1. Prospects for the introduction of the HPV vaccine in developing countries and overcoming barriers of access Daisy Mafubelu Assistant Director General World Health Organization – Geneva, Switzerland Fight Against Cervical Cancer: Challenges and Opportunities for Women's Rights to Health UNIFEM Meeting - September 2007

2. We have a unique opportunity A safe and very effective vaccine against a common and deadly cancer The first primarily for women, and the first for a reproductive health condition HPV vaccination has the potential to build synergy among immunization, cancer control and sexual and reproductive health programmes (with a particular focus on adolescents)

3. …but hard choices must be made How to best reach adolescents Prioritizing girls and young women/including boys and young men Managing misconceptions and expectations in linking with sexual and reproductive health services Balancing priorities given to primary prevention, secondary prevention, cancer treatment and palliative care Determining where to start Broadening the scope of the Expanded Programme on Immunization Finding innovative ways to finance vaccine introduction Building solidarity among the global community to guarantee equitable access for all people to the vaccines they need

4. In the reality of overburdened health systems …

5. Support for evidence-based decision making in countries Preparing for the introduction of HPV vaccines: Policy and programme guidance for countries (2006): Advocacy, Information and Communication; Delivery options; Stewardship and Financing Human papillomavirus and HPV vaccines: Technical information for policy-makers and health professionals (2007): T echnical info about vaccine such as safety, efficacy, immunogeniticy, duration of response, cross- protection with other oncogenic types, and cost effectiveness

6. Support for evidence-based decision-making in countries WHO Information Centre on HPV and Cervical Cancer http://www.who.int/hpvcentre Developed to accelerate the development and introduction of HPV vaccines in countries

7. Support for manufacturing standards and lab procedures Disseminate WHO Guidelines to Assure the Quality, Safety, and Efficacy of HPV vaccines (2007) –Manufacturing standards support prequalification process required before procurement by UN agencies Establish global HPV laboratory network and access to international standard reagents Support training on standard laboratory operating procedures to facilitate vaccine licensure and monitoring WHO supports general skills building of NRAs that may consider HPV vaccines for licensure at some point.

8. Community of Practice Communities of Practice –web-based forum –collects experience and opinions and experience about cervical cancer prevention and HPV vaccines among health professionals in countries Collate opinions from regional consultations Track literature on vaccine policy and uptake Collect and analyse country recommendations about HPV vaccines and their rationale http://HPV-vaccines.net

9. Research Opportunities through Communities of Practice 1. Assess HPV Vaccine Acceptability, Experiences with Introduction Among Users Global Forum accessible through: http://HPV-vaccines.net 2. Develop Generic Protocols to Conduct Qualitative Research, Assist in Conducting Research 3. Disseminate and Evaluate Tools for HPV Vaccin Introduction

10. Research question undertaken by WHO in collaboration with IARC –Res 1- Research opportunities through the community of practice –Res 2- Adolescent Study: Alternative Delivery Strategies –Res 3- Improving performance of cervical cancer prevention program To conduct country level research to inform global policy and to guide country level HPV vaccine introduction To ensure that clinical research needed for country introduction of HPV vaccine be performed –HPV vaccine and cervical cancer surveillance To implement processes to facilitate informed decisions for HPV vaccine introduction at country level –Development, introduction and use of a decision making tool

11. Other critical research questions - Biologic Efficacy and immunogenicity with simplified schedules, e.g., annual/semiannual 3 dose intervals or 2 doses Duration of immunity – is a booster needed? Age: Safety, efficacy, and immunogenicity when given to 4-6 year olds at school-entry Safety, efficacy and immunogenicity in HIV+ persons, Africans, pregnant women and males Co-administration with other vaccines (TdaP, MMR, Hepatitis B) and drugs (antimalarials, contraceptives) Cross protection

12. Other critical research issues - Programmatic Delivery modes: schools, Child Health Days, vaccination weeks, through adolescent or reproductive health programs Logistics: stability, cold chain, injection capacity Cost-effectiveness in low/medium income countries with limited screening Marginal cost and benefits of vaccinating males Affordability: –Investment case and demand forecasting –Vaccine modifications that might lower cost

13. Access to an affordable HPV vaccine HPV vaccine is a critical public health need for all women – Inequity in developping countries particularly for poorer women in less developed countries. Will the same women who access cervical cancer screening also get HPV vaccines? How can women get equitable access to an affordable, quality vaccine ? What will be the role of existing programmes and services ?

14. Planning for the future? Experience with the introduction of HPV vaccines could serve as a model in preparing for future vaccines against HIV - reaching those in need before onset of risk -protection for girls and women -planning for innovative delivery systems -addressing cost -closing the equity gap

15. Conclusions There is a promise of new interventions and vaccines. We must: Reposition sexual and reproductive health as a developmental issue Enhancing synergy between adolescent health and sexual and reproductive health Adopt rights-based, comprehensive and evidence-informed health policies and programmes Address health inequities associated with poverty and gender and work towards universal access for essential interventions Build leadership and mobilize resources for strengthening health systems and financing the introduction and scale up of new interventions and technologies

16. Conclusions Exciting possibilities with new vaccines but more data are necessary HPV vaccine is one element of a cervical cancer control strategy, therefore the overarching consideration is to position it within a comprehensive, integrated service delivery structure Because this vaccine "fits" in several different programmes, partnerships are key to any successful introduction