Human Papillomavirus and Mandatory Immunization Laws

Human papillomavirus (HPV) is a sexually transmitted virus that infects an estimated 14 million Americans annually.¹ More than 150 subtypes of HPV have been identified. Some types are carcinogenic and cause an estimated 27,000 cancers among men and women in the United States annually; non-carcinogenic subtypes can cause anogenital warts.²

The first HPV vaccine, a quadrivalent (HPV4) vaccine, licensed in 2006, offers protection against 4 subtypes of HPV (6, 11, 16, and 18) that cause 70% of cervical cancers and 90% of genital warts. The vaccine is administered as a series of 3 injections at 0, 2, and 6 months. A second HPV vaccine, which offers protection against subtypes 16 and 18 and protects against cervical cancer but not genital warts, was licensed in 2009.² The quadrivalent vaccine, HPV4, is now being replaced with HPV9, a vaccine that protects against 9 subtypes of HPV (6, 11, 16, 18, and 5 others) that cause 85% of cervical cancers.³

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended in 2007 that all females receive an HPV vaccine at 11-12 years of age so that protection is gained before exposure to the virus is likely to occur. The current recommendations include all adolescents and the vaccine is also recommended for unvaccinated women through 26 years of age, heterosexual males through 21 years of age, and men who have sex with men through 26 years of age.²

HPV vaccines are highly effective in preventing infection if administered before exposure. A 2016 study found that HPV infection rates decreased from 11.5% in 2003-2006 to 4.3% in 2009-2012 among 14- to 19-year-old girls after the vaccine became available.⁴ Evidence supports the vaccine’s safety; the only serious adverse reactions associated with the vaccine are syncope and skin infections.^2,5,6 Despite strong evidence of the vaccine’s effectiveness and safety, however, public acceptance and uptake of the vaccine are slow. Although the proportion of adolescents receiving other recommended vaccines is increasing, the proportion of adolescents receiving the HPV vaccine appears to be plateauing.⁶ In 2014, 60% of adolescents aged 13-17 years received at least 1 dose of HPV vaccine and 40% received all 3 doses,⁷ whereas 86% received the DTaP (diphtheria, tetanus, acellular pertussis) vaccine.⁸

HPV vaccination has been controversial in the United States because the vaccine touches on 2 contentious topics: teenage sexuality and mandatory vaccination. Because of the public’s perceptions about HPV’s status as a sexually transmitted virus and dissent about the recommended age of vaccination, states have had difficulty making the vaccine mandatory for school admission. Some opponents of a school entry mandate for this vaccine have argued that it infringes upon parental rights to discuss the topic of sex on their own terms.⁹ Others have raised concerns that HPV vaccination may increase teenage promiscuity,⁹ although evidence disproves this claim.¹⁰

HPV Vaccination School Entry Mandates

Vaccine requirements for school entry are a proven method for increasing child immunization rates and decreasing the incidence of vaccine-preventable diseases (VPDs).^11–13 Laws vary, however, because each state establishes its own vaccine requirements for school entry. All states provide exceptions from vaccination for medical reasons: as of July 2016, 47 states provided religious exceptions and 18 states allowed exemptions for personal beliefs.¹⁴ States with exemptions for personal beliefs have higher rates of unvaccinated children and higher incidence rates of VPDs.^2,11,12

School immunization requirements serve 2 purposes: (1) to protect children from infectious diseases while in a setting with high rates of disease transmission and (2) to achieve higher immunization rates in society for better herd immunity and lower disease rates. An HPV vaccination requirement would be added primarily for the latter reason, because the risk of transmitting the virus at school (i.e., through sexual routes) is low compared with the risk of transmitting infections through respiratory or fecal–oral routes. However, many states require vaccination against other diseases with routes of infection that are similar to the route of infection of HPV (e.g., hepatitis B). Nevertheless, parents have expressed concerns about vaccinating their adolescent children against HPV, including not knowing about the vaccine, believing the vaccine is unnecessary, questioning the safety of the vaccine, and not receiving a recommendation from their health care provider.^2,6

Legislators and health officials have recently increased their attention toward HPV vaccination. In the past 10 years, 42 states have seen legislation proposed on HPV vaccination, many of which included unsuccessful attempts to require HPV vaccination for school enrollment. Texas was the first state to require HPV vaccination through an executive order in 2007, but the legislature overrode the order later that yaer.¹⁵ Now, however, 10 years after approval of the vaccine and ACIP recommendations, and despite a finding that three-quarters of physicians who provide care for adolescents favor a school entry requirement for HPV vaccination,¹⁶ only Virginia, the District of Columbia, and Rhode Island currently require HPV vaccination for school entry.¹⁵

A Tale of 3 Mandates

States have the authority to mandate certain vaccines based on their inherent police powers.^17,18 However, states have been slow to mandate HPV vaccination for school entry. Uptake of the HPV vaccination 8 years after the ACIP recommendation for its administration to adolescent girls was slow compared with uptake of several other adolescent vaccines.¹⁹ Although many other vaccines were incorporated into most state vaccination laws within 8 years of the recommendation, the HPV vaccine has not followed this path. Commentaries have suggested that one obstacle to uptake of the HPV vaccine was the movement by many states, including Texas, to mandate the vaccine for school entry so soon after the vaccine’s approval and ACIP recommendation. Many public health experts believe that vaccines should be mandated only after adequate financing, supply, and “evidence of long-term safety” are established.²⁰ In addition, many individuals who were concerned about the new vaccine viewed the involvement of Merck, the vaccine manufacturer of HPV4 and HPV9, in state mandate efforts negatively.²¹

HPV vaccination requirements for school entry were successfully implemented in Virginia in 2008 and the District of Columbia in 2009; Rhode Island’s regulation became effective in 2015.¹⁵ A key difference between these 3 jurisdictions was the process for establishing such a mandate. Although Virginia and the District of Columbia passed laws through the legislative process, Rhode Island took a regulatory approach through the rule-making authority of the Rhode Island Department of Health. Another key difference was the populations to which the requirements apply. The mandates for the District of Columbia and Rhode Island apply to both sexes, whereas Virginia’s mandate only applies to girls.^22–24 The District of Columbia’s original mandate, which was passed in 2007, applied only to girls.²⁵ However, in 2014, the rule was amended to clarify that religious exemptions and opt-outs to the HPV vaccination needed to be filed each year they are claimed and also expanded HPV vaccination to include all children in grades 6 through 12.^24,26,27

The 3 jurisdictions also differ in their timing of the vaccine requirement. In Rhode Island, students must receive the first dose before entering the seventh grade, and the series must be completed before entering the ninth grade.²³ In Virginia, the first of 3 doses must be administered before entering the sixth grade, and in the District of Columbia, students entering the sixth grade must receive the first of 3 doses at 11 years of age.^22,24

Although all 3 jurisdictions require the HPV vaccination for school entry, they also have broad exemptions to the requirements, which could temper their impact. Virginia Governor Timothy Kaine’s amendment to Virginia’s legislation (later approved by the General Assembly) allows parents to exempt their child from the vaccination requirement after merely reviewing educational materials about the virus and signing a waiver.^22,28,29 Virginia’s law does not require documentation of the vaccination, unlike with other vaccines; rather, parents and guardians are encouraged to provide such documentation upon their child’s entry to school.²⁸

In the District of Columbia, the Committee on Health amended its bill to add 3 exceptions to the HPV vaccination requirement: (1) when the parent or guardian objected in good faith, in writing, asserting that the vaccine would violate his or her religious beliefs; (2) when the child’s physician certified in writing that the vaccination would be medically inadvisable; and (3) when the parent or guardian opted out for any reason by signing a document stating that the parent or guardian was informed of the vaccination requirement and chose not to participate.^30,31

Rhode Island’s HPV vaccination requirement is subject to the state’s exclusion, waiting period, and exemption rules.^23,32,33 Accordingly, students are exempt from the vaccine only if they have a medical exemption signed by certain health practitioners (e.g., physician, physician assistant, registered nurse practitioner) or if the parent or guardian attests that the immunization conflicts with his or her religious beliefs.³³ However, a spokeswoman for the Rhode Island Department of Health suggested that it will not prohibit schoolchildren who are not vaccinated against HPV from entering school, asserting that “no one’s child is being forced to be vaccinated against HPV,” and that parents can exempt their child “if they feel a deep conviction that HPV vaccination is not right for their child.”³⁴ Whether the spokeswoman was referring to the existing religious and medical exemption found in the regulations or if the Rhode Island Department of Health intends to treat the vaccine differently in practice is unclear.

Lessons Learned

Ten states unsuccessfully proposed legislation on HPV in 2015-2016, but only 3 states (Hawaii, New Jersey, and New York) would have mandated HPV vaccination for school entry.¹⁵ Going forward, other states seeking to create a mandate similar to those in Virginia, the District of Columbia, or Rhode Island need to look to these jurisdictions for lessons learned. One lesson is to gain the support of influential organizations. For example, the American Cancer Society provided a statement supporting the legislation in the District of Columbia, asserting that (1) the US Food and Drug Administration (FDA) determined the vaccine to be safe and effective for females aged 9-26 years and (2) the vaccine “is an extraordinary biomedical advance and holds remarkable potential for preventing the most common kinds of cervical cancer.”³¹ Despite the support of multiple organizations, however, opposition will inevitably arise and will need to be addressed.

Another lesson is that compromises may be needed to ensure passage. Virginia’s General Assembly compromised on several key elements of the legislation, creating “safeguards to make sure it was a cautious [sic] approach.” The first safeguard was to delay the effective date of the requirement. Although it was passed in 2007, the requirement became effective on October 1, 2008, meaning that it did not go into effect until the start of the 2009-2010 school year, which allowed 2 years for parents to prepare for the requirement.²⁸

Furthermore, even after a mandate is passed, jurisdictions should be aware that legislative opposition may continue. Every year since passage of the HPV vaccination mandate in Virginia, members of the General Assembly have introduced legislation to repeal the law, but such attempts have not succeeded.¹⁵ A bill introduced in the Rhode Island General Assembly in February 2016 would restrict the authority of the Rhode Island Department of Health from setting immunization standards for “diseases which are not transmissible in a school environment,” and would have explicitly prohibited the Rhode Island Department of Health from mandating the HPV vaccination as a requirement for school entry (the bill was held for further study on March 31, 2016).³⁵

Public Health Implications

Coverage estimates for HPV vaccination are low despite evidence of the vaccine’s effectiveness and safety. This large pool of unvaccinated adolescents in the United States means that considerable public health benefits are not being realized; many vaccine-preventable cancers caused by HPV will occur. Although numerous jurisdictions have faced difficulty passing an HPV vaccination mandate for school entry, now is an opportune time to move forward. Experts suggest that attempts to mandate the HPV vaccination failed because such attempts were made too closely after FDA approval and the ACIP recommendation. Ten years later, ample evidence supports the safety and effectiveness of HPV vaccines. Mandating HPV vaccination for school entry is a move that will protect the public’s health by preventing HPV-related morbidity and mortality.