The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States, with approximately 6.2 million cases diagnosed annually. There are more than 100 strains of HPV, over 40 of which can cause cervical cancer and genital warts. In June 2006, Gardasil, a vaccine produced by Merck that protects against four 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 in boys and men ages 9 to 26, and the use of another HPV vaccine manufactured by GlaxoSmithKline, Cervarix, for girls and women ages 10 to 25., The federal Advisory Committee on Immunization Practices (ACIP) now recommends routine vaccination against HPV for girls and boys ages 11 and 12.
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 is associated with the vast majority of cervical cancer cases.
In 2008, there were over 529,000 new cases of cervical cancer worldwide, and the overwhelming majority of these women were in developing countries, where cervical cancer screening programs and infrastructures for prevention, diagnosis, and treatment are weak. In the United States, it is estimated that more than 12,000 new cases of invasive cervical cancer and more than 4,000 deaths from cervical cancer occurred in 2007. The lower prevalence of cervical cancer in the United States is attributable to the increasingly widespread use of the Papanicolaou (Pap) test, also known as a Pap smear, which detects changes in cervical tissue and is a major tool in screening for early identification of cervical cancer. The U.S. Preventive Services Task Force (USPSTF) recommends women ages 21 to 65 receive Pap tests at least once every three years. If detected early, cervical cancer is highly treatable. The newest draft recommendations from the USPSTF now include a recommendation against routine HPV testing, which can determine whether the strain is invasive, as evidence shows Pap tests are sufficient prevention tools.
Following the FDA approval of the Gardasil and Cervarix vaccines, ACIP, a committee of the Centers of Disease Control and Prevention (CDC), recommended that the vaccine be administered routinely to girls 11 to 12 years of age, and health provider’s discretion for use in girls and women between the ages of 9 to 26. These recommendations were designed to encourage vaccination before initiation of sexual activity and before exposure to the virus.
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 against two HPV strains, 16 and 18. Since neither vaccine protects against all types of cervical cancer-causing HPV strains, it is still recommended that women receive regular Pap tests. Both vaccines should be administered in three doses over six months, however recently, researchers have been examining whether two doses of the HPV vaccine would be sufficient. Current research suggests the vaccine protection is long-lasting: six years of follow-up data indicate the vaccines are still effective and there is no evidence of waning protection.
While most of the initial focus has been on use of the HPV vaccine in women to prevent cervical cancer, there has been increased attention towards the potential use of vaccines in males. In 2011, ACIP recommended the use of Gardasil for boys and men age 9 to 26 for prevention of genital warts and some penile and anal cancers. ACIP recommends routine use for boys ages 11 and 12, and a "catch up" vaccine for males between ages 13 and 21. ACIP still recommends “permissive use” for men ages 22 to 26, which leaves the decision to the discretion of providers and patients.
Vaccine Utilization and Costs
In 2009, approximately 44% of girls ages 13 to 17 had received at least one dose and 27% had received all three doses. Some parents have not vaccinated their children, with fear of side effects being the most prevalent reason for resistance. While there was an initial push by some groups to mandate use of the vaccine, there was substantial resistance based on limited data about the long-term safety and efficacy of the vaccine, questions about the need for a mandate for a disease that is transmitted sexually, and financing concerns. Vaccine requirements are state-level policies, and currently, Virginia and the District of Columbia require the vaccine for girls’ entry into the sixth grade, but both of these mandates allow exemptions due to religious and personal beliefs. Texas was the first state to enact a mandate in 2007, by executive order under Governor Rick Perry, but legislators overrode this order.
Merck and GlaxoSmithKline are charging $300-$400 for the three doses, making these among the costliest vaccines on the market., As a result of the federal Affordable Care Act (ACA) of 2010, new private plans must cover the full cost of ACIP-recommended vaccines, including the HPV vaccine for females and males. The Vaccines for Children (VFC) program, a federal entitlement program, covers the cost for children under age 19 who are Medicaid eligible, uninsured, underinsured, Alaska Natives, or American Indians. Vaccine coverage is also available for women and men under 21 through the Medicaid Early and Periodic Screening and Diagnostic Treatment (EPSDT) Benefit.
Women 21 and older can face cost barriers to receiving the vaccine. 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. As of 2009, at least 28 states designate coverage for the HPV vaccine. For uninsured, low-income women, Merck and GlaxoSmithKline have established assistance programs to provide free vaccines. Generic versions of the vaccines are not projected to enter the market until 2015 or later.
- What have been the major implementation challenges in the administration of HPV vaccines? How can broader use of the vaccine be encouraged?
- What regulations and policies would allow low-income and underinsured individuals to gain greater access to vaccinations at both the state and federal level? What changes does the ACA make in terms of financing vaccines?
- What are the issues raised by expanding vaccination to boys?
Updated: May 2012