In February of 2007, controversy erupted when Texas became the first state to successfully pass a mandate requiring that all girls entering the sixth grade receive the Human Papillomavirus (HPV) vaccine. Eight months before in June of 2006, Gardasil— produced by the pharmaceutical company Merck—became the first HPV vaccine approved by the Food and Drug Administration (FDA) in the United States. Growing outcries against rushing to mandate such a new vaccine resulted in the overruling of Texas’s mandate later in 2007. Although the bill was eventually overruled, Texas was not alone— at least 23 other states in 2007 proposed some kind of HPV vaccine mandate. Though the original controversy climaxed in the first few years after the new vaccine’s FDA approval, the controversy has now shifted to revisiting the need for state mandates of the vaccine because the vaccine has been approved for almost ten years. State governments who have not yet passed an HPV vaccine mandate should reconsider their decision because the vaccine could be more cost-effective in the long-term, its safety and efficacy have been shown over a longer period of time, and reconsidering demonstrates concern for their population’s health and well-being.
Considering the implementation of a new vaccine mandate requires the government to inevitably consider cost. Nosayaba Osazuwa-Peters—assistant professor of otolaryngology (study of diseases of the ear and throat) at Saint Louis University, School of Medicine—deliberates in his article whether or not the United States should expand its HPV vaccine policy and writes this regarding the issue of cost: “It is evident that uptake of the HPV vaccine will always result in some kind of cost for both the government and individuals whether the HPV vaccine is mandated or not” (Osazuwa-Peters 5503). While this statement may seem blatantly obvious, it is important to understand that the cost of the vaccine itself and its administration is just part of the issue. Determining the amount that the government and individuals will pay is a much larger part of the issue. State governments must weigh how much they are willing to pay as well as how much individuals are willing to pay.Because the vaccine can protect against common strands that cause cervical cancer, the National Cancer Institute (NCI)—an agency of the U.S. Department of Health and Human Services— has conducted research about HPV disease and HPV vaccines and has also compiled information for the public’s use, such as information about cost. According to the NCI website, “[t]he retail price of the [HPV] vaccines is approximately $130 to $160 per dose,” but if clinics and hospitals account for variables such as staff time or vaccination equipment, they may charge additional fees for the administration of the vaccine (Human Papillomavirus (HPV) Vaccine). Upon seeing the retail price of the vaccine and the possibility of additional administration fees, individuals may be misled to believe that this is the final amount they will be paying. Some insurance plans require the individual to pay out-of-pocket, but Medicaid and most private insurance companies under the Affordable Care Act fully or partially cover the costs of HPV vaccination— much like a college offering grants and scholarships to decrease the retail price of tuition. Vaccine manufacturers also offer assistance programs to those with financial need. Assuming that the state purchases all the vaccines that are distributed through healthcare providers, the small amount individuals may pay is just a fraction of what the government pays to make the vaccine readily available and affordable for individuals at virtually every income level.
Because the HPV vaccine is relatively accessible and affordable to the general public already, passing a mandate would ideally increase vaccine uptake while maintaining low costs for individuals. By making the vaccine mandatory, the increase in demand would likely raise vaccine prices, which seems problematic for both individuals and the government, but the change in cost for individuals would likely be insignificant. The government would be more greatly affected by the price change because it already pays the majority of the cost.
It would seem that this would be less than ideal for state governments, who would now pay for HPV vaccines in addition to cancer screenings. While it is true that vaccines cannot replace cancer screenings, studies argue that the hundreds of dollars in initial vaccine cost to purchase two or three doses per individual may still be more cost effective in the long term by preventing cervical cancer and decreasing billions of dollars in cancer treatment costs covered by the state, which could have been prevented by vaccine protection.
Some authorities estimate the economic burden of HPV infections and their sequelae to cost $5 billion per year in the United States alone. Sanders and Taira found that vaccinating all 12-year-old girls in the United States against high-risk HPV types would be cost effective and prevent more than 1300 deaths during this population’s lifetime. The cost per quality-adjusted life year (QALY) from vaccinating against only types 16 and 18 (not including types 6 and 11) is in the range of $15,000-$25,000 per QALY. (Vamos, McDermott, and Daley 306)
In addition to the long term savings, the HPV vaccine could provide better quality of life for the population and save lives. The long term savings and increased quality of life for those protected against HPV are of greater value than the initial cost to administer the vaccine. If cost is restricting HPV vaccine policies, maybe it is time for state governments to reprioritize the monetary cost of the vaccine and the cost a life that could have been saved.
When the HPV vaccine was first approved by the FDA and introduced in 2006, the public was skeptical about the safety and efficacy the new vaccine. Although no serious side effects where associated with the vaccine, at least 82 adverse reactions to the vaccine were reported (Vamos, McDermott, and Daley 305). Additionally, the vaccine only protects against select strains of HPV. At a glance, it appears that the government overlooked or ignored these issues, but these problems must be put into context. With more than 11,000 females clinically tested, the vaccine’s safety and efficacy were proven in these clinical trials, sufficiently supported by a significant amount of data, and confirmed in the consumer market (Vamos, McDermott, and Daley 303). Roughly 82 of more than 11,000 cases reported adverse reactions, which were rare. Additionally, these commonly occurring side effects associated with other vaccines— including nausea, fever, rashes, and fainting spells— were not life-threatening. If the event that an injury or death would occur because of an adverse reaction to the vaccine, the National Childhood Vaccine Injury Act Program would provide compensation (Song, Silva, and Jenkins-Smith 529). Though the vaccine does not protect against every strain of HPV, it is clinically proven to be 100% effective against types 16 and 18 (which cause 70% of cervical cancers) and types 6 and 11 (which cause 90% of genital warts). Once an individual receives the HPV vaccine, it is believed to be effective for the rest of his or her life, but sometimes boosters are recommended because the length of efficacy has not yet been determined. Although more research is needed to establish a definitive length of efficacy, it does not detract from research showing that the vaccine is effective in protecting against common strains most often causing cancer and has lowered levels of HPV and cervical cancer. Lauri Markowitz and a group of experts analyzed National Health and Nutrition Examination Surveys from 2003-2006, before the HPV vaccine was introduced, and from 2007-2010, after the HPV vaccine was introduced. Their analysis showed that HPV prevalence declined from 11.5% in 2003-2006 to 5.1% in 2007-2010 after the introduction of the vaccine, a 56% decline (Markowitz, et al. 387). The potential health benefits far outweigh potential health risks.
Some state governments have made the HPV vaccine compulsory on the basis of safety, protection, and overall health of the state population (Mah, et al. 1850). Some parents oppose these mandates because they believe that immunization for a sexually transmitted infection is an individual matter for their child, disempowering the government’s claim to respond to a public health matter. It may be an individual matter in the regards that parents have the right to raise their children according to their personal religious, philosophical, or moral views about sexuality (Song, Silva, and Jenkins-Smith). The government respects these freedoms, and most states that have required the HPV vaccine have policies that entail a formal opt out for families with any religious, philosophical, or moral conflicts.
Two states, however, do not provide a formal opt out. In these states where HPV poses a higher threat, the protective measure of passing a mandate with no opt out was taken. While the government respects individual rights and freedoms, it will not compromise the general public’s well-being for the sake of an individual’s rights, according to John Stuart Mill’s harm principle. “The philosopher JS Mill, while a staunch proponent of individual liberty, recognized in his essay On Liberty in 1859, “‘the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others’” (qtd. In Miller 3).
It is hard to distinguish if the matter is truly individualistic or collectivistic and at which point it transitions from a personal matter to a collective matter because these ideas overlap. Although not every child may be at a high risk of contracting HPV, if the number of HPV cases are steadily rising and an epidemic breaks out, it becomes a public health matter even though not every individual was afflicted. Parents and state governments have different roles in children’s lives, but parents and government overlap by sharing the common goal of protecting and promoting the health of their children. Proposing a vaccine mandate would convey the government’s concern for the health and well-being of children and the entire population.
States take into consideration the prevalence of the HPV disease in their area of the country, which is tied to the need for the HPV vaccine. Individual states play a part in the larger issue of national health, and they also play a part in an even larger issue of global health. Although HPV may be a less frequently occurring disease across the country, especially in certain states, it is a high-risk disease that is prevalent in many developing countries across the world (Schwartz 1844). Though it is unlikely that an epidemic would break out in United States, higher potential for an HPV outbreak elsewhere in the world still exists, and that outbreak could become an epidemic that could certainly spread to the United States if not properly handled in a timely manner. States may dismiss the likelihood of such an epidemic happening, but the recent HIV/AIDS epidemic continues to plague countries across the world. States should also consider their role in national and global health in their decisions.
Many underdeveloped countries suffer from disease, but because of poverty levels, individuals cannot receive proper healthcare, even if the government would be able to fund it, including accessing vaccines. While a vaccine has specifically been created to combat HPV disease, those who are most afflicted by HPV will probably never be able to receive it and have no choice in the matter. These individuals cannot pay on their own, insurance does not exist, and vaccine programs are not in place. For the small percentage who could possibly afford it, the vaccine may not be readily available. The vaccine that someone has access to but is declining in the U.S. is the same vaccine that a mother half-way around the world wishes she could afford for her daughter, that a young woman with cervical cancer wishes she could have received, or that could have saved the life of a loved one who died much too young. In a prosperous country like the U.S., it is easy for people to lose sight of the many healthcare advantages they have compared to the rest of the world, with HPV immunization being one of them (Schwartz 1843). People willing choose not to take advantage of this immunization. It must be a shame not only for people across the world who could greatly benefit from it but also for the people who saw an opportunity to improve the quality of lives and decided to dedicated their time and talents to create the HPV vaccine.
The vaccine is no longer new, but lingering concerns about cost, safety and efficacy, and the roles of government and parents in deciding what is best for the child still remain. Cost will always be an issue. The initial safety and efficacy of the vaccine were proven in clinical studies before its FDA approval, and after almost ten years since then, those clinical studies have been confirmed in the consumer market. Instead focusing on who holds the right to make decisions concerning a child’s welfare, the government and parents should readjust their focus to the health issue at hand and recognize that they both want to promote and protect the child’s health. The heat of the mandate controversy may have faded, but HPV disease is not fading. Much more has been learned about the HPV vaccine since the controversy’s start in 2007, and now it is time for state governments who have not required the HPV vaccine to reconsider for the good of the greater population and future generations.