Prospects for the introduction of the HPV vaccine in developing

countries and overcoming barriers of access

Daisy MafubeluAssistant Director General

World Health Organization – Geneva, Switzerland

Fight Against Cervical Cancer: Challenges and Opportunities for Women's Rights to Health

UNIFEM Meeting - September 2007

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)

…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

In the reality of overburdened health

systems …

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): Technical info about vaccine such as safety, efficacy, immunogeniticy, duration of response, cross-protection with other oncogenic types, and cost effectiveness

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

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.

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

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

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 globalpolicy and to guide country level HPV vaccineintroduction

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

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

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

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 ?

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

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

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