HPV VACCINATION ROUTINELY RECOMMENDING CANCER PREVENTION

National Center for Immunization & Respiratory Diseases HPV VACCINATION ROUTINELY RECOMMENDING CANCER PREVENTION Melinda Wharton, MD, MPH Director, Immunization Services Division Mississippi Primary Health Care Association Annual Conference Biloxi, Mississippi May 31, 2017

Learning Objectives Describe trends in adolescent immunization coverage in the United States during the period 2006 2015 Identify groups currently recommended by the Advisory Committee on Immunization Practices to routinely receive HPV vaccine Identify at least one strategy which could be implemented in your practice or work setting to improve HPV vaccine coverage

number of cases per year Estimated numbers of HPV associated cancers attributable to HPV 16/18 and 5 additional types in 9 valent vaccine, United States 10000 9000 8000 7000 6000 5000 4000 3000 2000 1000 0 females males HPV 16/18 5 additional types Viens et al, http://www.cdc.gov/mmwr/volumes/65/wr/mm6526a1.htm

HPV Associated Cervical Carcinoma Rates by State, United States, 2008 2012 Rate are per 100,000 persons and age adjusted to the 2000 US standard population. Data are from population based registries participating in CDC s National Program of Cancer Registries or NCI s Surveillance, Epidemiology, and End Results Program, meeting USCS publication criteria for all years 2008 2012, and cover about 99% of the US population. Rates were suppressed if the data did not meet USCS publication criteria or if there were fewer than 16 cases. HPV associated cancers were defined as cancers at specific anatomic sites with specific cellular types in which HPV DNA frequently is found. All cancers were confirmed histologically. Cervical cancers (ICD O 3 site codes C53.0 C53.9) were limited to carcinomas (ICD O 3 histology codes 8010 8671, 8940 8941). Adapted from: Viens et al. Human Papillomavirus Associated Cancers United States, 2008 2012. MMWR 2016;65(26):661 666.

Updated Recommendations for HPV Vaccination: Routine and Catch Up Age Groups ACIP recommends routine HPV vaccination at age 11 or 12 years. Vaccination can be given starting at age 9 years. ACIP also recommends 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. October 2016: ACIP vote and approval by CDC; MMWR, December 16, 2017 6

Updated Recommendations for HPV Vaccination: Dosing Schedules For persons initiating vaccination before the 15 th birthday, the recommended immunization schedule is 2 doses of HPV vaccine. The second dose should be administered 6 12 months after the first dose (0, 6 12 month schedule). For persons initiating vaccination on or after the 15 th birthday, the recommended immunization schedule is 3 doses of HPV vaccine. The 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). October 2016: ACIP vote and approval by CDC; MMWR, December 16, 2017 7

Updated Recommendations for HPV Vaccination: Persons with Prior Vaccination Persons who initiated vaccination with 9vHPV, 4vHPV, or 2vHPV before the 15 th birthday, and received 2 doses of any vaccine at the recommended dosing schedule*, or 3 doses of any vaccine at the recommended dosing schedule, are considered adequately vaccinated. Persons who initiated vaccination with 9vHPV, 4vHPV, or 2vHPV on or after the 15 th birthday, and received 3 doses of any vaccine at the recommended dosing schedule, are considered adequately vaccinated. *Minimum interval between dose 1 and dose 2 in 2 dose schedule is 5 months October 2016: ACIP vote and approval by CDC; MMWR, December 16, 2017 8

Updated Recommendations for HPV Vaccination: Persons with Prior Vaccination 9vHPV may be used to continue or complete a series started with 4vHPV or 2vHPV. For persons who have been adequately vaccinated with 2vHPV or 4vHPV, there is no ACIP recommendation for additional vaccination with 9vHPV. Supplemental information and guidance for vaccination providers regarding use of 9 valent HPV vaccine: http://www.cdc.gov/hpv/downloads/9vhpv guidance.pdf October 2016: ACIP vote and approval by CDC; MMWR, December 16, 2017 9

Updated Recommendations for HPV Vaccination: Interrupted Schedules If the vaccine schedule is interrupted, the vaccination series does not need to be restarted. Number of recommended doses is based on age at administration of the first dose. October 2016: ACIP vote and approval by CDC; MMWR, December 16, 2017 10

Updated Recommendations for HPV Vaccination: Medical Conditions ACIP recommends HPV vaccination for immunocompromised persons aged 9 through 26 years with 3 doses of HPV vaccine (0, 1 2, 6 months). Persons who should receive 3 doses are those with primary or secondary immunocompromising conditions that might reduce cell mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasm, transplantation, autoimmune disease, or immunosuppressive therapy, since immune response to vaccination may be attenuated. * * The recommendation for a 3 dose schedule for immunocompromised persons does not apply to children with asplenia, asthma, chronic granulomatous disease, chronic liver disease, chronic lung disease, chronic renal disease, CNS anatomic barrier defects (e.g., cochlear implant), complement deficiency, diabetes, heart disease, persistent complement component deficiencies, or sickle cell disease. October 2016: ACIP vote and approval by CDC; MMWR, December 16, 2017 11

Summary of Dosing Recommendations Number of doses Dosing schedule Population 2 0, 6 12 months 3 0, 1 2, 6 months Persons initiating vaccination at ages 9 through 14 years, except immunocompromised persons* Persons initiating vaccination at ages 15 through 26 years Immunocompromised persons* initiating vaccination at ages 9 through 26 years *Persons with primary or secondary immunocompromising conditions that might reduce cell mediated or humoral immunity 12

Estimated HPV Vaccination Coverage among Adolescents Aged 13 17 Years, NIS Teen, United States, 2006 2015 100 90 80 70 60 50 40 30 20 Tdap MCV4 1 HPV girls 3 HPV girls 1 HPV boys 3 HPV boys 1 HPV girls & boys 10 0 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Survey Year Source: Reagan Steiner, et al. MMWR; August 26, 2016 / 65(33);850 858 13

Estimated vaccination coverage among adolescents 13 17 years of age National Immunization Survey Teen, United States and Mississippi, 2015 United States Mississippi Females 1 HPV 62.8% (±1.8%) 52.4% (±8.0%) 2 HPV 52.2% (±1.8%) 37.2% (±7.7%) 3 HPV 41.9% (±1.8%) 24.4% (±6.6%) Males 1 HPV 49.8% (±1.8%) 38.9% (±8.9%) 2 HPV 39.0% (±1.7%) 29.6% (±8.5%) 3 HPV 28.1% (±1.6%) 21.4% (±8.0%) http://www.cdc.gov/mmwr/volumes/65/wr/pdfs/mm6533.pdf

100 Vaccine Coverage among Children 19 35 Months, National Immunization Survey, United States, 1994 2014 90 80 Percent Vaccinated 70 60 50 40 30 20 3+ Hib Rotavirus 4+ PCV 3+ HepB 2+ HepA 1+ Varicella MMR (1+) DTP/Dtap (3+ ) Polio (3+) Hib (3+) HepB (3+) Varicella (1+) PCV (4+) Rotavirus* HepA (2+)* 10 0 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Year

Provider motivation and skill Parental acceptance Systems support

Lack of provider motivation and skill Lack of parental acceptance Barriers

Why Is HPV Vaccine Coverage So Low? Parents Parents are not offered vaccination Parents perceive vaccine as optional or unnecessary at that time Parents perceive that their providers discouraged vaccination Parents want information about vaccine safety Parents do not understand the reason to vaccinate at 11 to 12 years of age Providers Providers are reluctant to give multiple shots at one visit Providers introduce HPV vaccination at age 11 years but do not recommend it strongly Providers recommend vaccination based on their estimation of sexual activity Providers have limited experience with HPV and underestimate risk Providers perceive HPV as more emotionally charged than other vaccines Delaying vaccination leads to nonvaccination Both providers and parents know they are often unaware of the timing of sexual debut. Perkins RB et al. Pediatrics 2014;134:e666 e674

Reasons for Not Vaccinating Adolescents with HPV Vaccine, Unvaccinated Adolescents* Aged 13 17 Years, NIS Teen, United States, 2015 Parents of Girls Parents of Boys % (95% CI) % (95% CI) Not needed/necessary 19.6 (16.8 22.8) Not needed/necessary 20.6 (18.2 23.3) Not sexually active 13.9 (10.7 17.8) Not recommended 17.7 (15.3 20.3) Safety concerns/ side effects 13.4 (11.3 15.8) Lack of knowledge 12.9 (11.2 15.0) Lack of knowledge 11.7 (9.2 14.8) Safety concerns/ side effects 9.3 (7.7 11.1) Not recommended 9.5 (7.7 11.6) Not sexually active 8.3 (7.0 9.9) * Analysis limited to adolescents with zero HPV vaccine doses, whose parents reported that they were not likely to seek HPV vaccination for their adolescent in the next 12 months

Physicians Perceptions of Adolescent Vaccine Endorsement for Patients Ages 11 12, 2014 100 Proportion endorsing highly (physicians) and physicians estimate of parents 90 80 70 60 50 40 30 20 10 0 Tdap Meningococcal HPV Physicians themselves Parents Gilkey MB et al, Preventive Medicine 2015;77:181 185

Parent opinions on the importance of vaccines and provider estimates of parental responses Median Values 10 9 8 7 6 5 4 3 2 1 0 Parent Provider's estimate 9.4 9.2 9.5 9.2 9.5 9.3 9.3 9.3 9.2 Meningitis Hepatitis Pertussis Influenza HPV Adolescent vaccines 7.0 5.2 7.8 Adapted from Healy et al. Vaccine. 2014;32:579 584.

optional new vaccine not at risk you can wait

Cumulative incidence of genital HPV infection among sexually active female college students Winer et al. Am J Epidemiol 2003;157 24

Percentage of high school students who ever had sexual intercourse and who had sexual intercourse for the first time before age 13 years United States and Mississippi, Youth Risk Behavior Survey, 2015 100 90 80 70 60 50 40 30 20 10 0 Ever had sexual intercourse Grade 9 Grade 10 Grade 11 Grade 12 Female Male Ever had sexual intercourse, high school students, United States Females 39.2% Males 43.2% Had first sexual intercourse before age 13 years, United States Females 2.3% Males 5.6% Ever had sexual intercourse, high school students, Mississippi Females 44.0% Males 52.6% Had first sexual intercourse before age 13 years, Mississippi Females 3.8% Males 13.3% http://www.cdc.gov/healthyyouth/data/yrbs/pdf/2015/ss6506_updated.pdf

Why don t adolescents finish the HPV vaccine series? Reasons given by parents for incomplete vaccination (%) Conscious decision 11% Provider expectations for vaccine completion (%) Opportunistic 7% Inconvenience 24% Expect clinic reminder 65% Schedule second dose at time of 1st dose 41% Expect parent to schedule appointment 52% Perkins RB et al. Human Vaccines and Immunotherapeutics, 2016

What can we do about it?

HPV Vaccination: What Works Parents Parents want to prevent cancer Parents trust their provider s recommendation Parents think benefits outweigh risks Parents want a strong recommendation Providers Providers emphasize cancer prevention Providers normalize the HPV vaccine and coadminister with other vaccines Providers give a strong recommendation Perkins RB et al. Pediatrics 2014;134:e666 e674

What Can Healthcare Providers Do? Make an effective recommendation for HPV vaccination as cancer prevention for every 11 or 12 year old patient Assess HPV vaccine coverage for each provider in your practice and develop an office wide strategy to improve it Engage the entire practice not just healthcare providers in committing to improve HPV vaccine coverage Implement systems strategies to improve HPV vaccine coverage

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

Factors that May Impact HPV Vaccine Series Completion in Clinics with Higher and Lower Series Completion: Pro HPV Vaccination Culture 100 90 80 70 60 50 40 30 20 10 0 Local culture supports series completion Teamwork among clinicians Promoting series completion seen as provider's role Giving vaccines is standard Make return appointment for subsequent doses Provider at higher performing clinic Provider at lower performing clinic Hudson SM et al. Vaccine 2016

Systems Strategies to Improve HPV Vaccine Coverage Establish standing orders for HPV vaccination beginning at age 11 12 years in your practice Conduct reminder/recall beginning at 11 12 years of age Assess HPV vaccine coverage at every visit and prompt clinical staff to give HPV vaccine at that visit Schedule return visit for next dose before the patient leaves the office Document each dose in the child s medical record and the state s immunization information system

Impact of a Mailed Reminder Letter on HPV Series Completion in Girls and Young Women 60 Proportion completing 3 dose series by the end of 12 month evaluation period 50 40 30 20 10 0 Age 9 26 years Age 9 17 years Age 18 26 years Intervention Control Chao C et al, Journal of Adolescent Health 2015;56:85 90

Tactics for Successful HPV Vaccine Delivery, Denver Health Routine use of a robust immunization registry for multiple functions, including recording vaccine history and recommended needed vaccines at every visit Medical assistants check vaccine registry for recommended vaccines at every visit Standing order for routine immunizations Vaccines are given early in the visit when possible Education for providers to present Tdap, MCV, and HPV as a standard bundle of adolescent immunizations Provider level report cards with adolescent vaccination coverage rates Vaccination drives at school based health centers Farmer et al, Pediatrics 2016

Immunization Rates for Adolescents Denver Health, 2004 2014 Farmer et al, Pediatrics 2016

National, State, and Denver Health Immunization Rates, 2013 Farmer et al, Pediatrics 2016

What Can Community and State Level Organizations Do? Convene and commit to implementing effective strategies Immunization programs: AFIX focused on adolescent immunization Provider organizations: help members develop the motivation and skills to make an effective recommendation for HPV vaccination Cancer programs: motivate immunization providers to prevent cancers caused by HPV in their patients Health care payers: use HPV vaccine coverage as a quality measure All organizations: increase public awareness and support for HPV vaccination as cancer prevention All organizations: promote or implement systems strategies to improve HPV vaccine coverage

Thank you For more information, contact CDC 1 800 CDC INFO (232 4636) TTY: 1 888 232 6348 www.cdc.gov www.cdc.gov/vaccines www.cdc.gov/hpv www.cdc.gov/vaccinesafety The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.