WHO's Immunization Policy
Framework: Is it achieving its goals?
:
Professor Helen Rees
Chairperson, WHO’s Strategic Advisory Group of Experts (SAGE)
Wits Reproductive Health and HIV Institute, South Africa
Global Vaccines 202X, Philadelphia, May 2011
Civil Society and Immunization Policy
Who do we trust?
About the World and Vaccines
Lets take a lesson from HIV
• Grassroots activism in
developing and developed
worlds
• Political pressure
• Global Pharma partnerships
about costs
• Mobilising resources
• Global impact being
internationally watched
The Vaccine world
• Lacks grassroots activism
• Programmes been mostly top
down, taken for granted
• Enthusiasts work with each
other within the vaccine world
• Pharma a major player but
more transparency about
costing required
• Threatened by vaccine
hesitancy and weak health
services
About WHO
• WHO is the directing and coordinating
authority for health within the United
Nations system. In the 21st century, health
is a shared responsibility, involving
equitable access to essential care and
collective defence against transnational
threats.
• It is responsible for providing leadership on
global health matters
• Shaping the health research agenda
• Setting norms and standards
• Articulating evidence-based policy options
• Providing technical support to countries
• Monitoring and assessing health trends.
WHO’s challenge
There is no substitute for the WHO,
with its progressive constitution and
global legitimacy. It is not likely
that the same powers would be
granted to an international
organization if it were created
today. Consequently, while
remaining true to its normative and
bold vision of health for all,
the WHO must adapt to a new
political climate, demonstrate
global leadership, and deliver
results.
A critical appraisal of WHO’s
immunization policy framework
Can we trust
them?
I think so, they go
to lots of meetings…
Immunization Policy Advisory Framework
•Safety
•Standards
•Practice
•Burden assessment/
modelling
Other WHO Technical
Advisory Committees
Strategic Advisory
Group of Experts
(SAGE)
Regional Technical
Advisory Group
•National Policies & Strategies
•Prioritize problems & define
optimal solutions
•Implement national programme &
monitor impact
Countries
•Global policy
recommendations &
strategies
•Support regional/national
challenges
•Regional policies
& strategies
•Identify & set
regional priorities
•Monitor regional progress
National Technical Advisory
Group on Immunization
Strategic Advisory Group of Experts (SAGE)
 Principal advisory group to WHO for vaccines and
immunization: from research to delivery of
immunization and linkages with other health
interventions - all vaccines, all ages
 Reports directly to WHO’s Director General and involves
all relevant WHO departments
 Restructured in 2005 in context of Global Immunization
Vision and Strategy
Strategic Advisory Group of Experts (SAGE)
 Membership -15 members
 Individual capacity and broad range of expertise
 Balance of professional affiliation, area of
interest, geographic representation
 Declarations of interest
 Appointed by WHO DG upon recommendation
of external selection panel
 Rotation
 Reappointment subject to
participation/contribution and
review by selection panel
 Public call for nominations
Strategic Advisory Group of Experts (SAGE)
•
Meetings and operational procedures
– Two meetings a year (April and Nov)
– Two preparatory teleconferences for each meeting
– Only plenary sessions – transparent process
– Extensive representation from key
partner organizations
– Experts invited as needed
– Evidence-based
– Background documents web and Yellow Book
– Tracking sheet for follow-up on implementation
of recommendations
– Working groups
– Agenda setting
•
Strong links with Regional Technical Advisory Groups
•
Report and communications
http://www.who.int/immunization/sage/en/index.html
SAGE working groups
• Establishment and ToRs decided by
WHO and SAGE members
• Composition
– Public call for nominations
– At least two SAGE members &
additional experts
– Declaration of interests
• To review evidence and address
specific issues in great depth and
prepare for fruitful discussions at
SAGE when issue is complex
• Not allowed to make decisions or
speak on behalf of SAGE
• Time limited
• Currently 8 active working groups
SAGE Agenda-setting process
• Agenda developed in consultation with SAGE members, other
HQ departments, regional offices, stakeholders and countries
• Two year horizon
• Due diligence but need for sufficient evidence and preparation
including working groups, other technical advisory groups or
other committees
• Expected output
• For DECISION, DISCUSSION, or INFORMATION
• Search engine for topics previously discussed
• http://whqpasteur.who.int:8081/sage_search_php/index.php
Issues taken into consideration by SAGE
in the development of recommendations
• Disease epidemiology
– Disease burden including age specific mortality,
morbidity, and societal impact; specific risk groups;
epidemic potential; disease occurrence over time;
serogroup or serotype distribution; and changes in
epidemiology over time
• Clinical characteristics
– Clinical management of disease, disease severity,
primary/secondary/tertiary care implications, long
term complications of disease and medical
requirements
• Evidence-based recommendations based
on GRADing system
Issues taken into consideration by SAGE
in the development of recommendations
Vaccine and immunization characteristics
efficacy, effectiveness and population impact of vaccine; vaccine safety; indirect protective
effects or safety concerns; cold chain and logistics concerns; vaccine availability; vaccine
schedules; schedules social and programmatic acceptability, ability to monitor program
impact
Economic considerations
disease, vaccine and vaccine delivery costs, potential for vaccine price reduction, vaccine
cost and cost-effectiveness of immunization programmes, and affordability of immunization
Health system opportunities and existence of and interaction
with other existing intervention and control strategies
Social impact
Legal considerations
Ethical considerations
Is SAGE delivering on Access, Equity &
Ethics?
•
•
•
•
•
•
•
Transparent, public appointment process
Declaration of interests
Regional representation on SAGE & Regional viewpoints
Open plenaries & transparent decision making
Public access to decisions
Best evidence-based recommendations
Impact:
– Usefulness
– Communication and access
– Credibility
• Guided by equity, ethics and access
SAGE Agenda: April 2011 meeting
RUNNING ITEMS
SPECIFIC TOPICS
Global progress & implementation of
recommendations
Regional reports
Reports from other Immunization
Advisory Committees
- Advisory Committee of the
Initiative for Vaccine Research
- Global Advisory Committee on
Vaccines Safety
Report from the GAVI Alliance
Pandemic and seasonal influenza
vaccines
Tick-borne encephalitis
Meningococcal meningitis vaccines
Rubella vaccination immunization
schedules
Polio eradication
Update of evidence-based review
process and GRADing of quality
of scientific evidence
Cholera vaccine
Topic
Access
Equity
Ethics
Rubella
Piggy back on measles elimination
efforts
Noted the stark difference
between Africa and other
regions in rollout. Modelling
allowed recommendations to
cater for poorest functioning
EPI programmes
42 years later rubella
vaccine still not
available in Africa and
other developing
countries
Topic
Access
Equity
Ethics
Rubella
Piggy back on measles elimination
efforts
Noted the stark difference
between Africa and other
regions in rollout. Modelling
allowed recommendations to
cater for poorest functioning
EPI programmes
42 years later rubella
vaccine still not
available in Africa and
other developing
countries
Meningitis
Success of meningococcal A
conjugate vaccine in African
meningitis belt
Need to strengthen
surveillance
World did not ignore
disease outbreaks
specific to poor
countries
Topic
Access
Equity
Ethics
Rubella
Piggy back on measles elimination
efforts
Noted the stark difference
between Africa and other
regions in rollout. Modelling
allowed recommendations to
cater for poorest functioning
EPI programmes
42 years later rubella
vaccine still not
available in Africa and
other developing
countries
Meningitis
Success of meningococcal A
conjugate vaccine in African
meningitis belt
Need to strengthen
surveillance
World did not ignore
disease outbreaks
specific to poor
countries
Tick-borne
encephalitis
Acknowledge limited information
on boosters but allowed endemic
countries to continue with this.
Need for more clinical data
on boosters noting high costs
Topic
Access
Equity
Ethics
Rubella
Piggy back on measles elimination
efforts
Noted the stark difference
between Africa and other
regions in rollout. Modelling
allowed recommendations to
cater for poorest functioning
EPI programmes
42 years later rubella
vaccine still not
available in Africa and
other developing
countries
Meningitis
Success of meningococcal A
conjugate vaccine in African
meningitis belt
Need to strengthen
surveillance
World did not ignore
disease outbreaks
specific to poor
countries
Tick-borne
encephalitis
Acknowledge limited information
on boosters but allowed endemic
countries to continue with this.
Need for more clinical data
on boosters noting high costs
Cholera
Stockpiles for emergencies and for
endemic countries
Who pays for stockpiles and
are they used for endemic or
emergency scenarios?
Use of cholera in
emergencies
Topic
Access
Equity
Ethics
Rubella
Piggy back on measles elimination
efforts
Noted the stark difference
between Africa and other
regions in rollout. Modelling
allowed recommendations to
cater for poorest functioning
EPI programmes
42 years later rubella
vaccine still not
available in Africa and
other developing
countries
Meningitis
Success of meningococcal A
conjugate vaccine in African
meningitis belt
Need to strengthen
surveillance
World did not ignore
disease outbreaks
specific to poor
countries
Tick-borne
encephalitis
Acknowledge limited information
on boosters but allowed endemic
countries to continue with this.
Need for more clinical data
on boosters noting high costs
Cholera
Stockpiles for emergencies and for
endemic countries
Who pays for stockpiles and
are they used for endemic or
emergency scenarios?
Use of cholera in
emergencies
Polio
Affordable IPV vaccines for posteradication
Global eradication efforts
Does polio divert
energy from routine
immunization
Topic
Access
Equity
Ethics
Rubella
Piggy back on measles elimination
efforts
Noted the stark difference
between Africa and other
regions in rollout. Modelling
allowed recommendations to
cater for poorest functioning
EPI programmes
42 years later rubella
vaccine still not
available in Africa and
other developing
countries
Meningitis
Success of meningococcal A
conjugate vaccine in African
meningitis belt
Need to strengthen
surveillance
World did not ignore
disease outbreaks
specific to poor
countries
Tick-borne
encephalitis
Acknowledge limited information
on boosters but allowed endemic
countries to continue with this.
Need for more clinical data
on boosters noting high costs
Cholera
Stockpiles for emergencies and for
endemic countries
Who pays for stockpiles and
are they used for endemic or
emergency scenarios?
Use of cholera in
emergencies
Polio
Affordable IPV vaccines for posteradication
Global eradication efforts
Does polio divert
energy from routine
immunization
Influenza
Limited information about
epidemiology in LIC, LMIC.
Stockpiles for developing countries
Safety messaging to
developing countries about
narcolepsy
Limited access to H1N1
vaccines in LIC and
LMIC during pandemic
Topic
Access
Equity
Ethics
Rubella
Piggy back on measles elimination
efforts
Noted the stark difference
between Africa and other
regions in rollout. Modelling
allowed recommendations to
cater for poorest functioning
EPI programmes
42 years later rubella
vaccine still not
available in Africa and
other developing
countries
Meningitis
Success of meningococcal A
conjugate vaccine in African
meningitis belt
Need to strengthen
surveillance
World did not ignore
disease outbreaks
specific to poor
countries
Tick-borne
encephalitis
Acknowledge limited information
on boosters but allowed endemic
countries to continue with this.
Need for more clinical data
on boosters noting high costs
Cholera
Stockpiles for emergencies and for
endemic countries
Who pays for stockpiles and
are they used for endemic or
emergency scenarios?
Use of cholera in
emergencies
Polio
Affordable IPV vaccines for posteradication
Global eradication efforts
Does polio divert
energy from routine
immunization
Influenza
Limited information about
epidemiology in LIC, LMIC.
Stockpiles for developing countries
Safety messaging to
developing countries about
narcolepsy
Limited access to H1N1
vaccines in LIC and
LMIC during pandemic
Access, Equity, Ethics in new
SAGE agenda items
Access
Use of vaccines in
humanitarian
emergencies
Strengthening
surveillance networks
Accessibility to
affordable vaccines
Vaccine-hesitant
populations
Use of vaccines in
immunocompromised
populations
Equity
Ethics
Access
Optimizing
immunization
schedules
Impact of introduction
of new vaccines on
immunization and
health systems
Maternal immunization
to enhance the
protection of mothers
and infants
Involvement of the
private sector
The unimmunized and
partially immunized
child
Strengthening health
services
Equity
Ethics
Immunization Policy Advisory Framework
•Safety
•Standards
•Practice
•Burden assessment/
modelling
Other WHO Technical
Advisory Committees
Strategic Advisory
Group of Experts
(SAGE)
Regional Technical
Advisory Group
•National Policies & Strategies
•Prioritize problems & define
optimal solutions
•Implement national programme &
monitor impact
Countries
•Global policy
recommendations &
strategies
•Support regional/national
challenges
•Regional policies
& strategies
•Identify & set
regional priorities
•Monitor regional progress
National Technical Advisory
Group on Immunization
Regional Technical Advisory Group
Regional policies & strategies
Identify & set regional priorities
Monitor regional progress
Have a lot of autonomy
• Critically important to adapt SAGE recommendations
• Depends on high calibre staff and TAG appointees
• Depends on good understanding and coordination between
regional TAGS & regional offices
• TAG and office staff should be selected on technical merit not
on other criteria
• Need the ‘ear’ of health ministers
• Limited resources (human and financial) to fulfil tasks
National Immunization Technical
Advisory Groups (NITAGS)
National Policies and Strategies
Prioritize problems and define optimal solutions
Implement national programme and monitor impact
Have a lot of autonomy
National Immunization Technical
Advisory Groups (NITAGS)
National Policies and Strategies
Prioritize problems and define optimal solutions
Implement national programme and monitor impact
Have a lot of autonomy
•
•
•
•
•
•
Scarce skilled human resources in many countries, CoIs
Advisory and lack teeth unless empowered by health minister
Need local budgets
Not seen as priority to support EPI in many countries
Important to interpret SAGE recommendations at local level
May not be possible to have meaningful NITAGS in all
countries making regional role important
SAGE Challenges
•
•
•
•
Continuous evaluation & adjustments
Declaration of interests
Heavy work burden for members
Increased credibility and visibility  increased demands
and pressure
• Processes quite cumbersome
• Funding for SAGE core activities
• Understaffed and dependent on
few excellent staff
Thank you
With thanks to Phil Duclos, IVB
WHO vaccine position papers
Position papers = Key reference documents
Available in all official languages
Convergence of other WHO documents
(International Travel and Health, Essential
Drugs List, …)
Developmental and review process (SAGE,
extensive peer review, evidence-base, periodic
updating)
Format
Weekly Epidemiological Record
Current structure (Intro, background (Disease
epidemiology, the pathogen, disease), info on vaccines
(composition, safety, immune response, efficacy and
effectiveness, cost effectiveness and any other
relevant issue), WHO position on vaccine use)
Additional posting of information on the web:
GRADing tables, references,
summaries (one pager and PowerPoint
presentation)
Pathways for WHO
recommendations on vaccine use
Industry and other
partners
Global Advisory
Committee on
Vaccine Safety
SAGE
Background working group
Paper
Secretariat
Relevant existing
technical advisory
committee
Other relevant non immunization
related WHO policy
recommendation making body
Expert committee
on Biological
Standardization
Immunization
Practices Advisory
Committee
Quantitative
Immunization and
Vaccines related
Research Advisory
Committee
Input
Request for review of
evidence
SAGE
Recommendations
WHO DG
Regional TAGS &
NITAGS
Regional
consultations
WHO
Position
Paper
Country
Decision
making
Priority topics for SAGE meetings identified
through a survey of SAGE members
• Use of vaccines in humanitarian
emergencies
• Strengthening surveillance networks
• Accessibility to affordable vaccines
• Communication with vaccine-hesitant
populations
• Validation of coverage
• Use of vaccines in
immunocompromised populations
Priority topics for SAGE meetings identified
through a survey of SAGE members
• Optimizing immunization schedules
• Impact of introduction of new
vaccines on immunization and health
systems
• Maternal immunization to enhance
the protection of mothers and
infants
• Involvement of the private sector
• Strengthening of national technical
advisory groups on immunization
(NITAGs).
Challenges
•
•
•
•
Continuous evaluation & adjustments
Declaration of interests
Heavy work burden for members
Increased credibility and visibility  increased demands and
pressure
• Processes quite cumbersome
• Funding for SAGE core activities
• Technical contribution and coordination
Challenges
Importance of regional offices and Advisory Committees in the
adaptation of the SAGE recommendations
Weakness of NITAGS
Advisory nature of NITAGS means that recommendations can
be ignored
Financial sustainability for countries to implement
Weakness of health services
Vaccine hesitancy
Resources requirements
Staff
Core
Senior health officer
Technical assistant (currently missing)
Administrative assistant
Web assistant, documentalist, clerk, and communication
officer (part time)
Specific technical contribution
Resources excluding salaries US$ 700K +
Quality of evidence
Quality starting
factor is first
assigned base on
Study Design
Quality score is lowered1 if
Quality score is raised1 if
We are very confident that
the true effect lies close to that of
the estimate of effect on health
outcome (4)
Randomised trials
1)Limitation of design:2
-1 Serious
-2 Very serious
1)Large effect:
+1 RR or OR>2 (or <0.5) in 2+ studies
+2 RR or OR >5 (or <0.2) in 2+ studies
2)Inconsistency:
-1 Serious
-2 Very serious
We are moderately confident
in the estimate of effect on health
outcome: The true effect is likely to
be close to the estimate of the
effect, but there is a possibility that
it is substantially different (3)
Our confidence in the
estimate of the effect on the health
outcome is limited: The true effect
may be substantially different from
the estimate of the effect (2)
3)Indirectness:2
-1 Serious
-2 Very serious
Observational
studies, disease
surveillance and
post market safety
surveillance data
We have very little
confidence in the estimate of the
effect on the health outcome. The
true effect is likely to be
substantially different from the
estimate of effect (1)
1
4)Imprecision:
-1 Serious
-2 Very serious
5)Publication Bias:
-1 Likely
-2 Very likely
2)Dose response (population based):
+1 Evidence of decreased risk with
increased vaccine coverage including
evidence of reversal at population level
(disease returns when vaccine coverage is
decreased) population based dose
response
+2 Very strong evidence of decreased risk
with increased coverage
3)Antagonistic bias and confounding:
+1 All major confounders would have
reduced the effect
or +1 Ability of design to control for
confounding and avoid biases
+2 If in addition to design, consistency
across different settings, different
investigators, and possibly different designs
1= move up or down one grade (for example from high to intermediate), 2= move up or down two grades (for example from low to high)
2 Should
be commensurate with study design
SAGE: Drivers?
Best evidence-based recommendations
Impact
Usefulness
Communication and access
Credibility
Continuous enhancement of processes
as a result of feed-back and external reviews
Declaration of interests
Prior to appointment on committee and updating before each
meeting
Discussion with Chair
Public disclosure of DOI and short biography posted on web
Additional guidelines on assessing SAGE members' DOI and
framework on how to write public disclosure
Lot of work for secretariat
DOI one element only of credibility and process to avoid conflicts of
interest