The Best Interests of Children

Vaccinating as high a proportion of the population as possible is not simply a box to be checked by public health officials; it is a moral imperative, for several reasons. The most fundamental reason for promoting universal vaccination, as has been argued for other vaccines,^{Reference Verweij and Dawson27} is that it is in the best interest of the children receiving the vaccine. The HPV vaccine protects children from serious harm and carries minimal risk, creating a favorable risk-benefit ratio and satisfying a key criterion of medical decision-making on behalf of children.^{Reference Kodish28} For the rare case in which the risks outweigh the benefits for a particular child (e.g., a child with an allergy to the vaccine formula) an exemption can apply. (Opt-out provisions will be discussed later in the paper.) For the vast majority of children, however, vaccination is in their best interest. Furthermore, although universal vaccination has the secondary benefit of protecting society as a whole from HPV, vacci-nation is not akin to carrying out research on children for generalized gain; the vaccine is proven to be safe and effective, and it directly benefits the children who are vaccinated by protecting them from the harmful consequences of HPV, regardless of future sexual behavior. As Joseph Balog writes, we may promote ideal safe sex practices that we hope would reduce exposure to HPV, but these ideals “are not realistic enough, nor likely to occur soon and often enough, to match the effectiveness of a vaccine that is available now to eliminate real and immediate harm.”^{Reference Balog29}

After the vaccine's introduction, a number of scientists and ethicists argued that it is not the role of the government to decide what is in a child's best interest, and that mandating vaccination impinges on parental autonomy.^{Reference Colgrove, Abiola and Mello30} Indeed, parents who have objected to mandatory vaccination resent the use of compulsion by the state, which they say violates their right to make decisions for their own children.^{Reference Bedford31} It is understandable for parents to be protective of their children and resistant to state efforts that they see as potentially harmful to their children, or antithetical to their parenting practices. It is also important to acknowledge and respect the wide latitude that parents are given when making decisions on behalf of their children. However, if our ultimate goal is to look after the best interests of the child, who will be directly affected by the vaccination decision,³² we cannot take for granted that parents will always make the choice that is in their child's best interest. For example, despite the thorough debunking of the myth that vaccines cause autism, some parents continue to refuse MMR vacci-nation out of fear that their child will “get” autism.^{Reference Gostin33} Overestimating the harm of vaccination because of a discredited medical theory is not in the best interest of the child, despite the parents' sincere concern for their child's health. Similarly, some parents underestimate the likelihood that their child will be exposed to HPV, and subsequent harm caused by HPV — either at all or within the time-frame suggested by the ACIP recommendations. One Rhode Island parent protesting the state's mandate stated that she rejected vaccination because “A 12-year-old is not going to be going out and having sex and contracting an STD.”³⁴ While it is true that few children are willingly engaged in sexual activity at that age,³⁵ the purpose of the vaccine is to immunize children before they are exposed to HPV. Furthermore, numerous studies have demonstrated that parents routinely underestimate their children's sexual activity.^{Reference Mollborn and Everett36} If parents are frequently out of touch with their child's sexual behaviors, their ability to adequately weigh the risks and benefits of HPV vaccination and make an informed decision on behalf of their children is compromised, even if they fully intend to act in their child's best interest.

Other parents may refuse HPV vaccination because they do not wish to discuss sex with their children. Parents protesting the Rhode Island mandate felt that the law crossed “the line with personal and family values” and would force parents to have “appropriate discussions” with their children before vaccination.³⁷ Some have even speculated that HPV vaccination could promote risky sexual behavior, though there is no evidence that is the case.^{Reference Jena, Goldman and Seabury38} There is ample evidence, however, that parent-child communication about sexual activity starting before the child's sexual debut correlates with less risky sexual behavior for the child.^{Reference Beckett, Elliot and Martino39} Resisting HPV vaccination on the basis of wanting to delay conversations about sex is therefore unlikely to be in the best interest of the child.

Parents may also refuse vaccination because they want their children to abstain from sex until a much older age or until marriage. However, studies have demonstrated that abstinence-only sex education does not decrease rates of teen pregnancy, and may actually contribute to the high teenage pregnancy rates in the US.^{Reference Stanger-Hall and Hall40} Parental expectations of abstinence will therefore be unrealistic for some families, and vaccine refusal for this reason will leave pre-teens and teens unprotected if they engage in sexual activity against their parents' wishes. Parents who expect abstinence may be unaware of the rates of unintended teen pregnancy and other negative health outcomes, including among teens who have been taught to abstain from sex. If so, their ability to make informed vaccination decisions is undermined. Alternatively, parents may be aware that children who are taught abstinence are at risk for contracting HPV, but they still refuse vaccination in order to present a consistent message to their children. If so, parents are subjecting their child to the risk of contracting a potentially lethal virus for the sake of impressing the principle of abstinence on their child. Given the realities of adolescent sexual activity, vaccine refusal on this basis is not in the child's best interest. As James Colgrove wrote in a 2006 perspective on compulsory HPV vaccination, society has an interest in “safeguarding the welfare of children who may be harmed by the choices of their parents or guardians.”⁴¹ Requiring vaccination ensures that parents cannot act against their child's best interest for a variety of reasons, and that children are not denied the protection of vaccination because of their parents' beliefs — religious, cultural or otherwise.

The “best interests” argument is morally compelling and makes up the essence of why all children should receive the HPV vaccine. Legally, a “best interests” standard has been employed primarily in family law for determining child custody. It has also been referenced as a threshold for justifying state intervention on behalf of children in a medical context,^{Reference Sher42} though other principles seem to carry most of the legal weight.⁴³ Courts have found it challenging to apply the “best interests” standard literally in medical decision-making because it carries a risk of subjectivity and paternalism. Instead, courts have mainly relied on standards that are more clear-cut — like the justification that the state can override parental autonomy if an intervention is imminently necessary to save a child's life.^{Reference Arani44} For example, parents who are Jehovah's Witnesses cannot refuse a blood transfusion on behalf of their child,^{Reference Woolley45} and parents must appropriately restrain their children in automobiles.⁴⁶ Can the threat of contracting HPV be considered “imminent” and “life-saving”? We do not know when a given child will begin to engage in sexual behavior, and for some children, the threat of exposure to HPV could very well be imminent. As for life-saving, there is signifi-cant mortality associated with the cancers caused by HPV, so preventing HPV infection can be considered life-saving.

One could counter by saying that the likelihood that a child will contract HPV shortly after vacci-nation, develop pre-cancerous lesions that are not found by screening and treated, and ultimately die of HPV-associated cancer is too remote to consider vaccination “life-saving.”⁴⁷ This logic, however, could be applied equally to other vaccines that have already been mandated. For example, it is similarly unlikely that Hepatitis B will be contracted by pre-teen children, ultimately leading to their deaths. Ruling out an HPV vaccination mandate on the basis of “imminent” and “life-saving” standards would also require us to reject other existing vaccine mandates.

In cases where the child's life is not in imminent danger, there is no single, accepted legal approach. In the past, courts have used the reasoning that children have a “right to a normal life” for allowing state intervention in cases of child neglect.⁴⁸ Another standard that has been proposed is that the state may intervene when parental refusal of a medical treatment “places the child at significant risk of serious preventable harm.”⁴⁹ Both of these approaches can be used to support mandatory HPV vaccination; suffering from HPV-associated cancer is not part of a “normal life” and the vaccine protects against a serious and preventable harm.

Ultimately, the legality of mandatory vaccination, for HPV and other diseases, does not rest on the best interests of the children, or the well-being of the children receiving the vaccine. It rests on the public health necessity of protecting the population from preventable morbidity and mortality. In the 1905 case Jacobson v. Massachusetts, the United States Supreme Court decided that states have the right to mandate vaccination as long as vaccination is “for the common good,” “necessary for the public health or the public safety,” “reasonable” and not “arbitrary or oppressive.”⁵⁰ By limiting the spread of the disease, the state is promoting the common good, which affords it the right to override parental autonomy. Although the courts rooted the legality of mandatory vaccines in their public health benefits, the primary ethical basis for pursuing universal vaccination lies in the protective effect for the children who are vaccinated.

Solidarity

A second ethical basis for mandating HPV vaccination stems from the public health benefits of vaccination and the concept of solidarity. Vaccination against HPV should be universal not only for the sake of each vaccinated individual, but for the sake of the community as a whole, and those who are most vulnerable within the community. In the context of vaccines, “benefit to the community” has a very tangible meaning; the ultimate goal of mandatory vaccination is to guarantee coverage of a high enough proportion of the population to establish herd immunity. The proportion needed to develop herd immunity against HPV has not yet been defined, but preliminary findings reinforce the hypothesis that the higher the vaccination coverage, the greater the herd effects (lower prevalence of HPV infection beyond the direct effects of vaccination).^{Reference Drolet, Benard and Boily51} Even with mandatory vaccines, we sometimes struggle to achieve herd immunity, particularly when states allow broad authority for parents to opt-out of vaccination. It is therefore understandable that without a mandate, HPV vaccination rates are only around 40%, and rates will realistically remain low until vaccination is mandated.

The concept of solidarity asks us to move beyond the simple utilitarian calculus that the health of many should trump the autonomy of the individual. We are not merely self-interested individuals, we are interdependent members of society who live in and benefit from the community around us, and in turn have communal obligations.^{Reference Jennings52} What sorts of contributions, monetary or otherwise, should be considered obligatory for members of society is both ethically complex and politically fraught. People will weigh the values of personal liberty and societal gain differently, based on their perception of the magnitude of the liberty sacrifice and the gravity of the social benefit. One could argue that adding the HPV vaccine to a pre-existing list of mandatory vaccines, given its proven safety and efficacy, amounts to a minor sacrifice of personal liberty. One additional shot is a small burden relative to the possibility of eradicating HPV-associated cancers from the community. However, some parents might wish to refuse vaccination on the basis of the concerns discussed above, and may feel the cost to personal liberty acutely. While preaching solidarity will not appease staunch opponents to mandatory vaccination, the concept is nonetheless an important underpinning to public health ethics, and captures a cultural sense of obligation felt by many people, at one level or another.⁵³

Debate over whether to mandate HPV vaccination has largely avoided the notions of mutual obligation and solidarity, and even shied away from discussing the societal benefits of vaccination. Reluctance to emphasize broader benefits was especially apparent in earlier debates about including males in the ACIP vaccination recommendations. ACIP focused heavily on the benefits that the HPV vaccine would bring to boys in order to justify extending its recommendations. They noted, as an aside, that vaccination of males may result in a reduction of infection, disease and cancer in females, through herd immunity. However, they did not have sufficient data to support that claim and did not base their recommendation for males on the possibility of achieving herd immunity. Some even argued that due to the smaller risk of HPV-associated cancers in males as compared to females, males should not be required to receive the HPV vaccine. Benjamin Lemke used a “Modified Hand Formula” to calculate how much society should spend to reduce the disease burden of HPV through implementing a vaccine mandate. He weighed social economic burden and personal burden (in terms of “sacrificing constitutionally protected liberty interests”) against an estimate of the human costs of HPV,⁵⁴ and according to his calculus, mandatory vaccination would be justified in females only.

What Lemke, ACIP and others failed to consider, however, were moral reasons for vaccinating males in addition to females — in particular, the concept of solidarity. Even if females are more susceptible to HPV-associated cancers than males (which is debatable), the possibility of decreasing the incidence of cancer in females through vaccination of their male counterparts^{Reference Hughess, Garnett and Koutsky55} is, in and of itself, a reason to vaccinate males. Our society is filled with mothers, sisters, partners and daughters. To argue that vaccinating males is unjustified unless males themselves benefit sufficiently — according to an extremely narrow definition of ‘benefit’ — is to ignore the fact that human beings are closely interconnected to one another. The well-being of the individual is inextricably bound to the well-being of the community, especially with regards to communicable disease.

Solidarity not only requires us to think seriously about what we, as members, owe society at large, it also urges us to stand together with those who are most vulnerable. There are always people who are particularly susceptible to an infection or sensitive to its consequences — whether due to biological or social fragility. Vaccinating as many people as possible, and establishing herd immunity, allows us to protect those people by eventually eliminating the disease from the population. How far we should all go to guarantee protection for the most vulnerable members of society is also a question of competing values, and people will differ in their answers. However, getting the two doses of the HPV vaccine is a minor practical burden and seems like a reasonable task to require of everyone in order to eradicate HPV from the community and spare those who are particularly at risk.

Health Equity

A final moral reason for mandating HPV vaccination is for the sake of health equity. We have long known that black and Hispanic women suffer disproportionately from cervical cancer.⁵⁶ Recent studies have revealed that racial disparities in rates of cervical cancer, and cervical cancer mortality, are even larger than previously estimated.^{Reference Beavis, Gravitt and Rositch57} These disparities are generally attributed to reduced access to care, including cancer screening (particularly for Hispanic women)^{Reference Downs, Smith and Scarinci58} and the quality of cancer treatment.^{Reference Robin, Amini and Schefter59} Public health institutions have attempted to increase screening rates in minority communities and among uninsured and publicly insured women, but the disparities have persisted.⁶⁰

Given the disparities in HPV-associated cancers, minority populations in the US stand to gain the most from vaccination against HPV.⁶¹ The CDC's Vaccines for Children (VFC) program has offered to help with payment for the HPV vaccine,⁶² but the barrier to vaccination is not only cost-related. Unless parents have a relatively high level of health literacy, a particular concern for protecting against HPV-associated disease, or a pediatrician who strongly recommends vaccination, they simply may not know about the vaccine. Studies have shown that awareness of HPV,^{Reference Gelman, Nikolajski and Schwarz63} and HPV vaccination rates,^{Reference Ford64} are lower among black and Hispanic women as compared to non-Hispanic whites. For mandated vaccines, by contrast, there is no evidence of racial disparity in rates of vaccination.⁶⁵ Black and Hispanic children receive these vaccines at comparable rates to other children, suggesting that mandates would be an effective tool for reducing disparities in vaccination and cervical cancer. Mandating vacci-nation is not a substitute for improved education, screening and treatment in minority populations, but it can be an important means of achieving greater health equity with respect to HPV-associated disease.

This section has argued for mandating HPV vaccination for three reasons: 1) universal vaccination is in the best interests of children, 2) solidarity requires that we make minor sacrifices for the good of the community and the most vulnerable among us, and 3) mandatory vaccination will help reduce health disparities in rates of HPV-associated cancer. The final section of this paper will discuss concerns regarding implementation of a vaccine mandate.

Ethical Issues in Implementing an HPV Vaccine Mandate

Arguments against mandating the HPV vaccine have, to a great extent, focused on issues related to implementation of a mandate. Specifically, many opponents have questioned the validity of linking HPV vaccination to school entry, like other mandatory vaccines. The Supreme Court affirmed in the 1922 case Zucht v. King that mandatory vaccination laws could be tied to school attendance. The reasoning provided was that policies linking vaccination to school attendance “confer not arbitrary power, but only that broad discretion required for the protection of the public health.”⁶⁶ Since Zucht, state governments, ethics and legal scholars have attempted to delineate more precisely the circumstances under which a vaccine can be justly mandated. The prevailing theory is that vaccines ought to be mandated when the disease poses an “immediate risk of rapid transmission” within the school environment.⁶⁷ HPV, some argue, does not meet these criteria, since it is not imminently transferable through normal classroom activities.⁶⁸

Opel, et al. explain the traditional reasoning as follows: tying vaccination to school entry means that if a child does not receive the vaccine, he or she will be denied the right to school education. Therefore, denial of this fundamental right is only justifiable when vaccination is necessary to prevent a disease outbreak that will keep large numbers of children from attending school (due to “either illness or fear of contracting the disease from other schoolchildren”). HPV does not meet this qualification because it does not threaten to keep children out of school.⁶⁹ Although Opel, et al.'s reasoning is sound, they do not explain why the only acceptable justification for restricting access to public education for one child is access to public education for a greater number of children. Though public schooling is indeed a fundamental right, surely there are other societal goals that might supersede this right. For example, the societal goal of preventing future harm related to communicable disease, and the collective interest in limiting the spread of disease by achieving herd immunity. Opel, et al. acknowledge that choosing not to require HPV vaccination for school entry will almost certainly reduce rates of immunization.⁷⁰ While it is theoretically possible to mandate vaccination through another means, alternative strategies have yet to be fully explored and the infrastructure for school-entry mandates is already in place. Furthermore, tying vaccination to school entry is not truly intended to limit access to school education. While there are lower rates of vaccination among home-schooled children,^{Reference Smith, Chu and Barker71} there is little evidence to suggest that students who would otherwise have attended school were homeschooled because their parents refused vaccination.^{Reference Redford, Battle and Bielick72} Finally, there are already precedents for vaccine mandates that do not meet the conditions stipulated by Opel, et al. and others. Hepatitis B is mandatory in nearly all states, and it is transmitted through birth, sex, needle sharing, and direct contact with blood — not normal school activities. The tetanus part of the Tdap vaccine protects against an illness that is not communicable between humans at all. The traditional justification for tying vaccination to school entry not only fails to comprehensively weigh the risks and benefits of HPV vaccination, it also does not reflect the realities of mandatory vaccination today.

A second question relating to implementation of a vaccine mandate is whether and what opt-out provisions should be permitted. Philosophical exemptions preserve an outlet for personal autonomy for those parents who are adamantly opposed to vaccination, and also limit the number of legal challenges that the state will face for enforcing a vaccine mandate. Religious exemptions allow a small minority of families who have religious reasons to resist vaccination to do so. On the other hand, religious exemptions are difficult to enforce,^{Reference LeFever73} and broader opt-out provisions risk jeopardizing the herd immunity that was established as a result of mandatory vaccination. For example, there has been a resurgence of measles in certain populations, where anti-vaccine activism has convinced enough parents to opt out for rates to fall beneath the threshold for herd immunity.^{Reference Sun74} This paper has argued that universal vaccination is the ethical objective, for the sake of individual children and the community as a whole. Permitting only medical and religious exemptions is most consistent with this goal. However, public policy must always balance pursuit of the stated objective with maintenance of the public trust. Some have argued that if parents are resentful of a stringent vaccine mandate, they may lose faith in the public health system,⁷⁵ or may even refuse to vaccinate their children for other diseases.⁷⁶ Whether parents will be so resistant of HPV vaccination that they will become permanently mistrustful of the public health system, or refuse other vaccines, is ultimately an empirical question. Of the three places where HPV vaccination has been mandated, Rhode Island and Washington, D.C. have allowed religious and medical exemptions only.⁷⁷ Rates of HPV vaccination for females are now well above average, and rates of other vaccination are on par with other states.⁷⁸ Virginia, by contrast, created a special exemption for HPV, which allows parents to opt out for any reason.⁷⁹ As a result, rates of completion of the HPV vaccine series in Virginia are actually lower than the national average.^{Reference Kueter80} Thus it appears so far that limiting exemptions to religious and medical exemptions can increase rates of HPV vaccination without decreasing the rates of vaccination for other diseases. Furthermore, the experience with the Hepatitis B vaccine gives us reason to believe that parental opposition to vaccination will not be permanent. There was considerable debate over mandating the Hepatitis B vaccine, and after the vaccine was mandated, the debate faded over time.⁸¹ Nonetheless, states that implement vaccine mandates must be cognizant of the public's reaction and carefully monitor vaccine uptake for HPV and other vaccines in the years to follow.

Implementing a vaccine mandate is a complicated task that requires consideration of practical and political concerns. In addition to deciding whether to require HPV vaccination for school entry, what optout provisions to permit, and how best to maintain the public trust, states must also consider how much money they are willing to spend on implementing the vaccine, and how to educate the public in order to increase vaccine uptake and minimize vaccine refusal.