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 decisions

Should 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 1

74 25 Morbidity 2

79 7 Epidemic/Pandemic Potential

3

50 11 Disease Incidence in Highest Burden Regions

4

34 13 DALYs 5

51 1 Economic Impact 6

29 2 Case Fatality Rate 7

42 1 Inequity 8

26 1 Duration/Severity of Symptoms

9

34 2 Alternative Treatments 10

28 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

ACTION

ACQUIESCE

REFUSAL

DILEMMA

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.