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					Draft Mandates Paper: 09/12/2007


Mandates for adolescent immunizations: Recommendations from the Adolescent Working Group

of the National Vaccines Advisory Committee (working title)



Introduction

Compulsory or mandated vaccinations for school entry are credited with helping the United

States achieve high childhood vaccination coverage rates and subsequently low rates of vaccine-

preventable disease among young children. [Orenstein, 1999; Hinman, 2002] While school

mandates have proven to be a valuable public health tool, they have also generated concern and

debate regarding their ability to balance the public’s health and individual/parental rights. An

increasingly complex immunization schedule and broader focus on vaccinating older age groups

have led most states to adopt at least one school vaccine mandate directed at adolescents (Table

1).



In response to a request by the Assistant Secretary for Health, the Adolescent Working Group of

the National Vaccine Advisory Committee (NVAC) recently assessed issues related to the

development of a comprehensive and successful adolescent immunization program in the United

States. [NVAC, 2007] As part of that assessment, the Working Group identified immunization

mandates as one of the issues requiring national attention. This paper examines the issue of

adolescent vaccination mandates, highlights several points to consider regarding adolescent

mandates, and offers several recommendations to the Assistant Secretary for Health for

jurisdictions considering implementation of an adolescent vaccination mandate (Table 2).



Adolescent Vaccines




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In 1996, to strengthen the delivery of vaccines to adolescents along with other recommended

clinical preventive services, the Advisory Committee on Immunization Practices (ACIP)

recommended a preventive health visit for adolescents aged 11-12 years. [CDC, 1996a] At that

time, the tetanus and diphtheria toxoids (Td) booster was the only vaccine recommended for

routine administration to adolescents; the second dose of measles-containing vaccine, three doses

of the hepatitis B vaccine, and the varicella vaccine were recommended only if an adolescent had

not been vaccinated during childhood (or in the case of varicella vaccine, if an adolescent also

had no reliable history of disease). These catch-up recommendations were also relatively new,

having been added to the recommended schedule in 1989 (Measles-containing vaccine), 1991

(Hepatitis B vaccine), and 1996 (varicella vaccine). [CDC, 1989; CDC, 1991; CDC, 1996b]



Over the following decade, these adolescent vaccine recommendations remained the same;

however since January 2005, three new vaccines have been licensed and recommended for

adolescents: tetanus and diphtheria toxoids and acellular pertussis vaccine (Tdap); tetravalent

meningococcal conjugate vaccine (MCV4); and human papillomavirus vaccine (HPV). The

recommended age range for routinely administering these vaccines is also 11-12 years, and

catch-up vaccination is recommended for previously unvaccinated older adolescents. [CDC,

2007a; CDC, 2006a; CDC, 2005a; CDC, 2007b] Additional vaccines currently in development

will likely be added to the adolescent vaccination schedule in the future.



Vaccine Mandates

In the United States, school mandates for immunization are created and enforced at the state

level, either through legislative or regulatory mechanisms. [Orenstein, 1999] The first vaccine




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mandate in the U. S. was enacted in 1809 and required the general public of Massachusetts to be

vaccinated for smallpox; school mandates for smallpox vaccination appeared several years later

with the recognition that frequent and close contact in the school setting resulted in children

being particularly vulnerable to transmission of the disease. [Hinman, 2002] At the time,

smallpox was the only vaccine-preventable disease; subsequent mandates were added or

expanded as new vaccines were developed. While concerns about the conflict between personal

freedom and the duty of the state to protect the public’s health have always been a part of the

dialogue surrounding vaccine mandates, the constitutionality of vaccine mandates in general

[Jacobson v. Massachusetts, 197 U.S. 11 (1905)], and school entry mandates in particular [Zucht

v. King, 260 U.S. 174 (1922)], has been reaffirmed by the United States Supreme Court.

[Orenstein, 1999]



Regular enforcement of school-based mandates is more recent and is attributed to efforts in the

1970s to control measles transmission, when it was demonstrated that a decrease in measles

incidence in Alaska followed strict enforcement of measles vaccine requirements for

schoolchildren. [Middaugh, 1978; Orenstein, 1999] School mandates for adolescents have also

been associated with increased vaccination coverage levels [Averhoff, 2004; Jacobs, 2004;

Fogarty, 2004; Wilson, 2005; Olshen, 2007]. As of the 2005-2006 school year, mandates for

entry into middle school existed in 21 states for the Td booster, in 47 states for two doses of

measles-containing vaccine, in 33 states for three doses of hepatitis B vaccine, in 24 states for

varicella vaccine, and in one state for the HPV vaccine (Table 1). Legislation that would require

HPV vaccine administration, funding, or education is also currently pending in a majority of

states. [National Conference of State Legislatures, 2007]




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Considerations

Issues to address when considering an adolescent vaccine mandate include: vaccine cost, funding,

supply, safety, and effectiveness; target population, community and school district support,

disease burden and transmission, and existing vaccine exemption policies and

legislation/regulation. Priorities unique to each jurisdiction should also be identified and included

in the decision-making process, and adequate time for planning and implementation of a

proposed mandate is important to ensure that all considerations are fully addressed.



Vaccine costs and funding

It is crucial that there is adequate political will at the state government level to ensure vaccine

financing issues are resolved before a mandate is put into place. In the United States, vaccines

are funded with a combination of federal, state, and private money. For children through 18 years

of age, there are usually five sources of funding: the federally-funded Vaccines for Children

(VFC) program, state budget allocations, federal budget allocations made under Section 317 of

the Public Health Service Act (known as ―Section 317 funds‖), private insurance, and out-of-

pocket spending. It is estimated that approximately 46 percent of U.S. children receive vaccines

funded through the VFC program and an additional 45 percent of children have their vaccines

paid for either through private insurance or out-of-pocket spending; however, vaccine

availability for the remaining nine percent of children is dependent on variable levels of Section

317 funding, appropriated through Congress on a yearly basis, and to state budgets, which can

also vary substantially from one year to the next. [CDC, unpublished data] Inadequate Section

317 funding combined with limited or uncertain state budgets for vaccines result in gaps among




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children and adolescents who either do not meet VFC program eligibility criteria, lack private

insurance, or have parents/guardians with insufficient personal income to pay for all costs

associated with vaccination. [Lee, 2007] Moreover, the addition of each new vaccine, like HPV,

adds further stress to a system that is already strained; some states have reported a limited ability

to provide newer vaccines to underinsured children. [Lee, 2007] NVAC and other experts have

recommended increases in Section 317 funding in order to address this issue. [US Department of

Health and Human Services, 2005]



For adolescents who either have health insurance policies that cover recommended vaccines or

are eligible to receive vaccines through the VFC program, vaccine price may not be an issue;

however, other direct and indirect costs of care may still be barriers. For the remaining

adolescents who cannot receive recommended vaccines through either mechanism, vaccine price

may significantly affect their ability to comply with a vaccination mandate. Adequate provider

reimbursement for vaccine delivery is also needed to ensure healthcare providers’ continued

ability to vaccinate their patients. A state may choose to delay implementing a school mandate

for a vaccine until the necessary funds to purchase and deliver the vaccine are available. It is also

important to note that the initial implementation of a vaccine mandate—including education,

planning, and record keeping—can entail significant costs apart from routine vaccine purchase

and delivery. Such costs should also be considered when discussing new vaccine mandates.



Vaccine supply

Having an adequate supply of vaccine is essential for the successful implementation of any

school mandate. Because many new vaccines are produced by only one or two manufacturers,




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the vaccine supply may be vulnerable to production capacity limitations or disruptions,

especially during initial introduction. For example, the meningococcal conjugate vaccine was

licensed in January 2005 and recommended for adolescents in May 2005. A shortage occurred in

May 2006 which led the ACIP to issue interim recommendations to defer vaccination of children

aged 11 to 12 years for several months. [CDC, 2006b]



Vaccine shortages alone cause confusion and frustration. When such shortages involve vaccines

that have been mandated for school entry, such problems are compounded. It may be necessary

to suspend a mandate when vaccine shortages occur; this affects children, parents, healthcare

providers, and school administrators. Suspended mandates can also create a tremendous amount

of work for school health personnel, since they will likely be responsible for ensuring that the

student population is compliant with the mandate once the vaccine supply becomes adequate.



Vaccine safety and effectiveness

It has been argued that immunizations, which are given to otherwise healthy individuals, carry a

greater ethical burden to prove their safety than therapeutic interventions. [Chen, 1999] Although

newly developed vaccines undergo extensive testing for their safety prior to being licensed by

the Food and Drug Administration, [Jacobson, 2001] the public may be hesitant to receive a

newly licensed vaccine until it has a proven safety record. Because serious adverse events after

vaccination, such as anaphylaxis, are rare, prelicensure clinical trials may not feasibly enroll

enough participants to detect them (e.g., an adverse event that occurs after 1 in one million

vaccinations may require a clinical trial of at least one million people to detect a single case, and

many more than one million to determine with some certainty that an adverse event is associated




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with the vaccine). Clinical trials will also be unable to evaluate the safety of new vaccines in

groups not included in the trial, or the occurrence of delayed adverse events or adverse events in

subpopulations of vaccine recipients. For these reasons, postlicensure safety monitoring among

the larger, general population is an important component of vaccine safety. [Spier, 2004; Tozzi,

2004; Jacobson, 2001] The disadvantage of this approach is that a vaccine may already be in use

among the general public before a serious vaccine-associated adverse event is detected.

[Ellenberg, 2001] One example of this scenario was the withdrawal of the first US-licensed

rotavirus vaccine from the U.S. market in 1999 after its association with intussusception (a rare,

potentially life-threatening form of intestinal obstruction) among vaccine recipients. [CDC, 1999]

If a vaccine is mandated for school entry soon after it is licensed and recommended, and a

serious adverse event is found to be associated with the vaccine, the vaccine’s use (and any

corresponding mandate) may be suspended or discontinued. This may lead to public suspicion of

and opposition to all existing and future vaccine mandates and could also erode confidence in the

overall immunization program. Similarly, while vaccine effectiveness is studied extensively

during clinical trials, long-term studies of vaccine efficacy under actual delivery conditions are

not feasible before licensure. [Hviid, 2006] A longer interval between licensure and mandate

would also allow for studies of postlicensure vaccine effectiveness in the general population,

which could in turn strengthen public confidence in the utility of recommended vaccines.



Target population

Understanding the target population for receipt of a vaccine will help guide policymakers to

determine which students should be included in a school mandate. For example, a vaccine

recommended for 11 and 12 year olds would call for a mandate for entry into 6th or 7th grade. If




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there are catch-up recommendations for older populations, which is typical for newly licensed

vaccines, a state may want to implement a mandate that affects a wider school population (e.g.

6th – 12th grade) so that more students can benefit from the new vaccine. However,

implementation may not be feasible on this large a scale. When a new mandate is being

considered, data on current vaccine coverage levels in the target population can be used to assess

the scope of implementation efforts needed to achieve desired public health outcomes.



A potential source of controversy may occur when a mandate is directed at only a segment of the

student population. For example, the HPV vaccine is currently only licensed for females,

although it may be licensed for males in the future. A vaccine mandate directed specifically at

female students might have to go through the legislative or regulatory process a second time if

the vaccine were later recommended for male students as well. Some policymakers may also find

a school mandate directed toward females discriminatory in nature and may prefer not to enact a

mandate until it can be implemented among the entire target population.



Community and school district support

Support from the community and school system is important to the successful implementation of

a vaccine mandate. Since schools are involved in enforcement, it is essential that they support the

mandate and are willing and able to accept the workload increase that the new mandate may

create. Schools will also incur the associated administrative costs related to tracking and

enforcement of compliance with the mandate, and it is unclear how or if those costs would be

covered by the state. This would occur in the context of the many competing priorities that

schools face with ever-shrinking resources, and could lead to resentment of future unfunded




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vaccine mandates. Likewise, parent support for a new vaccine is important both for the

implementation of a new mandate and for the continued success of the overall immunization

program. For example, recent studies of parents, adolescents, and healthcare providers have

demonstrated variable support for the HPV vaccine; however, concerns have also been raised

about vaccinating younger adolescents and mandating a vaccine for school entry when the

disease is not transmitted through casual contact. [Kahn, 2003; Mays, 2004; Boehner, 2005;

Kahn, 2005; Zimet, 2005; Colgrove, 2006]



Disease burden and transmission

Disease burden is an important factor to consider in developing vaccine mandates. This includes

both the likelihood of disease exposure and the potential morbidity and mortality associated with

infection. While the incidence of many vaccine-preventable diseases has been dramatically

reduced due to high vaccination coverage levels, persons in the U.S. may still be exposed; for

instance, importation of measles disease is possible through international travel of unvaccinated

individuals. [CDC, 2006d] Other vaccine-preventable diseases, such as pertussis, are still

endemic in the United States. [CDC, 2006a]



The mode of disease transmissibility should also be considered when discussing vaccine

mandates. Early school mandates, such as those for smallpox or measles vaccines, were passed

on the rationale that they prevent diseases that are highly contagious in the school setting and

cause a high level of absenteeism among the student population. Some argue that Hepatitis B

vaccine mandates were an exception; however, transmission of Hepatitis B is possible in the

school setting. [CDC, 2006c]




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One of the new vaccines currently recommended for adolescents (quadrivalent HPV vaccine)

prevents infection that is not transmitted through casual contact in the classroom. Although the

HPV vaccine is expected to have tremendous impact on improving adolescent, and ultimately

adult health, when or if it should be mandated is controversial. However, it is of note that a

recent analysis of outpatient healthcare visits by U.S. adolescents aged 11-21 years from 1994-

2003 found that only nine percent of those visits were for preventive care. [Rand, 2007] Given

this low use of preventive care, mandates may still be helpful in facilitating vaccination coverage

in adolescents, even for diseases that are not easily transmitted through casual contact, by acting

as an incentive for adolescents to seek primary care.



Exemption policies and existing legislation/regulation

As of March 2006, all states permitted medical exemptions to school immunization requirements.

In addition, 48 states allowed religious exemptions and 19 states had a provision for personal

belief exemptions. [Omer, 2006] Personal belief exemptions include religious, philosophical and

any other unspecified non-medical exemptions. Personal belief exemptions provide the option

for parents/guardians to opt out of vaccination for children if vaccination conflicts with their

religious or personal beliefs. While personal belief exemptions may be viewed as an important

protection of individual rights, such exemptions can result in an increased risk of disease for

unimmunized individuals and their communities. [Feikin, 2000; Salmon, 1999]



Past research has demonstrated that the ease of obtaining a personal belief exemption is

associated with the rate of exemptions taken by parents; in other words, some parents may file




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exemptions because they are more convenient than completing the immunization schedule. [Rota,

2001] Likewise, objection to a specific vaccine (as opposed to the process of vaccination in

general) may lead parents to file an exemption, creating a ―culture of refusal‖ in which

exemptions to school mandates become increasingly common. One proposed solution is an

informed refusal process that includes parent education and annual renewal. [Salmon, 2005]

This can help reduce the likelihood that parents will file exemptions solely for convenience,

especially as new recommendations and mandates make the immunization schedule more

complex and costly.



Summary: NVAC Adolescent Working Group Recommendations Regarding State Vaccine

Mandates

In light of the considerations outlined above, NVAC recommends that the Assistant Secretary for

Health encourage jurisdictions considering adolescent immunization mandates to:



Secure Partnerships: Secure the input and partnership of state and local immunization program

personnel and adolescent healthcare providers in drafting legislation/regulation regarding

mandating adolescent vaccines. Work closely with school administrators and school health

personnel to ensure that potential school-level administrative and enforcement burdens are

minimized.



Address Infrastructure and Financing: Use the expert input of partners to address

infrastructure issues that may impact the implementation of an adolescent vaccine mandate.

These include such issues as: vaccine purchasing, supply, storage, safety profile, uptake, and




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target population. Identify and plan for all direct and indirect costs of vaccine administration,

including adequate provider reimbursement and costs associated with implementing a new

mandate, to ensure equitable access to mandated vaccines.



Be Consistent with Existing Policies: Look for ways to incorporate new mandates as

seamlessly as possible into existing vaccine legislation/regulation, and ensure that new mandates

do not contradict existing legislation/regulation in areas such as reporting of coverage levels,

penalties for non-compliance (e.g., being held out of school), and immunization information

system reporting requirements. Consistency with existing policies may also minimize vaccine-

specific or convenience exemptions when a new vaccine is introduced.



Seek Support: Ensure that adequate political and public support exists before incorporating an

adolescent vaccine mandate into existing state legislation/regulation. Education of parents and

healthcare providers on vaccines, vaccine-preventable diseases, and mandates is encouraged to

secure public understanding and support, increase voluntary uptake, and to minimize the

administrative burden on school health personnel.



After ACIP recommendations are made, policymakers should allow for an adequate time to

address the above considerations prior to determining whether or not to create and implement a

mandate for any vaccine. As recommended by the Association of Immunization Managers

(AIM), this implementation period would allow policymakers to consider and address critical

elements related to vaccine introduction as well as seek the input of state and local health

department personnel, thereby improving a school mandate’s potential effectiveness in




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increasing vaccination coverage. [AIM, 2006] The Washington State Board of Health has also

developed guidelines for the adoption of state vaccine mandates, in an effort to outline locally-

relevant criteria that can be applied by decision makers as new vaccines are licensed.

[Washington State Board of Health, 2006] These criteria include, among others, review of

vaccine effectiveness, disease burden, and implementation issues. Thorough consideration of

such issues before moving forward with a school mandate will help ensure that the full public

health benefit of vaccines recommended for adolescents is realized and that the U.S.

immunization program is strengthened overall.




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Centers for Disease Control and Prevention. Withdrawal of rotavirus vaccine recommendation.
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2006a;55(No. RR-3):1-43.




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Centers for Disease Control and Prevention. Notice to Readers: Limited supply of
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Chen RT. Vaccine risks: Real, perceived, and unknown. Vaccine. 1999;17(S3):S41-S46.

Colgrove J. The ethics and politics of compulsory HPV vaccination. New England Journal of
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Ellenberg SS. Evaluating the safety of combination vaccines. Clinical Infectious Diseases.
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Feikin DR, Lezotte DC, Hamman RF, Salmon DA, Chen RT, Hoffman RE. Individual and
community risks of measles and pertussis associated with personal exemptions to immunization.
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Fogarty KJ, Massoudi MS, Gallo W, Averhoff FM, Yusuf H, Fishbein D. Vaccine coverage
levels after implementation of a middle school vaccination requirement, Florida, 1997-2000.
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Hinman AR, Orenstein WA, Williamson DE, Darrington D. Childhood immunization: Laws that
work. The Journal of Law, Medicine, & Ethics. 2002;30(S3):122-127.

Hviid A. Postlicensure epidemiology of childhood vaccination: The Danish experience. Expert
Review of Vaccines. 2006;5(5):641-649.

Jacobs RJ, Meyerhoff AS. Effect of middle school entry requirements on hepatitis B vaccination
coverage. Journal of Adolescent Health. 2004;34(5):420-423.

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19):2428-2433.



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Kahn JA, Rosenthal SL, Hamann T, Bernstein TI. Attitudes about human papillomavirus vaccine
in young women. International Journal of STD & AIDS. 2003;14(5):300-6.

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financing for underinsured children in the United States. JAMA. 2007;298(6):638-643.

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exemptions to school immunization requirements: Secular trends and association of state policies
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Table 1. Vaccination mandates for middle school entry1, United States, 2005-2006.

       State        Td2     Hepatitis B        Measles         Varicella    MCV43    HPV4

                   (n=21)      (n=33)      (2nd dose; n=47)      (n=24)      (n=0)   (n=1)

Alabama              X                             X

Alaska               X             X               X

Arizona              X             X               X               X

Arkansas                           X               X               X

California                         X               X               X

Colorado                           X               X

Connecticut                        X               X               X

Delaware                           X               X

Florida              X             X               X

Georgia                            X               X               X

Hawaii                             X               X               X

Idaho                              X               X

Illinois             X             X               X

Indiana                                            X               X

Iowa                               X               X

Kansas               X                             X

Kentucky             X             X               X

Louisiana            X             X               X               X

Maine                                              X               X

Maryland                                           X



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Massachusetts       X              X         X   X

Michigan            X              X         X   X

Minnesota           X              X         X   X

Mississippi

Missouri            X              X         X

Montana             X                        X

Nebraska                           X         X   X

Nevada              X              X         X   X

New Hampshire       X              X         X   X

New Jersey                         X

New Mexico          X              X         X

New York                           X         X   X

North Carolina

North Dakota                                 X

Ohio                                         X

Oklahoma                           X         X   X

Oregon                             X         X   X

Pennsylvania                       X         X   X

Rhode Island        X              X         X   X

South Carolina                     X         X

South Dakota                                 X

Tennessee                          X         X

Texas               X              X         X   X



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Utah                 X                             X               X

Vermont              X             X               X

Virginia                           X               X                                       X

Washington                         X               X               X

West Virginia                                      X

Wisconsin                          X               X               X

Wyoming              X             X               X
1
  An X indicates a mandate as of the 2005-2006 school year. (Source: CDC.
http://www2.cdc.gov/nip/schoolsurv/immunizationrqmts.htm, accessed June 29, 2007).
2
  Td=Tetanus and diphtheria vaccine; As of the 2005-2006 school year, no states required
tetanus-diphtheria-acellular pertussis vaccine (Tdap) for middle school entry.
3
  MCV4=tetravalent meningococcal conjugate vaccine.
4
  HPV=human papillomavirus vaccine (Source: National Conference of State Legislatures.
http://www.ncsl.org/programs/health/HPVvaccine.htm#hpvlegis, accessed June 29, 2007).




                                           Page 20
Draft Mandates Paper: 09/12/2007


Table 2. Summary of NVAC Adolescent Working Group Recommendations Regarding State

Vaccine Mandates.


NVAC recommends that the Assistant Secretary for Health encourage jurisdictions considering
adolescent immunization mandates to:

Secure Partnership: Secure the input and partnership of state and local immunization program
personnel and adolescent healthcare providers in drafting legislation/regulation regarding
mandating adolescent vaccines. Work closely with school administrators and school health
personnel to ensure that potential school-level administrative and enforcement burdens are
minimized.

Address Infrastructure and Financing: Use the expert input of partners to address
infrastructure issues that may impact the implementation of an adolescent vaccine mandate.
These include such issues as: vaccine purchasing, supply, storage, safety profile, uptake, and
target population. Identify and plan for all direct and indirect costs of vaccine administration,
including adequate provider reimbursement and costs associated with implementing a new
mandate, to ensure equitable access to mandated vaccines.

Be Consistent with Existing Policies: Look for ways to incorporate new mandates as
seamlessly as possible into existing vaccine legislation/regulation, and ensure that new mandates
do not contradict existing legislation/regulation in areas such as reporting of coverage levels,
penalties for non-compliance (e.g., being held out of school), and immunization information
system reporting requirements. Consistency with existing policies may also minimize vaccine-
specific or convenience exemptions when a new vaccine is introduced.

Seek Support: Ensure that adequate political and public support exists before incorporating an
adolescent vaccine mandate into existing state legislation/regulation. Education of parents and
healthcare providers on vaccines, vaccine-preventable diseases, and mandates is encouraged to
secure public understanding and support, increase voluntary uptake, and to minimize the
administrative burden on school health personnel.




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