 2004 did the same.
Along the way, there have been studies from the National
Institutes of Health, the Centers for Disease Control, and
hundreds of other reliable academic groups. All of these
examinations point to the same conclusion. The body of evidence
was firmly established a long time ago.
However, this is a State issue, and that seems to be the
problem. CDC is doing the very best that you can to try to
convince every State--Mississippi leads. We're at the bottom--
not at the bottom, but fairly close to it. I'm very concerned
about it. At least the media today realizes that the one study
which was totally discredited--that there should be a very
strong statement by everybody involved that they should go
ahead and get these vaccinations.
I strongly recommend that, and I thank you for your
leadership.
The Chairman. Thank you, Senator Roberts.
We'll now go to Senator Baldwin. I want to mention again to
the Senators that at 11 we're going to excuse Dr. Schuchat and
call the second panel for 15 minutes. Then any Senator who
hasn't had a chance to ask a question will be the first one up.
Senator Baldwin.
Statement of Senator Baldwin
Senator Baldwin. Thank you, Mr. Chairman. I also want to
thank the Ranking Member for holding this hearing.
Our Nation's vaccine program has greatly reduced human
suffering and saved lives by preventing and reducing the
outbreak of preventable diseases. Thanks to national policies,
including the Affordable Care Act, now millions of families
have access to free immunizations. It's why I'm so concerned,
as I know many of my colleagues are, about the recent measles
outbreak and the surge in misinformation exacerbated by the
media and even some national figures. This misinformation, of
course, is surrounding vaccine safety.
To prevent against future outbreaks, it's vital that we
continue to invest in our Nation's vaccine production capacity,
support cutting edge science, and enhance public education
surrounding vaccine safety. I have a number of questions,
especially around our production.
Over 20 years ago, partially in response to a measles
outbreak, Congress recognized the critically important roles of
vaccines by passing and creating the CDC's Vaccine for Children
Program, which provides recommended pediatric vaccines to low-
income children. The CDC also maintains a stockpile for
pediatric vaccines.
Dr. Schuchat, could you tell us the current state of our
national pediatric vaccine stockpile, and is the measles
vaccine included in that supply? Can you elaborate on the role
of the stockpile in addressing outbreaks as well as how CDC
works to maintain it?
Dr. Schuchat. Yes. The Vaccines for Children Program
includes a stockpile that is approximately 50 percent of--
enough vaccine for 50 percent of the pediatric population to be
vaccinated for a year. We currently have over 3 million doses
of MMR vaccine.
The vaccine stockpile has been used both for outbreak
response, but it's also been used for vaccine shortages. Even
with a robust vaccine manufacturing industry, there are many
vaccines where there's only one or two manufacturers that
produce them, and when there are interruptions in supply, we'll
have to go to our stockpile to make sure that there's not an
interruption in use. It's really been a critical safety net for
the vaccine security.
Senator Baldwin. I want to explore a little further this
issue of production and interruptions in production, both with
diseases that are prevented by vaccines but also with the
influenza vaccine, where there may not be 100 percent match to
the strain that's prevalent in a given flu season.
Three issues--first, domestic manufacture versus overseas
manufacture in the case of an epidemic that's particularly
lethal has long been an issue. I understand we've improved
domestic production. Anything you could elaborate on that would
be helpful.
Second, production is usually still slow and based on
chicken eggs, and there have been many efforts to transition to
a cell-based production in the influenza vaccine. Where are we
on that?
And, third, with regard to diseases that are preventable by
vaccine, we have had drug manufacturers who have decided to
exit that area and oftentimes with little notice to the medical
profession. I've heard from front line pediatricians who say,
``We don't have enough in our clinic, and we have people coming
in, and we can't meet the demand.''
Is there better notice given to the CDC? Do we have more
safeguards in place to make sure that we don't have an alarming
shortage?
Dr. Schuchat. We had a big wakeup call about 10 years ago
in October 2004 where, overnight, half of the expected
influenza vaccine supply wasn't coming through. That really
prompted an enormous amount of reevaluation on the different
parts of government. We're in much better shape now. That year,
we eventually had about 58 million doses of flu vaccine.
This year, we have nearly 150 million doses of flu vaccine
that have been distributed. There are multiple new
manufacturers or additional manufacturers producing for the
U.S. market. We also have a number of formulations besides the
egg-based that have been approved by the FDA and are being
used. Cell-based and recombinant-based influenza vaccines are
included among this year's seasonal flu vaccine supply.
Looking toward the future, there's a lot of enthusiasm
across the government and across academia around investments
toward a universal influenza vaccine that might give us
broader, better and longer lasting protection than the annual
flu vaccines that we use today. There's a lot of progress in
the past decade. But, there's more work to be done.
In terms of the communication with the industry----
The Chairman. Dr. Schuchat, I'd like to try to get Senator
Franken in before you leave, if we may.
Senator Baldwin. We're good.
The Chairman. Thank you, Senator Baldwin.
Senator Franken.
Statement of Senator Franken
Senator Franken. Thank you, Mr. Chairman, for that.
I'm thinking that maybe this outbreak in measles is a bit
of a wakeup call. As Senator Warren said, there are a lot of
baby boomers and some of us who are--some of the Senators who
are older had measles and remember it. Maybe this is a really
good time for people, especially some educated people who were
foregoing this for their children, to understand things like
herd immunity, and that if you get a critical mass of people
not getting immunized, you have outbreaks like this.
What the costs are--just like the financial costs--there
was a 2005 NIH article that attempted to quantify the economic
impact on health infrastructure, and researchers estimated that
one case of measles costs the Federal, State, and local health
departments more than $140,000 to respond to just one case.
You talked about the return on investment for all of these
immunizations, and it's one of the most--it's obviously cost-
effective and also prevents a lot of suffering. We live in a
global world, and I just wanted to ask you about that
investment that we put into global public health and what the
importance of that is, in terms of our investing in this in
Africa and other places. Can you respond to that?
Dr. Schuchat. Yes. Measles has been eliminated from the
Americas, but it's still circulating around the world with
about 20 million cases a year. In some of the countries that
have had major outbreaks, it's really investing in their health
infrastructure and supporting their ability to have strong
immunization systems that will protect Americans as well as
strengthen their health.
We're really keen to be partners in the wholly eradication
initiative and the measles-rubella initiative in the GAVI
Alliance and in ways that we can help protect children
everywhere with vaccines that are safe and effective. It really
strengthens our communities' protection here at home and it's
really the right thing to do overseas as well.
Senator Franken. Because measles, in particular, is highly
contagious, and you're one plane ride away from an American
getting infected, speaking of which, what other infectious
diseases may be on the horizon? What might be the next measles,
and what might come from abroad, like MERS or--what else are we
looking for in the near future, possibly?
Dr. Schuchat. With infectious diseases, you really have to
be ready for the idea that the microbes are changing faster
than we are as people. This past year, we dealt with the
Enterovirus D68 problem, a severe respiratory illness in
children that we really hadn't seen. The last 2 years, we've
been dealing with the Middle East Respiratory Syndrome, a new
virus that was causing very severe disease in the Middle East
and in some travelers returning from there, with two cases here
in the United States.
Senator Franken. And that's the MERS?
Dr. Schuchat. MERS, right. We really think it's critical to
be strengthening public health infrastructure and capacity for
global health security in countries around the world so that we
don't let an epidemic like Ebola get as bad as it got but can
jump on it right away. We don't see importations of MERS, but
we recognize that these diseases are overseas and help the
countries that are battling them deal with them swiftly.
Senator Franken. That's why the CDC is so important. I
really want to thank you for your service to this Nation and to
the world. Thank you, Doctor.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Franken.
Dr. Schuchat, maybe I misheard something. The State
Department website says that U.S. immigration law requires
immigrant visa applicants to obtain certain vaccinations prior
to the issuance of an immigrant visa. An adult immigrant to the
United States who obtains a visa is required to obtain certain
vaccinations, correct?
Dr. Schuchat. Yes, I think that's right. I can double
check. We can confirm that for the record.
The Chairman. I'm reading it off of the State Department
website.
Dr. Schuchat. Oh.
The Chairman. I didn't want to leave a different impression
if a different impression was untrue.
Dr. Schuchat. Thank you.
The Chairman. Dr. Schuchat, thank you so much for your
time. There are a couple of Senators who haven't had a chance
to ask questions. I hope they will understand that we want to
invite the second panel to come up now, and they will be the
first ones up after the next 15 minutes of testimony.
I'll now move ahead and introduce the second panel to save
time, if I may. First, we'll hear from Dr. Kelly Moore. Dr.
Moore is director of the Immunization Program at the Tennessee
Department of Health. In this role, she is responsible for
promoting proper use of recommended vaccines, as well as
overseeing the response to outbreaks of vaccine-preventable
disease.
She has her undergraduate and medical degrees from
Vanderbilt, and a master's of public health from Harvard School
of Public Health. I'm completely objective, but the Tennessee
Department of Public Health is one of the finest in the
country.
Dr. Mark Sawyer is professor of Clinical Pediatrics and a
pediatric infectious disease specialist at the University of
California San Diego and Rady Children's Hospital in San Diego.
He's also the medical director at San Diego Immunization
Partnership and involved in a variety of immunization projects.
Dr. Tim Jacks is a pediatrician and the father of two
children who recently were exposed to measles in Arizona. He's
an Every Child By Two immunization champion. Every Child By Two
is a nonprofit dedicated to increasing vaccination rates among
children. His wife is in Arizona caring for their two children.
I'm grateful he could be here to tell their story.
Dr. Moore, let's begin with you. If the three of you could
summarize your comments in 5 minutes, we would appreciate it,
and then the Senators will continue questioning.
STATEMENT OF KELLY L. MOORE, M.D., MPH, DIRECTOR,
IMMUNIZATION PROGRAM, TENNESSEE DEPARTMENT OF HEALTH,
NASHVILLE, TN
Dr. Moore. Thank you, Chairman Alexander and Senator
Murray, for holding this hearing on the benefits of
immunization and for inviting me here to testify about the
public health perspective on vaccine-preventable disease. Most
people are unaware that even in a State with a strong history
of immunization, a single case of measles requires a major
public health response.
I'd like to begin by acknowledging Governor Bill Haslam and
First Lady Crissy Haslam for their commitment to immunization
as an essential step in promoting and protecting the health and
prosperity of Tennesseans. You could say Tennessee has a
culture of immunization.
For the past two influenza seasons, the majority of
Tennesseans age 6 months and up received a flu vaccine. In
2013, 95 percent of kindergarteners were immunized with all
required vaccines, including both doses of MMR. Just 1 out of
100 claimed a religious exemption, and just over 1 in 1,000
were exempted by a doctor for medical reasons.
The Federal Vaccines for Children Program has removed
barriers to access for eligible children since 1994. Our
State's online immunization information system, supported by
section 317 Federal funds, ensures that authorized users such
as clinics and schools have access to immunization records to
see what vaccines a child may need or to verify that they're
protected.
We have more work to do to reach high immunization rates
with vaccines designed for teens and adults that prevent
diseases such as meningitis, cancer, pneumonia, and shingles.
Public health partners with our clinical and pharmacy
colleagues to address misinformation and concerns about safety,
health benefits, and affordability.
To improve access, our department is using Federal
prevention and public health funds to help local public health
clinics become in-network providers for commercial insurance
plans so we can provide recommended vaccines to their
beneficiaries with no out-of-pocket cost.
When it comes to disease outbreaks, few realize how much
public health work goes into one case of measles. I vividly
recall each of the nine cases Tennessee has had in the decade
I've directed our immunization program. Our most recent
experience is a good example.
On a Friday afternoon last April, a doctor called his
regional public health office about an adult with an uncertain
immunization history and recent overseas travel who was in the
ER with classic symptoms of measles. The diagnosis was not in
question.
A game plan was quickly developed in a call with the State
immunization program to identify those who may have been
exposed in the 4 days the unsuspecting patient was highly
infectious. One hundred twenty-four people were identified. The
MMR vaccine could protect the most recently exposed susceptible
contacts if local public health could find them quickly enough.
Twenty-five contacts with uncertain immunity were
vaccinated on Saturday. Others were counseled about what to do
if symptoms developed. Among the 124 contacts, just three cases
among other adults developed. For these, the same isolation,
contact tracing, and notification process was practiced, but
faster. No additional cases occurred. In total, 406 contacts
were evaluated.
TDH worked with the media statewide to educate the public
and prepared clinicians through State health alerts and an
educational webinar. CDC measles experts provided consultation
and specialized testing that helped us optimize our outbreak
management tactics.
A great deal of credit in this story goes to the hard work
of public health at all levels. This result, however, could
only have been achieved in a community where a very high
percentage of the population was already immune. Had this
imported case landed among those who were unimmunized and
susceptible, there would have been a very different outcome.
Congress' sustained commitment to immunization and a strong
public health infrastructure through the VFC Program and
section 317 funding will continue to equip us to meet the
educational and operational challenges of keeping individuals
and communities healthy and safe through affordable,
accessible, and effective immunization services.
Thank you for the opportunity to testify here today. I've
provided a more detailed written testimony for the record, and
I'm glad to answer your questions.
[The prepared statement of Dr. Moore follows:]
Prepared Statement of Kelly L. Moore, M.D., MPH
summary
State and local public health fosters a culture of immunization in
Tennessee through close working relationships and partnerships with
pediatricians, family doctors, nurses, coordinated school health
programs and pharmacists. Public health supports this network in
several ways. The Federal Vaccines for Children Program has removed the
barrier of cost and access to immunization for any child without
insurance coverage. We use Federal section 317 funds to track
immunization coverage rates among young children and use these data to
educate healthcare providers to target our specific vulnerabilities. We
work closely with schools to help them properly enforce State school
immunization requirements in order to keep schools a safe and healthy
learning environment. Our section 317-funded State immunization
information system helps clinicians provide quality immunization
services and issue school immunization certificates. Public health
clinics are successfully working to become in-network providers for
commercial insurance plans so they can vaccinate beneficiaries without
deductible or copay.
Tennessee does well in immunizing our young children: about 93
percent have their first MMR before their first birthday. In the past
two influenza seasons, the majority of Tennesseans aged 6 months and up
were vaccinated against influenza, but there is room for improvement.
Our school-located influenza immunization clinics are one strategy we
are using. Our 2013-14 kindergarten entry data showed 95 percent had
all required vaccines, including two doses of measles, mumps and
rubella (MMR) vaccine; just 1 in 100 claimed a religious exemption and
just over 1 in 1,000 were exempted from one or more requirements by a
medical doctor for health reasons.
One overlooked element of the recent measles outbreak is the amount
of public health work needed to contain even a single case of measles
in a community. In April 2014, an adult with an uncertain immunization
history developed measles shortly after returning to Tennessee from
travel overseas. Public health investigators determined that the
patient had exposed 124 identified contacts in the days before
diagnosis. Swift action to reach these contacts and immunize those who
could benefit from a dose of MMR resulted in only three confirmed
secondary cases among other adults; no cases occurred among their
contacts. In total, 406 contacts were identified and evaluated. Such
strong outbreak response can only achieve this type of result in a
setting with a high level of immunity among the population. Our ability
to respond has been made more possible by increased emergency
preparedness funding since 2001, yet sustained support of the public
health immunization infrastructure is essential to keep the threat of
vaccine-preventable diseases at bay.
______
I would like to thank Chairman Alexander, Ranking Member Murray and
the committee for holding this hearing on the benefits of immunization
and inviting me here today to testify about the perspective and role of
State and local public health in the promotion of immunization and the
response to vaccine-preventable disease outbreaks.
I would like to begin by acknowledging Governor Bill Haslam and
First Lady Crissy Haslam for their commitment to immunization as an
essential step in promoting and protecting the health and prosperity of
Tennesseans. Whether getting an annual flu shot with a smile for the
cameras or championing the creation of KidCentralTN.com to help parents
access services to help them raise healthy children, the Governor and
First Lady have been steadfast champions of our immunization
activities.
You could say that Tennessee has a culture of immunization. For the
past two influenza seasons, the majority of Tennesseans age 6 months
and up were vaccinated against influenza. Three out of four Tennessee
toddlers are fully immunized on time by their second birthday, and most
that fall short could be caught up with just one more immunization
visit. Over 93 percent of them have had their first MMR. By the time
Tennessee children start kindergarten, 95 percent have a record of
immunization with all required vaccines, including both doses of MMR
needed to protect them from measles, mumps and rubella. Just 1 out of
100 had filed a religious exemption with the school and just over 1 in
1,000 were exempted from one or more vaccines by a doctor for medical
reasons. Our school nurses and administrators take their commitment to
enforcement of immunization requirements seriously, working closely
with public health, families and medical offices to identify and catch
up children who are behind on immunizations to keep our schools a safe
and healthy learning environment.
The Tennessee Department of Health (TDH) fosters our culture of
immunization by cultivating strong, supportive relationships with
healthcare providers, schools, parents and the public to promote and
provide immunizations needed across the lifespan. TDH programs focus on
promoting access, affordability, awareness and demand for vaccines. The
Federal Vaccines for Children (VFC) Program is critical to our success.
VFC-eligible children in our State can be vaccinated with federally
funded vaccine in any local health department and at over 500 other
participating clinics and hospitals statewide. Our section 317 Federal
immunization funds support the effective operation of our VFC Program,
including our educational programs for doctors and nurses, and regular
site visits to participating clinics by local public health staff to
promote compliance with the strong accountability and quality standards
expected of all participants in the VFC Program. Resources, training
and people are in place to enable every doctor and nurse serving VFC-
eligible children to provide the highest quality of immunization care
for all of the children they serve. These section 317 funds also help
us improve lagging adolescent immunization rates by addressing
awareness and educational needs among clinicians and families.
In addition to supporting the work necessary to keep the VFC
Program strong, a small quantity of Federal section 317 funds are
available to purchase and provide certain routine immunizations to
uninsured adults in Tennessee who seek care at our local health
departments. We use these same 317-funded vaccines to protect people
who may be at risk of contracting a vaccine-preventable disease during
an outbreak. These section 317 vaccines also are available to us today
should we need them to protect anyone who may be at risk after a
measles exposure.
Tennessee has recently used Federal section 317 funds to implement
a new, secure immunization information system, known as TennIIS, to
replace a legacy system with limited functionality. The State first
created its IIS, or Immunization Registry, in 1996, as a repository of
immunizations administered by health departments and by any other
immunization providers who chose to report them and accessible only to
authorized users. Today, TennIIS is fast becoming the heart of
Tennessee's immunization activities. All authorized users, such as
Vanderbilt's network of clinics in middle Tennessee, can look up
immunization records on their patients. For example, the health records
system used by Vanderbilt University clinics electronically updates
TennIIS with the immunizations they give and pulls down information
from TennIIS about immunizations given to their patients by other users
who report to the system. TennIIS provides decision support for busy
clinicians by instantly displaying what vaccines are due or overdue for
a child, based on the current CDC schedule. This simple tool helps
clinicians follow the complex current immunization schedule for optimal
patient care.
Our IIS, implemented and operated with our Federal section 317
funding, is an increasingly important tool in the prevention and
control of vaccine preventable diseases. Several months ago, the New
York City Department of Health notified the Immunization Program that
two young Tennesseans had been exposed to measles while visiting there.
A call such as this is a small public health emergency because of the
threat of measles. The State vaccine-preventable disease epidemiologist
normally alerts local public health to reach the affected people
without delay to find out if they are sick and to ask their
immunization status, which they rarely know with certainty. However, a
quick check of the IIS confirmed that both were up to date with MMR
vaccine and almost certainly protected from disease. The typical
scramble became a brief and reassuring call to the exposed individuals
because the needed immunization history was readily accessible to
public health.
In Tennessee, local school nurses and coordinated school health
directors are among our most important champions of immunization. These
men and women are responsible for enforcing immunization requirements
for the children in their schools to ensure that schools remain a safe
and healthy learning environment. They take this responsibility very
seriously and are often the ones to catch problems and alert the
parents and healthcare provider so they can be corrected. In 2013, the
Department of Health developed and launched a function in TennIIS to
simplify and improve the quality of immunization certificates for
school and daycare. A simple click of the button can produce a
complete, accurate immunization certificate based on a child's age and
grade. If the record is incomplete, a failed validation report
pinpoints exactly what is missing. Any TennIIS user can produce these,
including school administrators and immunizing pharmacists. Someday, we
envision that parents will be able to produce their own, further
simplifying this rite of school entry.
In many counties in Tennessee, schools partner with local public
health to offer influenza vaccine at school each fall. Such programs
are far more complicated to organize today than in the time many people
recall when children simply lined up for their sugar cubes and polio
vaccine. With more expensive vaccines, consent forms, private insurance
billing, VFC eligibility documentation and separate vaccine inventories
for different funding sources, these programs are not easy. Despite the
logistical hurdles, these partnerships strengthen the bonds between
educators and public health and raise awareness about the importance of
influenza vaccination for the whole community, as our statewide
influenza vaccination rates show.
When it comes to immunization, local public health departments long
ago ceased to be the primary providers of childhood immunizations as
children's primary care medical homes have taken over this role, but we
are relationship-builders and resources and we provide a safety net of
access for all routine immunizations. Tennessee public health
departments carry all routinely recommended vaccines for people of all
ages. When it comes to concerns about vaccine safety, the Immunization
Program is where the public and healthcare providers bring those
questions and the Program facilitates in depth consultation when
necessary with vaccine safety experts at the CDC and at Vanderbilt's
Vaccine Research Program.
What I hear when I visit local clinics is that one of the most
frustrating challenge to our front line public health nurses is keeping
up with which people qualify for vaccines from which sources and how
much they must pay. Years ago, with fewer, less expensive vaccines
available, the nurses were simply focused on ensuring that no child or
adult in need of vaccination left without being immunized. Today, we
have Federal VFC vaccine for eligible children, section 317 vaccine for
uninsured adults and State-purchased vaccines for insured children and
adults ineligible for Federal vaccines. Each inventory must be managed
and accounted separately. Once they have finished answering questions
about the vaccines themselves, explaining the differences in costs for
different groups is frustrating. They spend extra time to avoid making
a mistake and using vaccine from the wrong funding source. They long
for simpler days, but they work very hard to immunize everyone they can
and to properly account for every dose they use.
Challenging work is ahead to achieve these same high rates of
immunization for vaccines designed for the preteens, teens and adults
who are difficult to reach. Several of the vaccines recommended for
people in these age groups are relatively new, designed to prevent
diseases such as meningitis, cancer and shingles. Public health works
to inform and educate the public about these vaccines, addressing
misinformation and concerns about safety, affordability and health
benefits.
Until recently, our local health departments did not participate in
commercial insurance plans as in-network providers; a major effort is
underway using Federal Prevention and Public Health Funds to help local
public health clinics become in-network providers in order to provide
routine recommended vaccines to commercial insurance beneficiaries of
any age with no out-of-pocket cost. Currently, patients insured by a
plan we have not yet joined are asked to pay out-of-pocket for
vaccinations at our clinics, meaning that they often leave unimmunized
to try to locate an in-network provider to serve them. Some have found
this challenging in areas where the public health department may be the
nearest provider with the vaccine in stock. We are making progress in
obtaining in-network status with major plans to help close this gap.
The dedicated and creative people who work in local and State
public health, including our public health nurses, are the quiet heroes
who protect the public from vaccine-preventable diseases by promoting
immunization and by responding without hesitation when cases occur. In
recent discussions about the ongoing measles epidemic, few have
addressed how much tightly coordinated work is being done among local,
State and Federal public health officials in the public health response
to a single case. The story of Tennessee's 2014 measles outbreak
illustrates this point.
On a Friday afternoon in April 2014, an infectious diseases doctor
contacted the west Tennessee regional public health office about a
recently returned international traveler who had come to their hospital
emergency room with classic signs and symptoms of measles. Even without
laboratory results, the diagnosis was not in question. A game plan was
quickly developed among the regional public health team, the State
immunization program and partners in neighboring public health
jurisdictions to initiate laboratory testing and to identify those who
may have been exposed in the 4 days leading up to the diagnosis when
the unsuspecting patient was highly infectious while working and
visiting a primary care clinic. One hundred twenty-four people were
identified as contacts. Because the doctor contacted public health
immediately, we gained the advantage of a small window of time to
administer the MMR vaccine and protect some of the potentially
susceptible contacts, if the local public health team could find and
vaccinate them quickly enough. A clinic was arranged for Saturday
morning and 25 contacts with uncertain immunizations were vaccinated.
Those exposed more than 72 hours earlier were counseled about the
illness and what to do if symptoms developed. To expedite testing,
staff drove clinical specimens to the State lab for testing and
shipping onward to the CDC, where CDC later confirmed the diagnosis and
linked it to a large epidemic in the country recently visited by our
traveler who, like the others he infected, had simply been unaware of
his susceptibility.
Among the 124 people exposed to measles by our index case, just
three secondary cases among other adults occurred. For these three, the
same isolation, contact tracing and notification process was practiced,
only faster. No additional cases developed and the outbreak was
officially declared over in June. A total of 406 contacts were
evaluated in multiple local public health jurisdictions with State
communicable disease staff providing coordination and technical
support. Front line staff worked with patients and contacts. The
Tennessee Department of Health educated the public through the media
and kept our health care community informed through our State health
alert notices and a live webinar with subject matter experts. The CDC
measles epidemiologists and laboratory team provided specialized
laboratory testing and technical consultation to help optimize our
outbreak management tactics.
Despite how well this collaboration worked, the swift resolution
was achievable because of the already very high level of immunity in
the general population. No one in this situation opposed or refused
immunization. While prompt immunization after exposure likely prevented
some cases, the fact is that the vast majority of people exposed were
already immune. Increased emergency preparedness funding since 2001 has
helped public health become more effective at responding to outbreaks,
yet had this imported case landed among those who were unimmunized and
susceptible, there would have been a very different outcome.
Importations are not completely preventable, but by sustaining a highly
immunized population, such events can be managed by motivated and well-
trained public health responders.
Our public health professionals, along with our clinical partners,
schools and each immunized person in our community together hold back
the tide of vaccine-preventable diseases that washed over past
generations. Regular investments in training, support, technology,
vaccines and immunization services maintain this protective
infrastructure and allow us to live in health with these threats held
at bay. These outbreaks of vaccine-preventable diseases are like small
breaches that warn us of the threat we face should this infrastructure
break down. Should it be allowed to crumble, the breaches will become
larger and the consequences to our communities could be far greater.
I want to close by thanking you again for the opportunity to speak
to this committee on behalf of the dedicated State and local public
health professionals of Tennessee. We are justly proud of our culture
of immunization in Tennessee and the health and prosperity our
residents derive from it, but we have much more work to do. Our
immunization culture is promoted by public health and sustained by our
close, trusting working relationships with schools, healthcare
providers and parents. We all work hard to prevent fear and
misinformation from misguiding people about vaccines, their safety and
effectiveness. People need to be able to make well-informed decisions
about vaccines, and such decisions can only be made with clear and
reliable information from trusted sources. Our public health system
continues to work to extend the benefits of high immunization rates
among young children to reach preteens, teens and adults with vaccines
designed to protect them. Congress's sustained commitment to our
immunization programs, immunization information systems and public
health will strengthen our defense against the tide of vaccine-
preventable diseases that continue to threaten the vulnerable among us.
The Chairman. Thank you, Dr. Moore.
Dr. Sawyer.
STATEMENT OF MARK H. SAWYER, M.D., FAAP, PROFESSOR OF CLINICAL
PEDIATRICS, DIVISION OF INFECTIOUS DISEASES, UNIVERSITY OF
CALIFORNIA SAN DIEGO AND RADY CHILDREN'S HOSPITAL, SAN DIEGO,
CA
Dr. Sawyer. Chairman Alexander and Ranking Member Murray,
thanks very much for holding this hearing on a very important
topic, the reemergence of vaccine-preventable disease and what
we can do together to prevent further outbreaks.
As you've heard, I'm a pediatric infectious disease
specialist at the University of California San Diego and Rady
Children's Hospital in San Diego. I'm also a member of the
Committee on Infectious Diseases of the American Academy of
Pediatrics, and my testimony today has the strong endorsement
of AAP.
Vaccines are one of the greatest public health
achievements, as has been pointed out by Dr. Schuchat and
several of the Senators. Prior to the introduction of vaccines,
children suffered regularly from serious illnesses like
measles, diphtheria, polio, even bacterial meningitis.
The development and widespread use of vaccines has led to a
reduction or eradication of these once common childhood
illnesses. Because of the success of vaccines, I have never
seen a case of polio, diphtheria, or tetanus in my 30 years of
practice in pediatric infectious disease.
In a teaching session I held last week with 20 pediatric
residents in training, I asked them if any of them had seen the
measles. None of them had. However, as we have seen from our
current measles outbreak and continued outbreaks of pertussis
or whooping cough around the country, we are witnessing a
reemergence of vaccine-preventable diseases here in the United
States.
Unfortunately, my residents are going to get a chance to
see the measles. Pediatricians are concerned that the
reemergence of disease is a signal that bigger outbreaks are
yet to come.
Most of the cases in this current measles outbreak are from
California, and 13 are from my own community. Outbreaks like
this are increasing in frequency and size. This measles
outbreak, like all other measles outbreaks, is occurring
because we have too many intentionally unimmunized children in
the United States, and it illustrates the problem created by
unimmunized populations. A simple trip to Disneyland has led to
a multistate outbreak of measles involving more than 100
people.
Measles is one of the very few infectious diseases that
literally flies through the air. It is completely predictable
that such outbreaks will occur again if immunization rates stay
where they are or get worse.
While most parents do choose to vaccinate their children,
there are pockets of unimmunized children all over the country.
In San Diego, we have 1,500 kindergarten students who are not
fully immunized, and that number has been increasing steadily
over the last decade.
The current measles outbreak reminds us of an important
fact about infectious diseases. They are a shared public health
problem. When 1 percent is infected, people around them, people
they don't even know, become infected. The decision of a parent
to leave their child unimmunized, however well meaning, is a
decision that affects us all.
Although our public health community has done an excellent
job of controlling this current measles outbreak, when too many
people make the decision not to vaccinate their children,
outbreaks will no longer be controlled. Why is this happening?
All parents want what is best for their children, but many
parents are choosing to not have their children immunized
because they have received inaccurate information about the
risks and benefits of vaccines and the diseases they prevent.
I have held a number of forums in San Diego County, meeting
with vaccine hesitant parents to hear their concerns. Based on
what I've heard in these discussions, I conclude that the
internet can be a dangerous place for parents looking for
information about vaccines. The internet is replete with
anecdotes and misinformation that leads parents to think that
vaccines have caused harm.
What is overlooked by parents is the fact that just because
an adverse health outcome occurs in the time after a vaccine
doesn't mean that the vaccine caused the problem. It takes
science to prove or disprove a linkage between two events, and
our parents are not hearing the science.
The vaccine schedule recommended by CDC and AAP has been
developed with strong scientific standards and has been proven
to be both safe and effective. In every case, for every
vaccine, the risk from the disease outweighs any risk from the
vaccine.
In my opinion, the best way to decrease the number of
families refusing to vaccinate their children is to improve
communication about vaccine safety and effectiveness, to
increase the science literacy of our population, to limit the
philosophical exemptions from school entry requirements for
vaccination, and to continue to carefully monitor the safety of
all of the vaccines we use. Taking these steps can ultimately
help reduce the number of parents who choose not to vaccinate
their children.
The reemergence of vaccine-preventable diseases is alarming
and must be confronted if we are going to prevent further
outbreaks like the one we're currently experiencing.
Thank you for allowing me to testify, and I look forward to
your questions.
[The prepared statement of Dr. Sawyer follows:]
Prepared Statement of Mark H. Sawyer, M.D., FAAP
summary
My name is Mark Sawyer, and I am a professor of clinical
pediatrics, in the Division of Infectious Diseases at the University of
California San Diego and Rady Children's Hospital in San Diego, CA. I
am also a member of the Committee on Infectious Diseases with the
American Academy of Pediatrics (AAP). My comments today have the strong
endorsement of AAP.
The Great Success of Vaccines: Vaccines are the safest and most
cost-effective way of preventing disease, disability and death. Prior
to the introduction of vaccines children were regularly afflicted with
deadly diseases like measles, mumps, rubella, polio, and bacterial
meningitis. The development and widespread use of vaccines has led to
the reduction or eradication of these once common childhood diseases.
However, as we have seen from our recent measles outbreak and continued
outbreaks of pertussis in various areas of the country, we are
witnessing the reemergence of vaccine preventable diseases here in the
United States. I am concerned that this reemergence of disease is only
a signal of future, wider-scale outbreaks yet to come.
The Measles Outbreak at Disneyland: Currently, the United States is
experiencing a large, multistate outbreak of measles linked to
Disneyland in California. Most of the cases are from California and 13
cases are from my community. This measles outbreak occurred because we
have a rising number of unimmunized children in the United States and
illustrates the problem created by unimmunized populations. A simple
trip to Disneyland has triggered a multistate outbreak of measles
involving close to 100 people. It is completely predictable that such
outbreaks will occur again if immunization rates stay where they are or
get worse.
The Problem of Low Immunization Rates: Although most parents
immunize their children, pockets of unvaccinated children exist all
over the country and the number of unimmunized children has been
increasing steadily for more than a decade. The current measles
outbreak illustrates an important fact about infectious diseases--they
are a shared, public health problem. When one person is infected,
people around them, people they don't even know, can become infected.
The decision of a parent to leave their child unimmunized, however well
meaning, is a decision that affects all of us.
Why is This Happening? Many parents are choosing to not have their
children immunized because they have received inaccurate information
about the risks and benefits of vaccines and the diseases they prevent.
The Internet can be a dangerous place for parents looking for
information about vaccines because it is replete with anecdotes that
lead them to think vaccines have caused harm. What is overlooked is the
fact that just because one event follows another does not mean the
first event caused the second. It takes science to prove or disprove a
linkage between two events. The vaccine schedule as recommended by the
Centers for Disease Control and Prevention and the American Academy of
Pediatrics has been developed with strong scientific standards and has
been proven to be both safe and effective.
What Can We Do? The best way to reverse the number of families
refusing to vaccinate their children is to improve communication with
families about the safety and effectiveness of vaccines, increase the
science literacy of our population, limit exemptions from school entry
requirements for vaccination, and continue to carefully monitor the
safety of all the vaccines we use. In the meantime we need to maintain
our Public Health infrastructure to control the outbreaks that will
inevitably happen.
The reemergence of vaccine preventable diseases is alarming and
must be confronted if we are to prevent the further outbreaks of
disease. Thank you for allowing me to testify before the committee
today.
______
Chairman Alexander and Ranking Member Murray, thank you for holding
today's hearing on such an important topic--the reemergence of vaccine
preventable diseases and what we can do to prevent further outbreaks.
My name is Dr. Mark Sawyer, and I am a Professor of Clinical
Pediatrics, in the Division of Infectious Diseases at the University of
California San Diego and Rady Children's Hospital in San Diego, CA. I
have been in the clinical practice of infectious disease for more than
30 years and have worked in the area of vaccine delivery in my
community for the last 20 years. I am also a member of the Committee on
Infectious Diseases with the American Academy of Pediatrics. My
testimony today has the strong endorsement of the AAP, a non-profit
professional organization of 62,000 primary care pediatricians,
pediatric medical subspecialists, and pediatric surgical specialists
dedicated to the health, safety, and well-being of infants, children,
adolescents, and young adults.
the success of vaccines
It is undeniable that vaccinations are one of the greatest public
health achievements in medicine. Vaccines are the safest and most cost-
effective way of preventing disease, disability and death, particularly
in children. Prior to the introduction of vaccines children were
regularly afflicted with deadly diseases like measles, mumps, rubella,
polio, and bacterial meningitis. The development and widespread use of
vaccines has led to the reduction or eradication of these once common
childhood diseases. As a pediatrician, I have never seen a case of
polio, diphtheria or tetanus. I lived through the era when the most
common form of bacterial meningitis was essentially eliminated through
vaccination. In a teaching session I held last month with about 20
pediatric residents in training I asked them if they had ever seen
measles--none of them had. I'm afraid that is changing. As we have seen
in headlines across the country announcing the recent measles outbreak,
and earlier stories about the eruption of pertussis in various areas of
the country, we are witnessing the reemergence of vaccine preventable
diseases here in the United States. Pediatricians are concerned that
this reemergence of disease is only a signal of future, wider-scale
outbreaks yet to come.
the disneyland measles outbreak
Currently, the United States is experiencing a large, multistate
outbreak of measles linked in part to exposures at Disneyland in
California. From January 1 to January 30, 2015, 102 people from 14
States have been reported to the Centers for Disease Control and
Prevention (CDC) as having measles, many of them related to this
outbreak. Most of the cases (92) are from California, and 13 cases are
from my community. Most of those infected were intentionally
unvaccinated, some of them did not know their vaccination status, and a
minority of them were vaccinated. Once outbreaks get started even
vaccinated people can be affected because no vaccine is 100 percent
effective. The outbreak likely started from a traveler who became
infected with measles and then visited the amusement park while
infectious. The source, however, has not yet been identified. Given our
current immunization rates this will happen again.
Measles is one of the most highly contagious infections we know,
much more contagious than Ebola virus that we have read so much about
recently. It is one of the few infections that can literally fly
through the air and you can become infected simply by walking into a
room where someone with measles has been in the recent past. Measles
can also be transmitted before it can be diagnosed--4 days before the
characteristic rash appears. Measles starts with a fever, and soon
after it causes a cough, runny nose, and red eyes. Then a rash of tiny
red spots breaks out. The rash starts at the head and spreads to the
rest of the body, lasting for up to a week. Measles can lead to serious
health complications such as pneumonia, encephalitis, and even death--
about 1 in 1,000 may die.
As a pediatrician that specializes in infectious diseases, I am
alarmed by this recent outbreak. It illustrates the problem created by
the rising number of unimmunized children in the United States. A
simple trip to Disneyland has triggered an outbreak of measles in close
to 100 people. It is completely predictable that such outbreaks will
occur again if immunization rates stay where they are or get worse.
why is this happening?
The primary reason for this measles outbreak, and all other measles
outbreaks we have seen in recent years, is that we have too many people
who are intentionally not immunized. The measles vaccine works
extremely well and creates long-lasting immunity, but too many children
are not receiving the vaccine. We need to increase vaccination rates in
the United States in order to reduce the number of outbreaks that we
will see in the future. We can do that, but it is a big challenge.
Before discussing vaccine hesitancy or refusal, it is important to
note that most parents do choose to vaccinate their children, as
vaccination is the best choice for a parent to adequately protect his
or her child from very serious, contagious diseases. Every year the CDC
analyzes school immunization data collected by States to see how many
kindergartners have received their vaccinations and the latest results
from October of last year showed that for the 2013-14 school year
median vaccination coverage was 94.7 percent for the measles, mumps,
and rubella (MMR) vaccine; 95 percent for diphtheria, tetanus toxoid,
and acellular pertussis (DTaP) vaccine; and 93.3 percent for varicella
vaccine. The median total exemption rate was 1.8 percent. However,
vaccinations rates vary greatly by region and from school to school and
lower vaccination coverage and high rates of exemption from school
vaccine requirements cluster within communities, often times in
wealthier and higher educated locales.
We see this in San Diego County. First, our overall rate of
exemptions from school vaccine requirements for the 2014-15 school year
is 3.5 percent, which is higher than the national average and higher
than California as a whole. Second, and more importantly, those
obtaining an exemption from vaccine requirements are not evenly
distributed throughout our community. We have individual schools in
which 30-50 percent of the students are not fully immunized. These are
the schools at highest risk for outbreaks. This clustering of
unvaccinated children occurs all over the country. The graph below
shows the rates of exemption from school-required vaccines in San Diego
County (black line) and California (red line) over the past 14 years.
The trend is very concerning. The drop in exemption rates for 2014-15
can be attributed to a new State law that requires parents who choose
to exempt their children from vaccines at school entry have a form
signed by a healthcare provider that they have at least been educated
on the risks and benefits of their decision. The drop tells us that
when many parents receive accurate, scientifically valid information
about vaccines, they choose to immunize. But, we are left with some who
still decline.
An AAP survey of its pediatrician members found that 7 out of 10
pediatricians reported that they had a parent refuse an immunization on
behalf of a child in the 12 months preceding the survey. Most
frequently refused was the measles-mumps-rubella (MMR) vaccine,
followed by varicella (chicken-pox), pneumococcal conjugate, hepatitis
B, and diphtheria and tetanus toxoids and pertussis (whooping cough)
vaccine.\1\
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\1\ http://pediatrics.aappublications.org/content/115/5/
1428.full.pdf+html?sid=f4d4ccaf-c087-4854-8c99-2ce33ab197ad.
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Since most infectious diseases can still be just a touch or a
sneeze away, and unvaccinated children are at greater risk for
contracting these diseases, a large cluster of unvaccinated children
has a negative impact on an important benefit of vaccinations known as
``herd immunity.''
the importance of herd immunity
The reason that many infectious diseases have been on the decline
or eradicated is because of the public health concept of ``herd
immunity.'' Herd immunity occurs when a significant portion of the
population vaccinates against a disease, thereby protecting those who
cannot yet get vaccinated, or who are otherwise unable to get
vaccinated. Herd immunity is extremely important for infants who are
too young to receive vaccinations, people with weakened immune systems,
people with allergies to ingredients in vaccines, and those who may be
undergoing treatment for other diseases, like cancer, who cannot
receive vaccines. When the rest of the population is vaccinated,
disease transmission is disrupted and these at-risk populations are
unlikely to be exposed to the disease.
Herd immunity is crucial to protecting our population from disease
threats. Though measles is relatively uncommon in the United States, it
is still prevalent in other countries. An estimated 20 million people
are infected, and 122,000 die each year from measles. In today's global
society, people travel rapidly and frequently to many parts of the
world. This means that every day, our population is coming into contact
with diseases our own country has eradicated or severely limited.
Unfortunately, the complex concept of herd immunity is not easily
understood by the general population. Though vaccination rates remain
relatively high, many parents are taking advantage of a ``free-rider''
system. They are relying on the vaccination of everyone else to protect
their own child from getting sick. What they don't understand is that
herd immunity depends on what herd you are in. Schools with high rates
of unimmunized students do not have herd immunity. Once a disease is
introduced into such a school, everyone can get infected. Once an
outbreak starts it can spread outside that school to the general
community. We are seeing that with the current measles outbreak.
Herd immunity, or the lack thereof, illustrates an important fact
about infectious diseases--they are a shared, public health problem.
When one person is infected, people around them, people they don't even
know, can become infected. The decision of a parent to leave their
child unimmunized, however well meaning, is a decision that doesn't
just affect their family, it affects all of us. Two years ago I saw a
child with leukemia who was just finishing his chemotherapy, and who
was cured of his cancer, die of chicken pox. Despite the parents best
efforts he was exposed and because of his weakened immune system he
died from it. We all share infectious diseases.
why do parents decide not to immunize?
All parents want what is best for their children and so it is
important to examine why we are observing an increase in families who
believe choosing not to vaccinate their children is the best choice for
them. While we have witnessed the number of vaccine refusals and
exemptions increase over the past decade there is not one distinct
cause for this refusal--there are multiple factors that influence a
parent's decision but they usually start with an anecdote. Something
happens to a child in the period of time following routine vaccines and
it is human nature to conclude that the vaccines were responsible. An
association in timing of two events does not prove cause and effect. It
takes careful science to decide if one event caused the other. Parents
who decide not to immunize are not being exposed to or are not
believing the science that supports the safety of vaccines.
Ultimately, there are three main reasons why parents are choosing
not to vaccinate their children:
1. Fear of severe side effects.
2. Mistrust of the recommended vaccine schedule.
3. Religious and philosophical objections.
I have held a number of community forums in San Diego specifically
designed to engage vaccine hesitant parents, to hear their concerns,
and address them one-on-one. One common reason for refusal that I
continue to hear is the belief in the myths that vaccines cause autism,
brain damage, or other neurologic maladies. Although autism does
typically present clinically at an age when we give many routine
vaccines, any link between the two has been repeatedly disproven
through solid scientific research. Coupled with this myth is the
assertion that vaccines contain ingredients, such as mercury that can
be harmful to children. Once used commonly as a preservative in
vaccine, ethyl mercury (thimerosal), not to be confused with its toxic
counterpart methyl mercury, used to be added to vaccines. This allowed
for vaccines packaged in multiple dose vials to avoid contamination.
Out of an abundance of caution, thimerosal has been removed from almost
all vaccines, yet we have not seen a drop in the rates of autism.
Clearly the two were not related, yet people still hold to the idea
that vaccines contain mercury and that it causes autism. In fact, 2
years ago the AAP retracted a position it took in 1999 to support the
removal of thimerosal as a preservative as a precautionary measure. The
AAP reversed its decision in December 2012 because the evidence
collected over the past 15 years has failed to yield any evidence of
significant harm, including serious neurodevelopmental disorders, from
the use of thimerosal in vaccines.
Another common reason I hear for refusal is the notion that the
vaccine schedule is too rigorous for an infant or child, that somehow
the number of vaccines given will overwhelm the child's immune system.
If this were true, as an infectious disease specialist, I would be
seeing children with increased rates of infections at 2, 4, and 6
months of age following routine vaccines because their immune systems
were weakened. I don't. As a result of this vague concern, some parents
want their children to follow a nonstandard vaccine schedule that
introduces vaccines at a slower pace. Unfortunately, this approach
leaves children at risk for serious diseases at a time when they are
most vulnerable. The vaccine schedule as recommended by the Centers for
Disease Control and Prevention (CDC) and the American Academy of
Pediatrics has been developed with strong scientific standards and has
been proven to be both safe and effective. The main principle behind
the schedule is to protect children as early as we can for as many
diseases as we can. To have parents decide to delay protection makes no
sense and puts our community at risk.
There are also parents who refuse vaccinations for their children
based on religious beliefs. Although there are very few religions that
actually advise against the use of vaccines, every State except for
Mississippi and West Virginia allow parents to opt out of required
vaccines for religious reasons. This is not the problem. The problem is
States that have allowed people to refuse vaccines for non-religious
philosophical exemptions, like California. In California a parent can
just read something on the Internet, decide they don't want to have
their children immunized, and send them to school without vaccines.
Unfortunately, parents get a hold of inaccurate information and make a
poorly informed decision which then affects the public's health. I have
had parents tell me they are not immunizing their 5-year-old child
because they are afraid their child will get autism. If a child is
going to have autism, it happens before 3 years of age, so that parent
clearly was making a decision based on incorrect information. I have
had parents tell me that their child can't get the measles because it
doesn't exist in the United States anymore. Well, our current situation
tells us otherwise. The Internet can be a dangerous place for parents
looking for information about vaccines.
what can be done to get more people immunized?
There are four ways to begin to spur more parents to vaccinate
their children:
1. Emphasize the safety and effectiveness of vaccines.
2. Limit the type of exemptions allowed for vaccine requirements
for school entry.
3. Improve communication with families about vaccines.
4. Improve science literacy.
The best way to reverse the number of families refusing to
vaccinate their children is to improve communication with families
about the safety and effectiveness of vaccines, explain the concept of
herd immunity, improve the way the medical community talks to families
about their concerns and questions regarding vaccines, and increase the
science literacy of our population.
Parents need to know that the benefits of vaccines far outweigh any
risks. The inclusion of a vaccine on the recommended schedule and the
age it is recommended is based on careful review of the science that
leads to the conclusion, in every single case, that the risk from
disease far exceeds any risks associated with the vaccine.
No vaccine can be administered to a child unless it has been
carefully tested, researched, and approved. After a vaccine is approved
by vaccine experts within the Food and Drug Administration the safety
of the vaccine is carefully reviewed by the Centers for Disease Control
and Prevention, the American Academy of Pediatrics, and the American
Academy of Family Physicians, before that vaccine is routinely
recommended for use. The safety of all vaccines is carefully evaluated
after doctors begin giving vaccines as well. There are a number of
systems in place to make sure all vaccines continue to have a safe
track record. In fact, vaccine safety research has been and still is a
top priority, including working to eliminate even the very rare cases
of adverse reactions.
In compliance with the National Childhood Vaccine Injury Act of
1986, health professionals and vaccine manufacturers must report
specific adverse reactions to vaccines to the Vaccine Adverse Event
Reporting System (VAERS). VAERS is a national vaccine surveillance
system sponsored by the Centers for Disease Control and Prevention and
the Food and Drug Administration that collects reports on possible
reactions to vaccines and uses it to identify vaccine safety concerns
for study. VAERS receives about 30,000 reports of possible adverse
reactions each year. Among those, 13 percent are classified as serious,
meaning that they are associated with disability, hospitalization,
life-threatening illness, or even death. These reports are carefully
investigated using sound scientific methods to determine if there is a
real vaccine safety concern. VAERS is an important tool for continually
monitoring the safety of vaccines, and ensures that any potentially
unsafe patterns are quickly recognized.
The bottom line is that vaccines are extremely effective, and have
kept children healthy and largely disease-free for more than 50 years.
Most childhood vaccines are 90 to 99 percent effective in preventing
disease. Additionally, even in the rare case that a child who has been
vaccinated does get the disease, the child will often have a less
serious case.
exemptions from school entry vaccine requirements
In addition to improving communication with parents about the
benefits of vaccines, another option to help improve vaccination rates
is to limit the exemptions that are offered by States to opt out of
school vaccine requirements. While most States require students to be
vaccinated before attending school, many States have relatively
permissive exemption laws for vaccinating children, like the religious
and philosophical exemptions mentioned earlier. Parents are taking
advantage of these ``personal belief'' exemption laws on a much more
frequent basis than in the past. This is a concern for pediatricians
and the AAP believes that vaccine exemptions should be available but
with rigorous criteria and include the involvement of health
professionals. School entry requirements can be strengthened further
and help boost herd immunity by limiting exemptions from vaccine
requirements.
improved communication can help reduce fears
As a result of vaccine hesitancy, pediatricians have taken it upon
themselves to try to better educate parents about the benefits of
vaccination. Unfortunately, many parents are reading misinformation on
the Internet and through other unreliable sources and are skeptical of
the facts. Pediatricians can do their part by personally engaging with
families to answer their questions and concerns and to explain the
safety and effectiveness of vaccines. That means really listening to
parents and taking their fears seriously. It is important that health
care providers discuss these fears and lay out the benefits and
importance of vaccinations without seeming to talk down to parents. The
AAP has put together training materials to help pediatricians
communicate more effectively with parents about vaccines and recommends
that pediatricians take the time to thoroughly discuss each of the
vaccines that a parent may be hesitant about. It helps to have
evidence-based literature available to share with parents and have a
list of evidence-based Web sites that parents could go to and look up
more information on their own.
public health support
In the meantime, it is essential that public health agencies around
the country receive adequate funding to do the hard work of controlling
outbreaks when they occur. Without that combined effort, the Disneyland
outbreak would have been much bigger. On the Federal level, it is
imperative that the CDC receive adequate funding so that they can
continue the important work that they do in partnership with State and
local health departments. We have recently seen how important CDC was
to help control the outbreak of Ebola and we need to prioritize new
resources to the CDC and its National Center for Immunization and
Respiratory Diseases (NCIRD), as they play such an important role in
the prevention of disease, disability and death. Whether it is a rare
outbreak of Ebola, or reemerging diseases that were once considered
eliminated, we need to support our public health system which is
crucial in keeping our country safe from diseases that we know we can
protect ourselves from.
issues unrelated to parents
Outside of parents actively choosing not to vaccinate, there are
also some barriers that can affect the ability of some children to get
vaccines they need on time.
At times, there are shortages in the vaccine supply that affect
appropriate delivery of vaccines. Since 2003, there have been
increasingly disruptive shortages in vital vaccines. When health care
providers are unable to keep a steady supply of vaccines in their
offices, they miss the opportunity to vaccinate a child. In addition to
missed opportunities, these shortages may lead to increased
administrative burden on health care providers who must then track
these children down at a later date to ensure vaccination.
In addition, many newer vaccines are expensive. The Centers for
Disease Control and Prevention estimates that the acquisition cost for
immunizing an otherwise healthy child through the age of 18 years is
more than $900 for boys, and more than $1,200 for girls. This is a more
than sixfold increase from 1995. These costs primarily result from the
addition of newer vaccines to the schedule, or from substitution of
newer vaccines over the older ones.
Payment for almost all vaccines is available through private or
public sources. However, the cost of buying, storing, and administering
these vaccines has soared, straining the finances of many pediatric
practices. In addition to these acquisition costs, payment is an issue.
Payment levels vary between private insurance, Medicaid, and third-
party payers. As the costs of vaccines increases, these payments have
not followed suit.
The Federal Vaccines for Children (VFC) program, section 317
Federal grants, and State funds now purchase more than half of vaccines
administered in the United States. These programs do excellent work in
providing vaccines for children who are in need, but they also require
a large administrative and recordkeeping effort from practices.
Additionally, in many States, VFC payments are lower than the cost of
administering the vaccines, thus causing many practices to leave the
program. Finally, Medicaid payments for giving vaccinations are far
less than what Medicare pays, despite the fact that administering
vaccines to a child is more labor-intensive than administering vaccines
to an adult. It is imperative that the acquisition costs and payment
systems around vaccines be remedied in order to ensure that we are
vaccinating the maximum number of children that we can.
Many parents today are not aware of how dramatically vaccines have
improved the health of children. Before the U.S. measles vaccination
program started in 1963, about 3-4 million people in the United States
contracted measles each year, 48,000 were hospitalized, and 4,000
developed encephalitis because of measles. As mentioned earlier,
measles was declared eliminated from the United States in 2000, but
since then, there has been a rise in the number of cases.
summary
It is clear that vaccines have dramatically improved the health of
our society. What were once extremely morbid and mortal threats to
children and society have now been abated. Most parents today did not
grow up in a world where they were confronted with these deadly, and
very visible diseases. Many parents believe that their own decision not
to vaccinate is an isolated one, and that it only affects their child.
Unfortunately, this is not true. Every vaccine refusal weakens herd
immunity, and it is imperative that the public health aspect of
vaccination is emphasized. The reemergence of vaccine preventable
diseases is alarming and must be confronted if we are going to sustain
our past successes. While it will take a renewed focus and effort, if
we continue to educate the public on the safety and effectiveness of
vaccines, improve communication and dialog with those who harbor fears
of vaccines, and eliminate non-medical exemptions allowing parents to
opt out of vaccinating their children, we can shrink the clusters with
lower immunization rates that threaten herd immunity and reduce the
risk of more outbreaks of vaccine preventable diseases like we are
experiencing with today's measles outbreak.
Thank you for allowing me to testify before the committee today. I
look forward to your questions.
The Chairman. Thank you, Dr. Sawyer.
Dr. Jacks.
STATEMENT OF TIM JACKS, M.D., DO, FAAP, PARENT, PEDIATRICIAN,
AND EVERY CHILD BY TWO IMMUNIZATION CHAMPION, GILBERT, AZ
Dr. Jacks. Senator Alexander, Senator Murray, esteemed
Members of Congress, my name is Tim Jacks. I'm a board
certified pediatrician, and I'm on the front line of this
vaccination issue. I daily recommend vaccinations to my
patients and address concerns and questions they have regarding
immunizations. Lately, I've also been addressing many questions
over the ongoing measles outbreak.
I'm not here today as a medical professional. I'm here
today as a father. Three weeks ago, my infant son and daughter,
Magdalene, who is battling leukemia, were exposed to measles.
Since her diagnosis with leukemia 6 months ago, our home life
has revolved around my daughter Maggie's care. She has been
admitted to the hospital six times and spent nearly a month
there.
She's on a very regimented schedule of treatments, and she
takes medications three times a day, up to six medications at a
time. We have weekly visits to an outpatient clinic where she
has procedures, she has blood work drawn, and she gets her
chemotherapy infusions.
At one such clinic visit, my children were exposed to
measles. We were informed of this exposure and instructed to
return for shots of the measles antibodies, which we did. Now,
these antibodies are not perfect protection, but in the case of
my children, it's the only thing we can do to prevent them from
actually coming down with measles.
Right now, my two children are at home under quarantine.
While we are waiting the 3-weeks to see if they develop measles
or if they exit quarantine without any symptoms, I typed an
entry into Maggie's blog. This blog is something I use to
update family and friends to her treatment progress and just to
let people know how she's doing.
Typically, I get 100 people reading this blog. Needless to
say, it has gone viral. The title of this blog entry was ``To
the Parents of the Unvaccinated Child Who Exposed My Family to
Measles.'' In this blog, I vented my frustrations, my anger at
the situation, and I explained and, hopefully, educated some
people as to why my children and many other children like them
are at risk.
Eli, my 10-month-old son, has received all of his
immunizations on schedule, but is too young to receive his
first dose of MMR. My daughter, Maggie, who was also previously
fully immunized, is at extra risk right now because of her
weakened immune system due to her leukemia as well as her
treatments.
The blog went viral. In over 2 weeks, it received over 1.3
million shares on Facebook and has been read countless times. I
have been contacted and interviewed by CNN, Fox News, and many
other local and national media outlets. I have taken these
opportunities to share our story and, hopefully, raise
awareness to this issue.
My hope is that we can prevent some families from going
through the same thing that we've gone through these last 3
weeks. I also hope that we can prevent more families from
getting measles altogether. Prevention is simple--vaccinate.
As immunization rates drop, the herd immunity starts to
break down, and this herd immunity is the only thing protecting
my two young children from being exposed to measles or whatever
the next outbreak is. I urge a strong unified bipartisan voice
supporting the scientific evidence that vaccines are safe and
that they save lives.
We need a consistent message from the presidency to Capitol
Hill down to our local and State legislators, schools, and even
daycares. I urge Congress to take action supporting the
programs and infrastructure already in place to get these
vaccines to those that need them most and contain outbreaks
such as we are seeing today.
I will care for my family. I will work to promote health
among my patients, and through partnerships with organizations
like Every Child By Two and the Arizona Partnership for
Immunization, I will advocate for timely vaccinations for
children.
Thank you for your commitment to this issue. With your
help, we can stop the spread of vaccine-preventable diseases
and protect the innocent. We can protect our children. We can
protect my children.
Thank you.
[The prepared statement of Dr. Jacks follows:]
Prepared Statement of Timothy Jacks, M.D., DO, FAAP
summary
Because of the decline in vaccination rates, the United States is
seeing a resurgence of vaccine preventable illnesses.
Those most at risk from the current measles outbreak are children
too young to receive the MMR vaccine and those with medical conditions
(like leukemia) which compromise their immune system. Their only
protection is from the ``herd immunity'' of people around them.
Last month, my healthy infant son and 3-year-old daughter, who has
leukemia (blood cancer), were exposed to measles.
In response, I wrote a blog entry venting my emotions and educating
readers about our situation. The blog went viral, and I was approached
by the media.
As a pediatrician, I have engaged this wider audience. I have taken
this chance to educate and hopefully cleared up some of the confusion
regarding immunizations. I stand with the scientific community and
recommend that all children be vaccinated--and not just against
measles.
When considering immunizations, families need to understand the
risk of disease exposure and the seriousness of infection--especially
to the young and medically fragile among us.
I urge you to take a strong, unified, bi-partisan stand supporting
the scientific evidence that vaccines are safe and they save lives.
Finally, I urge Congress to take action in support of programs that get
vaccines to those who need them most and help contain disease
outbreaks.
Thank you.
______
Esteemed Members of Congress, Chairman Alexander and Senator
Murray, my name is Tim Jacks, DO. I am a board certified pediatrician
and fellow of the American Academy of Pediatrics. I work in Gilbert, AZ
and encourage on-schedule vaccinations for all my patients. Parents
regularly come with questions regarding routine immunizations.
Unfortunately, not every parent decides to follow the recommended CDC
vaccination schedule.
Because of these refusals, the United States has recently seen a
resurgence in measles cases, and we are struggling to contain this
outbreak. My job is on the frontline of this outbreak. The clinics and
urgent cares where I work are seeing many concerned families with
possible exposures.
I am not here today for professional reasons. The circumstances
that have brought me here today are deeply personal ones.
Last month, my two young children, one battling leukemia and the
other who is below the recommended age for MMR vaccination, were both
exposed to measles.
Our current journey began 6 months ago. Our daughter Maggie had
been looking a little pale and had more bruising than a rambunctious 2-
year-old should have. Labs were ordered. Later that evening, we
received a call that shook our small family to its core.
Maggie had cancer.
Specifically, she was diagnosed with ALL--acute lymphoblastic
leukemia--a form of blood cancer. Over the next week, Maggie was
admitted to Phoenix Children's Hospital, had a port placed for
infusions and blood draws, had many more tests run, and was started on
chemotherapy.
Since then, our family's day-to-day life revolves around Maggie's
treatment. She is on a very regimented treatment protocol. She visits
an outpatient pediatric specialty clinic at least weekly for blood
tests and chemotherapy infusions. She takes medicines three times a day
up to six at a time. She has been admitted six times in total and spent
nearly a month in the hospital.
The ongoing chemotherapies have put Maggie's leukemia into
remission, but they have also weakened her immune system. She is at
risk for serious illness from even the most benign exposures. Any fever
requires an ER visit, antibiotics, and possible admission. Because of
this we stay home most of the time.
Before cancer, Maggie had been fully immunized. Now due to her
weakened immune system, her previous immunity is limited, and she is
unable to receive further vaccines on schedule. She will remain at risk
until her 2\1/2\ years of treatment end. Eli, our infant son, has
received all recommended vaccines for his age but is still too young
for the MMR vaccine (given at 12-15 months of age). Because of this, my
children rely on the immunity of others to protect them from measles
and other diseases. When enough people are immunized, the spread of
disease slows or even stops. This is herd immunity, and it is starting
to break down.
Since her diagnosis, I have kept a caring-bridge blog chronicling
Maggie's journey through leukemia. This was my post the day after my
family's measles exposure.
To the parent of the unvaccinated child who exposed my family to
measles, I have a number of strong feelings surging through my body
right now. Toward my family, I am feeling extra protective like a papa
bear. Toward you, unvaccinating parent, I feel anger and frustration at
your choices.
By now we've all heard of the measles outbreak that originated in
Disneyland. Or more accurately, originated from an unvaccinated person
that infected other similarly minded vacationers. I won't get into a
debate about the whole anti-vaccine movement, the thimerosal
controversy (no longer even used in childhood vaccines), or the myth
that MMR causes autism (there are changes in autistic brain chemistry
prior to birth).
Let's talk measles for just a minute. It once was widespread in the
United States. It is now considered ``eliminated'' in the United States
(not continually circulating in the population--only contracted through
travel out of country). Measles is highly contagious (>90 percent
infectious) and can survive airborne in a room and infect someone 2
hours later. Another fun fact is that measles is transmittable before
it can be diagnosed--4 days before the characteristic rash appears.
``Measles itself is unpleasant, but the complications are
dangerous. Six to twenty percent of the people who get the
disease will get an ear infection, diarrhea, or even pneumonia.
One out of one-thousand people with measles will develop
inflammation of the brain, and about 1 out of 1,000 will die.''
(http://www.cdc.gov/vaccines/vpd-vac/measles/faqs-dis-vac-risks.htm)
That sounds fun!
Ok.
Calm down self.
I assume you love your child just like I love mine. I assume that
you are trying to make good choices regarding their care. Please
realize that your child does not live in a bubble. When your child gets
sick, other children are exposed. My children. Why would you knowingly
expose anyone to your sick unvaccinated child after recently visiting
Disneyland? That was a bone-headed move.
Why does this affect me and mine? Why is my family at risk if we
are vaccinating? I'm glad you asked.
Regarding measles, there are four groups of people.
All are represented in my family.
First, the MMR vaccine results in immunity for most who receive it.
Two doses provides protection that can be confirmed with blood titers.
My wife is in this group.
Second, about 3 percent of fully vaccinated children do not develop
a lasting immune response. They have low blood titers and are not
protected against measles. If exposed, this group will likely get the
illness. I am in this group. I was thankfully not exposed. [Repeat
testing has shown myself immune.]
Third, we have the unvaccinated. My son, Eli, is 10 months old. He
is too young to have received the MMR vaccine and thus has no
protection. Whether by refusal or because they are too young, exposed
unvaccinated children have a 90 percent chance of getting measles.
Fourth, there are children like my Maggie. These are children who
can't be vaccinated. Children who have cancer. Children who are
immunocompromised. Children who are truly allergic to a vaccine or part
of a vaccine (i.e., anaphylaxis to egg). These children remain at risk.
They cannot be protected . . . except by vaccinating people around
them.
Back to my story. . . .
It was Wednesday. Maggie had just been discharged from Phoenix
Children's Hospital after finishing her latest round of chemotherapy.
That afternoon she went to the PCH East Valley Specialty Clinic for a
lab draw. Everything went fine, and we were feeling good . . . until
Sunday evening when we got the call. On Wednesday afternoon, Anna,
Maggie, and Eli had been exposed to measles by another patient. Our two
kids lacked the immunity to defend against measles. The only protection
available was multiple shots of rubeola immune globulin (measles
antibodies). There were three shots for Maggie and two shots for Eli.
They screamed, but they now have some temporary protection against
measles. We pray it is enough.
Unvaccinating parent, thanks for screwing up our 3 week
``vacation'' from chemotherapy. Instead of a break, we get to watch for
measles symptoms and pray for no fevers (or back to the hospital we
go). Thanks for making us cancel our trip to the snow this year. Maggie
really wanted to see snow, but we will not risk exposing anyone else.
On that note, thanks for exposing 195 children to an illness considered
``eliminated'' from the United States. Your poor choices don't just
affect your child. They affect my family and many more like us.
Please forgive my sarcasm. I am upset and just a little bit scared.
Papa bear.
PCH has been great though this whole ordeal. We have done what is
physically possible to protect our children. Now we pray. Please pray
alongside us.
We are not currently contagious. Rest assured, if measles visits
our house, it will not spread to anyone else.
Thank you for your prayers and support.
When I typed this entry, I had no idea it would resound so clearly
with so many people. In less than 2 weeks, this post has received over
1.3 million shares on Facebook and reached countless readers. In
addition I was featured on CNN as well as other local and national
media outlets.
Both online and in my daily practice of medicine, there is a lot of
confusion and misinformation resulting in resistance toward
vaccinations. Some parents do not understand the wonders of the immune
system and how well equipped it is to deal with the immunologic
components within vaccines. Instead they believe there are too many
shots for a young developing immune system. Some still hold to the
debunked theory that the MMR vaccine causes autism. They are concerned
about the chemicals in vaccines. They are more afraid of a vaccine
reaction than getting the disease itself.
As a result, immunization rates drop. Herd immunity weakens.
Outbreaks happen. Children get exposed.
My measles-exposed children have been quarantined at home for
nearly 2 weeks now, and we anxiously watch for signs of disease. Every
warm forehead, every sign of rash, and every runny nose could be the
start of measles, and that brings me back to why I am here.
I don't want any family to repeat what we have gone through these
last few weeks.
The solution is simple. Immunize.
We need to get more children protected against these vaccine-
preventable diseases. We need families to understand the present danger
of exposure and the seriousness of infection--especially to the young
and medically fragile among us.
Every family has a decision to make regarding vaccinations. Let's
help make it a clear choice.
I urge you to have a strong, unified, bi-partisan voice supporting
the scientific evidence that vaccines are safe and they save lives. We
must maintain a consistent message at every level of society from the
presidency, to Capitol Hill, all the way down to our State legislators,
schools and even daycares.
While there are instances where it is medically necessary to
decline immunizations, State health authorities should make it less
convenient to refuse and require families to receive education
regarding the dangers of not vaccinating, both for the child and the
larger community.
Finally, I urge Congress to take action in supporting the programs
and infrastructure that gets vaccines to those that need them most and
helps contain outbreaks such as measles. It is important to remember as
congressional budgets are negotiated that vaccines offer the greatest
cost savings of all medical treatments. We must support the access to
and affordability of immunizations.
Back in Arizona, I will care for my family. I will work tirelessly
in promoting health in my patients. Through my work with Every Child My
Two and The Arizona Partnership for Immunization, I will continue
advocating for the timely immunization of our children.
Thank you for your commitment to this issue and for caring about
the children of this great nation. This issue is close to my heart as a
father and pediatrician. With your help, we can put an end to vaccine-
preventable illnesses and protect the innocent. We can protect our
children.
The Chairman. Thank you, Dr. Jacks, for your personal
story, and thank you, Dr. Sawyer and Dr. Moore.
Now, we'll go to the Senators who have not yet had a chance
to ask questions, and we'll begin with Senator Casey.
Statement of Senator Casey
Senator Casey. Mr. Chairman, thank you very much. I
appreciate this hearing. We certainly want to thank the
witnesses for bringing to this hearing room today your
experience, your knowledge, and the significant time that
you've dedicated your lives to on these issues.
Dr. Jacks, we're especially grateful that you're bringing
your own personal story. These issues are difficult enough, but
ever more so when you have a loved one, in your case, a
daughter, that is the subject of your own efforts. We're
grateful for you bringing that to us.
I'm tempted to ask, but I won't. I'll just refer to it as
kind of the why question--why this failure to vaccinate has
become so significant. That may be the question that we're all
asking. I guess maybe a better question to ask is what we can
do to push back against it. We're doing that today, and,
obviously, each of your testimonies have referred to that.
I wanted to get to some of the ground level work that has
to get done day in and day out, about which I don't know much,
and maybe some members of the panel do. What happens in our
schools, what happens in communities, and what happens even in
the offices of pediatricians?
Dr. Sawyer, you were talking about the fact that you, in
all your years, had never been exposed to this in a direct way
as a practitioner. I wanted to ask some specific questions
about pediatrics. Do you think we're reaching the point where
there has to be pediatric training that speaks to this, in
other words, a change in the training that reflects the
reluctance that some parents have to vaccinate?
Dr. Sawyer. Yes. That's an excellent question, and there
are efforts underway from the American Academy of Pediatrics
nationally and, in my case, locally. I have a curriculum for
residents about immunization. Three or four years ago, I added
a whole section of that curriculum to teach residents in
training about how to communicate about vaccine safety and
address the concerns of these parents in an open, non-
confrontational way with the hope that if we can just educate
our families and give them good accurate information, they will
make the right decision.
The problem is there's so much inaccurate information
circulating, and it's highly educated families who get on the
internet and read something and take it to heart before they
really critically look at the source of that information.
That's what we need to try to address.
I mentioned in my statement to raise the science literacy
in the United States. That's a tall task, but without that,
we're never going to win this battle.
Senator Casey. Thank you.
Dr. Moore, referring to your testimony, on page 3, you talk
about in the second full paragraph, and I'm quoting, ``In
Tennessee, local school nurses and coordinated school health
directors are among our most important champions of
immunization.'' Can you tell us about that and the importance
of that? Because as much as we have an obligation here in
Washington to get a message out and try to get the policy
right, a lot of the best work will be done in those settings.
Dr. Moore. That's true. I can't speak highly enough of our
local public health nurses and the school nurses and school
administrators who work with families, because, truly, these
parents often hesitate to vaccinate their children out of fear.
They want to do what's best for their child. These bells go off
when they hear scary things about vaccines, and it's very hard
to un-ring that bell. The people best equipped to do that are
the people they trust and are in close relationships with.
When I talk to local public health nurses, they care so
deeply about these families that they work with. A lot of this
can be overcome with credible information from trusted sources,
good relationships, and that's what these folks provided. I'm
always a phone call away when they have a question on a
technical thing. I can help them with that.
They're the ones with the relationships with the families
to help them overcome these fears. Our immunization rates are a
testimony to that ability for them to work through this with
families.
Senator Casey. I appreciate that. I'll wrap up with just
one statement. I know that in the debate about how to respond
to the Ebola crisis, among the best pieces of advice we all got
here was that local validators are a lot better than validators
outside of a local area. I won't say Washington, but you know
what I'm talking about.
Thank you for your work, and I'm grateful that you're here
today.
[The prepared statement of Senator Casey follows.]
Prepared Statement of Senator Casey
Chairman Alexander and Ranking Member Murray, thank you for
convening this hearing to discuss the reemergence of vaccine-
preventable diseases. I am grateful for today's opportunity to
shed light on an important public health crisis facing the
Nation.
Vaccines are one of the biggest accomplishments of modern
medicine, responsible for saving millions of lives and
preventing disease and disability around the world. Many people
alive in the United States today have never seen the illnesses
that vaccines prevent, like measles, smallpox or polio.
Globally, we eradicated smallpox entirely, and no longer need
to vaccinate against it.
Measles was considered eradicated in the United States as
recently as 2000, meaning that it was no longer circulating
naturally in the population. Any cases that occurred were
imported from countries where the disease is still endemic,
such as in many parts of Asia. Yet this year, we have already
seen over 120 cases of measles in the United States, mostly
linked to a sick child who went to Disneyland and infected
other children who had not been vaccinated. At least five of
the children to contract measles were too young to be
vaccinated, but many of the children who got sick were old
enough to be vaccinated.
I am deeply concerned that so many parents in the United
States are failing to vaccinate their children. This puts these
children in danger, but even more than that, it puts other
peoples' children in danger. We must all recognize our personal
and collective responsibility to get vaccinated, and to
vaccinate our children, in the name of protecting those who are
too young or medically unable to be vaccinated.
According to medical experts, the science behind the
measles vaccine is clear: the vaccine is one of the most
effective vaccines we have; if a child receives the recommended
two doses, she has almost total immunity. We saw the panic that
erupted around a handful of cases of Ebola last year--yet
people refuse to vaccinate their children against measles,
which is three times more infectious than Ebola.
I look forward to working together to raise awareness in
our communities of the importance of vaccination.
The Chairman. Thank you, Senator Casey.
Senator Murphy.
Statement of Senator Murphy
Senator Murphy. Thank you very much, Mr. Chairman and
Ranking Member, for this hearing.
Thank you to all of you, especially you, Dr. Jacks, for
taking the time to tell your story.
I wanted to talk for just a minute and ask a few questions
about the nuts and bolts of how exemptions work, because we've
seen a pretty rapid rise in exemptions in my State, for
instance, which has fairly loose rules regarding getting
exemptions, a feature we share with California, frankly. We've
seen just in the last 3 years, that the number of people who
are applying for and getting religious exemptions has doubled--
just in 3 years.
I heard in your testimony, Dr. Sawyer, that you're actually
proposing eliminating the philosophical objection. Can you just
speak for a minute on why you've made that proposal?
Dr. Sawyer. Yes. I made that proposal because, as you
pointed out, I live in California, where up until last year, in
order to exempt your child from school vaccinations, you simply
flipped over a paper at the school registration and signed it
that you had a philosophical objection, not a religious
exemption, not a medical reason your child couldn't be
vaccinated. You just don't believe in vaccines.
Just as you mentioned in your State, we've seen a steady
rise in those exemptions in California over the last decade.
There are very few religions that specifically advise their
followers to not vaccinate. It's this philosophical exemption
that's causing the problem, and it's driven by misinformation.
I'm certainly in favor of eliminating such philosophical
exemptions. A State Senator in California just introduced a
bill last week to do just that, and I'm certainly going to be
supporting that effort in California.
Senator Murphy. Let me suggest an alternative to the
elimination of the exemption. As you mentioned, all that you
need to do in a State like California or Connecticut is simply
sign a piece of paper. You actually get no information about
the consequences of not getting a vaccination. Yet the studies
are pretty clear that the more information that you give, the
less likely it is that people will take the exemption, and, in
fact, the less likely it is that you'll have outbreaks.
Here's a pretty stunning one from 2006. In States that had
higher bars for exemptions, they were 50 percent less likely to
have whooping cough outbreaks. You can recite other literature
that says the same thing.
I asked this to Dr. Sawyer, but I'm happy to get comments
from the rest of the panel. Let's say we just raise the bar for
a philosophical objection, and we say, for instance, that you
have to consult with your physician first, or you have to
review information about the risk of not getting your kids
vaccinated.
Do you think that that would be helpful if we weren't
successful in eliminating the exemption? I asked this to Dr.
Sawyer, but I'd be glad to hear other panelists' thoughts.
Dr. Sawyer. I'll respond first, because we have just done
that in California. Last year, we passed a law that requires
parents, in order to exempt their child, to have a form signed
by a healthcare provider that at least they've been educated.
That led to about a 1 percent drop in the rate of exemptions in
California as a whole. It is still at 2.5 percent to 3.5
percent in different communities within California.
We'll see next year whether that form continues to drop the
rate. My concern is we've seen the benefit of a one-time drop
and we're going to go back to the steady gradual increase in
exemptions, whether people stick to philosophical ones with
their doctors' information or whether they, as you pointed out,
start to exercise religious exemptions that they didn't before.
Senator Murphy. Just quick comments from----
Dr. Moore. Senator, Tennessee is one of the vast majority
of States that does not have a philosophical exemption and has
no intention of developing one.
Senator Murphy. Only 20 States have them.
Dr. Moore. Correct. About 29 or so have no philosophic
exemption, including Tennessee. We have to decide, as a
community, do we want to protect the most vulnerable among us,
or do we want to provide choices and options for protection? We
can't do both at the same time with a disease as contagious as
measles.
If we're prepared to accept the consequences of outbreaks
like this, then personal choice is perfectly fine. If we want
to protect the vulnerable, like Dr. Jacks' children, then
immunization needs to take place to do that. It's the best way
to do it.
Senator Murphy. Thank you, Mr. Chairman. My office is
looking at some proposed legislation that would provide some
incentives for States to increase the information that they're
giving to parents, not actually dictating what exemptions are
used, but to admit that as a national health priority, it
probably makes sense to make sure that the best information is
given out.
The irony is that if you're getting a medical exemption, in
most States, you actually have to have a note signed by a
doctor. If you're using a philosophical exemption or a
religious exemption, often all you have to do is sign the back
of that form. It seems like we should, at the very least, try
to marry those two standards together.
Thank you very much, Mr. Chairman.
The Chairman. Thank you, Senator Murphy.
Senator Bennet.
Statement of Senator Bennet
Senator Bennet. Thank you, Mr. Chairman, and thank you very
much to you and the Ranking Member for holding this hearing. It
strikes me, listening to the testimony, that we've been
victimized by two things.
One is a generation that has not experienced these diseases
because of vaccines and have lost sight of what they look like,
and, interestingly, to Dr. Sawyer's point, the unedited content
on the internet that people--more affluent families, I guess,
are reading.
I wonder, Dr. Sawyer, and then I'll ask the other
panelists--and let me also say to Dr. Jacks I thank you for
your testimony. I hope Maggie's having a chance at least to
watch you while you're doing this, or maybe doing something
more interesting at home. Thanks for being here.
Dr. Sawyer, maybe I'll start with you. Could you use this
opportunity to tell us what the biggest falsehoods are that are
being trafficked on the internet and what the answers to those
falsehoods are? If the other panelists would like to join in,
that would be great as well.
Dr. Sawyer. Well, as has been mentioned here several times
today, autism remains one of the major concerns of parents,
even though, as Dr. Schuchat pointed out, the science has
completely discredited any association between the two. Once
you get beyond that, the next thing you hear is that we're
overwhelming children's immune system with too many vaccines
too soon.
The whole philosophy of the immunization schedule is to
protect children as soon as we can for as many things as we
can. Delaying vaccines is really counterintuitive to the whole
purpose of the vaccination program.
If we were overwhelming children's immune system--I'm an
infectious disease doctor--those kids would then be getting
unusual infections because their immune system was overwhelmed.
We don't see that at 2 months, 4 months, and 6 months when we
give routine vaccinations.
The last major theme that you hear about are the
ingredients in vaccine and the concern that perhaps some of
them are toxic. Once again, that's been discredited and looked
at very carefully. FDA approves these vaccines in large part
based on their safety record.
Senator Bennet. Dr. Moore.
Dr. Moore. I will add to Dr. Sawyer's excellent list--that
I agree with--that the flu vaccine causes the flu. I hear that
every year over and over from well-educated folks, and that's
certainly one that we work to counteract because of the
benefits of flu vaccine. That's a common one. And then that HPV
vaccine might cause promiscuity. We hear that from time to time
as well from people concerned about the HPV vaccine given to
pre-teens.
Senator Bennet. Just to be clear to anybody listening to
this, these are all things that are scientifically demonstrably
incorrect.
Dr. Jacks, I wondered--you're a pediatrician. Do you have
advice for pediatricians across the country about how to handle
the conversation that they have with parents about vaccines?
Dr. Jacks. Yes. With regard to families that do have
questions and concerns, it's really just that. It's addressing
their questions and concerns. Back in the day, physicians could
take somewhat of an authoritative stance, and there was a great
deal of respect.
Nowadays, it's really more of a working with families to
come to a conclusion of what's best for their children, whether
it's immunizations or whether or not we want to treat an ear
infection. As a pediatrician, my goal is to, No. 1, develop
relationship with my families so that we do have that rapport,
and then for me to make my recommendations and address their
concerns specifically.
Senator Bennet. Do you have any--and, Dr. Sawyer, you train
pediatricians. This question of whether there are things that
pediatricians can do----
Dr. Sawyer. Right. The curriculum I mentioned, that we've
developed locally in San Diego as well as the Academy's
curriculum, basically takes people through the appropriate way
to listen attentively to people's issues and be respectful in
addressing them, but to continue to convey the science in the
most clear way one can so that families reach the right
conclusion.
Senator Bennet. Thank you.
Thank you, Mr. Chairman. I surprised the chairman because I
finished early.
The Chairman. That's 43 seconds----
Senator Bennet. Let the record--I'll never get that time
back.
The Chairman. We'll put it in the bank.
[Laughter.]
Senator Bennet. I'll take that.
The Chairman. We have time, and I'm sure all of us would
probably like to have a second round of questions.
Dr. Moore, I believe you said that the case of measles in
Tennessee was in Memphis, an adult in Memphis. Is that correct?
Dr. Moore. It was actually an adult in west Tennessee.
The Chairman. In west Tennessee.
Dr. Moore. Right.
The Chairman. You described how you moved in quickly, and
the number of people for just that one case that you had to be
in touch with was how many?
Dr. Moore. One hundred twenty-four people had come into
contact with that one case during the 4 days before they were
diagnosed.
The Chairman. This is an area where the vaccination rate
for measles is what?
Dr. Moore. Very good. I don't have the specific number for
that region, but it was clear--because 124 people were exposed
and only three people got sick--that it was very high.
The Chairman. So it was high. Well, as Dr. Sawyer was
talking earlier, I was thinking about the phrase, going viral,
and then Dr. Jacks used it. This generation understands the
idea of going viral.
You're talking about measles flying through the air. That's
unlike Ebola, that threw the country into a near--well, a
complete panic, actually,--last fall, when Congress
appropriated over $5 billion for Ebola-related efforts, and
hospitals changed procedures. Ebola dominated what was going on
in all the public health departments, yet it can only be spread
through contact with bodily fluids. Measles flies through the
air. This goes viral. This is a disease that goes viral.
We Senators, in a bipartisan way, understand the problem of
dealing with highly educated people who get bad information on
the internet. That happens to us every day. We deal with that.
We know what it is.
Let's go back to the going viral. What if this person in
west Tennessee, who Dr. Moore acted on quickly--what if that
person had been discovered in a part of Los Angeles where 60 to
70 percent of parents at certain schools have filed a personal
belief exemption from immunization requirements. Describe the
number of people and the multiplying of people that would have
to be contacted to make certain that the disease didn't spread.
Dr. Sawyer. Well, I can share the experience we had in San
Diego in 2008, which was our last outbreak. We had 12 cases and
over 800 people were exposed to those 12. It quickly goes up
exponentially, the number of people you have to track, and
unless public health is there to track those people and keep
them quarantined, it could easily just get completely out of
control.
The Chairman. You had 800 people, but then each of them
might have infected someone else, right?
Dr. Sawyer. Exactly. In that outbreak, we had close to 100
people quarantined for 3 weeks just to prevent that next wave.
We're all crossing our fingers here with this Disneyland
outbreak that maybe we're near the end. I noticed that the case
number went up by 20 just this last week, so I'm not sure we're
done with this yet.
The Chairman. So when you say ``flies through the air,'' we
have an example of going viral in modern parlance, I suppose.
Dr. Jacks, this may not be an exact comparison, but people
ask me why I continued to play the piano when I was young, and
I remember responding that I didn't remember my mother giving
me a choice about it. I guess I had a choice. We're not talking
about taking choices away today from parents.
We are talking about a conversation between a pediatrician
and a parent. How strongly do you recommend to parents that
they vaccinate their children? I suppose the most persuasive
thing you can do is tell them the story of your own children.
Do you just make a neutral observation about it, or do you come
to a conclusion and say, ``I think you should do it?''
Dr. Jacks. I definitely come to a conclusion of
recommending that we do vaccinate. I oftentimes don't approach
it quite that way because I want to get their thoughts and
opinions and their fears first so I can address those.
Yes, I talk to families--from a couple that's still
pregnant that hasn't had their first child yet to that first
visit after they're born to the routine visits where we would
do vaccinations. Every visit, whether they're 100 percent
getting vaccinated or whether they're still trying to decide,
I'm talking, and I'm answering questions, and I'm urging them
to make a good informed decision. My understanding and my
opinion is that, yes, vaccinations are absolutely one of the
best things that they can do to protect their young child.
The Chairman. I'm out of time. I know in our State, years
ago, my wife led an effort to establish a medical home for
every child about to be born--prenatal healthcare. I assume
anything in prenatal healthcare that allows a parent to know
more about the value of vaccinations before the child is born
is a very effective way to keep the vaccination rate high.
Senator Murray.
Senator Murray. Thank you, Mr. Chairman.
Dr. Moore, I wanted to ask about this, because I'm
especially interested in learning more about what can be done
to increase uptake of the HPV vaccine. We are really fortunate
to have a vaccine today that can prevent most forms of cervical
cancer, which I'm sure you know is the second leading cause of
cancer deaths among women in the United States. About 12,000
women get cervical cancer every year. About 4,000 are expected
to die from it, and we know that those are deaths that can now
be prevented.
What can State and local health departments do to more
effectively promote the HPV vaccine?
Dr. Moore. That's a wonderful question, and, certainly, we
know that a lot of young women and men are not being protected
against this virus yet who could be. In Tennessee, our
immunization rates are about one in three, and we'd like it to
be much higher.
We're working collaboratively with cancer advocates,
because they have wonderful experience raising awareness about
breast exams and pap smears. We're collaborating together to
try to help families understand that this new vaccine is a
cancer prevention tool that can help reduce the risk of an
abnormal pap smear for a young lady later in life.
We are also trying to make sure people understand this
vaccine is safe, it lasts, and it's very, very effective. We
bundle it with other routine vaccines, so it's given at the
same time in Tdap vaccine for pertussis protection in middle
school and the first meningitis shot, and it's just a part of
the routine pre-teen immunization bundle.
We're trying to help people understand that there's nothing
exceptional about this except that it is phenomenal cancer
prevention, and it's incredibly exciting to have a tool in our
hands that the last generation didn't have to protect women and
men from cancer for their lifetimes.
Senator Murray. Well, thank you. I appreciate that. I also
want to mention that in my home State, we have an incredible
public-private partnership. It's called VAX Northwest. At a
time when my State had the highest vaccine exemption rate in
the country, our State health department came together with
some key health promoting organizations, including Group Health
Foundation, Within Reach, and Seattle Children's Hospital, to
create this really innovative partnership which addresses
vaccine hesitancy through work with parents and our healthcare
providers alike. It has support from the Gates Foundation,
which was helpful, and the engagement of a lot of partners.
VAX Northwest is doing some really amazing work, which I
should mention also is being rigorously evaluated with the
intent of sharing a lot of lessons that they're learning with
other States.
I wanted to ask you, Dr. Moore, how can working with
private and nonprofit partners help health departments in their
efforts with vaccines?
Dr. Moore. Thank you. Health departments have a major role
in promoting immunization. We've long ago stopped being the
medical home for most children. They go to their own private
doctors' offices for immunizations now, which is providing the
best possible holistic care for the upbringing of that child.
We partner with these organizations in order to help
support them in doing the right thing, because what I find in
clinical practice is that pediatricians are incredibly busy
with everything they have to do, and it really helps them if
there is a group in public health focused on promoting just the
immunizations where we can provide them support, like our
immunization information system, that makes their jobs easier.
Our role, when it comes to doing site visits about the
quality of their immunization care through the VFC Program,
site visits that we do in their offices, educational programs
that we provide, promotional materials--we help give them the
resources they need for the private sector to do the best
possible job for the patients, because they're primarily the
ones vaccinating our children. This partnership has been
wonderful.
I'm all about relationships, and these relationships have
been great at developing strong collaborations and bolstering
immunizations in Tennessee, certainly.
Senator Murray. Thank you.
Dr. Jacks, thanks for being here today. I really appreciate
your willingness to come. Since you started speaking out about
your own family situation, have you been surprised to know how
many people don't know that some people cannot be vaccinated?
Dr. Jacks. Surprisingly, no, actually. There's been a lot
of good support, a lot of positive feedback. There's certainly
a small amount of negative feedback from certain populations.
It seems like the knowledge is there. I just don't think it's
in the public conscience when they're making the decision to
vaccinate or not vaccinate, and that's why I'm doing this. I
want to raise awareness of that issue so it can be part of the
discussion.
Senator Murray. I appreciate that. I just wanted to ask
you, as a pediatrician, what do you think are the key barriers
to vaccine uptake?
Dr. Jacks. Largely education and the misinformation that's
out there.
Senator Murray. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murray.
Senator Cassidy.
Senator Cassidy. Yes. First, I'd like to request unanimous
consent to enter into the record a statement from the March of
Dimes.
The Chairman. It will be done.
Senator Cassidy. Thank you.
[The information referred to may be found in Additional
Material.]
Obviously, we have declining resources on the Federal
level. I see that the Administration is cutting the 317 money,
Dr. Moore, that you referenced. I will also note, again, as a
fellow who used to work in a public hospital system, that we--I
wasn't a pediatrician. I just did a lot of pediatric
immunization work. There's always a great concern about
immunization.
Sometimes I would see people come to speak to our
pediatricians about immunization, and it was like coal to New
Castle. These folks cared about it. Jacks and Sawyer care about
it passionately. Can we use our 317 money more effectively? I
ask this not to challenge, but just to suggest.
When I look at that map of California, you can isolate
those communities which are not immunizing. We ought to pay
Jacks to come in and speak to those families so that they know,
if they have a domestic which is helping them in their home--
and they're wealthy--whose child was unvaccinated and recently
came from another country, their children are at risk. Dr.
Jacks could do that very effectively.
I guess I'm going to ask are we still using our 317 money
in a paradigm of 20 years ago, before VFC, before we had
immunization registries that could pinpoint where we had
pockets of the unimmunized, and before we realized that many
people are basing their decisions upon emotion and not upon
their physician's recommendation? Simple question--317--are our
programs rooted in 20 years ago, or are they adapting to our
ability to use data to pinpoint where we need intervention?
Dr. Moore.
Dr. Moore. Thank you for that question. I can say that
under Dr. Schuchat's leadership, the 317 program is definitely
focused on where we are today with our immunization programs.
The 317 funding that we have is going to support our
immunization information system that provides, as I mentioned,
clinical decision support for clinicians who need to keep up
with the complex current immunization schedule to provide
optimal care. It can provide that support. It makes it easy to
issue an immunization certificate.
We are also using those funds to provide education, not
only for clinicians in large conference settings, but also one-
on-one education. We will send a public health immunization
expert into a clinic to spend half a day with that----
Senator Cassidy. My point is that those clinicians, again--
they don't need a half a day. They just need to have posted
online their clinic's results compared to other clinics. The
natural competition is going to drive it. We know that from
infection disease rates in ORs. If you post a clinic's
immunization rate, and they're lacking, they're going to come
up.
I suspect if you did that for an elementary school--we're
going to post the rate of the children immunized here. Enter
but beware, because over 50 percent are not immunized. Do you
follow what I'm saying? It's a Petri dish for measles.
Dr. Sawyer, what are your comments on that?
Dr. Sawyer. First, I'd like to agree with your very last
comment about posting these rates for schools, because if we
want parents to be informed about vaccines in general, we
should also want them to be informed about the environment that
they're putting their children in. There's no doubt that a
school with 40 percent or 50 percent of unimmunized children is
where the next outbreaks are going to occur, because once they
get going, they'll spread.
Senator Cassidy. Is there a push to do so? I mean, that
really should be something--we should be letting parents know
as much as possible about both--because I read the pediatrics
article that staff provided. If a pediatrician pushes
immunization, she is more likely to convince a mom to vaccinate
than if she is a passive--``OK, that's fine. I'll sign the
note.''
To what degree are we posting individual clinics and/or
individual schools? It seems like you should be doing that in
Santa Monica.
Dr. Sawyer. Well, I can certainly comment for California.
The rates of school vaccinations are public information.
They're posted on the State's website. You have to go look for
them rather than--putting them right in the face of the parent
as they walk in on the first day of school might be more
effective.
Senator Cassidy. Dr. Jacks, any comments?
[No verbal response.]
OK. Well, I will yield back my 43 seconds. Thank you.
The Chairman. This time bank is getting full. We've got
Senator Franken.
Senator Franken. I don't think I'm going to take very long.
I appreciate all of your testimony and all your answers to the
questions. I just have--it may be too early to know the answer
to this. Maybe--all of you are on the front lines of this,
obviously.
Dr. Jacks, with your story, you're hearing a lot.
What is the public reaction to this in the last week or so?
Because, hopefully, we're disseminating some information here,
and the news has been. What do you sense has been the reaction
to the outbreak and to all the public information and all the
discussion on the news, et cetera? What has been the reaction
from those parents who waived the immunization for their child?
Is this being helpful? Is this a learning moment for America?
Dr. Sawyer. I would say absolutely. I have certainly heard
stories from local pediatricians who have been trying to
convince families for years to immunize, and when this measles
outbreak happened, they were walking in the door wanting to be
immunized. The publicity is very important to raise awareness
about the fact that these diseases are still out there. I
thank, again, the Senators for organizing this hearing to
partly do that.
Dr. Moore. Yes. I have had great experience getting a lot
of good questions from the media and from families,
particularly focused on our immunization exemption, which is
low.
Notably, the wealthiest county in Tennessee has almost four
times as high an exemption rate as the county next door--
Davidson County, from Metro Nashville--among kindergarten
students. That caught everyone's attention. Hopefully, even
though our exemption rates don't compare to California and some
other places, it's making people realize the consequences of
their choices.
Senator Franken. Dr. Jacks.
Dr. Jacks. I would just echo what they're saying. There's
definitely been a lot of good awareness about the issue. A lot
of families have come in to get immunized, both against the
measles as well as other immunizations. I just had a family
this last week, and the parents were kind of split on--do we
vaccinate or do we not? I remembered them, and they came in and
got all their vaccinations.
Senator Franken. This Lancet article from years ago
probably did a lot of damage. We've seen a--not an explosion,
but a big--maybe a growth in autism, at least in the diagnosis
of it, whether it's a genuine increase or just a better
diagnosis, and it's a devastating thing, autism. I know that
that fear resonated with people.
Again, this is maybe a wakeup moment, a learning moment,
and I hope that it is. I want to thank you for being here
today, and I want to thank the chairman for calling this
hearing.
I'm giving you a minute and 16, but I'm the end.
The Chairman. Thank you, Senator Franken.
Senator Murray, do you have closing remarks?
Senator Murray. I just wanted to thank all of our witnesses
today for being here and for all the work you're doing to help
keep people safe from vaccine-preventable diseases. I
particularly want to thank our chairman, Senator Alexander, for
holding this hearing at such an important time. Thank you.
The Chairman. I thank Senator Murray for her work and her
staff's work in putting together such an extraordinary group of
witnesses today. This has been very, very helpful, and not just
to us, but to anyone who has been listening.
Dr. Moore, we're, again, so proud of our public health
department in Tennessee. I think back, not just on this, but on
the quick reaction to the fungal meningitis episode, where your
department saved lots of lives.
Dr. Sawyer and Dr. Jacks, thank you for your leadership in
your field and your testimony. The hope we have is that Dr.
Jacks' message goes viral more rapidly than measles does, and
that it goes fast.
I have a hard time keeping my old Governor's hat off, and
it makes me think of the importance of our State organizations.
CDC really works through the States. The medical associations
work through their legislatures and associations, and they're
in touch with parents every day.
We would like to take some step to solve this problem. The
truth is, in my view, most of that reaction has to be with
those who are closest to the parents and who see them
regularly. The idea of a medical home for every child who is
about to be born is probably the surest and best way for States
to approach this, because parents who are talking to their
pediatricians are going to make sure their children are
vaccinated.
I have some closing remarks I'm supposed to make.
The hearing record will remain open for 10 days. Members
may submit additional information and questions for the record
within that time. The next hearing will occur tomorrow at 9:30
to look at the issue of ambush elections.
Thank you for being here today. The committee will stand
adjourned.
[Additional Material follows.]
ADDITIONAL MATERIAL
Prepared Statement of the March of Dimes Foundation
about march of dimes foundation
The March of Dimes, a unique collaboration of scientists,
clinicians, parents, members of the business community and other
volunteers affiliated with 51 chapters representing every State, the
District of Columbia and Puerto Rico, appreciates this opportunity to
submit testimony for the record of this important hearing on the re-
emergence of vaccine-preventable diseases. For over 75 years, the March
of Dimes has promoted maternal and child health through activities such
as funding research and field trials for the eradication of polio,
promoting newborn screening, and educating medical professionals and
the public about best practices for healthy pregnancy. Today, the
Foundation works to improve the health of women, infants and children
by preventing birth defects, premature birth and infant mortality
through research, community services, education and advocacy.
The March of Dimes is a national voluntary health agency founded in
1938 by President Franklin D. Roosevelt to support research and
services related to polio. Over the course of almost two decades, the
March of Dimes collected millions of dollars, raised one dime at a
time, to fund the ground-breaking research that resulted in the Salk
polio vaccine. That vaccine, along with the later Sabin polio vaccine,
put to rest the fears of parents everywhere that their children would
be stricken, suddenly and inexplicably, by a disease that could
paralyze or kill them. This history serves as the foundation for the
March of Dimes' passionate support for lifesaving vaccines and our
ongoing work to promote their development and use.
background
The March of Dimes shares the concern expressed by many
policymakers about the recent outbreak of measles that continues to
spread across the Nation, and more generally about the resurgence of
dangerous vaccine-preventable conditions. Over the past decades, the
United States has seen the virtual elimination of many feared diseases,
largely due to the development and effective administration of
vaccines. Public awareness about the dangers of these diseases and the
benefit of vaccines has been key to their elimination.
Infants are often more vulnerable to vaccine-preventable diseases
than any other population, due to the fact that their immune systems
are not fully developed enough to fight off infections that might pose
less of a threat to older children and adults. In some cases, vaccines
cannot be administered to young children until their immune systems
have matured sufficiently to mount an effective response. As such,
unvaccinated populations--be they children, adults, communities, or
health or child care workers--pose an exceptional, and sometimes
deadly, risk to infants.
Pertussis, commonly referred to as ``whooping cough,'' provides a
timely example. A recent surge in pertussis outbreaks across the
country has raised alarms throughout the health community. Prior to the
introduction of the pertussis vaccine in the 1940s, this disease was a
common cause of death among infants; in 1934, the Centers for Disease
Control and Prevention (CDC) reported 265,269 pertussis cases.\1\ After
introduction of pertussis vaccines, rates dropped dramatically, with
CDC reporting only 1,010 cases in 1976.
---------------------------------------------------------------------------
\1\ http://www.cdc.gov/pertussis/surv-reporting/cases-by-year.html.
---------------------------------------------------------------------------
However, pertussis cases have surged in recent years. In 2012,
48,277 cases of pertussis were reported by CDC, with many more likely
unreported or undiagnosed. From 2000 through 2012, there were 255
deaths from whooping cough reported in the United States; 221 of the
255 victims who died were babies younger than 3 months of age.\2\ Most
of these babies contracted pertussis from older children or adults who
carried the infection, most of whom were likely unaware of their
carrier status. Tragically, 80 percent of infants who contract
pertussis are infected by parents or other caretakers.
---------------------------------------------------------------------------
\2\ http://www.cdc.gov/vaccines/vpd-vac/pertussis/fs-parents.html.
---------------------------------------------------------------------------
Hundreds of thousands of Americans fell ill or died from pertussis
over the past decades, even though we had not long ago nearly
eradicated the infection in the United States. This resurgence was not
due to stronger pathogens or a lack of health care resources; it was
due to misinformation and a lack of understanding of the importance and
safety of being vaccinated.
vaccines, infants, and pregnant women
Like pertussis, measles has re-emerged, despite having been
declared eradicated in 2000. The measles vaccine became available in
1963, and less than 40 years later, the United States was declared free
of endemic measles due to widespread vaccination. Vaccination rates
dropped, and new cases started to emerge. In 2011, the highest number
of measles cases since 1996 was reported. 2015 is on track to record a
higher number yet.
As discussed above, declining vaccination rates are causing a
resurgence of pertussis as well. In 2010, California saw the largest
outbreak of pertussis cases since 1947. A study in Pediatrics evaluated
the association between non-medical exemptions from immunization
requirements and outbreaks. It found that the California outbreak was
associated with clusters of unvaccinated children with non-medical
exemptions.
The proliferation of non-medical exemptions erodes the overall
effectiveness of immunizing the U.S. population against dangerous
conditions. A single child who is not vaccinated can place at risk not
only themselves but many others, including some who cannot be
vaccinated for medical reasons. According to the CDC, nonmedical
exemptions are on the rise with a national rate of 1.8 percent, but
much higher rates in certain communities.\3\
---------------------------------------------------------------------------
\3\ http://www.cdc.gov/mmwr/preview/mmwrhtmi/mm6341a1.htm.
---------------------------------------------------------------------------
Although the lack of immunization among the general public and
clustered in various communities is dangerous, certain populations are
especially critical to vaccinate in order to protect infants. Health
care workers such as NICU nurses, orderlies, and doctors are often in
close contact with both families and extremely vulnerable populations.
Child care workers are also often in regular contact with children
and youth who may be carriers, and also with infants who have not yet
developed strong immune systems. For those who are more likely to
bridge contact between the vulnerable and the infected, vaccinations
should be prioritized, and when appropriate, required.
Pregnant woman are also a priority population for influenza and
pertussis (tetanus-reduced diphtheria toxoid-acellular pertussis
booster, or ``Tdap'') vaccinations. Despite the proven benefits of
certain immunizations for pregnant women and their infants, maternal
immunization rates in the United States remain low. Influenza
immunization is known to benefit pregnant women, conferring lower and
less severe flu incidence,\4\ \5\ and flu shots are associated with
reducing preterm birth in women immunized while pregnant.\6\
---------------------------------------------------------------------------
\4\ Jackson LA, Patel SM, Swamy GK, et al. Immunogenicity of an
inactivated monovalent 2009 H1NI influenza vaccine in pregnant women.
The Journal of Infectious Diseases, 204(6), 854-63.
\5\ Jamieson DJ. Kissin DM, Bridges CB, Rasmussen SA. Benefits of
influenza vaccination during pregnancy for pregnant women. American
Journal of Obstetrics and Gynecology, 207(3 Suppl), S17-20.
\6\ Omer SB, Goodman D, Steinhoff, MC, et al. Maternal influenza
immunization and reduced likelihood of prematurity, and small for
gestational age births: a retrospective cohort study. PLoS Medicine.
8(5), el000441.
---------------------------------------------------------------------------
Similarly, studies indicate that vaccination with the Tdap vaccine
during the final trimester of pregnancy could reduce hospitalizations
due to pertussis during an infant's first months of life, when the
infant cannot be immunized directly.\7\ Nevertheless, maternal
influenza immunization rates have hovered just above 50 percent for the
past few years after increasing during the H1N1 epidemic,\8\ \9\ \10\
and Tdap immunization rates are only about 29 percent, with some Tdap
immunizations taking place outside the time range recommended for
optimal efficacy.
---------------------------------------------------------------------------
\7\ Peters TR, Banks GC, Snively BM, Poehling KA. Potential impact
of parental Tdap immunization on infant pertussis hospitalizations.
Vaccine, 30(37), 5527-32.
\8\ Centers for Disease Control and Prevention. Influenza
vaccination coverage among pregnant women--United States. 2010-11
influenza season. MMWR, 60(32), 1078-82. Retrieved from http://
www.ncbi.nlm.nih.gov/pubmed/21849964.
\9\ Centers for Disease Control and Prevention. Influenza
vaccination coverage among pregnant women: 2011-12 influenza season,
United States. MMWR, 61, 758-63. Retrieved from http://
www.ncbi.nlm.nih.gov/pubmed/23013721.
\10\ Bridges CB. Preliminary Results Tdap Vaccination Coverage
Among Pregnant Women--September 2013 presentation to NVAC. Washington,
DC. Retrieved from http://www.hhs.gov/nypo/nvac/meetings/pastmeetings/
2013/tdap_vaccination_women_coverage_sept2013.
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policy recommendations
The United States has shown that we can defeat diseases like polio,
measles and pertussis. In order to do so, however, a concerted, long-
term effort is crucial. Any lapse in our vigilance and commitment can
allow these deadly diseases to return and spread unabated. For that
reason, the March of Dimes urges Congress to maintain and strengthen
our commitment to the multi-faceted national strategy required to keep
infectious diseases in check. This can be achieved through appropriate
funding for a wide array of programs, including the Vaccines for
Children program, Section 317 Immunization Grant Program for States,
CDC and State surveillance and reporting, and similar efforts.
In addition to these vital Federal programs, the March of Dimes
strongly supports actions at the State and local levels to promote
universal childhood immunization.
School immunization requirements are a vital public health tool to
promote the health of all children and to protect those schoolchildren
who cannot be vaccinated for medical reasons. The March of Dimes
opposes non-medical immunizations and works to educate parents and
caregivers about the importance of vaccinating their children on time
in accordance with the CDC's recommendations. The March of Dimes also
supports State-based programs that increase access to immunizations,
such as public health clinics, and that remove cost as a barrier to
lifesaving vaccines.
conclusion
Thank you for your attention to this vitally important child and
maternal health issue. The March of Dimes is committed to working with
Congress and other stakeholders to develop and implement solutions, to
provide timely information and education, and to procure and make the
investments needed to improve the health of every mother and child.
Response by Anne Schuchat, M.D. (RADM, USPHS) to Questions of Senator
Roberts, Senator Cassidy, Senator Casey, Senator Baldwin and Senator
Warren
senator roberts
Question 1. Given that many of our health care professionals were
trained after we thought we had eliminated diseases like measles, what
efforts has the CDC undertaken to help providers identify symptoms and
take appropriate action when coming across a possible case of measles?
Answer 1. CDC recognizes that early detection of measles cases is
critical to limiting further spread of the disease. CDC has and
continues to develop and disseminate key information to healthcare
providers, partners and the general public to increase awareness of
measles and the importance of vaccination. CDC uses social media, Web
sites, media briefings and other communication strategies to share
information. Specific to direct healthcare provider outreach, CDC
issued a Health Alert Network message, a mechanism for sharing
information about urgent public health incidents, ``U.S. Multi-State
Measles Outbreak, December 2014-January 2015'' on January 23, 2015. In
addition, CDC held a Clinician Outreach and Communication Activity
(COCA) call, a mechanism to prepare clinicians for response to emerging
public health threats and public health emergencies, on February 19,
2015. The purpose of this call was to discuss the current status of
measles outbreaks in the United States; describe the clinical
presentation of measles and the guidelines for patient assessment and
management; outline CDC vaccination recommendations for the general
public, international travelers, and healthcare professionals; and
identify CDC measles resources and training materials for
clinicians.\1\ Additionally, CDC has a dedicated hotline and email
account for specific questions from clinicians or the general public
regarding measles and measles vaccination.\2\
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\1\ The archived webcast and transcript are accessible at http://
emergency.cdc.gov/coca/calls/2015/callinfo_021915.asp.
\2\ 1-800-CDCINFO or [email protected].
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CDC has collaborated across the Department of Health and Human
Services, including partnering with the Health Resources and Services
Administration (HRSA) to leverage its networks of providers and
organizations that serve vulnerable populations. CDC also works with
healthcare organizations, including the American Academy of Pediatrics
and the American Academy of Family Physicians, to distribute weekly
information through email blasts and newsletters. Together, we also co-
branded an infographic to help with communication efforts.\3\
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\3\ Available at http://www.cdc.gov/measles/parent-
infographic.html.
Question 2. What guidance or advice does the CDC give to the
parents of kids who cannot be immunized due to allergies or because
they are otherwise immunocom-
promised and must rely on others in their community to choose
vaccination to help protect their own?
Answer 2. Those who cannot be immunized due to allergies or because
they are otherwise immunocompromised rely on ``community immunity''.
Community immunity is achieved when a critical portion of a community
is immunized against a contagious disease, allowing for most members of
the community to be protected against that disease because there is
little opportunity for an outbreak. Even those who are not eligible for
certain vaccines--such as infants, pregnant women, or immunocompromised
individuals--get some protection because the spread of contagious
disease is contained. For this reason, it is critical to maintain high
vaccination coverage rates among persons eligible for vaccination.
Parents of immunocompromised children should talk with their pediatric
healthcare provider about how best to protect their child from vaccine-
preventable diseases. Parents should also be encouraged to talk to
childcare facilities to learn about their vaccination policies and
requirements.
senator cassidy
Question 1. The United States conducts screening for communicable
diseases in some cases, such as Hepatitis C screening for those
entering the United States for adoption. Can you explain why those who
emigrate from some countries are not being screened for measles? Why is
there a difference in policy?
Answer 1. Immigrants (including adoptees) and refugees are required
to receive an overseas medical examination in accordance 42 CFR, Part
34: Medical Examination of Aliens. The requirements focus on the
detection of class A conditions, most notably active tuberculosis and
syphilis.
(a) Hepatitis C is not a class A condition and screening is not
required or performed as part of the overseas medical examination.
(b) Class A conditions include:
1. Tuberculosis
2. Syphilis
3. Chancroid
4. Gonorrhea
5. Granuloma inguinale
6. Lymphogranuloma venereum
7. Hansen's disease (leprosy)
8. Mental Disorders (with Associated Harmful Behavior)
9. Substance Abuse
overseas vaccination
As part of the overseas medical examination, vaccinations are
required for immigrants. On November 13, 2009, CDC posted a Federal
Register Notice revising the vaccination criteria for U.S. immigration.
CDC uses these criteria for vaccines recommended by the Advisory
Committee on Immunization Practices (ACIP) to decide which vaccines
will be required for U.S. immigration. The criteria are used at regular
periods, as needed, by CDC. Measles vaccination has been and continues
to be required for all immigrants.\4\
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\4\ See http://www.cdc.gov/immigrantrefugeehealth/exams/ti/panel/
vaccination-panel-technical-instructions.html#adoptees.
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(a) The age-appropriate vaccinations required for the immigration
examination based on the above criteria or per 8 U.S.C. 1182(a)(1) are:
1. Diphtheria
2. Tetanus
3. Pertussis
4. Polio
5. Measles
6. Mumps
7. Rubella
8. Rotavirus
9. Haemophilus influenzae type b
10. Hepatitis A
11. Hepatitis B
12. Meningococcal
13. Varicella
14. Pneumococcal
15. Influenza
(b) Adoptees are one class of immigrant visa holders and therefore
fall under the same vaccination requirements as immigrants. However,
certain adoptees are eligible for exemption for vaccinations.\5\
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\5\ Some information about vaccinations for adoptees is located at:
http://www.cdc.gov/immigrantrefugeehealth/adoption/overseas-exam.html
and http://www.cdc.gov/immigrant
refugeehealth/exams/ti/panel/vaccination-panel-technical-
instructions.html. General information about adoption is available at:
http://www.cdc.gov/immigrantrefugeehealth/adoption/index.html.
1. The vaccination requirements do not apply to adopted children 10
years of age or younger, provided the adoptive parent, prior to the
child's admission, signs an affidavit stating that the parent is aware
of U.S. vaccination requirements and will ensure that the child will
receive all required vaccinations within 30 days of the child's arrival
in the United States.\6\
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\6\ See http://www.state.gov/documents/organization/80002.pdf for
the affidavit form.
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2. The Hague Adoption Convention governs adoptions between the
United States and other countries in the convention.\7\ For countries
both in the convention (Hague) and not in the convention (non-Hague),
the vaccination requirements do not apply to adopted children 10 years
of age or younger, provided the adoptive parent, prior to the child's
admission, signs the affidavit concerning exemption from immigrant
vaccination requirements for a foreign adopted child.
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\7\ See http://adoption.state.gov/hague_convention/overview.php.
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3. If the adopted child has a history of vaccinations, the panel
physician must complete the DS-3025 form if reliable vaccination
documents are available.
(c) Refugees are not required to have vaccinations overseas before
arriving in the United States but they are required to have
vaccinations when they are eligible to adjust their status 1 year later
to legal permanent resident. However, because of the public health
benefits of vaccination in reducing the importation of vaccine-
preventable diseases and improving the health of U.S.-bound refugees,
CDC and the Department of State are currently supporting a program to
provide routine vaccinations, including measles, to U.S.-bound refugees
resettling from Ethiopia, Kenya, Uganda, Thailand, Malaysia and
Nepal.\8\
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\8\ See http://www.cdc.gov/immigrantrefugeehealth/guidelines/
overseas/interventions/immunizations-schedules.html.
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post-arrival hepatitis c screening
(a) After arrival in the United States, refugees undergo a
voluntary health assessment conducted in their State of resettlement.
Hepatitis C screening may be recommended as consistent with guidelines
for the general U.S. population.\9\
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\9\ http://www.cdc.gov/immigrantrefugeehealth/guidelines/domestic/
hepatitis-screening-guidelines.html.
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(b) The same general U.S. guidelines would apply to immigrants and
adoptees.\10\
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\10\ Specific guidelines for adoptees can be found at http://
wwwnc.cdc.gov/travel/yellowbook/2014/chapter-7-international-travel-
infants-children/international-adoption.
Question 2. Since the measles outbreaks are not widespread, but
rather isolated in certain communities, can the CDC and States target
prevention and notification strategies to these areas? For example, can
you require that schools and clinics be required to post immunization
rates especially in areas with low immunization rates, so that parents
are aware of the risk to their children or the absence of herd
immunity? This strategy would help parents with children whose immune
systems are compromised to avoid exposing them to unnecessary risk.
Answer 2. CDC's National Immunization Survey (NIS) is essential to
assessing national progress, documenting programmatic achievements, and
identifying disparities in immunization coverage rates. This
information is used by CDC and State and local immunization programs to
target outreach efforts. Each year, to assess State and national
vaccination coverage and exemption levels among kindergartners, CDC
analyzes school vaccination data collected by federally funded State,
local, and territorial immunization programs. CDC and the States also
publish exemption rates. Eighteen States provide local-level data
online, helping to strengthen immunization programs, guide vaccination
policies, and inform the public. Local-level school vaccination and
exemption data can be used by health departments and schools to focus
vaccine-specific interventions and health communication efforts in a
school or local area with documented low vaccination coverage or high
exemption rates. Where expanded health communication strategies or
other interventions are implemented, continued assessment and reporting
can be used to facilitate program improvement. Vaccination requirements
are within the purview of State authority. Although CDC does not have
regulatory authority over schools or healthcare facilities, it
encourages its State and local public health partners to make county-
level exemption data available.
senator casey
Question 1. In your written testimony, you discussed the first U.S.
measles vaccination program, which started in 1963. Did this program
encounter any resistance to vaccination, similar to the resistance we
are seeing from some individuals today? If so, how did it counter this
resistance, and are there any important lessons that we can use for
countering public resistance to vaccination in the 21st century?
Answer 1. Before the availability of the measles vaccine, there
were an estimated 3-4 million cases of measles annually in the United
States. In the years that followed the introduction of the vaccine,
measles declined 98 percent in the United States, suggesting widespread
public support for the vaccine. The measles resurgence of 1989-91 was
largely attributed to lack of access rather than decisions to forgo
vaccination, and was the impetus for the Vaccines for Children Program,
which provides vaccines to eligible uninsured and underinsured children
nationally.
The current outbreak of measles is an indication of how globally
connected we are. Measles is still endemic in many parts of the world,
with 20 million cases occurring worldwide annually. Even though both
CDC and the U.S. Agency for International Development support many
countries in building stronger immunization programs to vaccinate more
children around the world with multiple vaccines, including measles,
importations of measles remain a significant challenge. Unvaccinated
U.S. residents traveling overseas are at risk for measles, and
returning U.S. residents and foreign visitors to the United States may
develop measles and expose unvaccinated people in the United States.
When measles gets into communities of unvaccinated people in the United
States, such as people who refuse vaccines for religious,
philosophical, or personal reasons, outbreaks are more likely to occur.
New research recently published in the journal Pediatrics has found
that people who seek personal-belief exemptions for their children
often live near one another. We think these micro-communities are
making it difficult to control the spread of measles and are making us
vulnerable to having the virus re-establish itself in our country
again. In addition, they put others at risk who cannot get vaccinated
because they are too young or they have specific health conditions.
Question 2. You stated that 1 in 12 children in the United States
is not receiving his first dose of measles-mumps-rubella vaccine on
time. Has CDC collected any data on the reasons why this is happening
with this specific vaccine? For example is it mostly happening because
parents object to vaccines, or is access to vaccines an issue, or is
some other reason to blame? If CDC has not collected data on this, do
you plan to collect data on this in the future?
Answer 2. Unlike the measles outbreaks in the 1980s and 1990s,
access to vaccines does not appear to be the contributing factor to the
current outbreak. Coverage levels for many childhood vaccinations are
at, near, or above 90 percent, and reported cases for most vaccine-
preventable diseases have decreased by 90 percent or more in the United
States. The creation of the Vaccines for Children Program (VFC) has
been instrumental to achieving these high vaccination coverage rates
and reducing disparities. The VFC program serves children through 18
years of age who are uninsured, underinsured, Medicaid-eligible, or
American Indian or Alaska Native. CDC purchases and distributes
vaccines to VFC-enrolled providers and provides funding to 61 eligible
awardees for VFC-related operations activities. Currently, there are
more than 44,000 public and private providers in the VFC program, and
VFC distributes over 50 percent of all routinely recommended vaccines
for those 18 years and younger.
The current measles outbreak is an indicator of how globally
interconnected we are, with measles importations uncovering those
communities opting out of immunization, and indicating those
communities may be getting larger. Although the majority of parents
recognize the benefits of immunization and have their children
vaccinated, with less than 1 percent of toddlers receiving no vaccines,
certain concerns lead some parents to delay or refuse vaccinations. CDC
has conducted research to better understand why some parents choose not
to vaccinate their children. Parents give many reasons for vaccine
hesitancy despite overwhelming and consistent scientific evidence that
vaccines are safe and effective. For some, many vaccine-preventable
diseases don't have the visibility they once had and many parents
question whether vaccines are more dangerous for their child than the
diseases they prevent. Parents also have access to conflicting and
often inaccurate information about vaccines via the Internet, and
others express concern that there are too many vaccines given early in
life. Before 1985, the recommended immunization schedule included only
seven vaccines. The good news is that today, we can protect children
younger than 2 years of age from 14 potentially serious diseases with
vaccines. However, this has created a ``crowded'' and complex schedule
for parents and providers. While some parents express concern about the
number of vaccines in the childhood immunization schedule, the
scientific evidence has shown that the immunization schedule is safe,
and there is no evidence that suggests that the recommended childhood
vaccines can ``overload'' the immune system.
CDC knows that maintaining public confidence in immunizations is
critical to maintaining high vaccination coverage rates and preventing
outbreaks of vaccine-preventable diseases. CDC supports science-based
communication campaigns and other efforts to convey the benefits of
vaccines to the public to aid individuals in making informed vaccine
decisions to protect themselves and their loved ones. CDC also conducts
outreach to educate healthcare providers about current immunization
policy and clinical best practices to help them protect their patients
and communities from VPDs. CDC developed and will maintain a dynamic
provider toolkit for conversations with parents about vaccination that
includes evidence-based strategies, print materials, and web-based
tools.
Question 3. How do MMR vaccination rates compare to the rates for
other early childhood vaccines?
Answer 3. Like most childhood vaccines, the overall measles
vaccination coverage rate is high at 92 percent. However, 1 in 12
children in the United States is not receiving his/her first dose of
MMR vaccine on time, leaving them unnecessarily vulnerable to vaccine-
preventable diseases. This underscores considerable measles
susceptibility across the country. In addition, we see variability in
coverage across States. In 2013, there were 17 States where fewer than
90 percent of toddlers had received at least one dose of MMR. Within
States, some counties or communities have much lower vaccination rates
than the State average.\11\
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\11\ Additional information on vaccine coverage rates, including
rates by State can be found at: http://www.cdc.gov/mmwr/preview/
mmwrhtml/mm6334a1.htm's_cid=mm6334a1_w.
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senator baldwin
Question 1. In 2004, we saw a dangerous shortage of influenza
vaccine in the United States due in part to disruptions in vaccine
production overseas and our insufficient domestic production
capabilities. Since that time, can you please explain what work the CDC
is doing to:
Ensure that we have a sufficient number of domestic
vaccine manufacturers and robust domestic production capabilities;
Help speed development of vaccines with advanced
techniques and technologies such as cell-based manufacturing processes;
and
Increase communication and notice to providers as well as
other producers when a vaccine manufacturer exits the market?
Answer 1. CDC works closely with public health and provider
organizations to ensure that issues related to vaccine supply are
communicated in a timely fashion and that messaging is shared directly
with providers. While there has not a been a specific recent issue
related to flu-vaccine manufacturers exiting the market, CDC's
collaboration with public health and provider organizations, as well as
CDC's direct communication with its immunization awardees, provides an
important communication channel for sharing information related to
influenza vaccine supply and availability.
senator warren
Question 1. Because of smart investments over the last several
decades, we now have a vaccine for HPV that helps to prevent cancer,
and a vaccine for Hepatitis B that can prevent liver cirrhosis and
cancer associated with the virus. We also have vaccines that can
prevent some types of meningitis and pneumonia. We are still
struggling, however, to make sure that everyone has access to all of
the vaccines available. What do you see as the greatest challenges to
getting people of all ages--kids, teens, and seniors--vaccinated?
Answer 1. While we have achieved high coverage rates for most
childhood and adolescent vaccines, we have a long way to go regarding
human papilloma virus (HPV) vaccination, which prevents virtually all
cervical cancers, as well as other types such as anal, vulvar, and
oropharyngeal cancers. HPV vaccination coverage is troublingly low,
with only a third of U.S. girls receiving all three recommended doses
of HPV vaccine. The yearly national vaccination coverage estimate among
female teens for one dose of HPV vaccine has been more than 20 percent
lower than the estimate for one dose of Tdap vaccine (a booster given
to adolescents to extend coverage of the childhood diphtheria-tetanus-
pertussis vaccine), demonstrating that critical opportunities are being
missed to vaccinate young people against HPV with a vaccine known to be
safe and effective for cancer prevention.
To reach adults, we need different strategies than we have used
with the childhood program. Unlike children, who have scheduled routine
visits with their pediatrician, adults may see multiple physicians for
specialty care, many of whom may not offer vaccination services. CDC is
working to increase awareness of the need for vaccines for adults among
the general population and the provider community. We are also looking
at increasing access through non-traditional venues, including
pharmacies and retail clinics. CDC has developed new educational
materials aimed at increasing the public's awareness about vaccines
that adults need and is partnering with a wide range of vaccine
providers, including medical, pharmacy and nursing organizations, and
State and local health departments to increase awareness of the low
rates of adult immunization and to increase implementation of the
standards of adult immunization practice. These standards include
assessing adult patients' vaccination needs on a routine basis,
recommending needed vaccines, and then either offering vaccines, or if
the provider does not stock the vaccine, referring the patient to a
vaccine provider in their area. Providers and patients are both able to
find vaccine providers in their areas through use of the healthmap.org
website. Patients can also take the CDC vaccine quiz to find out which
vaccines might be right for them.\12\ Taking the quiz generates a list
of vaccines a person might need based on their age, medical conditions,
prior vaccinations and other factors. Patients can then take this list
to their provider to discuss which vaccines they need. In addition, the
National Vaccine Advisory Committee will be releasing a National Adult
Vaccine Plan that will help identify strategies for improving adult
vaccine coverage.
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\12\ The quiz can be accessed at http://www.cdc.gov/vaccines/
adults/index.html.
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Immunizations are never complete. Every day, babies are born who
will require vaccines to prevent 17 diseases across their lifespan. In
addition to addressing barriers to vaccination across the lifespan,
public health conducts ongoing monitoring of the safety and efficacy of
the Nation's vaccine policies and programs. The critical public health
workforce and systems that make this possible must be maintained to
continue our success.
Response to Questions of Senator Casey by Tim Jacks, M.D., DO, FAAP
Question. As a physician, and as a parent, what response would you
have for a parent who says that measles is a more acceptable health
risk for their children than what they feel are the potential health
risks of vaccines?
Answer. As a physician, I would reference back 52 years before
there was a measles vaccine. At that time, there were 500,000 cases of
measles per year in the United States. Measles caused severe illness,
over 25 percent of cases required hospitalization, about 500 people had
encephalitis (brain swelling/damage) and about 500 people died each
year from measles. In contrast, the MMR vaccine is extremely safe, and
severe allergic reactions occur in less than one per million
vaccinated. Measles is extremely contagious (>90 percent unprotected
exposed people contract it), and the vaccine is every effective (>99
percent protection after the two recommended doses).
As a father, I would speak from personal experience of my
daughter's exposure. Not vaccinating puts not only your child at risk
but also the larger community--those too young or unable to be
vaccinated for medical reasons. For my leukemia-battling daughter,
there was a very real risk of severe illness or death if she had
contracted measles.
Response to Questions of Senator Casey by Mark H. Sawyer, M.D., FAAP
Question 1. In your written testimony, you discussed the importance
of the Vaccine Adverse Event Reporting System (VAERS) for continually
monitoring the safety of vaccines and ensuring that any potentially
unsafe patterns are quickly recognized. Do you feel this system is
adequate to protect the American public? Is there any aspect of it that
you would like to see improved?
Answer 1. The VAERS system has been very effective in calling
attention to possible vaccine side effects but it is not adequate alone
to protect the American public. An association between the
administration of a vaccine and an adverse event does not prove
causation. It would be a grave error to rely on such associations
reported to VAERS to dictate vaccine policy. What is required is a
companion system, such as the current Vaccine Safety Datalink (VSD)
which is organized and supported by the Centers for Disease Control and
Prevention. The VSD allows events reported in VAERS to be studied
epidemiologically to prove cause and effect. By studying possible
vaccine side effects in the millions of people covered by the VSD we
can tell the public exactly how safe vaccines are. This will never be
possible during the initial studies conducted by manufacturers when
vaccines are being developed because it is impossible to study enough
people. The ongoing support for the VSD or similar system is key to
maintaining the public's trust in the safety of vaccines. The current
funding of the VSD does not allow every possible vaccine side effect to
be researched and in my opinion this program should be expanded so that
all possible effects of vaccines can be studied.
Question 2. You stated that none of the pediatric residents during
a training session reported ever seeing a case of measles, but that you
feel that this may change. In what ways, if any, do you think pediatric
training should change in order to account for the reluctance of some
parents to vaccinate their children, and the reemergence of vaccine
preventable illnesses such as measles?
Answer 2. Clearly we are in an era where parents are challenging
the advice of doctors. For example, a study published in Pediatrics on
March 2 found that the number of parents who are asking to delay their
children's vaccination schedule has increased in the last several
years. Doctors need to be trained in effective communication in order
to impart sound medical advice in this environment. I believe medical
educators have recognized this need and are adding curricular materials
to their training programs to prepare future doctors for these
conversations. I celebrate the fact that young doctors have never seen
measles and some types of bacterial meningitis--this is testimony to
the tremendous impact of vaccines.
Question 3. You discuss the need to restrict exemptions from school
entry requirements in order to help boost vaccine rates. Many State
legislatures are currently dealing with this issue, and often they will
hear testimony from parents who are seeking broader, non-religious
moral exemptions. What factors would you advise State legislators to
consider when they hear testimony from these parents?
Answer 3. Central to this issue is the role of government in
protecting the public's health. Legislators need to be current in their
understanding of the science that supports the utility and safety of
vaccines. They also need to have a firm grasp on the impact of
unimmunized populations on the general health of the community. There
is ample precedent for creating laws that curb some personal choice in
favor of protecting the public's health (e.g., public smoking). Those
opposed to vaccination will present legislators anecdotes linking
adverse health outcomes to vaccines. Left unchallenged these anecdotes
will sound compelling and lead to poor policy decisions. I would
encourage legislators to probe those who offer anecdotes for scientific
evidence that supports the anecdote. It is human nature to assume that
if event B happened after event A then event A caused event B. This
obviously is not always the case. Legislators need to access the
science that confirms the safety of vaccines.
Question 4. Is there any research being done to develop less
invasive vaccinations (e.g., flu nasal mist instead of the flu shot)?
Do you think less invasive immunizations would sway more parents to
vaccinate their children?
Answer 4. Yes, non-injection methods of vaccine delivery are being
evaluated and I do think their availability will help. No parent wants
to see their child suffer pain. We currently have some oral vaccines
and one nasal spray vaccine. If vaccines can be given orally, nasally,
or even through the skin using patch technology then much of the
objection to vaccines would vanish. Perhaps there is a role for the
Federal Government to fund research toward this end.
Question 5. Dr. Jacks shared his story in which his children were
exposed to measles in the hospital. Are there systems in place to limit
immunocompromised patients' exposure to patients with infectious
disease?
Answer 5. Certainly hospitals have systems in place to minimize
exposure to infectious disease. Fortunately there are only a few
infections that literally fly through the air so that you can acquire
infection simply by breathing the air. Measles is one such infection
but most infections require direct contact or at least close exposure
to an infectious person. Doctor's offices may not be as effective as
hospitals in preventing infections from spreading. They often don't
have the luxury of isolation rooms to place potentially contagious
individuals. Efforts could be increased to screen for possibly
infectious patients in doctor's waiting rooms and at least trying to
keep them out of waiting rooms.
Response to Questions of Senator Casey by Kelly L. Moore, M.D., MPH
Question 1. You have described your collaborative immunization
efforts with schools, public health departments, and medical offices.
The program for Women, Infants, and Children (WIC) is one such public
health program that often plays a role in improving immunization rates
of infants and young children through screening and referral. WIC
visits can be particularly influential in boosting MMR immunization
rates because the first dose is given at about 12-15 months of age.
Could you describe how your State's WIC programs help achieve high
immunization rates?
Answer 1. In Tennessee, the WIC offices are co-located with
immunization services at our local health departments. WIC program
staff review immunization records and refer children to the
immunization clinic if they are behind on immunizations. Immunization
and WIC visits can be scheduled at the same time for family
convenience. Regular contact with WIC staff who promote and counsel
parents about immunization helps keep immunization rates high among
infants and toddlers.
Question 2. You mentioned how beneficial your electronic
immunization information system, known as TennIIS, has been in
providing access to immunization records across medical and non-medical
settings. Can you tell us what kinds of steps you've taken to encourage
use of the data base by providers, schools, and daycares?
Answer 2. We promote the use of TennIIS through statewide
professional meetings of pediatricians and family physicians, as well
as with our partners in pharmacies, schools and school nursing. The
Department of Health made its first major effort to introduce
immunization providers to the States immunization information system
(IIS) in preparation for the 2009 H1N1 influenza pandemic vaccination
campaign when we expanded the system to function as a lifelong
immunization registry not limited to children. All immunization
providers who were interested in assisting with national immunization
efforts were required to create a free IIS user account for their
healthcare facility, including outpatient pediatric and adult clinics,
hospitals and pharmacies. Over 5,000 new individual users were added
during that time.
Today, the over 700 clinics participating in the Federal Vaccines
for Children Program (VFC) are required to use TennIIS to manage online
annual enrollment documents and to place vaccine orders. In addition,
any TennIIS user (including pharmacists and school staff) can produce a
simple, complete and accurate Official Immunization Certificate for
children entering daycare or school, based on the child's record in
TennIIS. If the record is incomplete, TennIIS produces a failed
validation report that pinpoints shortcomings in the child's record of
required immunization. This tool, while not mandatory, is so effective
at eliminating errors and saving time for families and clinic staff
that many immunization providers serving children consider TennIIS so
helpful they cannot imagine not participating.
Finally, Tennessee has reaped the benefit of the Center for
Medicaid and Medicare Services (CMS) Meaningful Use grants to
clinicians and hospitals to promote the implementation of interoperable
electronic health record systems (EHRs). As part of that program,
participating facilities that administer any immunizations are required
to submit immunization data to the State IIS through standard messaging
protocols. TennIIS staff are working as quickly as possible to activate
channels between EHRs and TennIIS among participants in the Meaningful
Use program, which will greatly improve the volume of valuable patient
immunization information in our voluntary system.
Response to Questions of Senator Roberts by Mark H. Sawyer, M.D., FAAP
Question. What advice do you give to the parents of kids who cannot
be immunized due to allergies or because they are otherwise
immunocompromised and must rely on others in their community to choose
vaccination to help protect their own?
Answer. Parents of children who cannot be immunized due to allergy
or an immunocompromising condition should try to minimize the exposure
of their children to unimmunized populations. This begins with the
immediate family. Parents should assure that all members of the family
are current on their immunizations including an annual influenza
vaccine. It would also be prudent for such parents to inquire about the
vaccination status of participants in organized group settings such as
daycare or school and when feasible only choose to place their at-risk
child among highly immunized populations. Toward this end, it would be
ideal if daycare facilities and both public and private schools were
required to make their immunization coverage rates readily available.
Response to Questions of Senator Warren by Tim Jacks, M.D., DO, FAAP
Question. Because of smart investments over the last several
decades, we now have a vaccine for HPV that helps to prevent cancer,
and a vaccine for Hepatitis B that can prevent liver cirrhosis and
cancer associated with the virus. We also have vaccines that can
prevent some types of meningitis and pneumonia. We are still
struggling, however, to make sure that everyone has access to all of
the vaccines available. What do you see as the greatest challenges to
getting people of all ages--kids, teens, and seniors--vaccinated?
Answer. While there are numerous hurdles to increasing vaccination
rates, the greatest challenge is educating the public. Many people
don't realize the dangers that these illnesses pose, and they are more
afraid of the prevention (vaccines) than the actual illness.
It has proven challenging to communicate the safety and
effectiveness of vaccines. The Nyhan study (published in Pediatrics,
March 3, 2014), showed that public health communications may not be
effective in reducing misconceptions or increasing vaccine uptake. As a
pediatrician, I have found this to be true. We have limited time to
evaluate a child and educate the parents about vaccines. Many families
are ready to immunize. Some families need just a little nudge to
proceed with vaccinations. For others, it takes repeated discussions
and exposure to the scientific truth behind vaccines before they reach
a decision. A minority of families arrive to my office having already
decided against vaccines due to widely prevalent myths and
misconceptions on the internet and in popular media. Often these
families are not even open to discussing vaccines or their concerns.
Another study, published earlier this month in Pediatrics (March 2,
2015), that found an increasing number of parents asking to delay their
children's vaccinations. The timely prevention and proximate risk of
disease has been lost to these parents. During the recent measles
outbreak, my office saw a great influx of families requesting
vaccinations. Many were immunized. Sadly, we have since seen a decline
in those coming in for catch-up vaccines.
While education is also important in the elderly population, they
face a greater lack of insurance coverage when compared to children.
VFC, section 317, Medicaid and CHIP have helped get large numbers of
children vaccinated, but adults still lag. The mandated coverage of CDC
recommended vaccination through the ACA will help expand coverage.
Response to Questions of Senator Warren by Mark H. Sawyer, M.D., FAAP
Question. Because of smart investments over the last several
decades, we now have a vaccine for HPV that helps to prevent cancer,
and a vaccine for Hepatitis B that can prevent liver cirrhosis and
cancer associated with the virus. We also have vaccines that can
prevent some types of meningitis and pneumonia. We are still
struggling, however, to make sure that everyone has access to all of
the vaccines available. What do you see as the greatest challenges to
getting people of all ages--kids, teens, and seniors--vaccinated?
Answer. Historically, one of the biggest barriers to adequate
immunization in our communities has been insurance coverage for
vaccines. Prior to the Vaccines for Children (VFC) program many
children went unvaccinated because they either didn't have insurance or
because their insurance didn't cover all vaccines. This is no longer a
problem and it is imperative that the VFC program remain supported.
More recently, the Affordable Care Act assured that all vaccines
recommended by CDC would be covered by insurance programs. This has
made a huge difference for adults who are not eligible for VFC vaccine.
It is equally important that this important legislation remain intact
so that vaccines are accessible to all.
Beyond the funding for vaccines the biggest challenge facing us is
the education of the public about the benefits of vaccines and the
maintenance of the infrastructure to assure vaccine safety. In order to
maintain the public's trust, systems such as the joint CDC/FDA Vaccine
Adverse Events Reporting System (VAERS) and the CDC-sponsored Vaccine
Safety Datalink (VSD) program are extremely important for studying any
new vaccine safety concerns that arise.
Finally, we need to raise the science literacy of our communities.
The science curricula of our middle and high schools need to include
education on the immune system, infectious diseases, and immunizations.
We need our next generation of parents to make better decisions about
immunizing their children in order to protect our whole community.
Response to Questions of Senator Warren by Kelly L. Moore, M.D., MPH
Question. Because of smart investments over the last several
decades, we now have a vaccine for HPV that helps to prevent cancer,
and a vaccine for Hepatitis B that can prevent liver cirrhosis and
cancer associated with the virus. We also have vaccines that can
prevent some types of meningitis and pneumonia. We are still
struggling, however, to make sure that everyone has access to all of
the vaccines available. What do you see as the greatest challenges to
getting people of all ages--kids, teens, and seniors--vaccinated?
Answer. The challenges associated with achieving the potential of
vaccines to prevent disease in the United States vary by age group:
Among children, the Vaccines for Children Program (VFC) guarantees
affordable access to eligible children who represent about 50 percent
of all children under 19 years of age. Immunization rates are high
among young children; in some ways, immunization programs have been
victims of our own success. Many young parents are unfamiliar with the
diseases vaccines prevent and have unrealistic perceptions of the risks
of vaccines. Our greatest challenge in this age group is to convince
parents of the safety and essential importance of timely immunization
with all recommended vaccines.
Among teens, parents need to understand that there are important
immunizations needed during the teenage years. In many States, like
ours, preteens are required to obtain the tetanus-diphtheria-pertussis
(Tdap) booster to go to school, which gives us an opportunity to
administer all recommended vaccines at that time; however, our greatest
challenge is vaccination against HPV to prevent cancer associated with
this common virus. There is a misconception that this vaccine should be
given ``just in time'' for sexual activity and that leads many parents
and healthcare providers to put off immunization. We know that it is
more difficult to complete a vaccine series in an older teen. We know
that the vaccine is long-lasting and only works to prevent (not treat)
infection, so it is safe and ideal to give it years before sexual
activity begins. We also know that the HPV vaccine triggers a better
immune response when given to preteens. For these reasons, we are
working to convince healthcare providers and parents of the critical
importance of completing this vaccine on time during the preteen years
to give the next generation of young men and women the best chance at a
lifetime of cancer protection.
Among adults, two major challenges we face are awareness of the
need for vaccines and affordable access to those needed vaccines.
Adults are often unaware of the vaccines recommended for them,
including Tdap, shingles vaccine, influenza and two types of
pneumococcal vaccine. Insurance plans in compliance with the Affordable
Care Act cover all recommended vaccines with no deductible or copay if
administered at an in-network provider location; however, if an in-
network provider does not offer the recommended vaccine, the adult may
have difficulty with access, particularly in rural areas where the
local health department clinic or local pharmacy may not be an in-
network provider. We are working with adult caregivers and pharmacists
to raise awareness about important adult immunizations and to simplify
access for adults to the vaccines they need at convenient times and
locations. Routine documentation of adult immunizations in a State's
immunization information system (IIS) can prevent missed immunizations
and excess immunizations that result from missing records for adults,
just as the IIS helps children. Efforts are underway to encourage adult
immunization providers and pharmacists to participate actively in State
IIS in all States that have lifelong immunization information systems,
as Tennessee does.
[Whereupon, at 11:53 a.m., the hearing was adjourned.]
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