Ethics & the Human Papillomavirus Vaccine
The objectives of this learning scenario created by NYU Langone’s High School Bioethics Project are to understand the fundamentals of cervical cancer screening, epidemiology, progression, and treatment; explore the ethical principles underlying pediatric reproductive decision-making; and discuss the public health model that informs mandatory childhood vaccination.
Curriculum Integration Ideas
This material may be used in life sciences classes during units for topics including the following:
- human reproduction and sexually transmitted diseases
- human physiology including cancer screening and prevention
- public policy discussions on pediatric vaccinations
Overview of Cervical Cancer
The cervix is the termination of the uterus that joins the uterus with the vagina. While cervical cancer is the most common gynecologic cancer, it is relatively unique among cancers in that most cases stem from an infectious cause. Approximately 65 percent of cases of invasive cervical cancer are caused by human papillomavirus (HPV) subtypes 16 and 18. In the United States, 1 in 159 women have a lifetime risk of developing this cancer. Risk factors include cigarette smoking, lower socioeconomic class, older age, obesity, high-risk sexual activity, and high number of full-term pregnancies. African Americans are also at higher risk. However, the greatest risk factor for cervical cancer is the lack of regular screening.
Routine screening for cervical cancer is paramount as most early cancers are asymptomatic. The main screening tool is the Papanicolaou (Pap) test, a simple outpatient test that is usually performed yearly. If abnormal Pap test results are noted, outpatient colposcopy, which includes visualizing the cervix under a microscope, may be performed. Biopsies can be taken during colposcopy to help make a diagnosis.
As in most cancers, accurate staging of the invasiveness of diseases is important to guide prognosis and treatment. Staging requires both imaging (CT and MRI scans) and surgical evaluation of the extent of the cancer and whether it has metastasized to lymph nodes. Treatment involves a combination of surgery, radiation, and chemotherapy depending on the severity of the disease. If cervical cancer is found and treated early, the 5-year survival rate is an impressive 100 percent. If the disease is allowed to progress, the 5-year survival rate drops to 18 percent.
The U.S. Centers for Disease Control and Prevention (CDC) recommends a variety of vaccinations during childhood and adolescence. Examples include vaccines against pertussis (whooping cough), chicken pox, and poliovirus. Most require a series of several injections to achieve sufficient levels of immunity.
Many of the CDC-recommended vaccinations are required for school-age children. People with medical contraindications to vaccine administration or allergies to a component of the vaccination are exempt from these requirements; other types of exemptions vary by state.
The HBV and HPV Vaccines
A unique class of required childhood vaccination is that against the hepatitis B virus (HBV). HBV is unique in that it is either sexually transmitted or transferred via blood; therefore, it is not spread by casual contact like viruses and bacteria protected against by the other recommended vaccines.
HPV vaccines that protect against types 16 and 18, which cause the majority of cervical cancers, have been available for many years. In fact, vaccination against these two types has shown to decrease the cervical cancer incidence in those vaccinated by 95 percent. There are two types of vaccines available currently, one that protects against only types 16 and 18 and another that also protects against types 6 and 11 (which cause genital warts). Unlike HBV, HPV can only be spread by sexual contact, not through blood transfer.
What Are Some of the Ethical Issues?
A wide variety of ethical issues have been raised by the HPV vaccine.
One of the main controversies surrounding the cervical cancer vaccine is the issue of pediatric decision-making. As children age, the balance changes from surrogate decision-making by their parents on their behalf to their own ability to make informed decisions. Parents must consent to their children receiving the vaccination; in some cases, children are old enough to assent and may disagree with their parents. In many states, reproductive care is considered confidential for adolescents and does not require parental consent. Since HPV is sexually transmitted, questions arise as to whether this may cause children to engage in high-risk sexual activity since there is a perceived protection from some of the ramifications. However, high-risk behavior can lead to a number of other sexually transmitted diseases, pregnancy, and emotional complications. What do you think? Should the cervical cancer vaccine be mandatory? For what, if any, conditions should parents be allowed to refuse a vaccine for their children?
Inequality and Sexually Transmitted Diseases
The first cervical cancer vaccine was released in 2006 and was approved by the U.S. Food and Drug Administration (FDA) only for girls aged 16 to 26. Critics, especially in the LGBTQ+ community, were vocal about the fact that the vaccine was not approved for use in boys and men, as they are also susceptible to genital warts from HPV, as well as anal and oral cancer caused by HPV types 16 and 18.
In September 2009, the FDA approved the use of the HPV vaccine in males aged 9 to 26. The delay in FDA approval was primarily due to insufficient data from clinical trials in this population. Should clinical trials be designed to equally treat or protect men and women? Can you think of other examples where men and women are treated unfairly by the design of clinical trials?
Due to the personally, politically, and culturally sensitive nature of reproductive diseases, research and treatment are often lacking compared with other diseases. For example, women are often embarrassed to discuss menopausal symptoms, or men may be embarrassed to discuss testicular pain. We do not currently have a vaccine to prevent any other cancer, yet the HPV vaccine remains cloaked in debate among politicians, parents, and health policy advisers. If HPV were transmitted by airborne particles and not through sexual activity, do you think the controversy surrounding its mandatory administration would be as pronounced?
Here are some sample questions to review during this lesson:
- Detail the risk factors for cervical cancer. Which ones are preventable?
- Discuss the importance of routine screening for cervical cancer.
- Identify the key ethical issues surrounding the cervical cancer vaccine. Would you recommend the vaccine for yourself? How about, in the future, for your children? What problems for informed consent are raised by each case?
- What is the difference between consent and assent?
- Discuss some other scenarios in which parents make medical decisions for their children. What potential conflicts can you think of when surrogates make decisions?
Centers for Disease Control and Prevention: 2020 Recommended Vaccinations for Infants and Children (birth through 6 years) Parent-Friendly Version
Schwartz JL … Caplan AL, editors. Vaccination Ethics and Policy: An Introduction with Readings . The MIT Press: Cambridge, MA; 2017.
Hoffman BL … Corton MM. Williams Gynecology, third edition. McGraw Hill Medical: New York; 2016.
Investigative Report: Gardasil, A Potential Lifesaver? [video]. CalTV. November 12, 2008.
Kohrman A … Wagner VM. Informed consent, parental permission, and assent in pediatric practice. Pediatrics. 1995. 95(2):314–317.