HPV FACT SHEET. The vaccine does not increase sexual activity. FACT: The vaccine is safe and it works.

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1 The University of Texas MD Anderson Cancer Center, and UTHealth Medical School and UTHealth School of Public Health, part of The University of Texas Health Science Center at Houston (UTHealth), and The Immunization Partnership HPV FACT SHEET HPV vaccination is recommended for routine vaccination of boys and girls at age 11 or 12 years and for girls and women through age 26 and for boys and men through age 21 who have not been vaccinated previously. HPV vaccines protect against certain high risk types of HPV that cause cancers such as cervical, oropharyngeal, vulvar, vaginal, penile, and anal. FACT: HPV and HPV-related diseases are common. The lifetime risk of acquiring an HPV infection is approximately 75% - 80%. 1 In 2014, there were an estimated 12,360 new cases of cervical cancer, 14,410 new cases of oropharyngeal cancer,* and 7,210 new cases of anal cancer in the United States. 2 The annual number of HPV-positive oropharyngeal cancers is expected to surpass the annual number of cervical cancers by the year FACT: The vaccine is safe and it works. In an unexposed population, the quadrivalent vaccine, which prevents four HPV types (16, 18, 6 and 11), was found to be 100% effective in reducing the risk of HPVrelated high-grade cervical, vulvar and vaginal lesions and HPV-related genital warts. 4 FACT: FACT: Treating diseases caused by HPV is expensive. HPV vaccines are covered by insurance under the Affordable Care Act and the Vaccines for Children program, for those eligible. 8 In the United States, the overall annual direct medical cost burden of preventing and treating HPV-related disease is estimated to be $8.0 billion. 9 In Texas, annual HPV-related disease costs for men and women approach $170 million. 10 FACT: The vaccine does not increase sexual activity. Studies have shown that in girls and women aged years, those who received the HPV vaccine were not more likely to become sexually active than those who did not receive the vaccine. 7 HPV can be transmitted through various forms of contact, and intercourse is not required to contract the infection. Countries administering the HPV vaccine are already seeing a decrease in HPV infection. 5 Like all vaccines, the HPV vaccine is most effective if it is given BEFORE a person is exposed to the disease. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continually monitor vaccine safety and show no safety concerns. 6 As of April 2014, approximately 67 million doses of HPV vaccine were distributed in the U.S., and no safety concerns have been linked to HPV vaccination. The FDA has approved, and the CDC, The University of Texas MD Anderson Cancer Center, Advisory Committee on Immunization Practices (ACIP) and The Immunization Partnership recommend the HPV vaccine for female and male adolescents. As of 12/2014, the FDA approved a 9-valent HPV vaccine which covers nine of the most common HPV subtypes that cause cancer and precancers. *Estimated number of cases occurring at HPV-related subsites of the pharynx (base of tongue and tonsil/oropharynx) HPV can be found on skin and mucosal surfaces throughout the body, such as the oropharynx. Percentage Vaccinated Vaccination Coverage Among Adolescents Aged Years, Texas, % 87.6% 38.9% Tdap Meningococcal 3-dose series completion HPV (Females) 15% 3-dose series completion HPV (Males)

2 HPV: Numbers & Statistics Cancer Estimates in US, ,13 in TX, Cancer Type New Cases Deaths New Cases Deaths Oropharyngeal (Throat/Tonsil)* 14,410 2, Cervical (Cervix Uteri)** 12,360 4,030 1, Vulvar (Vulva)** 4,850 1, Vagina** 3, Anus, Anal Canal and Anorectum** 7, Penile** 1, Total Estimated Cancer Deaths 9, *Estimated number of cases occurring at HPV-related subsites of the pharynx (base of tongue and tonsil/oropharynx) **In general, HPV is thought to be responsible for more than 90% of anal and cervical cancers, about 70% of vaginal vulva and oropharyngeal cancers, and more than 60% of penile cancers. Worldwide HPV Vaccination Rates 15 What can be done? Encourage universal HPV vaccine coverage of male and female adolescents. Encourage school-based vaccination programs in middle school. Provide HPV education and vaccination. Contact the following organizations for more information: National Cervical Cancer Coalition (NCCC) Website: Phone: Centers for Disease Control and Prevention(CDC) Website: Phone: 800-CDC-INFO Cervical Cancer-Free Texas Website: Rwanda 93% United Kingdom 84% - 92% Belgium 82% Portugal 81% Denmark 79% Australia 75% United States 32% The Immunization Partnership Website: Phone: References HPV Vaccination and Texas 2013 Immunization Survey 16 Texas Girls >1HPV >2HPV >3HPV 56.2% 46.3% 38.9% Texas Boys >1HPV 34.1% >2 HPV 25.2% >3HPV 15% Houston Girls >2HPV >3HPV >1HPV 33.9% 62% 51.9% Houston Boys >1HPV >2 HPV 40.3% 27.8% >3HPV 17.5% Bexar Co. Girls >1HPV >2HPV >3HPV 32.5% 54.8% 45.7% Bexar Co. Boys >1HPV 32.4% >2 19.1% HPV >3HPV 9.6% HPV Fact Sheet Contact The Comprehensive Cancer Control Cervical Cancer Workgroup is a collaboration of Houston Metropolitan Statistical Area (MSA) health, community, business, and governmental organizations working together to reduce the incidence and mortality of cervical cancer in the Houston MSA region. Website: html CompCancerControl@mdanderson.org 1. Weaver, B. A. (2006). Epidemiology and natural history of genital human papillomavirus infection. J Am Osteopath Assoc, 106(3 Suppl 1), S2 S8. 2. American Cancer Society. Cancer Facts & Figures Atlanta: American Cancer Society; Jemal A, Simard EP, Dorell C et al. Annual Report to the Nation on the Status of Cancer, , Featuring the Burden and Trends in Human Papillomavirus (HPV)-Associated Cancers and HPV Vaccination Coverage Levels. J Natl Cancer Inst 2013 February 6;105(3): Pomfret, T. C., Gagnon, J. M. Jr., Gilchrist, A. T. (2011). Quadrivalent human papillomavirus (HPV) vaccine: a review of safety, efficacy, and pharmacoeconomics. J Clin Pharm Ther, 36, Tabrizi, S. N., Brotherton, J. M., Kaldor, J. M., Skinner, S. R., Cummins, E., Liu, B., et al. (2012). Fall in human papillomavirus prevalence following a national vaccination program. J Infect Dis, 206, Baandrup, L., Blomberg, M., Dehlendorff, C., Sand, C., Andersen, K. K., Kjaer, S. K. (2013). Significant decrease in the incidence of genital warts in young Danish women after implementation of a national human papillomavirus vaccination program. Sex Transm Dis, 40(2), Kahn JA, Brown DR, Ding L, Widdice LE, Shew ML, Glynn S, Bernstein DI (2012). Vaccine-type human papillomavirus and evidence of herd protection after vaccine introduction. Pediatrics, August;130(2):e doi: /peds Epub 2012 Jul Centers for Disease Control and Prevention. Frequently asked questions about HPV vaccine safety Bednarczyk, R. A., Davis, R., Ault, K., Orenstein, W., Omer, S. B. (2012). Sexual activity-related outcomes after human papillomavirus vaccination of 11- to 12-year-olds. Pediatrics, 130, Rysavy, M. B., Kresowik, J. D., Liu, D., Mains, L., Lessard, M., Ryan, G. L. (2014). Human papillomavirus vaccination and sexual behavior in young women. J Pediatr Adolesc Gynecol, 27(2), Centers for Disease Control and Prevention. HPV vaccine questions and answers Chesson, H. W., Ekwueme, D. U., Saraiya, M., Watson, M., Lowy, D. R., Markowitz, L. E. (2012). Estimates of the annual direct medical costs of the prevention and treatment of disease associated with human papillomavirus in the United States. Vaccine, 30, Fonseca, V. (2007). Cervical cancer and HPV-related disease in Texas. Presented at the 82nd Annual Texas Public Health Association Conference, Galveston, TX, February Centers for Disease Control and Prevention. (2014). National Immunization Survey teen, United States, MMWR Morb Mortal Wkly Rep, American Cancer Society. Cancer Facts & Figures Atlanta: American Cancer Society; Siegel,R., Ma,J., Zou,Z., and Jemal,Al. (2014), Cancer statistics, CA: A Cancer Journal for Clinicians, 64: doi: /caac Texas Department of State Health Services Texas Expected Numbers of Cancer Cases and Deaths. Expected-Numbers-of-Cancer-Cases-and-Deaths.aspx. 15. Markowitz, L. E., Tsu, V., Deeks, S. L., Cubie, H., Wang, S. A., Vicari, A. S., et al. (2012). Human papillomavirus vaccine introduction the first five years. Vaccine, 30(Suppl 5), F139 F148. Binagwaho, A., Wagner, C., Gatera, M., Karema, C., Nutt, C., & Ngabo, F. (2012). Achieving high coverage in Rwanda s national human papillomavirus vaccination programme Elam-Evans, L., Yankey, D., Jeyarajah, J., Singleton, J., Curtis, C., MacNeil, J., et al. (2014). National and state vaccination coverage among adolescents aged years United States, MMWR Morb Mortal Wkly Rep, 63(29),

3 Just the Facts HPV & Cervical Cancer The Human Papillomavirus (HPV) represents a group of very common viruses that can cause the growth of abnormal cells that may develop into cancer. Up to 75 percent of men and women who have ever had sex will develop HPV at some time in their lives, according to the American Cancer Society. Most people will never know they have HPV because no significant symptoms develop and the immune system generally clears the virus before it is detected. A small percentage of people with HPV will have the virus for a longer time and develop cell changes that may lead to cancer. HPV Vaccine The HPV vaccine is the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts. It targets four types of HPV: types 6, 11, 16 and 18. Types 16 and 18 cause 70 percent of all cervical cancers, as well as a smaller percentage of vaginal and vulvar cancers. Types 6 and 11 cause about 90 percent of genital warts. An HPV vaccine has been approved by the Food and Drug Administration for females and males between the ages of 9 and 26 to reduce the risk of developing infection from HPV 6, 11, 16 and 18. The vaccine is most effective in girls and women who have not been infected with these types of HPV. For this reason, it is recommended that the vaccination series be given before a girl becomes sexually active. MD Anderson recommends that girls and boys receive the vaccine when they are ages 11 to 12. Parents may choose to vaccinate girls and boys as young as age 9. People ages 13 to 26 may be vaccinated to catch up on a missed vaccine or to complete the vaccination series. The current vaccine has not been tested in women over age 26; therefore, it is not recommended for women over this age. Because HPV types 16 and 18 account for only 70 percent of cervical cancers, those who receive the vaccine should continue screening exams with regular Pap tests. Susan Rafte is a mother who recently took her teenage daughter to get the HPV vaccine. As a breast cancer survivor who was diagnosed at age 30, I am very concerned about my daughter s future health, Susan says. I feel that if there is a way to possibly prevent or reduce her risks of getting cancer any cancer I want to be sure she has that advantage. HPV and Cancer HPV increases the risk for development of the following cancer types in women and/or men: cervical vulvar vaginal oral anal penile Almost all cancers of the cervix are caused by certain highrisk types of HPV. When these forms cannot be controlled by the body s immune system, they may stimulate the growth of precancerous cells in the cervix. Abnormal cells that are not detected and treated may become cancerous.

4 Just the Facts... HPV & Cervical Cancer HPV Testing MD Anderson recommends HPV testing, in addition to Pap tests, for certain women. HPV test samples can be collected at the same time as a Pap test. To collect the sample, a health professional wipes a small, soft brush on the cervix, located in a woman s vaginal passage. MD Anderson s HPV testing recommendations depend on a woman s age. HPV testing is not recommended as part of the regular Pap test for women younger than age 30. At this age, the immune system is more likely to clear the virus without treatment and regular HPV testing may result in unnecessary interventions and follow-up care. Also, cell changes caused by HPV infections take many years to become cancerous. However, if Pap test results are unclear, an HPV test may be performed to determine the presence of a strain of the HPV virus that may lead to cervical cancer. Speak with your health care provider about cervical cancer and screening exams, including HPV testing. Fallopian tube Cervical cancer is a gynecologic cancer that develops in the lining of the cervix. Contrary to popular belief, it is not the most common gynecologic cancer endometrial and ovarian cancers are more common. Certain high-risk strains of HPV are present in more than 99% of cervical cancer cases. Ovary Bladder Urethra Fimbria Uterus Cervix Anus Vagina Illustration by: Kathleen Wagner

5 Just the Facts... HPV & Cervical Cancer Cervical cancer occurs when cells in the cervix (the part of the womb, or uterus, which opens to the vagina) grow and multiply uncontrollably, damaging surrounding tissue and interfering with the normal functioning of the reproductive system. The most important thing any woman can do to lower her chances of developing cervical cancer is to reduce her risk factors and follow screening guidelines for detecting cancer early. When cancer is detected early, the chances of it being successfully treated are greatest. Cervical Cancer Symptoms Symptoms of cervical cancer may vary from woman to woman and may include: excessive vaginal discharge bleeding after intercourse abnormal bleeding between menstrual periods Many of these symptoms are not cancer, but if you notice one or more of them for more than two weeks, see your doctor. Risk Factors for Cervical Cancer Many factors influence the development of cervical cancer. Risk factors for cervical cancer are listed below. HPV infection Women infected with the sexuallytransmitted human papillomavirus (HPV) are at increased risk. sexual partners Women who have sex with multiple or high-risk male partners are at increased risk. early intercourse Having sexual intercourse at an early age can increase risk. cigarette smoking Smoking is a risk factor for cervical cancer. race More deaths from cervical cancer occur in African American, Hispanic and American Indian women. Diethylstilbestrol (DES) exposure Women exposed to DES, a synthetic hormone, before birth are at increased risk. HIV infection Women infected with HIV are at increased risk. weakened immune system Women with a weakened immune system due to an organ transplant, chemotherapy or chronic steroid use are at increased risk. Reducing Your Risks for Cervical Cancer You can take action to reduce your risks of developing cervical cancer. Making the healthy changes below does not mean you will not get cervical cancer, but it may lower your chances. follow recommended cervical cancer screening guidelines decrease risk of sexually transmitted diseases by always using a condom limit your number of sexual partners avoid sex with individuals infected with a sexually transmitted disease or who have had multiple sexual partners participate in a cervical cancer prevention study

6 Just the Facts... HPV & Cervical Cancer Know Your Risks MD Anderson has specific cancer screening schedules for women, based on their chances of getting cancer. The exam you get and how often you are tested depends on whether you are at average or increased risk for cancer. Women at increased risk have a higher chance of getting cancer than women at average risk. Those at increased risk may need to get additional tests, start screening at an earlier age or have exams more frequently. MD Anderson s screening guidelines for women at average risk for cervical cancer are listed below. For MD Anderson screening guidelines for women at increased risk, visit Cervical Cancer Screening Cancer screening exams are medical tests performed when a person has no symptoms. Women at average risk have an immune system that functions properly. They have not been exposed to diethylstilbestrol (DES) before birth and are not infected with the Human Immunodeficiency Virus (HIV). They also do not have a history of the Human Papillomavirus (HPV) or severe cervical dysplasia. These screening guidelines apply to women who are expected to live for at least another 10 years. Age 21 to 29, you should: Get a Pap test every three years. Age 30 to 65, you should choose ONE of the options below: 1. Get a Pap test and Human Papillomavirus (HPV) test every five years as long as your results are negative. 2. Get a Pap test every three years. Age 65 and older, you should: Speak with your doctor about whether you need to continue screening. MD Anderson does not recommend screening after age 65. MD Anderson Resources The Lyda Hill Cancer Prevention Center can help you understand your risk of developing cancer through risk assessment and, when appropriate, genetic testing. The center offers personalized risk-reduction strategies, including healthy lifestyle recommendations and the use of medications to reduce cancer risk. Specialists perform risk-based cancer screening exams based on age, gender and cancer risk. MD Anderson provides cancer care at many convenient locations in the greater Houston area. For more information about MD Anderson programs or services, or to make an appointment, contact askmdanderson at , or visit Want to learn more about your personal risk for cancer? Complete MD Anderson s Cancer Risk Check at Women who have had a hysterectomy that included removal of the cervix but have not had cervical cancer or severe cervical dysplasia, should speak with their doctor about whether to continue screening. If your hysterectomy did not include removal of the cervix, follow the screening guidelines above for your age. Take the time to discuss your own risks with your health care provider who can best advise you on the screening exams and risk-reduction strategies that are right for you. The University of Texas MD Anderson Cancer Center June

7 ADOLESCENT VACCINE SAFETY INFORMATION FOR PARENTS What Parents Should Know About HPV Vaccine Safety and Effectiveness Last updated JUNE 2014 HPV vaccines prevent cancer About 14 million people, including teens, become infected with human papillomavirus (HPV) each year. When HPV infections persist, people are at risk for cancer. Every year, approximately 17,600 women and 9,300 men are affected by cancers caused by HPV. HPV vaccination could prevent many of these cancers. HPV vaccines are safe There are two vaccines licensed by the Food and Drug Administration (FDA) and recommended by CDC to protect against HPV-related illness. All vaccines used in the United States are required to go through extensive safety testing before they are licensed by FDA. Once in use, they are continually monitored for safety and effectiveness. Numerous research studies have been conducted to make sure HPV vaccines were safe both before and after the vaccines were licensed. No serious safety concerns have been confirmed in the large safety studies that have been done since HPV vaccine became available in CDC and FDA have reviewed the safety information available to them for both HPV vaccines and have determined that they are both safe. The HPV vaccine is made from one protein from the HPV virus that is not infectious (cannot cause HPV infection) and nononcogenic (does not cause cancer). HPV vaccines work The HPV vaccine works extremely well. In the four years after the vaccine was recommended in 2006, the amount of HPV infections in teen girls decreased by 56%. Research has also shown that fewer teens are getting genital warts since HPV vaccines have been in use. In other countries such as Australia, research shows that HPV vaccine has already decreased the amount of pre-cancer of the cervix in women, and genital warts have decreased dramatically in both young women and men. HPV vaccines provide long-lasting protection Data from clinical trials and ongoing research tell us that the protection provided by HPV vaccine is long-lasting. Currently, it is known that HPV vaccine works in the body for at least 10 years without becoming less effective. Data suggest that the protection provided by the vaccine will continue beyond 10 years. HPV vaccine is recommended and safe for boys One HPV vaccine (Gardasil) is recommended for boys. This vaccine can help prevent boys from getting infected with the HPV-types that can cause cancers of the mouth/throat, penis and anus as well as genital warts. Like any vaccine or medicine, HPV vaccines might cause side effects HPV vaccines occasionally cause adverse reactions. The most commonly reported symptoms among females and males are similar, including injection-site reactions (such as pain, redness, or swelling in the area of the upper arm where the vaccine is given), dizziness, fainting, nausea, and headache. Brief fainting spells and related symptoms can happen after many medical procedures, including vaccination. Fainting after getting a shot is more common among adolescents. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries that can be caused by falls. When fainting was found to happen after vaccination, FDA changed prescribing information to include information about preventing falls and possible injuries from fainting after vaccination. CDC consistently reminds doctors and nurses to share this information with all their patients. Tell the doctor or nurse if your child feels dizzy, faint, or light-headed. HPV vaccines don t negatively affect fertility There is no evidence to suggest that HPV vaccine causes fertility problems. However, not getting HPV vaccine leaves people vulnerable to HPV cancers. If persistent high-risk HPV infection in a woman leads to cervical cancer, the treatment of cervical cancer (hysterectomy, chemotherapy, or radiation, for example) could leave a woman unable to have children. Treatment for cervical pre-cancer could put a woman at risk for problems with her cervix, which could cause preterm delivery or other problems. How can I get help paying for these vaccines? The Vaccines for Children (VFC) program provides vaccines for children ages 18 years and younger, who are not insured, Medicaid-eligible, American Indian or Alaska Native. You can find out more about the VFC program by going online to and typing VFC in the search box. CS _F DISTRIBUTED BY: U.S. Department of Health and Human Services Centers for Disease Control and Prevention

8 Tips and Time-savers for Talking with Parents about HPV Vaccine Recommend the HPV vaccine series the same way you recommend the other adolescent vaccines. For example, you can say Your child needs these shots today, and name all of the vaccines recommended for the child s age. Parents may be interested in vaccinating, yet still have questions. Taking the time to listen to parents questions helps you save time and give an effective response. CDC research shows these straightforward messages work with parents when discussing HPV vaccine and are easy for you or your staff to deliver. The HPV vaccine is cancer prevention message resonates strongly with parents. In addition, studies show that a strong recommendation from you is the single best predictor of vaccination. HPV vaccine is very important because it prevents cancer. I want your child to be protected from cancer. That s why I m recommending that your daughter/son receive the first dose of HPV vaccine today. Disease prevalence is not understood, and parents are unclear about what the vaccine actually protects against. HPV can cause cancers of the cervix, vagina, and vulva in women, cancer of the penis in men, and cancers of the anus and the mouth or throat in both women and men. There are about 26,000 of these cancers each year and most could be prevented with HPV vaccine. There are also many more precancerous conditions requiring treatment that can have lasting effects. Parents want a concrete reason to understand the recommendation that year olds receive HPV vaccine. We re vaccinating today so your child will have the best protection possible long before the start of any kind of sexual activity. We vaccinate people well before they are exposed to an infection, as is the case with measles and the other recommended childhood vaccines. Similarly, we want to vaccinate children well before they get exposed to HPV. Parents may be concerned that vaccinating may be perceived by the child as permission to have sex. Research has shown that getting the HPV vaccine does not make kids more likely to be sexually active or start having sex at a younger age. Parents might believe their child won t be exposed to HPV because they aren t sexually active or may not be for a long time. HPV is so common that almost everyone will be infected at some point. It is estimated that 79 million Americans are currently infected with 14 million new HPV infections each year. Most people infected will never know. So even if your son/daughter waits until marriage to have sex, or only has one partner in the future, he/she could still be exposed if their partner has been exposed. Emphasizing your personal belief in the importance of HPV vaccine helps parents feel secure in their decision. I strongly believe in the importance of this cancer-preventing vaccine, and I have given HPV vaccine to my son/daughter/grandchild/ niece/nephew/friend s children. Experts (like the American Academy of Pediatrics, cancer doctors, and the CDC) also agree that this vaccine is very important for your child. Understanding that the side effects are minor and emphasizing the extensive research that vaccines must undergo can help parents feel reassured. HPV vaccine has been carefully studied by medical and scientific experts. HPV vaccine has been shown to be very effective and very safe. Like other shots, most side effects are mild, primarily pain or redness in the arm. This should go away quickly, and HPV vaccine has not been associated with any long-term side effects. Since 2006, about 57 million doses of HPV vaccine have been distributed in the U.S., and in the years of HPV vaccine safety studies and monitoring, no serious safety concerns have been identified. Parents want to know that HPV vaccine is effective. In clinical trials of boys and girls, the vaccine was shown to be extremely effective. In addition, studies in the U.S. and other countries that have introduced HPV vaccine have shown a significant reduction in infections caused by the HPV types targeted by the vaccine. Many parents do not know that the full vaccine series requires 3 shots. Your reminder will help them to complete the series. I want to make sure that your son/daughter receives all 3 shots of HPV vaccine to give them the best possible protection from cancer caused by HPV. Please make sure to make appointments on the way out, and put those appointments on your calendar before you leave the office today! PreteenVaccines@cdc.gov CS242429A