YOU ARE THE KEY Strategies to Improve HPV Vaccination Rates

Transcription

1 YOU ARE THE KEY Strategies to Improve HPV Vaccination Rates West Virginia Rural Health Conference October 17, 2018 Elaine Darling, MPH, Senior Program Manager WV Immunization Network, The Center for Rural Health Development Michelle Chappell, MS Senior Manager, State Health Systems American Cancer Society

2 Overview of WIN WV Immunization Network (WIN): Statewide immunization coalition focused on improving and sustaining immunization rates. WIN works to foster comprehensive, sustainable state and community policies and practices to ensure that West Virginia s residents are protected from the consequences of vaccinepreventable diseases throughout their lifespan. The Center for Rural Health Development, Inc. ( The Center ) serves as the Lead agency for WIN. Other programs of The Center:

3 80% HPV Vaccination Rates by June 8, 2026 cancer.org/hpv ACS Public Health Platforms

4 Objectives 1. Describe the burden of HPV-associated cancers in the United States and in West Virginia; 2. State the ACIP recommendations for HPV vaccination; 3. Identify 3 evidence-based practices for improving HPV vaccination rates.

5 The Burden of HPV Infection & Disease

6 HPV Infection & Disease HPV is a group of more than 150 related viruses that infect epithelial tissue, including approximately 40 that infect the genital area. HPV is named for the warts (papillomas) some HPV types can cause. HPV is transmitted through intimate skin-to-skin contact. Not solely transmitted through penetrative sexual intercourse. Virgins still acquire HPV infection* After penetrative sex initiation, 45.5% of men acquired HPV within 24 months.* HPV can be passed even when an infected person has no signs or symptoms. Most people will never know that they have been infected. This Photo by Unknown Author is licensed under CC BY-SA *Source: Zhiyue Liu et al. Journal of Infectious Diseases (2017).

7 HPV Infection & Disease HPV is the most common sexually transmitted virus and infection in the U.S. Most females and males in the U.S. will be infected with at least one type of HPV at some point in their lives. In most cases, HPV goes away on its own and does not cause any health problems. When HPV is not cleared, it can cause health problems like genital warts and cancer. HPV can be passed even when an infected person has no signs or symptoms. Most people will never know that they have been infected.

8 HPV Types Differ in their Disease Associations

9 The Burden of HPV Infection & Disease 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 Source: Satterwhite et al. Sex Transm Dis. 2013

10 Prevalence of Oral HPV Population-based analysis of adults aged years who participated in the National Health and Nutrition Examination Survey (NHANES) from 2011 to 2014: 11.5% of men had an oral HPV infection 3.2% women had an oral HPV infection. For oral HPV 16 specifically, the prevalence was six times more common in men than in women (or 1.7 million men and 270,000 women in the United States) Oral HPV prevalence among men with concurrent genital HPV infection was 4-fold greater (19.3%) than among those without it (4.4%). Sonawane K, et al. Ann Intern Med. 2017;167:

11 HPV-Associated Cancers per Year, United States, An average of 38,793 HPV-associated cancers were diagnosed annually in the United States during ,000 among females 15,793 among males Among these cancers, CDC estimates that 30,700 (79%) can be attributed to HPV 28,500 (73%) of these are attributable to HPV types that are preventable with the 9-valent HPV vaccine. Sources:

12 Cancers Caused by HPV per Year, U.S., Percentage probably caused by any HPV type Number probably caused by any HPV type Based on Viens et al. MMWR 2016.

13 Number of HPV-Associated Cancers Among Men by Year and Cancer Site, U.S., Source: Viens LJ, Henley SJ, Watson M, Markowitz LE, Thomas CC, Thompson TD, Razzaghi H, Saraiya M, Centers for Disease Control and Prevention (CDC). Human papillomavirus associated cancers United States, MMWR 2016;65(26):

14 HPV-Associated Cancer Rates Among Men by Year and Cancer Site, U.S., Viens LJ, Henley SJ, Watson M, Markowitz LE, Thomas CC, Thompson TD, Razzaghi H, Saraiya M, Centers for Disease Control and Prevention (CDC). Human papillomavirus associated cancers United States, MMWR 2016;65(26):

15 WV has highest incidence of cervical cancer among states WV has 2 nd highest incidence rate among states WV has 6 th highest rate in nation WV has 6 th highest rate in nation WV has 3 rd highest rate among states WV ties for highest rate in nation (with KY) W.V. Incidence Rate Range in incidence rates among U.S. states & territories Source:

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18 The HPV Vaccine

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

20 Genital warts 63% of cancers in body parts where HPV DNA is often found 10% of cancers in body parts where HPV DNA is often found Source:

21 HPV Vaccines Currently Licensed in U.S. Bivalent 2vHPV (Cervarix) Quadrivalent 4vHPV (Gardasil) 9-Valent 9vHPV (Gardasil 9) Manufacturer GlaxoSmithKline Merck Merck HPV Types Included Contraindications 16, 18 6, 11, 16, 18 Hypersensitivity to latex* * May be present in tip of pre-filled syringes Hypersensitivity to yeast 6, 11, 16, 18, 31, 33, 45, 52, 58 Hypersensitivity to yeast

22 How a vaccine is recommended The Centers for Disease Control and Prevention (CDC) sets the U.S. childhood immunization schedule based on recommendations from the Advisory Committee on Immunization Practices (ACIP). ACIP recommendations stand as public health guidance for safe use of vaccines and related biological products.

23 How a vaccine is recommended Advisory Committee on Immunization Practices: Comprised of medical and public health experts who develop recommendations on the use of vaccines in the civilian population of the United States. Includes 15 voting members responsible for making vaccine recommendations. Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members following an application and nomination process. 14 of the members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine 1 member is a consumer representative who provides perspectives on the social and community aspects of vaccination. Also includes 8 ex-officio members who represent other federal agencies with responsibility for immunization programs in the United States, and 30 non-voting representatives of liaison organizations that bring related immunization expertise.

24 How a vaccine is recommended What does the ACIP consider in the vaccine recommendation process? FDA licensed indications and schedule Disease epidemiology and burden of disease Vaccine efficacy and effectiveness Vaccine safety Feasibility of implementation Economic analyses Recommendations of other groups (e.g. AAP, ACOG, etc.)

25 HPV Vaccine Recommendation CDC recommends routine vaccination at age 11 or 12 years to prevent HPV-associated cancers The vaccination series can be started at age 9 years Two doses of vaccine are recommended The second dose of the vaccine should be administered 6 to 12 months after the first dose. Meites et al. MMWR

26 HPV Vaccine Recommendations: Catch Up/Late For those who missed vaccination at years of age. Vaccination for females through age 26 years and for males through age 21 years who were not previously adequately vaccinated. Males aged 22 through 26 years may be vaccinated. Vaccination is also recommended through age 26 for gay, bisexual, and other men who have sex with men (MSM), transgender people, and people with certain immunocompromising conditions (including HIV infection). Meites et al. MMWR

27 Dosing Schedules Starting the vaccine series before the 15th birthday Recommended schedule is 2 doses of HPV vaccine Second dose should be administered 6 12 months after the first dose (0, 6 12 month schedule) Minimum interval between dose one and dose two in a 2-dose schedule is 5 months Meites et al. MMWR Starting the vaccine series on or after the 15th birthday* Recommended schedule is 3 doses of HPV vaccine Second dose should be administered 1 2 months after the first dose, and the third dose should be administered 6 months after the first dose (0, 1 2, 6 month schedule) Minimum interval between dose one and dose three in a 3-dose schedule is 5 months *and immunocompromised persons 9-26 years

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29 Estimated Vaccination Coverage Levels among Adolescents Years - West Virginia, Vaccination Coverage (%) Tdap Vaccine Meningococcal (MenACWY) Vaccine Healthy People 2020 Targets One Dose of HPV Vaccine (Girls) One Dose of HPV Vaccine (Boys) Completed HPV Vaccine Series (Girls) Completed HPV Vaccine Series (Boys) Year Source:

30 The Impact? Increasing HPV vaccination rates from current levels to 80 percent would prevent an additional 53,000 future cervical cancer cases in the United States among girls who now are 12 years old or younger over the course of their lifetimes. Thousands of cases of other HPV-associated cancers in the U.S. also likely would be prevented within the same time frame. A growing proportion of these cancers most notably, oropharyngeal cancers will occur in males if HPV vaccination rates for males continue to remain low.

31 1959 In 1959, The line of people awaiting polio shots at Evansville's Municipal Stadium was still long four hours after the clinic started, when this picture was taken, Aug. 9, During the eight-hour program, about 14,000 from Evansville and surrounding communities received shots. In 1959, there were 8,425 polio cases.

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33 Not recommended Lack of knowledge Not sexually active Not needed Safety concerns

34 Why are there still so many teens who have not received the HPV vaccine? Reasons for Not Vaccinating Adolescents with HPV Vaccine, Unvaccinated Adolescents Ages 13-17, NIS Teen, US 2014

35 Why does it have to be given at a young age?

36 U.S. Vaccine Safety System System Collaborators Description Vaccine Adverse Event Reporting System (VAERS) Vaccine Safety Datalink (VSD) CDC and FDA CDC and 9 Integrated Health Care Systems Frontline spontaneous reporting system to detect potential vaccine safety issues Large linked database system used for active surveillance and research ~9.4 million members (~3% of US pop.) Clinical Immunization Safety Assessment (CISA) Project Post-Licensure Rapid Immunization Safety Monitoring Program (PRISM) CDC and 7 Academic Centers FDA and 6 partner organizations Expert collaboration that conducts individual clinical vaccine safety assessments and clinical research Large distributed database system used for active surveillance and research ~170 million individuals

37 Over 10 Years of HPV Vaccine Safety Data Reactions after vaccination may include Injection site reactions: pain, redness, and/or swelling in the arm where the shot was given Systemic: fever, headaches HPV vaccines should not be given to anyone who has had a previous allergic reaction to the vaccine or who has an allergy to yeast (Gardasil/Gardasil 9) Brief fainting spells (syncope) and related symptoms (such as jerking movements) can happen soon after any injection, including HPV vaccine Patients should be seated (or lay down) during vaccination and remain in that position for 15 minutes Gee, et al. Hum Vaccin Immunother

38 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

39 Evaluating and Monitoring 9-valent HPV Vaccine Safety in the United States Monitoring of VAERS Reports Clinical review of deaths and other pre-specified adverse events Data mining to identify disproportional reporting Vaccine Safety Datalink: Near real time monitoring of 10 pre-specified outcomes Sentinel System: Near real time active surveillance and surveillance of serious, unexpected events Manufacturer post-marketing commitments Two, 10-year studies to assess long-term safety Observational study to further characterize the safety profile in 10,000 persons Pregnancy registry

40 HPV Vaccination is Safe HPV vaccine safety studies have been very reassuring: HPV vaccine has a good safety profile To date, vaccine safety studies have not observed any signal that shows that HPV vaccination causes death, neurologic conditions, autoimmune conditions, or venous thromboembolism (VTE).

41 HPV Vaccine Impact

42 Monitoring Impact of HPV Vaccine Programs on HPV-Associated Outcomes

43 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

44 Prevalence of HPV before & after introduction of HPV vaccination in the United States Prevalence, % % decrease 34% decrease Any HPV Non 4vHPV HR 4vHPV Any HPV 4vHPV Non 4vHPV HR Any HPV Non 4vHPV HR 4vHPV years years years Markowitz L et al. Pediatrics

45 Impact of HPV vaccination in Australia Start of Australia HPV vaccination program Females Males

46 The Guardian, March 3, 2018 In 2007, the Australian government began providing the vaccine for free to girls aged years, and in 2013, it extended the program to boys. Girls and boys outside those ages but under 19 can also access two doses of the vaccine for free. In 2016, 78.6% of 15-year old girls and 72.9% of 15-year old boys had been vaccinated. The HPV rate among women aged 18 to 24 dropped from 22.7% to 1.1% between 2005 and Immunization rates have risen further since High coverage is creating a herd protection effect. As long as we continue the screening program, we will continue to pick up those with the virus already, and as long as we keep up the vaccination, we could have no new cases in years. -Ian Frazer, University of Queensland Professor and the co-inventor of the vaccine

47 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 year 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

48 Impact on Oral Cancers Reduced Prevalence of Oral Human Papillomavirus (HPV) 4 Years after Bivalent HPV Vaccination in a Randomized Clinical Trial in Costa Rica (PLoS One. 2013) Investigated vaccine efficacy (VE) of the bivalent HPV 16/18 vaccine against oral HPV infections 4 years after vaccination. Estimated VE of 93.3% Effect of Prophylactic Human Papillomavirus (HPV) Vaccination on Oral HPV Infections Among Young Adults in the United States. (J Clin Oncol. 2018) 18.3% of the US population 18 to 33 years of age reported receipt of at least one dose of the HPV vaccine before the age of 26 years (29.2% in women and 6.9% in men). The prevalence of oral HPV16/18/6/11 infections was reduced in vaccinated versus unvaccinated individuals by 88.2% HPV vaccination was associated with reduction in vaccine-type oral HPV prevalence among young US adults. However, because of low vaccine uptake, the population-level effect was modest overall and particularly low in men.

49 HPV Vaccine Duration of Protection Studies suggest that vaccine protection is longlasting No evidence of waning protection Available evidence indicates protection for at least 10 years Multiple studies are in progress to monitor duration

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

51 Now what?

52 There are things that everyone can do to improve HPV vaccination rates in WV

53 Physicians, Physician Assistants, Nurse Practitioners, Nurses Evidence-based interventions: 1. Make a presumptive recommendation for cancer prevention The biggest predictor of HPV vaccination uptake is an effective recommendation from a clinician: Your child is due to Tdap, HPV, and meningococcal vaccinations today. Or Your child is due for vaccines that prevent tetanus, whooping cough, HPV cancers, and meningitis. Do you have any questions?

54 Indicated or elective? The association of providers' words with HPV vaccine receipt Indicated Staff member s language makes it clear that HPV vaccination is a recommended treatment at the visit: You are due for the HPV vaccine or I recommend the HPV vaccine. Vaccination rate: 87%

55 Indicated or elective? The association of providers' words with HPV vaccine receipt Elective Medical staff s presentations did not clearly express any recommendation for the vaccination decision, framing the HPV vaccine as an option that could be chosen if the parent wished: If you want to start today, you can, or you can wait until next year or Are you familiar with the HPV vaccine? Vaccination rate: 68% Contraindicated Staff discouraged vaccination at any point in the visit. Vaccination rate: 0%

56 Indicated or elective? The association of providers' words with HPV vaccine receipt Indicated recommendation has greatest impact on undecided parents 92% accepting vaccination after an indicated recommendation 68% after an elective recommendation Source: Fenton et. al. Human Vaccines & Immunotherapeutics, May 2018

57 Physicians, Physician Assistants, Nurse Practitioners and Nurses Evidence-based interventions: 2. Minimize missed opportunities by using every opportunity to provide vaccination Provide an opportunity for vaccination-only visits or offer weekend clinic hours for vaccination. Collaborate with your health information technology (IT) colleagues, office manager, and fellow clinicians to establish effective strategies, such as: Provider prompts. Electronic health record (EHR) alerts for all age-eligible patients and set reminders in your EHR system for the second dose. Utilize WV Immunization Information System access current vaccination records and use forecasting tools.

58 Physicians, Physician Assistants, Nurse Practitioners and Nurses Evidence-based interventions: 3. Take the team approach by empowering every member of your team to become an HPV vaccine champion. Implement standing orders. Consistency Counts: every member of a practice plays a critical role in understanding and advocating for HPV vaccination as cancer prevention and should work together to reduce missed opportunities for vaccination. Provide in-service training for the entire practice on HPV vaccination and establish consistent messaging to parents. Pre-clinic team meetings or huddles. Practice motivational interviewing techniques.

59 Pharmacists Scope of Practice Change: 2018 legislative change: pharmacists and pharmacy interns may administer HPV and influenza vaccines to patients age eleven through eighteen years of age, with written informed parental consent, when presented with a prescription from a physician. May also administer HPV vaccine to adults.

60 Dentists & Dental Hygienists HPV vaccine recommendations and dosing schedule are in line with timing of routine dental exams. Communication with patients and caregivers The oral cancer exam opens the door for patient education on tobacco use, HPV and HPV vaccine. Talk about HPV vaccination in terms of cancer prevention.

61 Expanded Age Indication for HPV-9 to Include Individuals years old In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study. Source: FDA News Release,

62 Health Advocates Spread the word that HPV vaccine is Cancer Prevention. Someone You Love: The HPV Epidemic CEUs available at State license for public screenings Curriculum developed to accompany use in WV health classes at: Oropharyngeal cancer survivor video at

63 Other sources of information CDC s Vaccine Homepage: Free printed CDC materials: American Academy of Pediatrics HPV Champion Toolkit: us/advocacy-and-policy/aap-health-initiatives/pages/hpv-champion- Toolkit.aspx American Cancer Society HPV Resource Clearinghouse: ghouse/ Immunization Action Coalition: Children's Hospital of Philadelphia's Vaccine Education Center: WIN s website: American Dental Association:

64 Elaine Darling Senior Program Manager, West Virginia Immunization Network The Center for Rural Health Development, Inc. 75 Chase Dr. Hurricane, WV (304) Michelle Chappell, MS Senior Manager, State Health Systems, American Cancer Society