Global Vaccines 202X: Access, Equity, Ethics

1. Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum Philadelphia, USA Priorities, policies, perceptions & the public. Prof. David M. Salisbury CB Director of Immunisation, Department of Health, LONDON, UK. CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

2. Prioritization of New Vaccines • Different groups need to make decisions about vaccines • Countries • International organizations • Advisory groups • Donors • Manufacturers • Others • Types of decisions • Should a vaccine be introduced • Which diseases/vaccines to prioritize • Which activities to prioritize • R & D investment • Pre-introduction planning • Implementation • Other interventions than vaccine

3. WHO Categorization of Vaccine-Preventable Diseases • Objectives • Categorize vaccine-preventable diseases by public health priority • Diseases with vaccines currently available (but not routinely recommended/widely used) or available in the near-term • Provide guidance to Member States, partners, and industry: for which diseases to prioritize activities • Features • “Rational consensus“ decision-making method • Input (structured) from global health community and experts on diseases and criteria used to make public health priorities

4. Issues we had to consider • Perspective: global vs. regional vs. country-level • Consideration of diseases vs. vaccines • Ultimately focused on diseases • Vaccine characteristics (e.g. efficacy, cost, etc.) and country-level issues (e.g. affordability, programmatic capacity, etc.) to be considered in subsequent exercises • Method for Prioritization • Accountable, reproducible, neutral, fair • Rational consensus, using pairwise comparisons • Analytic timeframe: 5 years • Ongoing as disease and vaccine landscapes change • Challenging deadline in which to conduct exercise • Recognition that first step

5. Results of Landscape Analysis: Diseases Considered in the Project • Diseases for which vaccines are currently licensed and available (but not routinely recommended or widely used) • Cervical cancer (human papillomavirus infection) • Cholera • Hepatitis A • Influenza (seasonal) • Japanese encephalitis • Meningococcal disease (groups ACYW135) • Meningococcal disease (group B) • Mumps • Pneumococcal disease • Rabies • Rotaviral enteritis • Rubella • Typhoid fever • Varicella • Yellow Fever • Diseases for which vaccines may be available (licensed) by 2012 • Dengue • Hepatitis E • Malaria

6. Disease-Related Criteria Ranked Highly in Phase I

7. Results of Landscape Analysis: Diseases Not Considered • Diseases for which vaccines are under development but not expected to be licensed or available by the year 2012 (based on current data) • Adenovirus infection • Amoebiasis • Brucellosis • Calicivirus gastroenteritis • Campylobacter enteritis • Chikungunya • Chlamydia infections • Cytomegalovirus infection • Diarrhea caused E. coli (ETEC, STEC, EPEC) • Ebola • Epstein Barr virus infection • Gonococcal infection • Helicobacter pylori infection • Hepatitis C • Herpes Simplex Virus (HSV2) infection • Histoplasmosis • HIV/AIDS • Hookworm • Leishmaniasis • Leprosy • Melioidosis • Mycobacteriaulcerans • Pigbel disease • Parainfluenza infection • Paratyphoid fever and non-typhisalmonellosis • Respiratory Syncytial Virus infection • Rift Valley Fever • SARS • Schistosomiasis • Shigellosis • Streptococcal diseases (group A and B) • Staphylococcal diseases • Syphilis • Tuberculosis (second generation) • Trachoma • West Nile Virus infection

8. Combining Phase II and Phase III for Disease Prioritization: What are our the global results (preliminary)? Highest Priority: Malaria, S. Pneumo High Priority: Cervical Cancer (HPV), Cholera, Dengue, Japanese Encephalitis, Meningococcal ACWY, Rabies, Rotavirus, Seasonal influenza, Typhoid Fever, and Yellow Fever; Medium Priority: Hepatitis A, Hepatitis E, Meningococcal B, Mumps, Rubella, and Varicella

9. Decade of VaccinesResearch and Development Work Group • Approach based on prioritised diseases • How do we rationalise the balance between priority based on objective criteria and feasibility for product development? • RSV and CMV could emerge as priority vaccines but low feasibility for safe and effective products within the timelines of the project. • Bacterial infections where antibiotic resistance is increasing. • Influenza could be a win/win.

10. Decade of VaccinesResearch and Development Work Group • Approach based on timelines • Use four year blocks as working basis • First four years: • Already visible where additional resources have high prospects for achieving goals. • Likely to be operational, practical and lower chance of big impact (or it would already be funded). • Second four years: • ‘Vaccinology’: implementation of existing theoretical concepts to overcome existing barriers to effective products. • Third four years: • The really difficult challenges where priority is defined but current prospects look poorer: RSV, tropical infestations. • Immunology rather than ‘Vaccinology’ is the priority.

11. Decade of VaccinesResearch and Development Work Group • Approach based on timelines • Use four year blocks as working basis • First block: • Operational/near term • Second block: • Translational • Third block: • Immunological. • Does this translate to the three thematic sub-groups?

12. Decade of VaccinesResearch and Development Work Group • Approach based on cross-cutting • Delivery • What are the key R&D questions for programmes and implementation? Operations/implementation? • Delivery technologies – microneedles, patches? • Does R&D Group propose them or answer them? • Would thermostability be sufficiently worthwhile to prioritise? Note polio vaccine thermostability efforts of CVI – WHO EPI said it didn’t want it but MV was the cold chain limiting product! • If ‘Delivery’ prepares the way for introduction of new vaccines, how is that influenced by R&D Group?

13. R&D WORKING GROUP STRUCTURE • TRANSLATIONAL RESEARCH • Production cost reduction through process engineering • Thermostable vaccines • New vaccine combinations • New delivery systems • TRANSFORMATIONAL RESEARCH • There are a number of issues that overlap with the Delivery and Global Access working groups • Operational research, innovation in comms, KAP, Transformational/Operational Translational Core group Immunological • LONG TERM RESEARCH • High-risk long-term research (nanoparticles, etc.)

14. Disease burden + TB HIV PCV Malaria RSV MenA Flu Hep C Scientific feasibility + Cost - Scientific feasibility - Cost + Men B Q Fever Disease burden -

15. Cumulative Government cost and incremental per child costs following ACIP recommendations 1975 – 2010 and 2000 – 2010 respectively. From Davis MM; Human Vaccines 2010.

18. Criteria and scoring used in the UK to select HPV vaccine for purchase by the National Immunisation Programme (2007/8).

19. Criteria and scoring used in the UK to select HPV vaccine for purchase by the National Immunisation Programme (2007/8).

23. UK Public perceptions research • The data are from the 33rd wave of the Parents’ Childhood Immunisation Tracking Survey, which has been running since 1991 • Twice yearly until 2005, annual surveys since then • The survey aims to provide information for strategic planning through tracking opinions, attitudes and behaviour in relation to: • Immunisation in general • The immunisation programme • Experience of immunisations • The introduction of new vaccines • In addition the survey monitors current childhood immunisation advertising, publicity and communications • Wave 33 is the first time interviews have been carried out with parents of 3-4 year olds, with the aim of covering the whole immunisation process, from birth to pre-school • Previously only parents of 0-2 year olds have been interviewed, and so all historical data are based on this sample

24. Methods • Random location sampling in England amongst primary care givers (usually parents, and referred to as parents throughout) of 0-4s • Interviews carried out in home using multi-media CAPI • Fieldwork took place from18 January to 24 February 2010 • Quotas set for parents of 0-2s and 3-4s to ensure a minimum of 1000 interviews in each group, including a boost of parents of 3-4s • 1730 interviews achieved in total • 1142 parents of 0-2s and 1007 parents of 3-4s • 419 had a child in both age groups • Data weighted to reflect the Social Grade and regional profile of parents of 0-4s, and age of children under 4

25. Whether seen advertising, information or publicity (other than commercial advertising) about … (top 8) 58% 2008, 5-6 in 10 since 2000 Based on all respondents Base: 2010 - parents of 0-4s (1730), parents of 0-2s (1142), parents of 3-4s (1007)

26. Awareness of immunisations 92% 87% 75% 67% 63% 57% 52% 49% 35% 27% Base: 2010 - parents of 0-4s (1730) Based on all respondents

27. Disease very serious / more serious for 0-2s than 3-4s Meningitis Septicaemia Pneumonia Polio Swine flu Diphtheria Rubella Tetanus Little change in perceived severity of diseases over time Hib Measles Whooping cough Mumps Diarrhoea and vomiting Chickenpox Seasonal flu Ear infection Base: 2010 - parents of 0-4s (1730) Based on all respondents

28. Perceived disease seriousness & mother's age (% 'very serious')

29. Whether automatically had 0-2/3-4 immunised or weighed up the pros and cons * * Base: 2010 - parents of 0-2s (1142), parents of 3-4s (1007) Base: Parents of 0-2s - 2010 (1142),previous years c.1000 Based on all respondents

30. What made parents go ahead with immunisations for 0-2/3-4 when due Because it was the sensible thing to do and I wanted my daughter to be protected Because the health visitor told me and I knew it was the safest thing to do * Base: 2010 - parents of 0-2s (859), parents of 3-4s (723) All mentions by at least 5% of either group Based on all who automatically had immunisations done when due

31. What information would have liked about immunisations for 0-2/3-4 year old (spontaneous) Base: 2010 - parents of 0-2s (415), parents of 3-4s (372) Based on all who wanted more information All mentions by at least 5% of either group

32. Can we use fear of disease to motivate parents?

33. HPV vaccination: a normal routine part of a day at school.

34. Statistics from YouTube

36. World Health Report 2002. Chapter 3 ‘Perceiving risks’.

37. Conclusions. Priorities, policies, perceptions & the public. • We do not yet have a rational basis for prioritisation beyond the short-term. • This means that we do not effectively influence academia, the biotech community or industry to invest in where we believe the greatest gains will be made. • Our own processes of policy selection may or may not be rational and defensible. • The public takes a more holistic view than we may do: they see the need to protect their children and themselves as a part of normal behaviour and do not think in a disease by disease specific way. Their ‘logic’ for decision making may be different to ours and reiterating how serious non-apparent diseases may be is counter-productive. • We need to become more strategic, more rational and more understandable to our relevant constituencies than we have been before, if we are to influence resource use in a way that is cost-effective.