The authors of a new Rice University Baker Institute for Public Policy briefing paper advocate that the state of Texas create a program for adolescents to obtain the full series of human papillomavirus (HPV) vaccine shots. HPV is a sexually transmitted virus known to cause cancer.
The paper, entitled “Human Papillomavirus Vaccine: A Public Health Opportunity for Texas“, co-authored by fellow in science and technology policy Kirstin R.W. Matthews, Ph.D. and Contributing Expert for Science and Technology Policy and research analyst in the Institute’s Science and Technology Policy Program Monica M. Matsumoto, proposes a set of policy recommendations for increasing vaccine coverage, including school-entry mandates and educational campaigns targeting parents and physicians.
The coauthors say that in the United States, human papillomavirus (HPV) infections affect more than 79 million men and women, and account for more than 4,000 deaths from cervical cancer annually (Markowitz et al. 2014), and that globally, some 530,000 new cases of cervical cancer — almost always caused by HPV — are diagnosed each year.
In a brief historical review, they note that the US Food and Drug Administration (FDA) licensed the first HPV vaccine to prevent the spread of four prevalent forms of the virus associated with cervical cancers and genital warts in 2006, and that these vaccines hold the potential to save thousands of lives, especially as no cure currently exists. However, Dr. Matthews and Ms. Matsumoto observe that political controversy that has erupted regarding HPV vaccine, such as religious objection to affirming any public policy measure funded by taxpayers that could be interpreted as condoning sexual activity among adolescents has limited the vaccine’s acceptance and use among the public, which the coauthors contend potentially jeopardizes an opportunity to reduce cancer rates in Texas and the broader United States. Put bluntly, some parents express concern that the HPV vaccine will increase rates of sexual activity, acting as a “license for sex,” ad vaccine opponents, especially advocates of abstinence-only prevention, contend that HPV vaccination may provide a false or inflated sense of protection against STIs.
The coauthors note that upon introduction, HPV viruses cause epithelial cells to grow quickly and uncontrollably. In most cases HPV is not life threatening, ninety percent of HPV infections disappear within two years, and the body is usually able to respond and clear the infection without medical intervention. However, if the immune system is unable to eliminate the infected cells, viral activity may persist to form lesions and eventually tumors, which in some cases can become cancerous. The process is insidious, and the period between initial HPV infection and tumor formation may be as long as several decades.
And with approximately 40 different HPV types that spread through direct skin-to-skin sexual contact, HPVs are the most prevalent sexually transmitted infections (STI) in the United States — indeed so common that the majority of sexually active men and women in the United States will become infected at some point in their lifetime. From 2006 to 2010, approximately 33,000 cancers diagnosed in the United States were associated with HPV infections, including 10,400 cervical cancers. Two high-risk HPVs — types 16 and 18 alone — are linked to 70 percent of cervical cancers; 85 percent of anal cancers; and roughly half of vaginal, vulvar, and penile cancers. The coauthors report that oropharyngeal cancer, which affects the back of the tongue, tonsils, and middle of the throat, is on the rise, and more than two-thirds of cases have been linked to HPV-16.
Dr. Matthews and Ms. Matsumoto observe that while there is no cure for an HPV infection, many symptoms, including warts and precancerous lesions, can be treated with drugs, cryosurgery, electrosurgery, and laser surgery, among other options, and that treatment for cancer patients with or without HPV infections is generally the same. Prior to availability of HPV vaccine, the only way to prevent HPV infections was to avoid all skin-to-skin sexual contact, but two vaccines, Cervarix and Gardasil, have been developed to prevent the HPV infections most commonly associated with genital warts and cancer.
Merck & Company’s Gardasil vaccine was approved by the FDA in 2006, and provides protection against four HPV types: 6, 11, 16, and 18 — targeted because of their association with cervical cancers (i.e., HPV-16 and -18) and genital warts (i.e., HPV-6 and -11). The coauthors cite research showing that Gardasil has proved 90 to 100 percent effective at preventing infection from the four targeted HPV strains over three years, and it has also been approved for use in males to prevent genital warts and anal cancer.
GlaxoSmithKline’s Cervarix was created in 2009 to protect against the two most common high-risk viruses — HPV-16 and -18 — in women.
Because the vaccine is still relatively new, duration of its protection is unknown. Dr. Matthews and Ms. Matsumoto say current research indicates vaccine efficacy for both Cervarix and Gardasil remaining high for at least eight years.
Gardasil has been approved for both males and females in the 9- to 26-year-old age range, while Cervarix has been approved only for females in the 10- to 25-year-old age range. The sometimes contentious point is that since the HPV vaccine is a preventive measure and has no effect on persons already infected with HPV, vaccination is recommended before onset of sexual activity, and the CDC’s Advisory Committee on Immunization Practices (ACIP), with endorsement from the American College of Obstetricians and Gynecologists, recommends routine HPV vaccine for both girls and boys aged 11 to 12 in the United States. The American Cancer Society makes similar recommendations for girls but currently has no recommendations for males.
Dr. Matthews and Ms. Matsumoto note that over 100 countries have licensed HPV vaccine, and the United Kingdom has achieved over 80 percent coverage through its school- based program. Several other countries, including Canada, Rwanda, Malaysia, and Germany, have also begun offering the HPV vaccination for female adolescents as part of their routine vaccinations covered by government funding.
In the paper, Dr. Matthews and Ms. Matsumoto review a range of potential barriers to HPV vaccination programs including access, cost, misinformation, and politics, and cite CDC director Tom Frieden observing that one of the top reasons for low uptake of the HPV vaccine is because doctors didn’t recommend it, citing broader research studies showing that, in general, a physician’s recommendation to vaccinate is the single most influential factor in determining whether parents get their children vaccinated. Specifically, female adolescents whose health care provider recommends the HPV vaccine are five times more likely to receive it than adolescents who did not receive the recommendation. In 2013 only 57 percent of girls between the ages of 13 and 17 in America had received the HPV vaccine, and fewer than 38 percent had received all three doses.
As to cost, the vaccine being priced at $130-300 per dose is a significant inhibition for many families if it has to be funded out of pocket, driving the cost of the recommended three-injection regimen as high $900. And unlike a simple flu shot, the HPV vaccine requires a doctors prescription and visit, which increases the overall financial and logistical obstacles.
However, the coauthors note that due to ACIPs recommendations, health insurance must cover the three-shot innoculation series, and that in an effort to reduce impediments to access, Merck and GlaxoSmithKline offer assistance programs, such as free or discounted HPV shots for patients with qualifying financial needs.
Meanwhile, federal programs including the Vaccines for Children Program, Medicaid, and the Immunization Grant Program cover ACIP-recommended vaccines for qualifying youth .
Dr. Matthews and Ms. Matsumoto point to HPV infections and associated cancers becoming a major issue in Texas, with cervical cancer rates in the state are notably higher than the national average, and despite these statistics, only 32 percent of 13- to 15-year-old girls in Texas had received all three doses of the HPV vaccine in 2011, with the data showing that the state’s lowest coverage rates in 2011 were centered around the two most populous cities: Houston (27 percent) and Dallas (23 percent).
By contrast, El Paso County’s strong public HPV vaccination program appears to have effectively boosted local coverage rates, with 75 percent receiving one dose and 45 percent receiving three doses of the vaccine, although vaccination rates overall remain far below the DHHS goal of 80 percent three-dose coverage. Dr. Matthews and Ms. Matsumoto note that the HPV vaccine has been a particularly politicized subject in Texas, with the Texas Legislature In September 2007 enacting H.B. 1098, which removed a prior executive order by Governor Rick Perry mandating the HPV vaccine for girls entering middle school. They observe that currently, Texas is without a policy on HPV vaccinations and is thus missing out on a public health opportunity.
You can access the CDC’s interactive cancer statistics map here:
A Rice news release says that Gardasil maker Merck has suspended its state lobbying efforts throughout the country, and although safety and efficacy of the vaccine continue to be supported by research studies, public skepticism about the vaccine has persisted.
“With the current low national levels of coverage, routine HPV vaccination for both boys and girls will quickly provide the highest level of immunity until widespread vaccinations for girls can be achieved,” Dr. Matthews says. “The vaccine is an effective means to reduce the risk of contracting a host of potential health problems, and both scientists and public health experts recognize its safety and efficacy. The administration of the vaccine during early adolescence is a well-informed preventive health measure.”
On Dec. 3, Rice University’s Baker Institute for Public Policy will host a public discussion on HPV vaccinations and Texas public health. For more information and to register, visit:
Policy Brief Paper “Human Papillomavirus Vaccine: A Public Health Opportunity for Texas” (PDF):
Rice University’s Baker Institute for Public Policy
Centers For Disease Control And Prevention
Rice University’s Baker Institute for Public Policy
Centers For Disease Control And Prevention