Published online August 1, 2008
PEDIATRICS
Vol. 122
No. 2
August 2008, pp.
e504-e510
(doi:10.1542/peds.2007-3218)
A Critique of Criteria for Evaluating Vaccines for Inclusion in Mandatory School Immunization Programs
Douglas J. Opel, MDa,b,
Douglas S. Diekema, MD, MPHa,b and
Edgar K. Marcuse, MD, MPHb,c
a Treuman Katz Center for Pediatric Bioethics, Children's Hospital and Regional Medical Center, Seattle, Washington
b Department of Pediatrics
c School of Public Health and Community Medicine, University of Washington, Seattle, Washington
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ABSTRACT
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Several new vaccines for children and young adults have been introduced recently and now appear on the Advisory Committee on Immunization Practices’ recommended childhood and adolescent immunization schedule (meningococcal, rotavirus, human papillomavirus). As new vaccines are introduced, states face complex decisions regarding which vaccines to fund and which vaccines to require for school or child care entry. This complexity is evidenced by the current debate surrounding the human papillomavirus vaccine. We present a critique to the approach and criteria for evaluating vaccines for inclusion in mandatory school immunization programs that have been adopted by the Washington State Board of Health by illustrating how these criteria might be applied to the human papillomavirus vaccine. We conclude that these 9 criteria can help ensure a deliberate and informed approach to important public policy decisions, but we argue that several clarifications of the review process are needed along with the addition of a 10th criterion that ensures that a new vaccine mandate relates in some manner to increasing safety in the school environment.
Key Words: ethics • health policy • human papillomavirus • immunizations
Abbreviations: HPV—human papillomavirus • ACIP—Advisory Committee on Immunization Practices • IAC—immunization advisory committee • TAG—technical advisory group
Requiring vaccination for school entrance in the United States has historically aimed to prevent outbreaks of vaccine-preventable illness at school.1,2 As such, mandatory vaccination policies have led to a significant decrease in the incidence of many vaccine-preventable diseases.3 This success can be attributed to the effectiveness of the vaccines themselves and to having learned several policy lessons along the way; for instance, mandatory vaccination can be effective only if there is a reliable supply of safe vaccine, if governments are willing and able to bear the burden of ensuring vaccine safety and enforcing mandates,1 and if individual freedoms are weighed against public benefits.4–6
Currently, 4 to 7 vaccines, varying by state, have been made mandatory for school entrance.7 Effective in 2009, Virginia will make receipt of the human papillomavirus (HPV) vaccine mandatory for girls who are entering the sixth grade, and many other states are considering similar state legislation and regulation.8 The Texas governor, for example, issued an executive order that mandated receipt of the HPV vaccine, but it was later overturned by the Texas legislature.9
As legislation is being deliberated, there has been growing discussion of the appropriateness of requiring versus recommending the HPV vaccine.4,5,10–14 Some have argued against a mandate of this vaccine because of the lack of experience with it at this early stage in its implementation.8 Others have cited concerns for autonomy11 or the fact that the vaccine's primary justification is not to "prevent immediate harm to others."10 Those in support of linking the HPV vaccine to school entrance refer to the important role that school mandates have played in raising immunization rates.8
As this debate continues, it is important to distinguish between recommending a vaccine (as the Advisory Committee on Immunization Practices [ACIP] does), deciding whether state funds will be used to pay for the vaccine (encouraging vaccine uptake by eliminating cost to recipients), requiring vaccination of a state's citizens as a public health measure (compelled administration), and making school attendance in a state contingent on receiving a vaccine (school mandate). A decision to recommend vaccine administration is a different decision than a state encouraging vaccination by supplying the vaccine to qualified clinicians or compelling vaccination through a mandate. Finally, if states judge that the public health value is sufficient to justify compelled vaccination, whether school attendance is the appropriate mechanism for compulsion remains a separate issue.
In anticipation of the complex decisions that are involved in determining which vaccines ought to be included in school immunization requirements, the Washington State Board of Health established an immunization advisory committee (IAC) for the purpose of developing criteria that could be used in the selection of those vaccines that would be required for school entry. Although some requisites for school immunization are available,15 the 9 criteria developed by the IAC were meant to offer more specific requirements and to assist the board in making decisions about school mandates. These criteria could also be used to prioritize vaccine funding in a setting of limited resources. As states around the nation develop policy regarding the HPV vaccine, we offer a critique of the IAC's criteria and framework for vaccine review in an attempt to aid determinations of how to prioritize vaccine coverage.
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THE WASHINGTON STATE BOARD OF HEALTH FRAMEWORK FOR VACCINE REVIEW
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The Washington State Board of Health convened an IAC in December 2005 to recommend criteria that the state could use to evaluate which antigens to include in the required immunizations for entry into school or child care. The members of this committee included 2 of us (Drs Diekema and Marcuse); stakeholders from the fields of public health, school health, medicine, child advocacy, and medical ethics; and parents. The IAC met 3 times to develop the recommendations presented here, which were adopted by the board on June 14, 2006.16
In developing the criteria, the IAC endorsed the harm principle. The harm principle provides a basis for identifying the threshold at which state action is justified, as when a state decides to compel vaccination.17 The government's authority in the health arena arises primarily from its constitutionally sanctioned "police power" to protect the public's health, welfare, and safety.18 In On Liberty, Mill provided an ethical basis for the exercise of these police powers: "The only purpose for which power can rightfully be exercised over any member of a civilized community, against his will, is to prevent harm to others. His own good, either physical or moral, is not a sufficient warrant."19 Feinberg20 further refined the harm principle by arguing that to be justified, restriction of an individual's freedom must be effective at preventing the harm in question, and no option that would be less intrusive to individual liberty would be equally effective at preventing the harm. Using the analyses of Mill and Feinberg, the IAC interpreted the harm principle broadly such that it would be justifiable to require a vaccine for children who are entering child care and/or school when without this vaccine any of the following would result: (1) an individual's decision to not vaccinate his or her own child could place another's health in jeopardy; (2) the state's economic interests could be threatened by the costs of care for vaccine-preventable illness, related disability, or death and by the cost of managing vaccine-preventable disease outbreaks; or (3) the state's duty to educate children could be compromised.16
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CRITERIA AND PROCESS FOR REVIEW
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The IAC developed 9 criteria to consider when evaluating vaccines for inclusion in mandatory school immunization programs and grouped them into 3 categories: vaccine effectiveness, public health disease burden, and implementation (Table 1). As a first step, the IAC made 3 assumptions that deserve consideration as important components of the criteria. The criteria may be useful, however, regardless of whether these assumptions are met. The IAC assumed that (1) a process existed for parents to opt out of immunization requirements, (2) the vaccine(s) containing the antigen was accessible, and (3) cost was not a barrier.16 Washington State is a so-called universal purchase state and, as such, allocates state funds to supplement federal funds to make all ACIP-recommended childhood vaccines available to all children and youth through 18 years of age.
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TABLE 1 The Washington State Board of Health's 9 Criteria to Consider When Evaluating Antigens for Inclusion in Mandatory School Immunization Programs
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The process for reviewing proposed antigens for potential inclusion in the required list of immunizations for school entry is then threefold. First, the above-listed assumptions are reviewed by the Washington State Board of Health to determine if they have been satisfied. In addition, the board determines whether there is sufficient information related to the vaccine of interest for it to be evaluated against the 9 criteria. This helps the board perform a preliminary review to assess the likelihood that the vaccine in question would indeed meet these criteria. Although the board agreed to wait for 2 years after the Department of Health had made the vaccine available to clinicians licensed to administer immunizations in Washington State, it recognized the need to forgo this waiting period in circumstances determined by the board to constitute a "pressing public health need."16
Second, a technical advisory group (TAG) is appointed by the board to formally review the vaccine in question against the 9 criteria. The TAG comprises representatives from public health, primary care, epidemiology, and ethics and, when appropriate, can be broadened to include parents, school administrators, and those involved with immunization administration, child advocacy, and child care. The board supplies the TAG with relevant information and current literature about the vaccine in question; in addition, the Department of Health provides the TAG with Washington State–specific information regarding the disease targeted by the vaccine. When the vaccine in question is a combination vaccine, each antigen of the combination vaccine is considered separately against the criteria. These separate considerations are then evaluated by the TAG to make a recommendation about the combination vaccine in total. No well-delineated, formal process exists to assist the TAG in moving from conclusions about separate antigens to a final recommendation about the combination vaccine.
Third, each of the 9 criteria are applied to the vaccine in question by using available data and the professional and scientific judgment of the TAG members. Each criterion need not be weighed equally, but all 9 criteria must be considered. The TAG's deliberations are formulated into a recommendation to the board, including the TAG's opinion about whether the vaccine in question should be added to the Washington Administrative Code. The board then reviews this recommendation and considers possible action.
The Washington State Board of Health's review process raises several issues. First, the process for review begins with the assumption that opt-out opportunities exist. Although essential to acceptance of compulsory vaccination, the Washington State Board of Health's process does not address the level of ease at which these exemptions can be claimed, and it does not assess when the prevalence of exemptions might affect the risk of disease (eg, threaten public health). Second, appointments to the TAG are made by a public health agency and largely reflect the need for a diversity of opinion. The TAG appointment process requires only representation of certain disciplines, and there is no mention of how to assess a member's qualifications. We maintain that there is potential for bias in the criteria's application, and without additional criteria for selecting TAG members, the findings of a given TAG could be unduly influenced by conflicts of interest or other commitments. A third issue is that scientific evidence may not be as persuasive to some members as it is to others. Although this reflects today's challenges in public policy making, it is unclear how disagreements between TAG members are to be handled and a consensus achieved.
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THE CRITERIA AND THE HPV VACCINE
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The new HPV vaccine provides an opportunity to also critique the IAC's criteria. Although the board's process for review allows for each of the 9 criteria to be weighed differently by those applying them, they are nevertheless meant to be both comprehensive and detailed to address the several layers involved in public policy decisions. We will consider these criteria developed by the IAC to not only determine whether their application would result in support for mandating the new HPV vaccine but also to evaluate their content. The application of the criteria to the HPV vaccine that follows, therefore, is solely ours and does not represent the Washington State Board of Health or its committees.
The 4 vaccine-effectiveness criteria are the first that we will apply to the HPV vaccine. The first criterion (ACIP-recommendation requirement) has clearly been met; however, it is important to clarify that although an ACIP recommendation may establish a standard of practice, it does not establish a mandate. The ACIP recommendation must be viewed as 1 of several qualifications needed to justify mandatory status, as these criteria are meant to illustrate.
Whether criterion 2 (effectiveness established by immunogenicity), 3 (cost-effective from a society perspective), and 4 (safe with an acceptable level of adverse effects) have each been met is arguable, because the vaccine's use in the United States is just beginning. Criterion 2 has been partially met by the immunogenicity and efficacy data from prelicensing vaccine trials. Four clinical trials have shown that the quadrivalent HPV vaccine is 95.2% to 100% effective at preventing HPV infection and disease associated with the 4 HPV types included in the vaccine (6, 11, 16, and 18) in 16- to 26-year-olds.21 However, community-based evaluations to determine the HPV vaccine's effectiveness in larger populations and its long-term safety have not been completed yet.10,12 Criterion 3 is difficult to satisfy at this early stage, because cost-effectiveness studies have shown varying results depending on which model, each considering different levels of vaccine efficacy and coverage, is used.22 Without firm cost-effectiveness data, it is not yet possible to determine how the HPV vaccine measures against other required immunizations. Although it is possible that certain societal values could surface at the time of a discussion involving a vaccine's mandatory status (and that these values could overcome incomplete cost evaluations or a poor cost-effectiveness analysis), there is no evidence as of yet of a predominant, overriding societal position.14 Finally, criterion 4 is difficult to apply because it largely depends on the weight given to data on postlicensure adverse effects in large populations. These data could take years to accumulate. As of May 8, 2007 (11 months after licensure), 5% of Vaccine Adverse Event Reporting System reports related to HPV have been defined as serious.23 Four deaths have occurred among female recipients of the HPV vaccine but were determined to not have been caused by vaccination. We consider this postlicensure data to be reassuring and, when combined with prelicensure reports, sufficient to meet criterion 4.
Criterion 5 (vaccine prevents disease that is a public health burden) is seemingly well met by the HPV vaccine, which can prevent much cervical cancer, cervical dysplasia, and related conditions. Also, criterion 6 (reduced transmission risk) is likely met, because a large proportion of the population (adolescent girls) will be vaccinated and contribute to decreased prevalence of HPV disease. It is important to note, however, that because males are not included in current vaccine coverage plans, person-to-person transmission is only reduced and not eliminated.
The implementation criteria represent other areas of concern for mandating the HPV vaccine for school entry. Although there is evidence that the vaccine is garnering public acceptance (criterion 7),24–26 low awareness and knowledge of HPV, stigma, and parental attitudes and beliefs remain barriers to acceptance.27,28 Burden of compliance on the part of the caregiver (criterion 9) has not yet been studied. Provider acceptance seems to be tied partly to the relatively high cost of the 3-dose vaccine series ($360) compared with other routine childhood immunizations.10,14 Many physicians cannot afford to maintain a supply of the vaccine unless its cost will be fully reimbursed29 (although this is likely to be more relevant for nonuniversal purchase states). Likewise, other administrative burdens in addition to cost (criterion 8), such as legal liability and fair compensation in the event of a serious adverse effect, have not been clearly delineated.10
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HPV VACCINE, THE HARM PRINCIPLE, AND SCHOOL MANDATES
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Although our application of the IAC criteria to HPV found that it only partially meets many of the 9 criteria at this time and, thus, would likely not be recommended for inclusion in mandatory school immunization programs at this time, we would challenge the IAC's application of the harm principle that served as a foundation for its criteria and argue that the IAC's application of the harm principle perhaps does not justify making the HPV vaccine a requirement for school entry at any time. Because HPV is primarily transmitted by sexual contact, school children are not placed at significant risk for contracting HPV simply by virtue of being around unvaccinated individuals at school.10,13 In this way, HPV strays from the raison d'être originally used for school mandates, which relied on transmission of highly infectious agents, such as measles, that were capable of infecting others through ordinary close contact (ie, the kind of contact that occurs regularly in the school setting). Orenstein and Hinman noted that "[i]t was control of real disease rather than reaching an immunization target which spurred school laws efforts. During the 1970s the predominant age group affected by measles was school age children and schools were major sites of transmission... . Recently school laws have been used to implement new recommendations."2
This prompts us to make 2 observations about the IAC's justification for a vaccine mandate attached to school entry. First, "mandates" take different forms in different states. In many states, the vaccine requirement for school entry is not truly a requirement in the sense that parents can opt out of the requirement for virtually any reason. In other states, the opt-out provisions are quite restrictive and onerous, more closely resembling a true mandate. We would argue that in states with easily met "opt-out" provisions, the school entry "requirement" is not truly a state mandate and, thus, does not represent a state action that needs to be justified under the harm principle.
Second, we argue that the IAC's interpretation of the harm principle fails to distinguish between justification for a vaccine mandate and justification for a vaccine mandate attached to school entry. The IAC interprets the harm principle broadly, such that if any of the previously mentioned situations arises (an individual's decision to not vaccinate his or her own child could place another's health in jeopardy, the state's economic interests could be threatened, or the state's duty to educate children could be compromised), there is justification for mandating a vaccine for school entry. This broad interpretation, however, is flawed. For instance, in states with school-entry requirements that more closely resemble a true mandate, vaccine mandates need not, and perhaps should not, be synonymous with school mandates. More so, a state's decision to mandate a vaccine does not necessarily justify a requirement of vaccination before school entry. We feel that the IAC's broad interpretation of the harm principle should be intended to provide justification solely for vaccine mandates. Only for those situations in which an unvaccinated child's presence in the school setting could place another's health in jeopardy or the state's duty to educate children could be compromised should a vaccine mandate be attached to school entry.
HPV provides a good example as to why a distinction between vaccine mandates and vaccine mandates for school entry is important when interpreting the harm principle. If, for example, states using the IAC's interpretation of the harm principle decide that HPV carries such significant public health value that it satisfies justification for a vaccine mandate solely on the basis of the fact that the state's economic interests could be threatened, it does not necessarily follow that this alone would be sufficient to justify restricting school attendance until the vaccine requirement has been met. That is, this interpretation of the harm principle might justify mandating the HPV vaccine, but it does not justify attaching the mandated HPV vaccine to school entry. Therefore, we argue that any vaccine mandate attached to school entry should only be justifiable when failing to vaccinate would place others at significant risk of contracting serious disease (in this case, HPV) in the school setting or the state's duty to educate children could be compromised. School education is a fundamental right, and it is a function of the state to protect that right. If the state's ability to educate children is affected by a disease outbreak that prevents children from attending school because of either illness or fear of contracting the disease from other schoolchildren, mandating the administration of a vaccine against that disease would be justified.
The HPV vaccine, therefore, exposes the problem that requiring vaccination for entry into school potentially denies children a public good (public education) because of a decision made by their parents. The primary "harm" of school denial is borne by someone other than the decision-maker. Although this harm of school denial can be justified for some vaccines, it is not easily justified for HPV. For instance, for diseases that are easily spread through casual contact, such as measles or diphtheria, an argument for excluding students who lack vaccination from school can be justified by the 2 interpretations of the harm principle stated above (ie, that the state has an obligation to ensure that all children are safe at school, and restricting entry to those who are vaccinated against highly communicable diseases helps to ensure a safe environment for children attending public school). The same argument, however, cannot be made for HPV vaccination, for which the mode of spread (sexual activity) is not an inherent risk of the school environment. Thus, HPV illustrates the circumstance under which failure to vaccinate does not clearly justify using denial of school entry as the consequence.
Therefore, we argue that although the beginning of the school year certainly provides a convenient method for verifying immunization status, HPV renders difficulties in justifying a vaccine mandate attached to school entry. Eliminating a school-entry requirement for vaccines such as HPV, however, will almost certainly reduce the rates of immunization for those vaccines (as well as decrease other benefits created by school laws, such as overcoming uneven vaccination patterns), and alternative enforcement measures would need to be explored. Some have suggested that alternative strategies to increase vaccination coverage include vaccination in the medical home, reminder-recall systems, and health plan pay-for-performance schemes.30 Other strategies might include a vaccine mandate that is not attached to school entry, requiring those who decide not to comply with the mandate to pay a nominal fee to offset the increased costs to the state or enroll in an educational session at the local public health department. Such mechanisms would need to be studied further but suggest that viable alternatives to school laws do exist.
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A SUGGESTED 10TH CRITERION
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Our critique of the IAC's interpretation of the harm principle suggests that another criterion is needed. Although school mandates are an effective way of increasing immunization rates, it is not clear that school mandates are an appropriate way to increase immunization rates for vaccines that prevent diseases that bear no relationship to the safety of the school environment. We would argue that connecting such a vaccine to school entry is ethically suspect and suggest that the consideration of mandating a vaccine for school entry should involve a 10th criterion: that the vaccine containing this antigen should bear some relationship to increasing safety in the school environment.
The inclusion of hepatitis B virus and tetanus vaccines in most school mandates might be seen as reason to question this 10th criterion. Indeed, although our suggested 10th criteria might have presented an obstacle for requiring the hepatitis B and tetanus vaccines before school entry, it does not invalidate the criterion but suggests that the criterion might have been helpful as states considered whether to require these vaccines for school attendance. Nevertheless, it could be argued that tetanus and hepatitis B vaccines can more easily satisfy the 10th criterion than HPV. For instance, because the school has a duty to protect children and children are at risk of tetanus exposure while in the school environment because of cuts and scrapes that occur on school grounds during sanctioned school activities such as recess and physical education classes, the tetanus vaccine protects against the risk of exposure to tetanus while children are at school. Likewise, hepatitis B virus may be sufficiently different from HPV such that the two might reasonably be treated differently under our 10th criterion. For instance, there are no risk factors identified in 40% of cases of hepatitis B infection in children and adolescents,31 which perhaps lends weight to the justification for the hepatitis B vaccine for school entry on the grounds that transmission may be occurring unknowingly at school. Furthermore, the routes for transmitting hepatitis B from person to person that are known are not confined to high-risk activities.32 Albeit less frequent, there have been cases of preschool-aged children transmitting hepatitis B via casual contact.33 As such, a child with hepatitis B might place other children at risk by attending preschool, which creates a weightier justification for mandating immunization at that age. This route of casual contact, however, does not exist for HPV. Therefore, because those children who have HPV and attend school are not putting other children at risk simply because its sole transmission is by sexual contact, mandating HPV vaccination for school entry on the grounds of reducing risk of harm in the school environment is problematic.
One could certainly argue that sexual activity, although not sanctioned by the school, sometimes occurs in association with school events such as proms and dances. Although this may be true, sexual contact that leads to disease exposure is not a risk of attending school but, rather, of the social development of persons who attend school above certain ages. Some resistance to a school mandate, in fact, has arisen precisely because some individuals feel these social behaviors are within the realm of personal autonomy and the prevention of certain behaviors is a decision for the parents and not for the state.30 There seems to be a limit to what can be considered to be school related, and we would maintain that justifications for mandating a vaccine for school entry under the 10th criterion of ensuring school safety ought to reflect the kind of contact that is inherent in participating in sanctioned school events.
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CONCLUSIONS
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We present and analyze the 9 criteria adopted by the Washington State Board of Health that help establish justification for requiring an immunization for school or child care attendance. These criteria and the process for their review are a potential mechanism to ensure a deliberate and informed approach to such a significant public policy decision. Application of these criteria to the HPV vaccine would likely result in the recommendation that it not be made mandatory for school entry. However, several aspects of the Washington State Board of Health's process need to be developed further. The process of appointing members to the TAG needs to be refined to compensate for bias. How a consensus between TAG members is reached, as well as how combination vaccines are evaluated, needs to be clarified. Finally, our analysis of the HPV vaccine and school mandates in the context of the harm principle have led us to suggest that a more restrictive interpretation of the harm principle is needed to set apart justification for vaccine mandates attached to school entry and justification for vaccine mandates in general. We suggest that a 10th criterion be added for use when states are deciding whether to make school attendance contingent on vaccine receipt. Our critique of the Washington State Board of Health's criteria and review process in the context of HPV offers specific guidance in determining which vaccines are justified for inclusion in school-entry immunization requirements.
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ACKNOWLEDGMENTS
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We thank Walter A. Orenstein for his review of an early draft of this article.
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FOOTNOTES
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Accepted Apr 2, 2008.
Address correspondence to Douglas J. Opel, MD, Children's Hospital and Regional Medical Center, Metropolitan Park West, M/S: MPW 8-2, 1100 Olive Way, Suite 500, Seattle, WA 98101. E-mail: djopel{at}u.washington.edu
The authors have indicated they have no financial relationships relevant to this article to disclose.
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ABSTRACT
THE WASHINGTON STATE BOARD...
