The Path Ahead for the HPV Vaccine

The question of whether a state has the right to institute a mandatory vaccination policy against human papillomavirus (HPV) for school children remains hotly disputed. In June 2006, the national Advisory Committee on Immunization Practices (ACIP) strongly advised routine vaccination for girls 11 to 12 years of age, and it now strongly advises the same vaccination policy for boys in the same age bracket. The ACIP consists of medical as well as public health professionals who establish guidelines for vaccination policies in the United States and make recommendations targeting the application of vaccines.

The Role of the ACIP Committee

The ACIP was created under the Public Health Service Act (1944).¹ The Committee consists of 15 voting members who are responsible for making recommendations with respect to the use of public vaccination. The Secretary of the US Department of Health and Human Services (DHHS) is entitled to elect the members of the committee.¹ Fourteen members are drawn from professionals in the fields of vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine. The fifteenth membership is reserved for a consumer representative who is expected to deliver a community point of view on the impact of any putative vaccination policy. There are also 8 ex officio members who represent other federal agencies charged with the responsibility for executing immunization programs in the United States. In addition, 30 non-voting representatives from liaison organizations contribute their experience and know-how on immunization matters.

The ACIP meets three times each year at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia. At these meetings, ACIP members and CDC staff present new research and engage in dialogue on related subjects, such as relevant scientific data, vaccination effectiveness, clinical trial outcomes, manufacturer’s package insert, and safety. Additionally, they examine the current state of vaccine-preventable diseases as well as variances in vaccine supply and/or shortages.

State Authority Over HPV Vaccinations

Although the ACIP presents its own recommendations, school vaccination requirements are determined on a state-by-state basis by respective legislatures. Some state legislatures have devolved the power to mandate vaccinations to state regulatory agencies, whereas others have voted to retain such authority.

In cases in which states have relegated the authority to mandate vaccination to regulatory bodies, the legislatures in question, as a matter of course, must still allocate funding. The general public may, in principal, favor the availability of such vaccines, but it may not favor mandatory inoculation in schools. Such objections may be related to questions of the vaccination’s cost and overall safety, as well as to an individual parent’s right to opt out a child from any proposed immunization program. Others potentially harbor ethical objections to a mandatory vaccine related to a sexually transmitted disease.

In 2006, the Michigan State Senate proposed a bill requiring HPV school vaccination for sixth-grade girls.² The bill, however, did not pass. In the same year, Ohio proposed legislation mandating vaccination, but this bill also failed to pass. Since then, legislators in some 42 states and territories have proposed legislation to: a) mandate the vaccine, or b) either to allocate funding or to raise public awareness about the HPV vaccine, particularly among school children. Currently, 25 states and territories have enacted legislation related to HPV vaccination, and 3 jurisdictions require HPV vaccinations for school attendance.² Of note, 10 states initiated HPV-related legislation for the 2015-2016 sessions, and at least another eight states proposed HPV-related legislation for their 2017—2018 sessions.²

If states mandate such vaccination programs, they must, of necessity, also allocate appropriate funding, which includes government payer programs covering the uninsured. These states must also determine whether to make such coverage a requirement for insurance plans. These questions have kindled a debate on the question of whether such vaccines ought to be mandatory in the first place.

Beyond the state level, it is worth noting that the HPV vaccine is now available through a federal program called Vaccines for Children (VFC), which is operative in all 50 states. The program covers vaccines for children 9 to 18 years of age who are eligible through federal health care payer programs.

Conclusion

While state legislatures continue to make efforts to preserve public health by enforcing the administration of HPV vaccinations in one form or another, the debate ensues at community levels as to whether such a vaccine should be required or made voluntary. The balance of protecting the public against HPV virus harm and an individual’s right to object to submission to receiving such a vaccine is a continuing dialogue among public stakeholders. Importantly, the availability of such a vaccine worldwide as an option for those who believe it will improve public health is a testament to new strides in research and improved quality of life.

Ned Milenkovich, PharmD, JD, is chair of the healthcare law practice at Much Shelist PC and former vice chair of the Illinois State Board of Pharmacy.

References

• The Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP). CDC website. https://www.cdc.gov/vaccines/acip/about.html. Accessed February 20, 2018.
• The National Conference of State Legislature. HPV Vaccine: State Legislation and Statutes. The NCSL website. http://www.ncsl.org/research/health/hpv-vaccine-state-legislation-and-statutes.aspx. Accessed February 20, 2018.