HPV Vaccine Ina Park, MD, MS

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1 HPV Vaccine Ina Park, MD, MS California Department of Public Health STD Control Branch Alameda County Immunization Update 2014

2 Over 170 types of HPV classified Updated incidence/prevalence estimates (CDC): 14 million new infections per year 79 million people infected in the US devilliers, 2013, Virology Satterwhite, 2013, STD

series; $365 HPV Vaccines Quadrivalent: Merck Gardasil Types 6, 11, 16, 18 Prevents warts, cervical

3 Gardasil PI. Cervarix PI. Bivalent: GSK Cervarix Types 16, 18 Prevents cervical cancer FDA-approved for females dose series; $365 HPV Vaccines Quadrivalent: Merck Gardasil Types 6, 11, 16, 18 Prevents warts, cervical cancer, anal cancer FDA-approved for females and males dose series; $375 Nonavalent: Merck V503 Types 6, 11, 16, 18, 31, 33, 45, 52, 58 FDA biologics license application Dec 2013

4 Reduction in pre-cancer endpoints Nonavalent vs quadrivalent vaccine Endpoint CIN 2/3 or AIS, VIN2/3, VaIN 2/3 Nonavalent n=7099 Quadrivalent n=7105 % reduction % Non-inferior immunogenicity for types 6/11/16/18 ( ) CIN = Cervical Intraepithelial Neoplasia VIN = Vulvar Intraepithelial Neoplasia AIS = Adenocarcinoma in situ VaIN = Vaginal Intraepithelial Neoplasia Merck, EUROGIN Abstract SS 8-4, Nov 2013

5 IS HPV VACCINE SAFE? ~57 Million doses ~1700 As of March 2013 confirmed deaths related to HPV vaccine 0 85 Data: Graphic:

6 HPV vaccine safety monitoring - VAERS ~57 million HPV4 doses distributed in the United States from 6/2006 through 3/2013 No new safety concerns have been identified in postlicensure vaccine safety surveillance among male or female recipients of HPV4 vaccine Among the 7.9% of reports coded as serious, most frequently cited are headache, nausea, vomiting, fatigue, dizziness, syncope, generalized weakness Syncope continues to be a frequently reported adverse event among adolescents Adherence to a 15-minute observation period after vaccination is encouraged

7 Who should NOT get the vaccine? Pregnant women Lactating women: OK Patients with a serious allergy to any component of the vaccines HPV4: Yeast HPV2: Latex (if using pre-filled syringes)

8 ACIP HPV Vaccine Recommendations Population Gender Age Females (may start at 9) Males (may start at 9) MSM & HIV+ Males Recommendation Routine vaccination with either HPV4 or HPV Routine vaccination with either HPV4 or HPV2* Routine vaccination : HPV Routine vaccination :HPV Permissive recommendation: HPV Routine vaccination: HPV 4 * Irrespective of history of abnormal Pap, HPV, genital warts MMWR, May ; 59(20): , MMWR, December ; 60(50);

9 Providers recommend vaccination too late Survey of N=1,013 Family Physicians, Pediatricians, and ObGyns 34.6% of physicians reported always recommending the HPV vaccine to early adolescents vs 52.7% to middle adolescents, and 50.2% to late adolescents/young adults. Vadaparamil 2011, Vaccine

10 Q and A for Audience Average age of penile-vaginal sex in US? Boys Girls Sexual behaviors before penile-vaginal sex?

11 HPV acquisition prior to sexual debut among U.S. female Among n=114 girls aged 4-15 years referred to peds gyn (no history of abuse) 13.6% had high risk HPV (Winer 2009) Among n=22 virginal adolescent females, 45% had HPV, primarily due to sexual behaviors other than penile-vaginal sex (Shew 2013) Among n=250 college-age women 9% had HPV prior to seuxal debut (Winer 2010)

12 If we wait until mid/late adolescence

13 Preteen Vaccine Week! Also available in Spanish NPHIC GOLD AWARD

14 Preteen girls talk about HPV ShotbyShot.org: Personal Stories Project of CA Immunization Coalition IZ Branch collaborates & promotes Heather s story: cervical cancer Kristen s story cervical cancer

15 2014 New HPV Materials Flyer on HPV facts Featuring Kristen s story Poster for Dr. Offices Appointment Cards

16 Estimated Vaccine Coverage (%) Estimated Vaccine Coverage (%) HPV Vaccine Coverage, CA vs US Adolescents Ages National Immunization Survey, 2012 US CA US CA Girls 1 dose Girls 3 doses 0 Boys 1 dose Boys 3 doses MMWR 2013/ 62(29):591-5.

17 Estimated Vaccine Coverage (%) US HPV Vaccine Coverage Remains Flat in 2012 Girls Ages National Immunization Survey, Year 1 dose 2 doses 3 doses Potential coverage with 1 dose of HPV vaccine if no missed opportunity* *Missed opportunity: healthcare encounter occurring on/after girl's 11th birthday after March 23, 2007 (ACIP's HPV4 recommendations published), during which a girl received at least one vaccine but did not receive HPV vaccine. MMWR 2013/62(29):591-5.

3-dose Series Completion (%) Estimated HPV 3-Dose Series Completion*, Adolescents Ages 13-17 National Immunization Survey,

males who received 3 doses among those who had 1 HPV dose and 24 weeks between the first dose and the interview date MMWR:

18 3-dose Series Completion (%) Estimated HPV 3-Dose Series Completion*, Adolescents Ages National Immunization Survey, Girls Boys Year *3-dose completion = percentage of females or males who received 3 doses among those who had 1 HPV dose and 24 weeks between the first dose and the interview date MMWR: 2008 / 57(40):1100-3; 2009 / 58(36): ; 2010 / 59(32): ; 2011 / 60(33): ; 2012 / 61(34):661-77; 2013 / 62(34):

20 Increased Distribution of HPV Vaccine to CA Providers in 2013 HPV vaccine doses distributed to enrolled VFC providers in CA 2012: 508,445 doses 2013: 616,410 doses ( 21%)

21 Reporting to California Immunization Registry (CAIR) 2012: HPV vaccine doses reported: 394,221 Patients receiving HPV vaccination in CAIR: 292, : HPV vaccine doses reported: 415,116 ( 5.3%) Patients receiving HPV vaccination in CAIR: 301,697 ( 3.3%)

22 Monitoring HPV Vaccine Impact Important to understand impact of the HPV vaccine in general population Looking at impact on cervical cancer would take several decades Early signs of impact would include reductions in HPV infection, and genital warts Impact cervical cancer precursors (CIN 2, CIN3, AIS) surrogate measures for cervical cancer outcomes

23 Prevalence (%) 30 Prevalence of HPV 6, 11,16, 18* in cervicovaginal swabs, by age group NHANES, and % decline Age group (yrs) Markowitz, et al. JID 2103 *weighted prevalence 23

24 Percent with Genital Warts Genital warts among females by age group, CA Family PACT * * * -34.8% -10.0% +10.1% * +9.4% < *P trend <.05 Bauer, et al AJPH 2012

25 PARTING WORDS Make strong recommendations to parents Vaccinate pre-teens Put systems in place to ensure completion of series

An update on the Human Papillomavirus Vaccines. I have no financial conflicts of interest. Case 1. Objectives 10/26/2016

An update on the Human Papillomavirus Vaccines Karen Smith-McCune Professor, UCSF Department of Obstetrics, Gynecology and Reproductive Sciences John Kerner Endowed Chair I have no financial conflicts