Background Brief

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The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States, with about 6.2 million cases diagnosed annually. [1] There are more than 100 strains of HPV, with over 30 types that can cause cervical cancer and genital warts. In June 2006, a vaccine produced by Merck called Gardasil, that protects against certain strains of HPV, was approved by the U.S. Food and Drug Administration (FDA) for use in girls and women ages 9 to 26. Since that initial ruling, the FDA has also approved the use of Gardasil for the prevention of genital warts in boys and men, ages 9 through 26 and also approved the use of another HPV vaccine manufactured by Glaxo Smith Kline, called Cervarix, for girls and women ages 10 to 25.  While these advances have the potential to benefit the health of many young individuals, policymakers and health professionals are addressing many issues including: public and provider education, health care financing, parental consent and confidentiality, and access to care.

The Basics: HPV and Cancer

HPV is an STI that can be transmitted through genital contact without intercourse. Most HPV infections are asymptomatic and will typically resolve themselves. Certain strains, however, can have serious clinical consequences, including genital warts, cervical cancer, and penile and anal cancers. HPV infection is associated with the vast majority of cases of cervical cancer.

In 2007, there were over 550,000 new cases of cervical cancer worldwide, and approximately 260,000 deaths from cervical cancer. The overwhelming majority of these women were in developing countries, where cervical cancer screening programs and infrastructures for prevention, diagnoses, and treatment are weak. [2] In the United States, the cervical cancer incidence rate is much lower. It was estimated that 11,000 new cases of invasive cervical cancer and approximately 4,000 deaths from cervical cancer occurred in the United States in 2009. [3] This lower rate is attributable to the success of the widespread use of the Papanicolaou (Pap) test, which detects changes in cervical tissue, and is a major tool in screening for early identification of cervical cancer.

If detected early, cervical cancer is highly treatable. In the United States, it is recommended that women receive Pap tests at least once every three years. However, many women still do not receive Pap tests at the recommended frequency. In particular, Asian/Pacific Islander women have significantly lower rates of Pap tests than women of other races. Cervical cancer incidence and mortality are approximately 1.5 times higher among African American and Latina women, compared to White women. [4] Researchers have postulated several reasons for these disparities, including fear, cost, lack of physician referral, and cultural issues. [5] While most of the initial focus has been on use of HPV vaccines in women for prevention of cervical cancer, there has been growing attention to the potential use of vaccines in males for prevention of genital warts as well as some cancers.  In 2009, the FDA approved the use of the Gardasil vaccine for boys and men ages 9-26 for prevention of genital warts.  The CDC’s ACIP did not recommend routine use as it did for females, but instead “permissive use,” which leaves the decision to the discretion of providers and patients.

HPV Vaccines

Following the FDA approval of the Gardasil vaccine, the federal Advisory Committee on Immunization Practices (ACIP), a committee of the Centers for Disease Control and Prevention (CDC), recommended the new vaccine be administered routinely to girls 11 to 12 years of age. Use at a health provider’s discretion was also recommended for girls and women between the ages of 9 to 26. [6] These recommendations were designed to encourage vaccination before initiation of sexual activity, and were based on data from clinical trials demonstrating a greater immune response in girls ages 10 to 15 compared to young women ages 16 to 25. [7]  Research is under way to examine whether use of HPV vaccines should be expanded to a broader age group of women.

Gardasil prevents infection of four strains of HPV—two strains (16, 18) that cause 70% of cervical cancer cases and two strains (6, 11) that cause 90% of genital warts cases. The Cervarix vaccine, which is used more broadly in several countries outside the U.S., protects only against HPV strains 16 and 18. Neither vaccine protects against all types of cervical cancer-causing HPV. Therefore, regular Pap tests remain a critical tool for early detection of precancerous cells. [8] Gardasil should be administered in three doses over six months. Presently, there is only enough research to show vaccine effectiveness for 5 years. Further research will determine whether booster shots are needed. Furthermore, clinical trials were conducted in 9- to 26-year-old females, so effectiveness is only known for this age group, not for older women or males. [9]

Vaccine Implementation and Costs

ACIP recommendations are followed closely by health care professionals. Health care professional associations often base their own policies off of these recommendations. [10] After ACIP makes its recommendations, each state decides whether the vaccine should be required for entry into childcare or school. [11] There are no federal laws that mandate vaccination; thus, mandatory vaccination laws will vary from state to state. While there was an initial push by some groups to mandate use of the vaccine, there was substantial backlash, based on a number of factors, including limited scientific data about the long-term safety and efficacy of the vaccine, questions about the need for a mandate, and commercial marketing strategies.  As a result, few states have adopted mandates.

Another hurdle for broader use of the vaccine is the cost. Merck and GlaxoSmithKline are charging $300-$400 for the three doses, making these among the costliest vaccines on the market. [12] Private insurance companies usually cover ACIP-recommended vaccines, so most insured individuals will likely have coverage, although it is still too soon to tell. The Vaccines for Children (VFC) program, a federal entitlement program, covers the cost for children under age 19 who are uninsured or underinsured, on Medicaid, Alaska Natives, or American Indians. [13]

However, for women 19 and older, the policies are different. Under Medicaid—the primary form of coverage for low-income women—vaccines are considered an "optional" benefit, which means that each state decides whether or not it will be a covered service, and it is not clear how many states have opted to cover the vaccine. For uninsured women, Merck established an assistance program to provide free vaccines, including Gardasil, to uninsured and low-income adults ages 19 and older who visit private practices that already provide Merck vaccines. [14] Many uninsured women in this age group rely on publicly funded clinics and health centers, not physicians in private practice.

Public Acceptability

Numerous studies have evaluated acceptability and attitudes regarding the use of the HPV vaccine. A review of research regarding STI and HPV vaccine acceptability indicates that health care providers and professional health organizations play a large part in a parent’s decision to vaccinate his or her child. Parents are more likely to follow the recommendations and information put forth by health care providers, and health care providers are more apt to follow a professional health organization’s endorsement of a vaccine. [15] In 2008, it was estimated that 37% of girls ages 13 to 17 in the U.S. had received at least one dose of the Gardasil vaccine. [16]

The approval of these vaccines holds great promise for millions of women world wide. Not only can it greatly reduce deaths attributable to cervical cancer, but it also has the potential to reduce the economic and emotional burdens that women experience when they are faced with an abnormal Pap smear that requires further testing and treatment. The key to the success of this new vaccine will be in how policymakers, health care providers, parents, and women and girls respond to make sure that all those who can benefit from this new technology have access to it.

Discussion Questions

• What have been the major implementation challenges in the administration of HPV vaccines? How have policymakers addressed access to the vaccine? What are the future directions regarding implementation?
• What regulations and policies are needed to allow low-income and underinsured individuals to gain greater access to vaccinations at both the state and federal level?
• What issues have been raised in efforts make the HPV vaccine mandatory?
• What else can be done to decrease cervical cancer incidence and mortality rates? What can be done to address racial and ethnic disparities in terms of access to screenings?

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[1]  The Centers for Disease Control and Prevention, HPV and HPV Vaccine – Information for Healthcare Providers, June 2008.
[2]  World Health Organization, Comprehensive Cervical Cancer Control: A Guide to Essential Practice, 2006.
[3]  American Cancer Society, What Are the Key Statistics About Cervical Cancer, 2009.
[4]  The Centers for Disease Control and Prevention, United States Cancer Statistics: 2002 Incidence and Mortality, 2005.
[5]  The Office of Minority Health, Eliminate Disparities in Cancer Screening & Management, June 30, 2006.
[6]  The Centers for Disease Control and Prevention, CDC Press Briefing: ACIP Recommends HPV Vaccination, June 29, 2006.
[7]  Center for Biologics Evaluation, Product Approval Information – Licensing Action, June 2006.
[8]  The Centers for Disease Control and Prevention, HPV Vaccine Questions and Answers, June 2006.
[9]  Ibid.
[10]  The Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP), June 2006.
[11]  National Vaccine Information Center, State Exemptions, June 2006.
[12]  Monie, et al. 2008. Ceravix: A Vaccine for the Prevention of HPV 16,18-associated Cervical Cancer, Biologics:Targets & Therapy 2(1)
[13]  The Centers for Disease Control and Prevention, Vaccines for Children (VFC) Program, July 19, 2006.
[14]  Merck, Merck Vaccine Patient Assistance Program, 2009.
[15]  Zimet, G.D. December 2005. Improving Adolescent Health: Focus on HPV Vaccine Acceptance. Journal of Adolescent Health 37(6):S17–23.
[16]  The Centers for Disease Control and Prevention, Naitonal, State, and Local Area Vaccination Coverage Among Adolecents Aged 13-17 Years--U.S., 2008.

Acknowledgements:  Heidi Hisey, Jane An, Usha Ranji, and Alina Salganicoff of the Kaiser Family Foundation.
Updated: February 2010.

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