1. You are the Key to HPV Cancer Prevention Speaker Name Speaker Title Speaker Affiliation {Updated April 2016; Replace with date of Presentation}

2. Objectives 1. Define the importance of HPV vaccination for cancer prevention and the rationale for vaccinating at ages 11 or 12. 2. List the recommendations for HPV vaccine for girls and for boys. 3. Provide useful and compelling information about HPV vaccine to parents to aid in making the decision to vaccinate. 4. Locate resources relevant to current immunization practice.

3. HPV INFECTION & DISEASE Understanding the Burden

4. HPV Types Differ in their Disease Associations Mucosal sites of infection Mucosal sites of infection Cutaneous sites of infection Cutaneous sites of infection ~ 80 Types “Common” Hand and Foot Warts “Common” Hand and Foot Warts ~40 Types Genital Warts Laryngeal Papillomas Low Grade Cervical Disease Genital Warts Laryngeal Papillomas Low Grade Cervical Disease Low risk (non-oncogenic) HPV 6, 11 most common High risk (oncogenic) HPV 16, 18 most common Cervical Cancer Anogenital Cancers Oropharyngeal Cancer Cancer Precursors Low Grade Cervical Disease Cervical Cancer Anogenital Cancers Oropharyngeal Cancer Cancer Precursors Low Grade Cervical Disease

5. HPV Infection  Most females and males will be infected with at least one type of mucosal HPV at some point in their lives  Estimated 79 million Americans currently infected  14 million new infections/year in the US  HPV infection is most common in people in their teens and early 20s  Most people will never know that they have been infected Jemal A et al. J Natl Cancer Inst 2013;105:175-201

6. Every year in the United States 27,000 people are diagnosed with a cancer caused by HPV That’s 1 case every 20 minutes

7. Cancers Caused by HPV, U.S. CDC, United States Cancer Statistics (USCS), 2006-2010 Cancer site Average number of cancers per year probably caused by HPV Percentage per year MaleFemaleBoth Sexes Anus1,4002,6004,00091% Cervix010,400 91% Oropharynx7,2001,8009,00072% Penis7000 63% Vagina0600 75% Vulva02,200 69% TOTAL9,30017,60026,900

8. New Cancers Caused by HPV per Year United States 2006-2010 CDC, United States Cancer Statistics (USCS), 2006-2010 Women (n = 17,600) Anus n=2,600 15% Cervix n=10,400 59% Vagina n=600 3% Vulva n=2,200 13% Oropharynx n=1,800 10% Men (n = 9,300) Anus n=1,400 15% Oropharynx n=7,200 77% Penis n=700 8%

9. Annual Report to the Nation on the Status of Cancer: HPV-Associated Cancers  From 2000 to 2009, oral cancer rates increased  4.9% for Native American men  3.9% for white men  1.7% for white women  1% for Asian men  Anal cancer rates doubled from 1975 to 2009  Vulvar cancer rates rose for white and African- American women  Penile cancer rates increased among Asian men Jemal A et al. J Natl Cancer Inst 2013;105:175-201

10. Cervical Cancer  Cervical cancer is the most common HPV- associated cancer among women  500,000+ new cases and 275,000 attributable deaths world-wide in 2008  11,000+ new cases and 4,000 attributable deaths in 2011 in the U.S.  37% cervical cancers occur in women who are between the ages of 20 and 44  13% (or nearly 1 in 8) between 20 and 34  24% ( or nearly 1 in 4) between 35 and 44 CDC. HPV–associated cancers—US, 2004–2008. MMWR 2012;61(15):258–261. Cervical Cancer Counts by Age. US Cancer Statistics data from 2010, CDC.gov.

11. U.S. Cervical Cancer Rates by Race and Ethnicity, 2004–2008 Watson et al. MMWR 2012;61:258-261.

12. Cervical pre-cancer in U.S. females  1.4 million new cases of low grade cervical dysplasia  330,000 new cases of high grade cervical dysplasia American Cancer Society. 2008; Schiffman Arch Pathol Lab Med. 2003; Koshiol Sex Transm Dis. 2004; Insinga, Pharmacoeconomics, 2005

13. HPV VACCINE Evidence-Based HPV Disease Prevention

14. HPV Prophylactic Vaccines HPV Virus-Like Particle  Recombinant L1 capsid proteins that form “virus-like” particles (VLP)  Non-infectious and non-oncogenic  Produce higher levels of neutralizing antibody than natural infection

15. HPV Vaccines Currently Licensed in U.S. Bivalent 2vHPV (Cervarix) Quadrivalent 4vHPV (Gardasil) 9-Valent 9vHPV (Gardasil 9) ManufacturerGlaxoSmithKlineMerck HPV Types Included 16, 186, 11, 16, 18 6, 11, 16, 18, 31, 33, 45, 52, 58 Contraindications Hypersensitivity to latex* Hypersensitivity to yeast Dose Schedule 3 dose series: 0, 1, 6 months 3 dose series: 0, 2, 6 months 3 dose series: 0, 2, 6 months * May be present in tip of pre-filled syringes

16. HPV Vaccine Comparison These Genital warts ~66% of ~15% of HPV Types Cervical Cervical Cause: CancersCancers

17. Girls & Boys can start HPV vaccination at age 9 Preteens should finish HPV vaccine series by 13 th birthday Plus girls 13-26 years old who haven’t started or finished HPV vaccine series Plus boys 13-21 years old who haven’t started or finished HPV vaccine series HPV Vaccine Recommendation

18. Updated ACIP Recommendations Age  Routine vaccination at age 11 or 12 years*  Vaccination recommended through age 26 for females and through age 21 for males not previously vaccinated  Vaccination recommended for men through age 26 who have sex with men (MSM) or are immunocompromised (including persons HIV-infected) Formulation by gender (assuming availability) 18 *vaccination series can be started at 9 years of age MMWR 2015;64:300-4 9vHPV4vHPV2vHPV Females ✔✔✔ Males ✔✔

19. Updated ACIP Recommendations: Interchangeability If vaccination providers do not know, or do not have available the HPV vaccine product previously administered: For protection against HPV 16 and 18,  Females: Any HPV vaccine product may be used to continue or complete the series  Males: 4vHPV or 9vHPV may be used to continue or complete the series 19 MMWR 2015;64:300-4

20. ACIP Recommendations: Timing of the Series  2vHPV, 4vHPV and 9vHPV are each administered in a 3-dose schedule  Interval between doses 1  2: 1-2 months  Interval between doses 1  3: 6 months  The minimum interval between doses 1 and 2 is 4 weeks  The minimum interval between doses 2 and 3 is 12 weeks  The minimum interval between dose 1 and 3 is 24 weeks.  If the vaccine schedule is interrupted, the series does not need to be restarted 20 MMWR 2015;64:300-4

21. HPV VACCINE SAFETY

22. cdc.gov/vaccines/parents/infographics/journey-of-child-vaccine.html The Journey of Your Child's Vaccine

23. VAERS: HPV Vaccine Safety Monitoring  Ongoing safety monitoring has shown most reports are non-serious  Among the 7.6% of reports coded as “serious,” most frequently cited possible side effects are headache, nausea, vomiting, and fever  Syncope (fainting) continues to be reported following vaccination among adolescents  Adherence to a 15-minute observation period after vaccination is encouraged 23 MMWR. 2014;63(RR05);1-30.

24. Key Findings – CDC and Non-CDC  Venous thromboembolism (VTE) 1  Study evaluating the risk of VTE in vaccinated persons age 9-26 years  Found no increased risk of VTE following 4vHPV  Autoimmune and neurologic conditions 2  Study addressing concerns about autoimmune and neurologic disease following 4vHPV vaccination.  Found no association between 4vHPV vaccination and 16 autoimmune conditions  Injection site reactions and syncope 3  4vHPV vaccination may be associated with skin infections where the shot is given during the two weeks after vaccination and fainting on the day the shot is received  No major safety concerns found 1 Gee et al, Vaccine 2011 2 Chao C et al. J Intern Med 2012 3 Klein NP, et al.. Arch Pediatr Adolesc Med. 2012 Dec; 166(12):1140-8.

25. IOM Review: Syncope & Anaphylaxis  IOM reviewed possible associations between 8 vaccines and adverse health events. Key findings:  Evidence “favors acceptance” of a causal relationship between HPV vaccine and anaphylaxis (rare)  Evidence “convincingly supports” a causal relationship between the injection of a vaccine and syncope  Inadequate evidence was found for causal relationships between HPV vaccination and 12 other specific health events studied Institute of Medicine. The National Academies Press, 2012.

26. 9vHPV Vaccine Safety  Seven pre-licensure studies including 15,000 males and females  Generally well tolerated  Adverse event profile similar to that of 4vHPV across age, gender, race, and ethnicity  More injection-site reactions expected among those who receive 9vHPV

27. HPV VACCINE IMPACT Monitoring Impact of HPV Vaccine Programs on HPV-Associated Outcomes

28. HPV vaccine impact monitoring  Post licensure evaluations are important to evaluate real world effectiveness of vaccines  Population impact against early and mid outcomes have been reported: HPV prevalence  Australia, Norway, Denmark, Sweden, UK, US Genital warts  Australia, New Zealand, Denmark, Sweden, Germany, Quebec, US Cervical lesions  Australia, British Columbia, Denmark, Sweden, US 28

29. Prevalence of HPV before & after introduction of HPV vaccination in the United States 64% decline 34% decline

30. Proportion of Australian born females and males diagnosed as having genital warts at first visit, by age group, 2004-11 Ali, et al. BMJ 2013 Impact of HPV vaccination in Australia Females Males 30

31. Systematic Review and Meta-Analysis: Population-Level Impact of HPV Vaccination  Review of 20 studies in 9 high income countries  In countries with >50% coverage, among 13- 19 year olds  HPV 16/18 prevalence decreased at least 68%  Anogenital warts decreased by ~61%  Evidence of herd effects Drolet et al. Lancet Infect Dis 2015 31

32. Challenges in Monitoring HPV Vaccine Impact on Cervical Lesions  Detected through cervical cancer screening  Changing screening recommendations  Lack of cervical cancer screening registries in some countries  Incomplete linkages with vaccination registries 32

33. HPV Vaccine Duration of Immunity  Studies suggest that vaccine protection is long-lasting; no evidence of waning immunity  Available evidence indicates protection for at least 10 years  Multiple cohort studies are in progress to monitor the duration of immunity

34. HPV Vaccination Is Safe, Effective, and Provides Lasting Protection  HPV Vaccine is SAFE  Benefits of HPV vaccination far outweigh any potential risks  Safety studies findings for HPV vaccination similar to safety reviews of MCV4 and Tdap vaccination  HPV Vaccine WORKS  Population impact against early and mid outcomes have been reported in multiple countries  HPV Vaccine LASTS  Studies suggest that vaccine protection is long-lasting  No evidence of waning protection

35. FRAMING THE CONVERSATION Talking about HPV vaccine

36. Adolescent Vaccination Coverage United States, 2006-2014 Revised APD Definition NIS-Teen 2008-2014 *APD = Adequate provider data

37. Impact of Eliminating Missed Opportunities by Age 13 Years in Girls Born in 2000 Missed opportunity: Healthcare encounter when some, but not all ACIP-recommended vaccines are given. HPV-1: Receipt of at least one dose of HPV. MMWR. 63(29);620-624.

38. Reasons parents won’t initiate HPV vaccination for children MMWR 2014; 63(29);625-633;

39. Value Parents Place on the Vaccines Adapted from Healy et al. Vaccine. 2014;32:579-584.

40. Provider estimations Adapted from Healy et al. Vaccine. 2014;32:579-584.

41. Clinicians underestimate the value parents place on HPV vaccine Adapted from Healy et al. Vaccine. 2014;32:579-584.

42. Clinicians Underestimate the Value Parents Place on HPV Vaccine Adapted from Healy et al. Vaccine. 2014;32:579-584. The perceived and real concerns of parents influence how the provider recommends and administers HPV vaccine.

43. Give an Effective Recommendation to Receive HPV Vaccine at Ages 11 or 12  An effective recommendation from you is the main reason parents decide to vaccinate  Many moms in focus groups stated that they trust their child’s doctor and would get the vaccine for their child as long as they received a recommendation from the doctor Unpublished CDC data, 2013.

44. EFFECTIVE recommendation for HPV vaccination? What is an

45. Same Way Same Day

46. Make an Effective Recommendation  Same way: Effective recommendations group all of the adolescent vaccines Recommend HPV vaccination the same way you recommend Tdap & meningococcal vaccines.  Same day: Recommend HPV vaccine today Recommend HPV vaccination the same day you recommend Tdap & meningococcal vaccines. Unpublished CDC data, 2013.

47. Your preteen needs three vaccines today to protect against meningitis, HPV cancers, and pertussis.

48. Tdap HPV MenACWY

49. Now that Sophia is 11, she is due for three vaccines. These will help protect her from meningitis, HPV cancers, and pertussis. We’ll give those shots at the end of the visit.

50. Some Parents Need Reassurance  Many parents simply accept of this bundled recommendation  Some parents may be interested in vaccinating, yet still have questions. Interpret a question as they need additional reassurance from YOU, the clinician they trust with their child’s health care  Ask parents about their main concern (be sure you are addressing their real concern) Unpublished CDC data, 2013.

51. Why does my child need HPV vaccine?

52. HPV vaccination is important because it prevents cancer. That’s why I’m recommending that your child start the HPV vaccine series today.

53. What cancers are caused by HPV infection?

54. Certain HPV types can cause cancer of the cervix, vagina, and vulva in females, cancer of the penis in men, and in both females and males, cancers of the anus and the throat. We can help prevent infection with the HPV types that cause these cancers by starting the HPV vaccine series today.

55. Is my child really at risk for HPV?

56. HPV is a very common and widespread virus that infects both females and males. We can help protect your child from the cancers and diseases caused by the virus by starting HPV vaccination today.

57. Why so young?

58. When should the bike helmet go on? A B C

59. Girls & Boys can start HPV vaccination at age 9 Preteens should finish HPV vaccine series by 13 th birthday Plus girls 13-26 years old who haven’t started or finished HPV vaccine series Plus boys 13-21 years old who haven’t started or finished HPV vaccine series HPV Vaccine Recommendation

60. Most clinicians wait too long to make strong recommendations for HPV vaccine

61. HPV vaccination works best at the recommended ages of 11 or 12 years. That’s why I’d like for your son to start the HPV vaccine series today.

62. I have some concerns about the safety of the vaccine—I keep reading things online that says HPV vaccination isn’t safe. Do you really know if it’s safe?

63. I know there are stories in the media and online about vaccines, and I can see how that could concern you. However, I want you to know that HPV vaccine has been carefully studied for many years by medical and scientific experts. Based on all of the data, I believe HPV vaccine is very safe.

64. Vaccines, like any medication, can cause side effects. With HPV vaccination this could include pain, swelling, and/or redness where the shot is given, or possibly headache. Sometimes kids faint when they get shots and they could be injured if they fall from fainting. We’ll protect your child by having them stay seated after the shot.

65. Could HPV vaccine cause my child to have problems with infertility?

66. There is no data available to suggest that HPV vaccine will have an effect on future fertility. However, women who develop cervical cancer could require treatment that would limit their ability to have children. Starting the HPV vaccine series today could prevent that from happening and protect your daughter’s ability to bear children.

67. I’m just worried that my child will perceive this as a green light to have S-E-X.

68. Numerous research studies have shown that getting the HPV vaccine does not make kids more likely to be sexually active or start having sex at a younger age. Starting the HPV vaccine series today will give your child the best protection possible for the future.

69. How do you know if the vaccine works?

70. Ongoing studies are showing that HPV vaccination works very well and has decreased HPV infection, genital warts, and cervical precancers in young people, in the years since it has been available. Starting the vaccine series today will help ensure your child gets the best protection possible.

71. Why do boys need HPV vaccine?

72. HPV infection can cause cancers of the penis, anus, and throat in men and it can also cause genital warts. Getting HPV vaccine today for your son can help prevent the infection that can lead to these diseases.

73. Would you get HPV vaccine for your kids?

74. Yes, I have given HPV vaccine to my child because I believe in the importance of this cancer-preventing vaccine. The American Academy of Pediatrics, the American Academy of Family Physicians, NIH cancer centers, and the CDC, also agree that getting the HPV vaccine is very important for your child.

75. I heard there is a new HPV vaccine that works better. Should I be getting that for my child who already was vaccinated?

76. Currently there is no recommendation to vaccinate someone with 9-valent HPV vaccine who previously completed the HPV vaccine series. All three HPV vaccines currently available contain the types that most commonly cause cancer.

77. When do we need to come back?

78. Your child will need a second dose in 1-2 months. The third dose will be due in 6 months from today. When you check out, please make sure to make an appointment for about 6 weeks from now and 6 months from now, and put those appointments on your calendar before you leave today!

79. If a parent doesn’t say yes… Ask Clarify & restate their concerns to make sure you understand. Acknow- ledge Emphasize it is the parents’ decision. Acknowledge risks & conflicting info sources. Applaud them for wanting what is best for their child. Be clear that you are concerned for the health of their child, not just public health safety. Advise Clarify their concerns: make sure you understand & are answering the question they actually care about. Allow time to discuss the pros & cons of vaccines. Be willing to discuss parents’ ideas. Offer written resources for parents. Tailor your advice using this presentation.

80. In response to a parent supportive of vaccination but with HPV safety concerns:  Instead of: “Actually, studies show that there are no serious side effects from the vaccine so I think you should let your daughter get it. It’s really important.”  Coming to ‘Yes’: “It sounds like you are generally in support of vaccines, but you have concerns about the safety of HPV. Is that right? “So if you had information that convinced you the HPV vaccine was safe you might consider letting your daughter have it?” “I’d like to share with you what I know about the safety of the vaccine…”

81. If a parent declines… Declination is not final. The conversation can be revisited. End the conversation with at least 1 action you both agree on. Because waiting to vaccinate is the risky choice, many pediatricians ask the parent to sign a Declination Form

82. Increase the number of target patients who come in & leave vaccinated 1. Know your coverage rates 2. Align office policy with mission 3. Align communication with mission

83. 1. Know your coverage rates  AFIX visits for VFC providers  Data from EHR  Ordering data

84. 2. Align office policy with mission  Immunize at every opportunity  Standing orders  Prompt the person who is supposed to order the vaccine  Reminders  Recalls

85. 3. Align communication with mission  EVERYONE in the office needs to be saying the same thing

86. The Opener by the Nurse/MA  Encourage convenient same-day vaccination “Today, Pat should have 3 vaccines. They’re designed to protect him from the cancers caused by HPV and from meningitis, tetanus, diphtheria, & pertussis. Do you have any questions for me?”  If a parents hesitates, the MA/nurse should say “Our practice is so dedicated to cancer prevention that I’m sure the doctor will want to talk with you about your concerns.”

87. www.cdc.gov/hpv HPV Information & Resources

88. HPV VACCINE IS CANCER PREVENTION And YOU are the key! #WeCanStopHPV