CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics
2-4 May 2011The Franklin Institute Science Museum. Philadelphia,
USA
Global Vaccines 202X: Access, Equity, Ethics2-4 May 2011
The Franklin Institute Science MuseumPhiladelphia, USA
Priorities, policies, perceptions & the public.
Prof. David M. Salisbury CBDirector of Immunisation, Department of Health,
LONDON, UK.
Prioritization of New Vaccines
Different groups need to make decisions about vaccines
CountriesInternational organizationsAdvisory groups DonorsManufacturersOthers
Types of decisionsShould a vaccine be introducedWhich diseases/vaccines to prioritizeWhich activities to prioritizeR & D investmentPre-introduction planningImplementationOther interventions than vaccine
WHO Categorization of Vaccine-Preventable Diseases
ObjectivesCategorize 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
Issues we had to consider
Perspective: global vs. regional vs. country-levelConsideration of diseases vs. vaccines
Ultimately focused on diseasesVaccine characteristics (e.g. efficacy, cost, etc.) and country-level issues (e.g. affordability, programmatic capacity, etc.) to be considered in subsequent exercises
Method for PrioritizationAccountable, reproducible, neutral, fairRational consensus, using pairwise comparisons
Analytic timeframe: 5 yearsOngoing as disease and vaccine landscapes change
Challenging deadline in which to conduct exerciseRecognition that first step
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 RabiesRotaviral enteritisRubellaTyphoid feverVaricellaYellow Fever
Diseases for which vaccines may be available (licensed) by 2012Dengue Hepatitis E Malaria
Disease-Related Criteria Ranked Highly in Phase I
Total # of votes # of 1st Place Votes
Criteria Rank
87 59 Mortality 174 25 Morbidity 279 7 Epidemic/Pandemic
Potential3
50 11 Disease Incidence in Highest Burden Regions
4
34 13 DALYs 551 1 Economic Impact 629 2 Case Fatality Rate 742 1 Inequity 826 1 Duration/Severity of
Symptoms9
34 2 Alternative Treatments 1028 0 Long-term sequelae 11
Results of Landscape Analysis: Diseases Not Considered
• 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• Mycobacteria ulcerans• Pigbel disease• Parainfluenza infection• Paratyphoid fever and non-typhi salmonellosis• 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
Diseases for which vaccines are under development but not expected to be licensed or available by the year 2012 (based on current data)
Combining Phase II and Phase III for Disease Prioritization: What are our the global results (preliminary)?
Model Name: MASTER COMBINED RESPONDENTS3
Synthesis: Summary
.160
.102
.076
.068
.066
.066
.066
.065
.064
.055
.054
.043
.031
.021
.017
.016
.016
.015
Page 1 of 105/11/2007 09:39:18
Lara WolfsonLara Wolfson
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
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.
Decade of VaccinesResearch and Development Work Group
Approach based on timelines
Use four year blocks as working basisFirst 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.
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?
Decade of VaccinesResearch and Development Work Group
Approach based on cross-cutting
DeliveryWhat 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?
Core group
Immunological
Transformational/
Operational
LONG TERM RESEARCH• High-risk long-term research (nanoparticles, etc.)
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,
R&D WORKING GROUP STRUCTURE
Translational
Scientific feasibility +Cost -
Scientific feasibility -Cost +
Disease burden +
Disease burden -
HIV
Men A
Men B
RSVMalaria
TB
Hep C
Q Fever
PCV
Flu
Cumulative Government cost and incremental per child costs following ACIP recommendations 1975 – 2010 and 2000 – 2010 respectively.From Davis MM; Human Vaccines 2010.
Criteria and scoring used in the UK to select HPV vaccine for purchase by the National Immunisation Programme (2007/8).
Criteria and scoring used in the UK to select HPV vaccine for purchase by the National Immunisation Programme (2007/8).
UK Public perceptions researchThe 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 generalThe immunisation programmeExperience of immunisationsThe 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
MethodsRandom 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 total1142 parents of 0-2s and 1007 parents of 3-4s419 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
Whether seen advertising, information or publicity (other than commercial advertising) about … (top 8)
Base: 2010 - parents of 0-4s (1730), parents of 0-2s (1142), parents of 3-4s (1007)
Based on all respondents
58% 2008, 5-6 in 10 since 2000
Awareness of immunisations
Base: 2010 - parents of 0-4s (1730)
Based on all respondents
87%92%
75%
67%63%
57%52%
49%
35%
27%
Meningitis
Polio
Pneumonia
Swine flu
Septicaemia
Diphtheria
Rubella
Hib
Mumps
Seasonal flu
Measles
Diarrhoea and vomiting
Whooping cough
Chickenpox
Ear infection
Tetanus
Disease very serious / more serious for 0-2s than 3-4s
Little change in perceived severity of diseases over time
Base: 2010 - parents of 0-4s (1730)
Based on all respondents
Measles Tetanus Pertussis Diphtheria Polio Meningitis
%
0
20
40
60
80
100
15-24 25-34 35+
Perceived disease seriousness & mother's age (% 'very serious')
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
**
What made parents go ahead with immunisations for 0-2/3-4 when due
Base: 2010 - parents of 0-2s (859), parents of 3-4s (723)
Based on all who automatically had immunisations done when due
All mentions by at least 5% of either group
Because the health visitor told me and I knew it was the safest
thing to do
Because it was the sensible thing to do and I wanted my daughter to be
protected
*
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
Can we use fear of disease to motivate parents?
HPV vaccination: a normal routine part of a day at school.
Statistics from YouTube
ACTIONACQUIESCE
REFUSALDILEMMA
Fear ofdisease
Fear ofvaccine
No fearof
disease
No fearof vaccine
World Health Report 2002. Chapter 3 ‘Perceiving risks’.
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.