Vaccines are among the most cost-effective interventions ever developed and have saved lives of countless children.1 New vaccines are available that can prevent an ever-expanding number of infectious diseases, and some can even prevent chronic diseases and cancers.2,3 However, public health practice is still challenged by vaccine-preventable diseases once thought to be conquered, an increasingly crowded and complex recommended immunization schedule,4 increased quality assurance responsibilities, and shrinking budgets and workforces.

In March 2007, the National Association of County and City Health Officials partnered with the Robert Wood Johnson Foundation and the University of Michigan Center for Law, Ethics, and Health to host a workshop on ethics in public health practice. This workshop was particularly timely, given the events that have started to evolve for local health departments (LHDs) about immunizations. In the past few years, the Advisory Committee on Immunization Practices (ACIP) has recommended multiple new vaccines targeted toward adolescents, including human papillomavirus (HPV) vaccine and tetanus, diphtheria, and acellular pertussis (Tdap) vaccine, and recently decided in February 2008 to expand annual influenza vaccination to include all children aged 6 months to 18 years beginning in the 2009-2010 influenza season.5

In addition to targeting adolescent students, who are less likely to have a medical home*, some of the more recently licensed vaccines prevent diseases that are perceived by the public and some healthcare providers to cause less morbidity and mortality than older scourges such as measles, polio, or Haemophilus influenzae type b (Hib) meningitis. Nonetheless, to achieve the maximum individual and societal benefit from newer vaccines for school-aged children and adolescents, strategies are needed to optimize vaccine coverage in this population. In this context, issues of law, ethics, and health are particularly relevant to the topic of mandated vaccination.

Willie Sutton famously said that he robbed banks because "that's where the money is."⁶ This line of reasoning may extend to expanding school mandates as well. Although many public health practitioners would agree that it would be optimal to consolidate healthcare, including immunizations, within a medical home, figuring out a way to reach all of the children who fall under these new recommendations is a particularly daunting challenge. LHDs' immunization programs may look to schools as venues for immunization services-because that is where the children and adolescents are.

However, parental objections to recommended vaccines and especially to immunization-related school-entry mandates highlight the fundamental ethical dilemmas inherent in many public health initiatives: the often-conflicting values of seeking better population-wide health outcomes and preserving individual liberties and rights. To provide a snapshot of where these issues are in the country and how some jurisdictions are dealing with them, two relevant examples from LHDs are highlighted.

Seattle King County, Washington

In Washington State, criteria have been developed for use by the board of health to determine which vaccines should be required for childcare center or school entry.7 To prevent undue infringement on individual liberty, vaccine mandates are considered justifiable when, without them, an individual's decision could place others' health in jeopardy; the state's economic interests could be threatened both by the costs of care for vaccine-preventable illness, related disability, or death and by the cost of managing vaccine-preventable disease outbreaks; or the state's duty of educating children could be compromised.

The criteria assume that a process exists for exemption from mandated immunization requirements in cases when vaccination is not appropriate (eg, for medical, religious, or philosophical reasons) and that mandated vaccines are accessible to those for whom it is mandated and cost is not a barrier (Washington is a universal access state). The criteria address vaccine effectiveness (criteria 1-4), disease burden (criteria 5 and 6), and implementation (criteria 7-9). These criteria are as follows:

1. A vaccine containing this antigen is recommended by the ACIP and included on its recommended childhood immunization schedule.

2. The antigen is effective (in terms of immunogenicity and population-based prevention).

3. The vaccine containing this antigen is cost-effective (from a societal perspective).

4. Experience to date with the vaccine containing this antigen indicates that it is safe and has an acceptable level of adverse events.

5. The vaccine containing this antigen prevents diseases with significant morbidity or mortality implications (in some subset of the population).

6. Vaccinating the child with this antigen reduces the risk of person-to-person transmission.

7. The vaccine containing this antigen is acceptable to the medical community and enjoys a high degree of public trust.

8. The administrative burdens of delivery and tracking of vaccines containing this antigen are reasonable.

9. The burden of compliance for the vaccine containing this antigen is reasonable for the parent/caregiver.

Currently, school children in Washington State are required to be immunized against hepatitis B virus, measles-mumps-rubella, Tdap, polio, and varicella; preschoolers are also required to be immunized against Hib disease.

With respect to the newly recommended HPV and influenza vaccines, the criteria related to cost-effectiveness, implementation, and, possibly, disease burden would likely generate considerable debate in any discussion of potential mandates.

Milwaukee, Wisconsin

In the 2005-2006 school year, only 45 percent of K-12 students in Milwaukee Public Schools (MPS) were up to date on their legally mandated immunizations in comparison with 89 percent statewide. Through a combination of school-based vaccination clinics and records reconciliation (between the MPS student database and the Wisconsin Immunization Registry), the 2007-2008 MPS figure has risen to nearly 70 percent. The City of Milwaukee Health Department (MHD) has a collaborative relationship with MPS and the district attorney's office to enforce school mandates, and this has strongly contributed to recent rate improvements. Nonetheless, the MHD does not automatically support every proposal to mandate additional vaccines.

The MHD has an active presence on the Wisconsin Council for Immunization Practices (WCIP), the body that makes vaccine mandate recommendations to the state health department. The MHD makes its recommendations to the WCIP on the basis of the following primary considerations:

1. The vaccine is safe and effective.

2. The disease is consequential in terms of morbidity or mortality.

3. The vaccine supply is likely to be stable.

4. Adequate financing is available to provide the vaccine.

Using these criteria, for example, the MHD urged the WCIP to delay mandating the HPV vaccine (primarily on supply and financing grounds and a desire to see a longer safety record), but supported the recent addition of Tdap vaccine and second dose of varicella to the school mandate list.

Discussion

The debate over vaccines, vaccine safety, and school-entry mandates complicates public health practice because both suboptimal vaccine coverage rates and the decision to abstain from vaccination result in preventable cases of diseases of personal and public health significance. School mandates, although proven effective in improving vaccine coverage, are not without cost, particularly with respect to the administrative burden on schools. These mandates should reflect the values of the community and require the cooperation of both the public and healthcare providers to be successful. It is not a simple decision about treading on parental rights, or a simple decision about a family's health, but rather a decision that may affect the health of the school community, the larger community within that school's jurisdiction, and the health of those with whom the unvaccinated children interact-particularly those children, adolescents, and adults who cannot be vaccinated for medical reasons.8

Several organizations, such as the Association of Immunization Managers, have developed position statements on these issues of when to consider and when to implement school-entry mandates.9 How well these documents translate into practice remains to be evaluated.

Issues such as poverty, poor health infrastructure, and a lack of appropriate information mean that many families cannot get the immunizations they need. These factors contribute to the fact that immunization coverage rates for children vary tremendously from state to state and, where measured, from county to county.10 School mandates are a way to act as an equalizer for those who fall through the cracks.

These conditions make service delivery tremendously uncertain and uneven and raise the stakes of decision making about immunization mandates.11,12 Practitioners and policy makers find themselves in ethically tense situations because of these factors-how and when to implement the recommended vaccine mandates and to whom. The ACIP's recommendations and guidelines are helpful, but they do not provide strategies on how to make decisions about vaccine mandates judiciously and within a sphere of ethics specific to public health practice.

Conclusion

Vaccine mandates represent an important area of focus for ethics, equity, and public health practice. Time will tell if the various position statements and practices regarding vaccine mandates can, with the help of public health ethical principles, be brought into a more consistent and harmonized format across the nation.

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