The HPV Vaccine: Access and Use in the U.S.
The human papillomavirus (HPV) vaccine is the first and only vaccination that helps protect individuals from getting many different types of cancer that are associated with different HPV strains. The vaccine protects young people against infection from certain strains of HPV, the most common sexually transmitted infection (STI) in the United States. Since HPV vaccines were first introduced in the U.S. in 2006 there have been changes in the range of protection they offer and the dosing regimen. The vaccines were originally recommended only for girls and young women and were subsequently broadened to include boys and young men. This factsheet discusses HPV and related cancers, use of the HPV vaccines for both females and males, and insurance coverage and access to the vaccines.
HPV and Cancer
There are more than 150 strains of HPV, and while most cases of HPV infection usually resolve on their own, there are more than 40 strains that can cause cancer. HPV is the most common STI in the U.S. and is often acquired soon after initiating sexual activity. Approximately 42.5 million Americans are infected with HPV and there are more than 13 million new infections annually. More than 43% of American adults ages 18-59 are infected with genital HPV, with higher rates among men (45%) than women (40%). HPV-related cancers have increased significantly in the past 15 years — in 2015, 43,000 people developed an HPV-related cancer compared to 30,000 in 1999. While HPV-related cervical and vaginal cancer rates have decreased in recent years, rates for oropharyngeal and anal HPV-related cancers have increased.
U.S. Preventive Services Task Force Cervical Cancer Screening Recommendation
The USPSTF recommends screening for cervical cancer in women age 21 to 29 years with cytology (pap smear) every 3 years, and for women 30 to 65 a screening with cytology alone every 3 years, or a high risk human papillomavirus (hrHPV) test every 5 years, or cytology in combination with a hrHPV every 5 years.
HPV is related to over 90% of cervical cancer cases, with two strains (16 and 18) responsible for approximately 70% of cervical cancer cases. Most cases of cervical cancer occur in women in developing countries, but it remains a challenge in the U.S. In the U.S., it is estimated that over 14,480 new cervical cancer cases will be diagnosed in 2021. While cervical cancer is usually treatable, especially when detected early, more than 4,290 deaths from cervical cancer will occur in 2021. Guidelines by the U.S. Preventive Services Task Force (USPSTF) recommend that most women ages 21 to 65 receive a Pap test once every three years and recommends that women over 30 get a high-risk HPV test every 5 years.
- Overall, cervical cancer rates have fallen in the U.S. Between 1999 to 2015, cervical cancer rates decreased by 1.6% a year, a continuation of a trend since the 1950s as a result of cancer screenings. Cervical cancer is the most common HPV-related cancer among women.
- Despite widespread availability of pap testing, disparities in cervical cancer incidence and mortality rates by race persist in the U.S. While Hispanic women have the highest incidence of cervical cancer, their cervical cancer mortality rates are comparable to the national mortality rates. Black women, on the other hand, have the second highest incidence of cervical cancer and the highest mortality rates of the disease (Figure 1). Compared to women with insurance, uninsured women are less likely to access preventive health services such as Pap tests. Higher shares of Hispanic and Black women have never been screened for cervical cancer compared to White women (14% and 12% percent, respectively, compared to 6% of White women). This could be due to differences in insurance coverage. Hispanic women have the highest uninsured rates in the country (23%) compared to 8% of White women and 12% of Black women. More than half of cervical cancer cases are detected in women who have never been screened or have not been screened as frequently as recommended in guidelines.
- One notable paradox however, is that Black women also have the highest rates of recent Pap testing to screen for the disease yet experience the highest mortality rate from cervical cancer. Seventy-nine percent of Black women ages 21 to 49 reported having received a Pap smear in the past two years compared to 68% of White women, 66% of Hispanic women and 65% of Asian women. Lower rates in follow-up treatment after an abnormal pap smear, differences in tumor biology, limited access to treatment, diagnosis at later stages of disease progression, and distrust in the medical system may account for some of the disproportionate impact of cervical cancer on Black women.
- The racial disparity in mortality rates between Black and White women may be greater than previously thought. A study found that when excluding women who have had hysterectomies (which typically involves removing the cervix and eliminates the risk for cervical cancer) from the sample, mortality rates were 77% higher among Black women and 46% higher among White women.
- Cervical cancer screening rates declined during the early part COVID-19 pandemic. One study found that between March 15 and June 16, 2020, about 40,000 cervical cancer screenings were missed. Another found that during California’s first stay-at-home order, cervical cancer screenings decreased by about 80% among women in the Kaiser Permanente Southern California network. While cervical cancer screening rates have rebounded to a degree, they have not returned to pre-pandemic levels.
- A KFF survey of OBGYNs found that 71% of physicians reported that it was difficult to provide preventive reproductive health care services, like STI and cervical cancer screenings, during the COVID-19 pandemic. In that same survey, 38% of OBGYNs said they were somewhat or very worried that their patients who experienced delays in following up on abnormal pap smears because of the pandemic would face negative health care consequences.
Oropharyngeal and Anal Cancers
- Approximately 19,775 cases of oropharyngeal (throat) cancer occur annually in the U.S, most (70%) of which are probably caused by HPV. Oropharyngeal cancers are now the most common HPV-associated cancer, surpassing cervical cancer. However, it’s important to note that smoking and alcohol use are also risk factors. Oropharyngeal cancers are more common among men than women (Figure 2). Research suggests that HPV vaccines can help protect against throat cancer, since many are associated with HPV 16 and 18, two of the strains that the vaccine protects against.
- HPV is also responsible for the majority (91%) of the over 7,000 annual cases of anal cancer in the U.S. Most cases of anal cancer are among women, but men who have sex with men are also at higher HPV strains 16 and 18, as well as a history of cervical cancer, and suppressed immune systems are all risk factors for anal cancer. Like oropharyngeal cancer, there has been an increase in the rate of anal cancers in the past 15 years.
Since 2017, Gardasil®9 is the only HPV vaccine available in the U.S.
- The FDA first approved first-generation Gardasil®, produced by Merck, in 2006, which prevented infection of four strains of HPV – 6, 11, 16, and 18. In December 2014, Gardasil®9 was approved by the FDA. This vaccine protects against 9 strains of HPV: the four strains approved in the previous Gardasil vaccine, as well as 31, 33, 45, 52, and 58.
- These strains are associated with the majority of cervical cancer, anal cancer, and throat cancer cases as well as most genital warts cases and some other HPV-associated ano-genital diseases.
- The vaccine was initially approved for cervical cancer prevention, but in 2020 the FDA broadened its approval to include the prevention of oropharyngeal cancer and other head and neck cancers.
- Gardasil®9 has been approved by the FDA for use in males and females ages 9 to 45.The federal Advisory Committee on Immunization Practices (ACIP) recommends that all girls and boys get vaccinated at age 11 or 12, or as early as age nine, and that adolescents and young adults ages 13-26 be given a “catch-up” vaccination.
- ACIP now recommends that 9–14 year old teens receive two doses of the HPV vaccine over six to 12 months, instead of the original recommendation of three doses. Teens and young adults who initiate vaccination at age 15 through 26 should receive three doses over six months.
- These recommendations are designed to promote immunization when the vaccine is most effective – before the initiation of sexual activity and exposure to HPV. Those already infected with HPV also can benefit from the vaccine because it can prevent infection against HPV strains they may not have contracted, but the vaccine does not treat existing HPV infections. Additionally, the vaccine elicits a higher immune response from adolescents ages 11 to 12 than in older teens.
- While the FDA expanded its approval of the HPV vaccine to include adults ages 27 to 45, ACIP does not recommend routine catch-up vaccinations for all adults in this age group. ACIP recommends that adults ages 27 to 45 who have not been properly vaccinated who may be at risk for new HPV infections consult with a medical professional about receiving vaccine.
- The HPV vaccine, as well as all other routine vaccines, may be administrated on the same day as any of the COVID-19 vaccines or within 14 days.
- Since the HPV vaccine was first introduced, there has been a significant decline in the prevalence of four HPV strains included in the first Gardasil vaccine (4vHPV) (Figure 3). Compared to the years prior to the vaccine being introduced (2003–2006), there has been an 88% decline in the prevalence of 4vHPV types among young women ages 14–19 and an 81% decline among women ages 20–24. There have also been declines among unvaccinated women, suggesting that herd immunity may be occurring due to a decrease in 4vHPV types circulating because of HPV vaccines.
- Current research suggests the vaccine protection is long-lasting: more than 10 years of follow-up data indicate the vaccines are still effective and there is no evidence of waning protection, although it is still unknown if recipients will need a booster.
Outreach and Utilization
Awareness of the importance of the HPV vaccine has grown, and take-up has increased since it entered the market.
- In 2019, over half of adolescents aged 13-17 were up-to-date with their HPV vaccinations (HPV UTD) (Figure 4). Asian and Hispanic adolescents and adolescents with Medicaid coverage were more likely to be HPV UTD compared to White adolescents and adolescents with private insurance or who were uninsured. HPV vaccination rates among teen boys are lower than for girls (52% vs. 57% HPV UTD in 2019), but they have been rapidly rising since 2011.
- Some people begin the vaccine series but do not complete it. In 2019, 73% of adolescent girls and 70% of boys received at least one dose of the HPV vaccine.
- HPV vaccination rates vary by state, from 31%% of adolescents being HPV UTD in Mississippi to 79% in Rhode Island. (Figure 5). Hawaii, Rhode Island, Virginia, and D.C. have laws that require HPV vaccination for school entry. D.C. and Virginia require the HPV vaccine for girls to enter the sixth grade, but allow parents to opt out of the requirement due to medical, moral, or religious opposition. Rhode Island requires all seventh-grade students to be vaccinated. State laws regarding HPV have been controversial because of concerns that HPV vaccinations may encourage risky sexual behaviors among teens. However, a recent study found that state laws regarding HPV vaccination and education are not associated with changes in adolescent sexual behaviors.
- There have been relatively few adverse events reported after HPV vaccination. Commonly reported symptoms include injection-site reactions such as pain, redness and swelling, as well as dizziness, fainting, nausea, and headache. A review of eight years of post-licensure follow-up studies of Gardasil® worldwide found no serious health risks associated with the vaccine.
There are multiple sources of private and public financing that assure that nearly all children and young adults in the U.S. have coverage for the HPV vaccine. Many of the financing entities base their coverage on the recommendations of the CDC’s Advisory Community for Immunization Practices (ACIP) an independent body of experts that issues the immunization recommendations for the U.S. population.
- The Affordable Care Act (ACA) requires most private insurance plans to cover some recommended preventive services and ACIP recommended immunizations without consumer cost-sharing. Plans must cover the full charge for the HPV vaccine for the recommended populations, pap tests, and HPV testing for women.
- Medicaid — The Vaccines for Children Program pays for vaccinations for all children through age 18 with Medicaid. Women and men ages 19 and 20 with Medicaid are covered for all ACIP-recommended vaccines as an Early and Periodic Screening Diagnosis and Treatment program (EPSDT) service. Adults who qualified for Medicaid as a result of the ACA expansion are covered for the vaccine, HPV testing, as well as pap tests without cost-sharing because Medicaid expansion programs are subject to the same coverage requirement for preventive services as private plans. For adults 21 and older who qualify for Medicaid through other eligibility pathways, vaccine coverage is an optional benefit and is decided on a state-by-state basis. As of 2015, at least 39 states and DC
- Vaccines for Children (VFC) Program — This federally-financed pays for vaccines recommended by the ACIP for children ages 18 and under who are either Medicaid-eligible, uninsured, American Indian or Alaska Native, or underinsured. ACIP recommended VFC coverage for Gardasil 9 in February 2015 for males and females ages 9 through 18.
- Immunization Grant Program (Section 317 of the Public Health Service Act) — Provides grants to states and local agencies to help extend the availability of vaccines to uninsured adults in the United States. These are often directed towards meeting the needs of priority populations, such as underinsured children and uninsured adults. Merck has also established assistance programs to provide free vaccines to uninsured low-income adults in the United States.
- Children’s Health Insurance Program (CHIP) — State CHIP programs that are separate from their Medicaid programs must cover ACIP-recommended vaccines for beneficiaries since they are not eligible for coverage under the federal VFC.
The HPV vaccine has been available in the U.S. for several years and uptake has risen. Since its introduction in 2006, the vaccine covers more strains of HPV, its use has been extended to males as well as females, the dosage has dropped from three to two shots, and the cost is fully covered by private insurance and public programs. With these improvements, the vaccine holds the promise to safely and dramatically reduce rates and prevent many kinds of cancers that have long been responsible for the deaths of women and men across the United States and the world.