On September 12, 2006, 3 months after the Food and Drug Administrationlicensed a vaccine against human papillomavirus (HPV), Michiganlawmakers became the first in the United States to propose thatvaccination be compulsory for girls entering sixth grade. Parentswho objected would be able to opt out of the requirement underthe same provisions that apply to other vaccinations. The billpassed the state senate by an overwhelming margin a week laterand awaits consideration by the house. Other states are likelyto follow Michigan's lead.
The development of Gardasil, Merck's HPV vaccine, is of majorpublic health importance. The vaccine protects against fourstrains of HPV, the most common sexually transmitted diseasein the United States, including the two strains that cause mostcases of cervical cancer. More than 6 million people in thiscountry become infected with HPV every year, and nearly 10,000 women are diagnosed with cervical cancer. Because the vaccinehas the greatest benefit when it is given before a person becomessexually active, the Advisory Committee on Immunization Practicesof the Centers for Disease Control and Prevention recommendedthat it be given routinely to girls at 11 or 12 years of age;it is not yet approved for use in boys. The committee took noposition on whether vaccination should be required by law; suchpolicy decisions are made by individual states.
Moves to make the vaccine compulsory are sure to ignite a newround of polarizing debates. Controversy over the product beganbefore it was licensed, when some religious conservatives expressedconcern that the availability of a vaccine against a sexuallytransmitted disease would undermine abstinence-based preventionmessages. Advocacy groups such as Focus on the Family ultimatelycame to support availability of the vaccine, but they remainopposed to mandating its use. In their view, such a requirementconstitutes an attempt by the secular state to force a childto undergo an intervention that may be irreconcilable with herfamily's religious values and beliefs.
It is a mistake, however, to view the contrasting stances onHPV-vaccine mandates as solely, or even primarily, evidenceof a conflict between science and religion. A more complicateddynamic will shape the ongoing discussion.
On one side, support for legal requirements is strongly influencedby the perception of HPV as a women's health issue. The severeconsequences that the disease may have for women lends urgencyto the effort to maximize use of the vaccine through all policymeans, including mandates. Women in Government, a Washington-based,bipartisan organization of female legislators, is leading apush to make HPV vaccination compulsory in every state. Thegroup has issued recommendations for ensuring that the vaccineis accessible and affordable, including a recommendation thatstates add it to their Medicaid programs and encourage privatehealth plans to cover it. The group follows in the traditionof breast-cancer activists, who have mobilized through manypolitical channels to combat an illness that disproportionatelyburdens women.
On the other side, opposition to mandates will come from a farwider range of constituencies than just religious conservativesworried about threats to teenagers' sexual abstinence. Vaccinerequirements — even generally well-accepted laws covering"classic" childhood diseases such as polio, measles, and pertussis— have been resisted in recent years on a wide range ofphilosophical, political, scientific, and ideological grounds.
During the past two decades, in the face of a sharp increasein the number of recommended pediatric vaccines, unproven theoriesalleging connections between vaccines and illnesses includingautism, diabetes, and multiple sclerosis have been spreading.A social movement involving diverse participants has challengedthe safety of vaccination and mounted attacks in courtroomsand legislatures on compulsory vaccination laws. Forty-eightstates allow parents who object to vaccination on religiousgrounds to excuse their children from requirements, and 20 ofthose states also allow exemptions for parents who have secularphilosophical concerns.1 Approximately 1 to 3% of U.S. childrenare excused by their parents from vaccine requirements, thoughthe rate varies from state to state; schools in a few communitieshave exemption rates as high as 15 to 20%. Activists have soughtto liberalize the circumstances under which parents may optout of vaccine requirements, a trend that reflects the widevariation in people's reasons for rejecting vaccines: devotionto "natural" or alternative healing, libertarian oppositionto state power, mistrust of pharmaceutical companies, beliefthat vaccines are not as safe as experts claim, and convictionthat children receive more shots than are good for them.2
Laws making vaccination compulsory raise unique ethical andpolicy issues. High levels of herd immunity protect all membersof the community, including those who cannot receive vaccinesbecause of medical contraindications. This protection providesa justification for compulsion. The availability of religiousor philosophical exemptions mitigates concern about governmentalintrusion on individual decision making. Opinions vary, however,about the permissible scope of exemptions. Data show that schoolswith exemption rates as low as 2 to 4% are at increased riskfor disease outbreaks and that children who have been exemptedfrom vaccine requirements have a much greater risk of acquiringinfectious diseases than their vaccinated peers.1 Minors havea right to be protected against vaccine-preventable illness,and society has an interest in safeguarding the welfare of childrenwho may be harmed by the choices of their parents or guardians.
Bioethicists, who generally hold the values of patient autonomyand informed consent to be preeminent, tend to be skepticalabout compulsory vaccination laws. Not surprisingly, some haveexpressed wariness about or opposition to mandating HPV vaccination.3,4Because HPV is not casually transmissible, they argue, thereis a less compelling rationale for requiring protection againstit than against measles or pertussis, for instance; in the absenceof potential harm to a third party, such laws may be consideredunacceptably paternalistic. Similar concerns have been raisedabout school-based requirements for vaccination against hepatitisB: because the virus spreads primarily among sexually activepeople and injection-drug users, some parents argued that thevaccine should be given only to those groups rather than toall children. Such targeting of the vaccine, however, provedto be less effective than universal vaccination in reducingthe incidence of the disease.
A large body of evidence demonstrates that school-based lawsare an effective and efficient way of boosting vaccine-coveragerates. Requiring HPV vaccination by law will almost certainlyachieve more widespread protection against the disease thanwill policies that rely exclusively on persuasion and education.In the view of advocates, this effectiveness provides a clearjustification. "The only way to ensure that as many girls aspossible receive the HPV vaccine is to require it before theyenter middle school," said Beverly Hammerstrom, the Michiganstate senator who introduced the legislation. Whether such amandate might extend to boys, should the product be approvedfor such use, remains uncertain.
A critical question is whether achieving a higher level of coveragejustifies the infringement on parental autonomy that compulsoryvaccination inevitably entails. Different ethical frameworksthat accord varying weights to communitarian and individualisticvalues will lead to contrasting answers to this question.
Ethical and epidemiologic analyses are essential to decisionsabout mandating the HPV vaccine; so are political calculations.Any new vaccine that a state adds to its list of requirementsmust be judged in the context of both the increasingly lengthyand complex regimen of vaccines that children now receive andthe possibility that additional mandates may inflame grassrootsopposition, be it religious, philosophical, or ideological.5Although issues of religion and adolescent sexuality have dominatedthe discussion, the move to require HPV vaccination raises broadquestions about the acceptability of mandatory public healthmeasures, the scope of parental autonomy, and the role of politicaladvocacy in determining how preventive health measures are implemented.
Dr. Colgrove is an associate research scientist at the Center for the History and Ethics of Public Health, Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York.
- Salmon DA, Teret SP, MacIntyre RC, Salisbury D, Burgess MA, Halsey NA. Compulsory vaccination and conscientious or philosophical exemptions: past, present, and future. Lancet 2006;367:436-442.
- Colgrove JK. State of immunity: the politics of vaccination in twentieth-century America. Berkeley: University of California Press, 2006.
- Zimmerman RK. Ethical analysis of HPV vaccine policy options. Vaccine 2006;24:4812-4820.
- Lo B. HPV vaccine and adolescents' sexual activity. BMJ 2006;332:1106-1107.
- Temte JL. Should all children be immunised against hepatitis A? BMJ 2006;332:715-718.