Draft Agenda Meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) 9 11 April 2013 CCV/CICG, Geneva

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Version: 04 April 2013 Draft Agenda Meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) 9 11 April 2013 CCV/CICG, Geneva Tuesday, 9 April 2013 Time Session Purpose of session, target outcomes and questions for SAGE 9:00 Welcome - introduction 20 min. H. Rees, Chair of SAGE 9:20 Report from Director, IVB - Session 1 Global report including key updates and challenges from regions, J.-M. Okwo-Bele, WHO, 40 min. Discussion: 1h 50 min. 10:30 Coffee/tea break Break 30 min. 11:00 Report from Director, IVB - Session 1, (Contd.) 12:20 Reports from other Advisory Committees on Immunization - Session 2 Report of the Global Advisory Committee on Vaccine Safety (GACVS), M. Wharton, Chair of GACVS, 10 min. Discussion: 10 min. Report of the Immunization Practices Advisory Committee (IPAC), S. Deeks, Chair of IPAC, 10 min. Discussion: 10 min. 40 min. 13:00 Lunch Break 1h

14:00 Dengue - Session 3 Introduction to dengue epidemiology and disease burden, C. Simmons, Hospital for Tropical Diseases, Ho Chi Minh City, 10 min. Current status of dengue vaccine development, J. Roehrig, US Centers for Disease Control and Prevention, 20 min. Critical issues for future vaccine introduction, P. Palihawadana, SAGE member, 10 min. Discussion: 50 min. Update on disease and vaccine development status Initial feedback from SAGE on: - Data needs for future recommendations on vaccine use - Critical issues in preparation for future vaccine introduction 1h 30 min. 15:30 Coffee/tea break Break 30 min. 16:00 Global polio eradication initiative - Session 4 Polio Eradication and Endgame Strategic Plan: Issues for SAGE decisions in 2013-15. B. Aylward, WHO, 10 min. Discussion: 10 min. Detection and interruption of poliovirus transmission: progress and contingency planning to address insecurity and social acceptance in the last endemic areas. H. Jafari, WHO, 20 min. FOR DISCUSSION - To orient SAGE on the key technical decisions which will be required during the coming 36 months, to facilitate SAGE and Regional TAG planning. - To seek SAGE advice on managing the two major emerging risks to eradication in the last endemic areas: insecurity and social acceptance. 18:30 Cocktail Discussion: 30 min. Planning for OPV2 withdrawal: status of pre-requisites and Polio Working Group priorities for 2013-14. E. Miller, Chair of SAGE Polio Working Group, 20 min. Discussion: 30 min. Polio legacy planning in the Polio Strategic Plan 2013-2018, TBD, 10 min. - To seek SAGE concurrence on the workplan of the SAGE Polio Working Group. - To outline current thinking on GPEI legacy planning and seek input from SAGE in advance of developing a discussion paper for 2013 Regional Committee Meetings. 2

Wednesday, 10 April 2013 08:00 Yellow fever - Session 5 Introduction and status report on yellow fever control, O. Tomori, Chair of SAGE working group on Yellow Fever vaccines, 10 min. Questions: 10 min. Evidence review with respect to the duration of protection and vaccine safety in special populations, E. Staples, SAGE working group on Yellow Fever vaccines, 30 min. Other evidence reviewed by the SAGE working group. A. Barrett, SAGE working group on Yellow Fever vaccines, 15 min. Discussion: 15 min. Proposed recommendations. O. Tomori, Chair of SAGE working group on Yellow Fever vaccines, 10 min. Discussion on the proposed recommendations: 40 min. FOR DECISION Present SAGE with the report of the SAGE working group on yellow fever vaccines and request SAGE s endorsement of the proposed recommendations. Specifically, SAGE will be asked to: Reconsider the need for booster doses every 10 years; Review the safety profile of the vaccines and update the recommendations in the context of safety issues including in particular with respect to immunization of HIV infected populations and immunocompromised, in pregnant or lactating women, people over 60 years old and in context of viscerotropic and neurological diseases; Review the role of routine vaccination versus outbreak control; Review the impact of the combined vaccination strategy (routine immunization and preventive campaigns); Review of interference between yellow fever and other vaccines and co-administered vaccination. SAGE will also be asked to identify critical research questions. SAGE recommendations on vaccine use will then be used to update the 2003 WHO position paper on the use of yellow fever vaccines. 10:30 Coffee/tea break Break 30 min. 3

11:00 Non-specific effects of vaccines on childhood mortality - Session 6 Why are we reviewing the evidence on non-specific effects of vaccines on mortality in children under 5 years of age and update on the related SAGE working group? T. Nolan, Chair of SAGE Working Group on Non-Specific Effects of Vaccines, 15 min. Sequence of vaccination in Low and Middle Income Countries data from DHs and MICs surveys, C. Sanderson, London School of Hygiene and Tropical Medicine, UK, 15 min. Systematic reviews protocols: A. Reingold, University of California, Berkeley, USA, 15 min. Discussion: 45 min. AND DISCUSSION To update SAGE on the establishment and proceedings of the SAGE WG on Non-Specific Effects of Vaccines. To get SAGE s input on the key related questions from the global immunization policy perspective? Ask SAGE if the proposed protocols suitable to inform these questions? What adjustments are appropriate? Get SAGE s input on what other evidence should be critically appraised and synthetized. 1h 30 min. 12:30 Lunch Break 1h 13:30 Overcoming vaccine hesitancy - Session 7 SAGE working group on vaccine hesitancy: terms of reference and process of work, X. Liang, Chair of the SAGE working group on vaccine hesitancy, 10 min. Vaccine hesitancy: definitions, scope, context specific causes and impact. B. Gellin, Member of the SAGE working group on vaccine hesitancy, 20 min. Strategies to address hesitancy, success and failures stories. S. Goldstein, Member of the SAGE working group on vaccine hesitancy, 15 min. Conclusions, recommendations and proposed way forward. X. Liang, Chair of the SAGE working group on vaccine hesitancy, 15 min. Discussion: 50 min. FOR DISCUSSION Present SAGE with a report of the SAGE working group on vaccine hesitancy on activities implemented to date. SAGE s agreement on the definitions, scope and overall approach to vaccine hesitancy. SAGE s feed-back on: the review of strategies to address vaccine hesitancy and its determinants and on further planned work. the proposed list of questions for the assessment of vaccine hesitancy. the draft landscape analysis of organizations dealing with vaccine hesitancy. Review and discuss the conclusions, current recommendations and way forward proposed by the working group in relation with its terms of reference. 15:30 Coffee/tea break 30 min. 4

16:00 Overcoming vaccine hesitancy Session 7 (Contd.) 16:30 Report from GAVI - Session 8 Report from the GAVI Alliance, S. Berkley, GAVI Alliance, 20 min. 40 min. 17:10 End of day 5

Thursday, 11 April 2013 08:00 Optimization of Haemophilus influenza type b immunization schedules - Session 9 Why are we reviewing the evidence on Hib vaccine and what are the questions for SAGE today? J. Abramson, SAGE member, 10 min. What evidence is available (from long term impact studies in 35 countries, observational studies and RCTs) on the number of doses, age at administration, interval between doses, duration of protection and combination vaccines. R. Hajjeh, US Centers for Disease Control and Prevention, 25 min. Adjusting the Impact and assessment of incremental benefits of various Hib vaccines schedules given the disease epidemiology and the actual age at vaccination, A. Clark, London School of Hygiene and Tropical Medicine, 10 min. Questions for clarification: 15 min. What are the optimal schedules for Hib vaccines for children living in different epidemiological settings? J. Abramson, SAGE member, 10 min. FOR DECISION What are the optimal schedules for Hib vaccines for children living in different epidemiological settings? How many primary doses, need for boosters? Age at first dose, interval between doses? Does the type of vaccine influence the choice of schedule? Effect of type of Hib vaccine on effectiveness. Effect of wp and ap on Hib vaccine effectiveness. 2h Discussion: 50 min. 10:00 Coffee/tea break Break 30 min. 10:30 Update on RTS,S/AS01 and the malaria vaccines pipeline - Session 10 Status of RTS,S/AS01 project. D. Kaslow, Malaria Vaccine Initiative, 15 min. Assessment and critical issues for policy assessment. P. Smith, (By telephone connection), Chair of the Joint Technical Expert Group on malaria vaccines (JTEG), TBC, 20 min. Discussion: 45 min. Updated Malaria Vaccine Roadmap and Development of malaria vaccine preferred product characteristics (for prevention of disease young children and for achievement of elimination). P. Alonso, (By telephone connection), Member of the Malaria Policy Advisory Committee, 10 min. Discussion: 30 min. 12:30 Closing 12:50 End of meeting FOR DISCUSSION Update SAGE on on RTS,S/AS01 and the malaria vaccines pipeline. Request SAGE s input into WHO/JTEG actions required to prepare for 2015 policy decision on RTS,S/AS01 malaria vaccine. Request SAGE s input on the development of preferred product characteristics. 2h 6