1. HPV VACs V accinate A dolescents against C ancer s HPV Vaccine Myths & Concerns [Presenter – Date] MYTH BUSTING

2. SEX Autism Death Parents don’t want their child vaccinated Awkward Conversation too early Not my child… MYTHS BUSTED

3. Today you will learn  [insert objectives]

4. I want to convince you:You should be able to: 1.HPV vaccination is worth your passionate advocacy 1.Explain the importance of HPV vaccination & rates 2.HPV vaccine is worth giving long before exposure 2.Discuss rationale for vaccinating 11 or 12 year olds and including males 3.Your recommendation can make all the difference to the family’s acceptance 3.Provide useful & compelling communication strategies and practical tips to inform parents about HPV

5. HPV VACCINE Evidence-Based HPV Disease Prevention

6. 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

7. 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.

8. HPV-Associated Cervical Cancer Incidence Rates by State, United States, 2006-2010 www.cdc.gov/cancer/npcr

9. Without vaccination, annual burden of genital HPV-related disease in U.S. females: American Cancer Society. 2008; Schiffman Arch Pathol Lab Med. 2003; Koshiol Sex Transm Dis. 2004; Insinga, Pharmacoeconomics, 2005 4,000 cervical cancer deaths 10,846 new cases of cervical cancer 330,000 new cases of HSIL: CIN2/3 (high grade cervical dysplasia) 1.4 million new cases of LSIL: CIN1 (low grade cervical dysplasia) 1 million new cases of genital warts Nearly 3 million cases and $7 billion

10. 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

11. Tips and Time-savers for Talking with Parents CDC RESEARCH SHOWS: 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. TRY SAYING: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 does of HPV vaccine today.

12. MYTH The HPV vaccine is unsafe

13. Talking Points  More than 67 million doses distributed in the US  Safety continually monitored in 80 countries  No serious concerns identified 1 1 Centers for Disease Control and Prevention. (n.d.). Frequently Asked Questions about HPV Vaccine Safety. Retrieved from http://www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.htmlhttp://www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.html

14. 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 Garland et al, Prev Med 2011; Ali et al, BMJ 2013; Markowitz JID 2013; Nsouli-Maktabi MSMR 2013

15. HPV VACCINE SAFETY

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

17. MYTH The HPV vaccine causes serious side effects including death

18. Talking Points  The vaccine was tested in numerous clinical trials and proved to be safe  Most common side effects: pain, redness, swelling at injection site  CDC verified no causal link to death 1  Allergic reaction can occur if a person is allergic to a vaccine ingredient such as yeast 2 1 Centers for Disease Control and Prevention. (n.d.). Frequently Asked Questions about HPV Vaccine Safety. Retrieved from http://www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.htmlhttp://www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.html 2 Cancer Council Victoria. (n.d.). Myths and facts about HPV and the vaccine. Retrieved from http://www.hpvvaccine.org.au/parents/myths-and-facts-about-hpv-and-the-vaccine.aspx http://www.hpvvaccine.org.au/parents/myths-and-facts-about-hpv-and-the-vaccine.aspx

19. 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 19 MMWR. 2014;63(RR05);1-30.

20. VSD Rapid Cycle Analysis (RCA), 4vHPV  RCA allows VSD to detect adverse events following vaccination in near real time  After approx. 600,000 HPV4 doses among females, no significant risk for any of the pre-specified adverse events after vaccination (including GBS, seizures, syncope, appendicitis, stroke, venous thromboembolism, and allergic reactions) Gee J et al, Vaccine 2011;29:8279-8284.

21. Ongoing HPV Safety Activities at CDC  Review of reports to VAERS to search for unusual adverse events or changing patterns of adverse events  VSD addressing HPV vaccine safety in special populations:  Safety of 4vHPV among males  Inadvertent 4vHPV vaccination during pregnancy  VSD addressing HPV vaccine safety concerns that may arise from case reports and/or the media

22. Non-CDC HPV Vaccine Safety Activities  Post-licensure commitments from manufacturers  Vaccine in pregnancy registries  Long term follow-up in Nordic countries  Official reviews  WHO’s Global Advisory Committee on Vaccine Safety 1  Institute of Medicine’s report on adverse effects and vaccines, 2011 2 1 www.who.int/vaccine_safety/Jun_2009/en/ 2 www.iom.edu/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx

23. 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.

24. 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.

25. 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

26. “no evidence of any serious short- term or long-term safety issues”  An Overview of Quadrivalent Human Papillomavirus Vaccine Safety - 2006 to 2015  Vichnin, et al  Pediatric Infectious Disease Journal

27. Tips and Time-savers for Talking with Parents CDC RESEARCH SHOWS: Understanding that the side effects are minor and emphasizing the extensive research that vaccines must undergo can help parents feel assured. TRY SAYING: 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 79 million doses of HPV vaccine have been distributed in the U.S., and in the years of HPV vaccine safety studies and monitoring, not serious safety concerns have been identified.

28. MYTH The HPV vaccine causes fertility issues

29. Talking Points  No data suggest the vaccine will have a negative effect on fertility  Getting vaccinated and protecting against cervical cancer can help protect the ability to get pregnant and have healthy babies 1 1 Centers for Disease Control and Prevention. (2014). HPV Vaccine – Questions & Answers. Retrieved from http://www.cdc.gov/vaccines/vpd-vac/hpv/vac-faqs.htm http://www.cdc.gov/vaccines/vpd-vac/hpv/vac-faqs.htm

30. Treatment of precancerous lesions can lead to increased risk of preterm delivery.  330,000 women undergo cone/ LEEP procedures every year  LEEP/HPV infection associated with obstetric morbidity  Preterm delivery  Preterm rupture of membranes  Low birth weight  Long term developmental outcomes, neonatal intensive care costs

31. MYTH The HPV vaccine contains harmful ingredients

32. Talking Points  HPV vaccines contain a small amount of aluminum adjuvant, much less than we ingest daily  Aluminum-containing vaccines have been used for decades in > 1 billion people without problem  NVPO and WHO reviewed aluminum exposure through vaccines and determined that no changes were needed 1 1 Offit, P.A. (2014). Vaccines and Aluminum. Retrieved from http://vec.chop.edu/service/vaccine-education- center/vaccine-safety/vaccine-ingredients/aluminum.htmlhttp://vec.chop.edu/service/vaccine-education- center/vaccine-safety/vaccine-ingredients/aluminum.html

33. MYTH The HPV vaccine is unnecessary unless you’re sexually active, and encourages sexual activity

34. Talking Points  We want to vaccinate people before exposed to HPV  HPV vaccine produces higher immune response in preteens 1  HPV is so common that almost everyone will be exposed 2  No correlation between HPV vaccine and increased rates of sexual activity 3 1 Cancer Council Victoria. (n.d.). Myths and facts about HPV and the vaccine. Retrieved from http://www.hpvvaccine.org.au/parents/myths-and-facts-about-hpv-and-the-vaccine.aspx http://www.hpvvaccine.org.au/parents/myths-and-facts-about-hpv-and-the-vaccine.aspx 2 National Cancer Institute. (2015). Human Papillomavirus (HPV) Vaccines. Retrieved from http://www.cancer.gov/about- cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet#r18http://www.cancer.gov/about- cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet#r18 3 Jena, AB, Goldman, DP, Seabury, SA. Incidence of Sexually Transmitted Infections After Human Papillomavirus Vaccination Among Adolescent Females. JAMA Intern Med. 2015;175(4):617-623. doi:10.1001/jamainternmed.2014.7886

35. Tips and Time-savers for Talking with Parents CDC RESEARCH SHOWS: Parents may be concerned that vaccinating may be perceived by the child as a permission to have sex. TRY SAYING:Research has show that getting the HPV vaccine does not make kids more likely to be sexually active or start having sex at a younger age.

36. Tips and Time-savers for Talking with Parents CDC RESEARCH SHOWS: Parents might believe their child won’t be exposed to HPV because they aren’t sexually active or may not be of a long time. TRY SAYING:HPV is so common that almost everyone will be infected at some point. It is an 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.

37. HPV Vaccine is Best at Ages 11 or 12 Years While there is very little risk of exposure to HPV before age 13, the risk of exposure increase thereafter.

38. Higher effectiveness with vaccination at younger ages. Gertig DM, BMC Med 2013 % Reduction in cervical dysplasia 5 years after vaccination, by age at vaccination Age at vaccination Percent dysplasia reduction

39. Tips and Time-savers for Talking with Parents CDC RESEARCH SHOWS: Parents want a concrete reason to understand the recommendation that 11-12 year olds receive HPV vaccine. TRY SAYING: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 other recommended childhood vaccines. Similarly, we want to vaccinate children before they get exposed to HPV.

40. How does the Chair of ACIP do it? “When discussing HPV vaccine with 11 and 12 year- olds and their parents, I will ask the simple question: When do you want your children to put on their bike helmets?  A. Before they get on their bike  B. When they are riding their bike in the street  C. When they see the car heading directly at them  D. After the car hits them I usually end up with a smile and a successfully launched series.” Temte JL, Pediatrics 2014, letter to the editor

41. MYTH The HPV vaccine is only for females

42. Talking Points  HPV vaccine is strongly recommended for males and females  Vaccination helps protect boys from HPV types that can cause cancers of the throat, penis, and anus  Vaccination helps prevent genital warts  Vaccinated boys are less likely to spread HPV to future partners 1 1 Centers for Disease Control and Prevention. (2014). HPV Vaccine – Questions & Answers. Retrieved from http://www.cdc.gov/vaccines/vpd-vac/hpv/vac-faqs.htm

43. 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

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

45. 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%

46. Tips and Time-savers for Talking with Parents CDC RESEARCH SHOWS: Disease prevalence is not understood, and parents are unclear about what the vaccine actually protects against. TRY SAYING:HPV can cause cancers of the cervix, vagina, and vulva in women, cancer of the penis in men, and cancers of the anus and mouth or throat in bot women and men. There are about 27,000 of these cancer each year – and most could be prevented with HPV vaccine. There are also many more precancerous conditions requiring treatment that can have lasting effects.

47. MYTH The HPV vaccine is not effective and doesn’t prevent cancer

48. Talking Points  HPV vaccine has been proven to prevent cell changes and infections that correspond with HPV-associated cancers  Studies have shown a significant reduction in abnormal Pap test results 1,2 and genital warts 3,4 1 Pollock KGJ, Kavanagh K, Potts A, Love J, Cushien K, Cubie H, Robertson C, Cruickshank M, Palmer TJ, Nicoll S, Donaghy M. (2014). Reduction of low- and high-grade cervical abnormalities associated with high uptake of the HPV bivalent vaccine in Scotland. British Journal of Cancer, 111:1824-1830. doi: 10.1038/bjc.2014.479 2 Baldur-Felskov B, Dehlendorff C, Munk C, Kjaer SK. (2013). Early Impact of Human Papillomavirus Vaccination on Cervical Neoplasia – Nationwide Follow-up of Young Danish Women. Journal of the National Cancer Institute, 106(3): djt460. doi: 10.1093/jnci/djt460 3 Ali H, Donovan B, Wand H, Read THR, Regan DG, Grulick AE, Fairley CK, & Guy RJ. (2013). Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ 2013;346:f2032. doi: http://dx.doi.org/10.1136/bmj.f2032 4 Bauer HM, Wright G, Chow J. (2011). Evidence of Human Papillomavirus Vaccine Effectiveness in Reducing Genital Warts: An Analysis of California Public Family Planning Administrative Claims Data, 2007–2010. American Journal of Public Health, Vol. 102(5), pp. 833-835. doi: 10.2105/AJPH.2011.300465

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

50. 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: Genital warts  Australia, New Zealand, Denmark, Sweden, Germany, Quebec, US HPV prevalence  Australia, Norway, Denmark, Sweden, UK, US Cervical lesions  Australia, British Columbia, Denmark, Sweden, US 50

51. NHANES HPV Prevalence Studies  National Health and Nutrition Examination Survey (NHANES) data used to compare HPV prevalence  Before the start of the HPV vaccination program (2003-2006 ) &  From the first 4 years after vaccine introduction (2007-2010)  Results  In 14-19 year olds, vaccine-type HPV prevalence decreased 56% (11.5% in 2003-2006 to 5.1% in 2007-2010)  Other age groups did not show a statistically significant difference over time Markowitz, et al. J Infect Dis 2013 Vaccine effectiveness for prevention of infection was an estimated 82%

52. 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 52

53. 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 yr olds  HPV 16/18 prevalence decreased at least 68%  Anogenital warts decreased by ~61%  Evidence of herd effects  Some evidence of cross protection against other types Drolet et al. Lancet Infect Dis 2015 53

54. 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 54

55. Tips and Time-savers for Talking with Parents CDC RESEARCH SHOWS: Parents want to know that HPV vaccine is effective. TRY SAYING: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.

56. Addressing all concerns in 45 seconds Provider: Meghan and Mark are due for their HPV vaccine. Parent: Why do they need an HPV vaccine? Provider: The HPV vaccine will help protect them from cancer caused by HPV infection. We know that HPV infection is dangerous– 27,000 people in the US get cancer from HPV every year. And we know that the HPV vaccine is safe– over 187 million doses have been given worldwide and there haven’t been any serious side effects. Parent: I don’t think they need that yet… Provider: Vaccines only work if they’re given before exposure– we never wait until a child is at risk to give any recommended vaccines. HPV vaccine is also given as early as possible because it produces a better immune response in younger adolescents. That’s why it is so important to start the shots now and finish all 3 of them in the next 6 months.

57. Tips and Time-savers for Talking with Parents CDC RESEARCH SHOWS: Parents do not know that the full vaccine series requires 3 shots. Your reminder will help them to complete the series. TRY SAYING: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!

58. Rapid acquisition of HPV following sexual debut Study of 18-23 year-old males (n=240) Partridge, JID 2007

59. MYTH People already know about the HPV vaccine, and will ask for it if they want it

60. Talking Points  A strong provider recommendation is the single best predictor of vaccination 1  37% of parents have no prior knowledge about the vaccine before their child’s provider educates them 2 1 Centers for Disease Control and Prevention. (n.d.). Frequently Asked Questions about HPV Vaccine Safety. Retrieved from http://www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.htmlhttp://www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.html 2 Wisk LE, Allchin A, Witt WP. (2014). Disparities in human papillomavirus vaccine awareness among U.S. parents of preadolescents and adolescents. Sexually Transmitted Diseases, 41(2): 117–122. doi: 10.1097/OLQ.0000000000000086

61. Clinicians Underestimate the Value Parents Place on HPV Vaccine Adapted from Healy et al. Vaccine. 2014;32:579-584.

62. Each adolescent visit may be the last chance to vaccinate!  30% of adolescents never present for preventive care  1 in 15 adolescent visits is for preventive care  Preventive visits decline after age 13  Early adolescents (11-13 years old) had 3 times more preventive visits than late adolescents Yuping Tsai (Journal of Pediatrics. 2014;164:625-30)

63. Delay more common than refusal Providers and parents may not understand that the vaccine is most effective when all three doses are finished by age 13. And delays intended to be temporary may become permanent Perkins et al, Pediatrics, 2014

64. Tips and Time-savers for Talking with Parents CDC RESEARCH SHOWS: Emphasizing your personal belief in the importance of HPV vaccine helps parents feel secure in their decision. TRY SAYING: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, American Cancer Society, and the CDC) also agree that this vaccine is very important for your child.

65. MYTH The effectiveness of the HPV vaccine decreases over time

66. Talking Points  Current data suggest protection is ongoing with no sign of waning 1  Mechanism of immune memory has been demonstrated  If discovered that immunity does wane, a booster may be recommended 1 Deleré Y1, Wichmann O, Klug SJ, van der Sande M, Terhardt M, Zepp F, Harder T. The efficacy and duration of vaccine protection against human papillomavirus: a systematic review and meta-analysis. Dtsch Arztebl Int., 111(35- 36):584-91. doi: 10.3238/arztebl.2014.0584

67. 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 8-10 years  Multiple cohort studies are in progress to monitor the duration of immunity

68. Resources for Busting Myths and Addressing Concerns

69. Resources:  ACS Myth Busting  CDC Tips and Timesavers  AAP Common Concerns

70. Q&AQ&A