**The Promise and Challenge of Adolescent Immunization**

Adolescent Working Group of the

National Vaccine Advisory Committee

Manuscript word count: 3,114

Corresponding Author:

> Gary L. Freed, MD, MPH
>
> University of Michigan
>
> 300 North Ingalls Building, 6E08
>
> Ann Arbor, MI 48109-0456
>
> Office: (734) 615-0616
>
> Fax: (734) 764-2599

e-mail:<gfreed@med.umich.edu>

The National Vaccine Advisory Committee (NVAC) created a working group
to address issues related to adolescent immunization. In response to a
request from the Assistant Secretary for Health, this Working Group
conducted an assessment of the current landscape of adolescent
immunization and identified issues that will require national attention
in the coming months and years if current and future recommended
adolescent immunizations will be used to their potential. Following
identification and the achievement of a national consensus on the issues
to be addressed, the NVAC, through its Adolescent Working Group, will
receive input from a variety of stakeholders to develop policy
recommendations to address these issues.

There is now a unique and important opportunity through immunization to
reduce morbidity and save lives of adolescents in the United States.
Adolescents hold the promise of a productive and satisfying adulthood,
but this promise may be threatened by a variety of preventable health
conditions. Several health issues are of national concern for the
adolescent population, including obesity and substance abuse. However,
many of these problems are frustrating because there are no clear and
effective actions which, if implemented, can impact virtually the entire
age group. Conversely, vaccine preventable diseases are unique in that
they are both serious *and* readily preventable.

Our country has a long history of using immunizations to protect
individuals and populations at both ends of the age spectrum, but little
experience between those ranges. Now, several new vaccines have created
an imperative to reach the adolescent population and to protect them
against a group of significant -- but eminently preventable -- diseases,
thereby increasing the chance of our youth to enjoy long and productive
lives. However, to achieve the promise of these new preventive health
interventions our nation must focus on effective vaccine delivery to
this population.

Specifically, three new vaccines are now available and recommended for
adolescents that prevent a total of 5 diseases that can have a range of
devastating health consequences.^1^ Individual vaccines protect against
meningococcal meningitis and human papilloma virus and a combined
vaccine protects against tetanus, diphtheria and pertussis. All three
vaccines have been shown to be safe and effective.

**THE DISEASES NOW PREVENTABLE THROUGH ADOLESCENT IMMUNIZATION**

**[Meningococcal Vaccine]{.underline}**

Meningococcal disease is a bacterial infection that is a leading cause
of meningitis among children 2 -- 18 years of age in the United States
and a cause of severe and devastating sepsis.^2^ Of the 1,400-2,800
individuals in the U.S. who contract meningococcal disease each year,
10-14% will die despite aggressive treatment. Of those who survive,
debilitating side effects are common, including loss of limbs, deafness,
mental retardation, seizure disorders, and strokes. The meningococcal
conjugate vaccine was licensed in 2005 and is recommended for all
children at their routine recommended early adolescent visit (11-12
years of age) as well as those entering high school and for college
freshmen living in dormitories. ^3,4^

**[Human Papilloma Virus Vaccine]{.underline}**

In 2003, more than 11,000 women were diagnosed with, and almost 4,000
women died from, cervical cancer in the United States each year. The
overall incidence of cervical cancer was 8.1 per 100,000 women. Almost
all cervical cancers are caused by the human papillomavirus.^5^ The
recently licensed HPV vaccine was shown in clinical trials to provide
close to 100% protection against cervical cancer precursor lesions due
to the two types of human papillomavirus (types 16 and 18) that cause
70% of cervical cancer as well as genital warts due to two types (6 and
11) that cause 90% of genital warts. The vaccine is recommended to be
given to 11-12 year old adolescent girls in a three-dose series over six
months. Previously unvaccinated females 13-26 years of age are also
recommended to receive this vaccine.^5^

**[Tdap Vaccine]{.underline}**

The combined Tdap vaccine protects against tetanus, diphtheria and
pertussis.^6^ Despite substantial success in vaccinating infants against
these diseases, coverage is not complete, and protection against
pertussis appears to wane after 5 -- 10 years. Consequently, a large
proportion of reported cases of pertussis in the United States are now
found in the adolescent age group, and many outbreaks occur in school
settings where adolescents congregate. Further, adolescents are now a
reservoir of disease which can infect infants. A large proportion (38%)
of adolescents in Massachusetts with pertussis reported prolonged
coughing of at least one month at the time of diagnosis, resulting in
multiple health care visits as well as school absenteeism.^6^ In 2006,
the Advisory Committee on Immunization Practices (ACIP) recommended that
*"*adolescents aged 11-18 years should receive a single dose of Tdap
instead of tetanus and diphtheria toxoids vaccine (Td) for booster
immunization against tetanus, diphtheria, and pertussis."^6^ The
preferred age for receiving the vaccine is 11-12 years.^7^

**A NEW ERA IN ADOLESCENT IMMUNIZATION**

Understanding and acting upon the imperative of ensuring that these new
vaccines as well as the previously recommended vaccines are administered
to the adolescent population requires a paradigm shift on the part of
health care providers, policy makers, and parents alike. Historically,
vaccination has been framed as an intervention for young children, while
behavioral health challenges like nutrition and sexual behavior are
illustrative of key issues that compromise adolescent health. Indeed,
vaccinations for young children *are* important. And the behavioral
health challenges that face adolescents *are* critical. But at the same
time, there are now immunizations that can prevent serious and
life-threatening diseases among adolescents.

*The ability to effectively prevent significant morbidity and potential
mortality, especially among a population that constitutes our Nation's
future, creates an imperative to make adolescent vaccination a national
health priority.*

***Adolescent Health Care Utilization***

Ensuring that there exists an effective means of delivering these
vaccines is a necessary precursor for high vaccine coverage rates.
Unfortunately, unlike infants, the delivery of preventive care for
adolescents is more complex. The imperative to provide and promote
adolescent vaccination will require the support of an infrastructure for
this to be accomplished effectively and at a reasonable cost.

The unfortunate reality is that fewer adolescents, compared with other
pediatric age groups, access the medical system for preventive care,
either in public or private delivery venues. When they do access the
health care system, it is most often for acute care.^8^ If the U.S. is
to achieve high rates of vaccine coverage for adolescents, there will
need to be a system that meets their needs and fits their patterns of
behavior.

Currently, the utilization of the existing private or public health
preventive care infrastructure to achieve high vaccination coverage
rates for these new vaccines among adolescents is woefully inadequate.
Adolescents access a patchwork of sites and services for health
information and health care; in fact, research to date is mixed on the
extent to which adolescents get health care -- particularly preventive
care - at all. Recent analyses of national data suggest that over 30% of
adolescents receive no health care in a 12 month period.^9^ Although
more than 50% do have some type of visit to a primary care provider, the
probability of having a primary care visit in a given year declines
substantially with increasing age.^8^ A study of medical records from
Harvard Pilgrim Health Care, demonstrated that most visits by
adolescents (73%) were for acute, not preventive care. Within this
insured population, all with assigned primary care providers, 33% of 11
year olds had no preventive care visits in any given year. This number
increased to 44% for those 17 years of age. Even fewer adolescents have
the three health visits required to complete the HPV vaccine series.^10^
Thus, even in a "best case" scenario of insured children in a
well-organized health care delivery system, with assigned primary care
providers, preventive care is markedly underutilized and not
sufficiently organized to reach desired immunization rates.

Other research has shown that adolescents self-report a much higher rate
of preventive visits in a given year. ^11^ However, this finding is not
supported by billing data from the Health Plan Employer Data Information
Set (HEDIS), in which a study demonstrated that only 34% of adolescents
had a preventive visit over a 12-month period.^12^ This apparent
contradiction may be the result of adolescents erroneously perceiving
health care visits in general to be preventive when many of them are, in
fact addressing specific health concerns. Another possibility is that
physicians may be providing preventive services but coding the visit for
something other than well care when preventive care is not covered by
insurance. Regardless, it appears likely that adolescents overestimate
their own use of preventive care.

Adolescents do, however, identify unmet needs in their own health care
use; in the National Longitudinal Study of Adolescent Health, almost 20%
reported that there was a time in the past year when they thought they
should obtain medical care, but did not.^13^ Bringing adolescents into
the health care system by promoting vaccinations could be thought of as
a an invitation that brings them into the system for other important
health and health care messages and activities, including important
advice and screening as they transition into adulthood.

***New Ideas for Old Problems***

The issues surrounding adolescent immunization compel our nation to
consider new ways of looking at old problems. Although adolescents have
long not utilized preventive health care, it is now even more important
they do so. This results in the need to raise new issues that warrant
public debate including the identification of where fiscal and
programmatic responsibility lies within the government (e.g., local,
state, federal) and the private sector to achieve preventive health
goals for this age group. Further, levels of responsibility for
adolescent immunization across and among diverse entities (i.e., public
health and educational systems) must be considered.

In order to create a system for adolescent immunization, we have to
assess the motivation and obstacles for participation across potential
settings, identify real and potential logistical issues, and assess
funding constraints and solutions. It is likely that unprecedented
collaborative efforts and creative approaches may be necessary to
achieve recommended vaccination rates among the adolescent population.

**ISSUES TO ADDRESS**

There are several unique issues that challenge the U.S. health care
system to fully vaccinate the adolescent population. These challenges
must be acknowledged, evaluated and discussed openly if our nation is to
create an accessible and effective network for adolescent vaccination.
Among those topics with unique applications to adolescent immunization
are venues for vaccine administration, consent for immunizations,
communication, financing, surveillance, and the potential for school
mandates.

***Venue***

There exist limited entry points used regularly by adolescents to enter
the health care system. Helping adolescents move into a system of care
would require both increasing utilization at the entry points that do
exist and also creating new, and more easily accessible entry points --
some of which will necessarily fall outside of what we typically
consider the traditional health care system.

Although physician offices can provide vaccines to a significant portion
of adolescents, without a significant change in health care seeking
behavior patterns and greater attention being paid to missed
opportunities for immunization in this age group, other venues must be
considered to reach national immunization goals and assure maximum
protection.

The question therefore arises as to what aspect of the health care
community best serves to identify, capture and provide service to
adolescents. Certainly, vaccinations have long been the purview of the
primary care physician. However, in the case of adolescents' health care
utilization patterns, this venue may actually not be the ideal location
for all adolescents. Additional health care settings likely to provide
additional access include pharmacies, family planning and sexually
transmitted infection clinics, obstetrician-gynecologist offices,
emergency departments, teen clinics and health departments. Each venue
must be evaluated to assess its potential in both attracting critical
numbers of adolescents as well as supporting the necessary
infrastructure for their immunization with all recommended vaccines for
this age group. However, these sites will not replace the role of the
primary care physician in the delivery of comprehensive preventive care.

When considering locations where adolescents congregate and may be
available to receive health care, schools are frequently cited as an
obvious locale. Vaccinating adolescents in schools has a number of
obvious challenges (e.g., organization, financing) that warrant
substantial study and consideration over whether this is a potential
"best" venue. Therefore, the advantages and disadvantages of
school-based vaccinations for adolescents have to be assessed
empirically and fully.

Likely none of these potential venues, by itself, attracts a significant
enough proportion of adolescents on which to base a population-wide
strategy. Public discourse is also needed to consider the public and
private investment required to explore approaches to improving
access/availability and perhaps most importantly, to create the
productive collaborations without which a move toward achieving full
adolescent vaccine coverage cannot succeed.

***Consent***

The ability of adolescents to consent for health care -- including
vaccinations -- differs substantially by state and by health
condition.^14^ This variability could have a significant impact on our
nation's ability to achieve immunization coverage in this age group.
Therefore significant and potentially controversial issues arise upon
making a vaccination available to adolescents -- especially in
nontraditional settings. For example, some states may allow adolescents
to consent to receive their own vaccinations, but others may not.
Although consent requirements are the purview of states, there may be
utility in the provision of a federal template for recommendations on
the issue. It is also possible that in some states new vaccines which
protect against sexually transmitted diseases may have different consent
status than other vaccines, as does treatment for sexually transmitted
infections. A review and examination of consent laws as they exist and
pertain to adolescent vaccines in the context of creating the
infrastructure necessary to achieve high levels of adolescent
vaccination must be conducted.

***Communication Specific to Adolescents***

A new approach to communication and new communications materials is
necessary to ensure that the public, providers, parents and the
adolescents themselves understand the need and the appropriate timing of
these vaccinations. In the infant and childhood vaccine setting,
education and information are geared toward parents. However, if
adolescents are receiving care with or without parental involvement,
information must be focused on the adolescents themselves in addition to
parents and providers. Knowledge about reaching adolescents should be
garnered from other health and health care areas and brought to bear on
vaccine issues. Convincing adolescents and young adults to engage in
preventive behaviors is difficult. It is unknown whether the need for an
injection will be even more challenging to disseminate than other
messages. Current policies and programs have not been successful in
immunizing a significant portion of adolescents with the previously
recommended tetanus booster. Especially in the case of those vaccines
against STIs, it will be critical to ensure that adolescents understand
the limitations of the vaccines and continue to protect themselves in
other ways.

***Financing***

Financing issues regarding adolescent immunization are unique in two
specific areas, the cost of adolescent vaccines, and the rate of
insurance coverage for adolescents.

These new vaccines for adolescents are among the most expensive vaccines
recommended today for any age group. Their aggregate estimated price in
the private sector is approximately \$500. As such, their inclusion in
the recommended immunization series has the potential to put a
significant strain on both the public and private financing sectors.
These costs, when combined with the fact that fewer adolescents have
insurance coverage (public or private) for preventive services than
other children must be addressed if we as a nation hope to realize the
promise of these vaccines. ^15,16^ Otherwise, the financial barriers for
adolescents themselves, as well as the providers who may also incur
significant financial burden associated with these vaccines, may impede
implementation of these recommendations.

In the public sector, a smaller proportion of adolescents, compared with
infants, are eligible for the federal Vaccines For Children program.
Thus, greater strain on state budgets will likely result if these
recommendations are to be fully implemented.

***Surveillance***

Experts worldwide recognize surveillance as important to effective
implementation and evaluation of public health programs.^17-20^ U.S.
surveillance systems have constrained capacity to yield data related to
disease burden, vaccination coverage, and vaccination impact among
adolescents. For example, while data pertaining to adolescents will be
collected through the National Immunization Survey for the 4^th^
quarters of 2006 and 2007, these data will not be state-specific.
Furthermore, there is no funding source for future, more comprehensive
surveillance critical to guiding program planning and

policy.

Well-defined national vaccination coverage targets are needed for
adolescents. A limited number of goals for coverage among adolescents
aged 13-15 years were included in the *Healthy People 2010.*^21^
However, future goals should be defined clearly.

For surveillance systems to work, many healthcare providers delivering
immunizations to adolescents in communities and other settings (e.g.,
military, corrections facilities, colleges) will require education
regarding the importance of disease reporting, adverse event reporting,
and participating in immunization information systems (IIS). In turn,
most states need to strengthen these systems and healthcare quality
measures linked to IIS warrant consideration.

***School Mandates***

School entry requirements, or mandates, have proven to be an effective
mechanism to raise immunization rates among children in the U.S.^22-24^
These new adolescent vaccines raise the issue as to whether such laws
should be considered as part of a strategy for achieving high
immunization rates. As school entry requirements are under the purview
of individual states, there is no federal legislative role in this
process. However, states have relied on guidance from specific federal
agencies regarding such requirements in the past. Because some of these
new vaccines differ from older vaccines with regard to the nature of
transmission of the disease they prevent, they raise novel legal and
policy issues that must be addressed to determine if a school mandate
strategy should be implemented.

**MOVING FORWARD**

The National Vaccine Advisory Committee will move forward expeditiously
to develop recommendations for the nation to address the most acute
issues regarding adolescent immunization as outlined in this problem
statement. (Table 1)

Our nation is in a new position regarding the health care of
adolescents. With increasing challenges to their health, including
obesity, diabetes, sexually transmitted diseases and poor mental health,
adolescents are vulnerable as they grow into adults. With three new
vaccines available to combat five serious diseases there is an
opportunity to prevent these specific illnesses, help adolescents
increase their health care access and to support their growth and
development to productive adults. There is also unique opportunity to
establish a culture of immunization among adolescents that may lead them
to pursue immunization as adults as well as eventually for their own
children in greater numbers. Now, our nation must find the ways to
ensure the promise of these new preventive measures are fulfilled. Some
of these issues raised will require additional information to determine
the best course of action. For the future of our nation, the time to
begin this process is now.

References:

1.  Centers for Disease Control and Prevention website: Vaccines and
    Immunizations, accessed July 13, 2006, available at:
    http://www.cdc.gov/node.do/id/0900f3ec8000e2f3

2.  Centers for Disease Control and Prevention. Meningococcal Disease
    and Meningococcal Vaccines Fact Sheet, April 2005. Accessed July 13,
    2006, available at:
    http://www.cdc.gov/nip/vaccine/mening/mening_fs.htm

3.  Bilukha OO, Rosenstein N, National Center for Infectious Diseases,
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4.  American Academy of Pediatrics Committee on Infectious Diseases.
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10. Lee G, personal communication, July 10, 2006.

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12. McInerny TK, Cull WL, Yudkowsky BK. Physician reimbursement levels
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Table 1.

**[The Most Acute Issues Facing Successful Adolescent
Immunization]{.underline}**

1.  Modifications in the adolescent health care infrastructure to
    support the additional needs generated by new vaccines.

2.  Development of additional venues to supplement the current
    adolescent healthcare infrastructure for immunization.

3.  Standardization and clarification of consent laws for the
    administration of vaccinations to minors.

4.  Creation of novel communication strategies to facilitate information
    dissemination to the parents, guardians and the adolescents
    themselves on the importance of immunization.

5.  Generation of financial strategies for the public and private sector
    to make administration of immunizations to adolescents financially
    viable to patients and providers.

6.  Development of long-term surveillance strategies to assess disease
    burden, vaccination coverage, and vaccine impact among adolescents.