1. National Vaccine Advisory Committee HPV Recommendations Wayne Rawlins, MD NVAC Member HPV Working Group Co-C hair

2. Disclosures I, Wayne Rawlins, have been asked to disclose any significant relationships with commercial entities that are either providing financial support for this program or whose products or services are mentioned during my presentations. I have no relationships to disclose. I may discuss the use of vaccines in a manner not approved by the U.S. Food and Drug Administration but in accordance with ACIP recommendations 2

3. The views represented in this presentation are those of NVAC. The positions expressed and recommendations made here do not necessarily represent those of the U.S. Department of Health and Human Services, the U.S. government, or the individuals who served as authors of, or otherwise contributed to, the report. 3

4. Background More than 25,000 cases of HPV associated cancer are diagnosed annually in the U.S. Currently there are three HPV vaccines available in the US which have been clinically proven the prevent HPV infection leading to HPV related cancers To prevent cancers associated with HPV infections, the Advisory Committee on Infection Practices (ACIP) has recommended routine HPV vaccination to both boys and girls Despite this HPV vaccination rates are well below the HP2020 target 4

5. NVAC Charge In February 2013, the Assistant Secretary for Health (ASH) charged the National Vaccine Advisory Committee (NVAC) to: Review the current state of HPV immunization, Understand the root cause(s) for the observed low vaccine uptake (both initiation and series completion), and Identify existing best practices all with a goal of providing recommendations on how increase use of this vaccine in young adolescents. 5

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7. The Role of The National Vaccine Advisory Committee (NVAC) 7 The National Vaccine Advisory Committee (NVAC) advises and makes vaccine/immunization policy recommendations to the Assistant Secretary of Health in her capacity as the Director of the National Vaccine Program (NVP) NVAC consists of 17 voting members Also includes 13 non-voting ex officio federal members and 10 liaison stakeholder representatives 3 public meetings per year Webcast Meeting proceedings, presentations, reports, and information about the Committee available at http://www.hhs.gov/nvpo/nvac/index.htmlhttp://www.hhs.gov/nvpo/nvac/index.html NVAC forms topic-specific working groups to provide the Committee with analyses to help inform Committee deliberations and final recommendations

8. HPV Working Group Timeline 8 Aug 2013Update from CDC regarding the July 28 MMWR Sept – Oct, 2013Background: Epidemiology of coverage and solution strategies Nov 2013 – Jan 2014Provider barriers and solution strategies Feb, 2014PCP Report review March – June, 2014System barriers and solution strategies June – Aug, 2014Series completion, communication to parents, utilizing all stakeholders, new research on dosing Sept 2014 – Jan 2015Discussion and development of recommendations Feb, 2015Presentation of draft recommendations to NVAC April 6, 2014 – May 6, 2014 Report available for public comment on Federal Register June, 2015NVAC discussion and vote on recommendations

9. Presentations to the Working Group 1 Current epidemiology of vaccination coverage and VPD/background and proposed solution strategies CDC - MMWR July report Melinda Wharton (CDC) Shannon Stokley (CDC) International perspective (UK and Canada) David Salisbury (Department of Health of United Kingdom) John Spika (Public Health Agency of Canada) Industry perspective Liana Clark (Merck) Research - communicationDan Kahan (Yale University) 9 2 Provider barriers and federal opportunities Provider Groups Elizabeth Sobczyk (American Academy of Pediatrics) Jamie Loher (American Academy of Family Physicians President's Cancer Panel Follow up from PCP report Barbara Rimer (President’s Cancer Panel)

10. Presentations to the Working Group 4 Parental and adolescent barriers and federal opportunities Communicating with parents and teens Jessica Kahn (Cincinnati Children’s Hospital Medical Center) Adolescent Health community strategies Wilma Robinson (HHS Office of Adolescent Health) School-located Pre-teen & Teen Vaccination – The School Nurse Perspective Nichole Bobo (National Association of School Nurses) 10 5 Potential changes to vaccine products and dosing Alternative schedules/New vaccine developmentDoug Lowy (NIH) 3 Systems barriers and federal opportunities Utilizing pharmacies: What remains to be done with state legislation and registries Mitch Rothholtz (American Pharmacists Association) Alternative Locations/programs - schools (Chicago) Ken Alexander (The University of Chicago) Rachel Caskey (The University of Illinois at Chicago) AFIX Noel Brewer (University of North Carolina) Shannon Stokley (CDC)

11. Process During public meetings, NVAC regularly updated on Working Group deliberations NVAC was presented draft recommendations for consideration at multiple public meetings Draft report put out for public comment and review Available for 30 days on Federal Register Six comments received with one comment in dissention Overall support Coordinated and consistent messaging State level suggestions Coordination of care Unanimously adopted by the NVAC, June 2015 Transmitted to the ASH by NVPO for consideration 11

12. REVIEW OF NVAC RECOMMENDATIONS

13. NVAC HPV Working Group and the President’s Cancer Panel NVAC established the Human Papillomavirus (HPV) Working Group (WG) in February 2013. Concurrently, the President’s Cancer Panel (PCP), a federal advisory committee of the National Institutes of Health’s National Cancer Institute charged with highlighting opportunities for primary prevention of cancer and the use of HPV vaccines to prevent HPV- cancers 13

14. Summary of President’s Cancer Panel Recommendations Goal 1: Reduce missed clinical opportunities to recommend and administer HPV vaccines Goal 2: Increase parents’, caregivers’, and adolescents’ acceptance of HPV vaccines Goal 3: Maximize access to HPV vaccination services Goal 4: Promote global HPV vaccine uptake 14

15. Recommendation 1 The ASH should endorse the PCP report, Accelerating HPV Vaccine Uptake: Urgency for Action to Prevent Cancer, and adopt the recommendations outlined therein. 15 Endorsed at June 2014 NVAC meeting

16. Recommendation 2 As the PCP recommended, NVAC should, monitor “the status of uptake and implementation of the recommendations.” This should be done by hearing an annual progress report from HPV vaccination stakeholders identified in the PCP report. 16 Endorsed at June 2014 NVAC meeting

17. June 2014 Meeting After endorsing Recommendation 1 and 2, NVAC reviewed the PCP report to determine if the charge by the ASH was completely addressed Three additional recommendations were identified 17

18. Recommendation 3: The ASH should work with relevant agencies and stakeholders to develop evidence-based, effective, coordinated communication strategies to increase the strength and consistency of clinician recommendations for HPV vaccination to adolescents (both males and females) in the recommended age groups and to improve acceptance among parents/guardians, adolescents and young adults. 18 Endorsed at June 2015 NVAC meeting

19. Recommendation 4: NVAC recommends the ASH should work with the relevant agencies and stakeholders to strengthen the immunization system in order to maximize access to and support of adolescent vaccinations, including HPV vaccines. 19 Endorsed at June 2015 NVAC meeting

20. Recommendation 5: The ASH should encourage the review or development of available data that could lead to a simplified HPV vaccination schedule. In addition to a review that could impact existing vaccines, manufacturers of HPV vaccines in development should also consider opportunities to support the simplest HPV immunization schedule while maintaining vaccine effectiveness, safety, and long-term protection. 20 Endorsed at June 2015 NVAC meeting

21. Follow up on recommendations since June 2015 Recommendations voted in at June 2015 meeting June 2015 NVAC update on HPV vaccination activities National Institutes of Health/National Cancer Institute National Association of City and County Health Officials American Cancer Society National HPV Roundtable Publication of NVAC recommendations to address low HPV vaccination coverage rates in January/February 2016 Public Health Reports 21

22. Thank You 22