Update on Implementation of NUV - WHO · NUV Regulatory Issues Regulatory pathways and network...
Transcript of Update on Implementation of NUV - WHO · NUV Regulatory Issues Regulatory pathways and network...
Update on Implementation of NUV
Carsten Mantel WHO/FCH/IVB/EPI
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Introduction of New VaccinesThe continuum of activity
Introduction of New VaccinesThe continuum of activity
REGULATORYNORMS & STANDARDS
RESEARCHClinical &
operational
POLICY RECOMMENDATIONSCOUNTRY DECISION
MAKING
VACCINE SUPPLY PROCUREMENT
PRICINGFINANCING
COUNTRY IMPLEMENTATIONPlanning, Training,
Logistics
SURVEILLANCE & MONITORING
Coverage, Disease, Impact AEFI, PIEs
INTRODUCTIONINTRODUCTION OF NEW VACCINES INTO NATIONAL IMMUNIZATION PROGRAMMESOF NEW VACCINES INTO NATIONAL IMMUNIZATION PROGRAMMES
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Maintaining the "Big Picture" on NUVMaintaining the "Big Picture" on NUV
� Global NUVI Plan of Action regularly
updated
� Global forum provided at annual
NUVI Meetings and NUVI Retreats
NUVI Achievements
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Hib Vaccine, 2008Hib Vaccine, 2008
� Hib "Endgame"
� 136 countries -
home to ~40% of
world's infants –have introduced Hib
vaccine
� 57 countries left -
some with large birth cohorts
In Routine Immunization Schedule in 2008 – 136 countries (70%)
In Routine Immunization Schedule in 2008 Part of the Country – 1 country (1%
Introduction planned from 2009 - 29 countries (15%)Source: WHO/IVB database, 193 WHO Member States. 09 February 2009 – Provisional data
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Rotavirus WHO RecommendationRotavirus WHO Recommendation
� Present recommendation limited to the Americas and the European
Region
� April 2009 SAGE meeting will discuss possible extension to Africa,
Asia, Eastern Mediterranean Region
� Summary of evidence for SAGE being prepared by Expert Group
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Rotavirus Vaccine, 2008Rotavirus Vaccine, 2008
� 18 countries have
introduced RV vaccine
� 3 countries interested in Eastern
Mediterr. Region
� Supported through
Accelerated Vaccine Introduction Initiative
In routine immunization schedule in 2008 - 18 countries (9%)
In Routine Immunization Schedule in 2008 in part of the country – 1 country (1%)
Introduction planned from 2009 - 1 country (1%)
Source: WHO/ IVB Database as of 10 February 2009 – Provisional data
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Pneumococcal Conjugate Vaccine, 2008Pneumococcal Conjugate Vaccine, 2008
� 29 countries have introduced PCV7
� 13 countries (11 GAVI eligible)
interested to introduce PCV10 or
PCV13
� Support through
Advanced Market Commitment (AMC) In routine immunization schedule in 2008 - 29 countries (15%)
In routine immunization schedule in 2008 for risk groups - 13 countries (7%)
In routine immunization schedule in 2008 in part of the country – 1 country(1%)
Planning to introduce from 2009/10 - 9 countries (5%)
Source: WHO/ IVB Database as of 10 February 2009 – Provisional data
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PCV IntroductionPCV Introduction
� PCV7 introduction in Rwanda and The Gambia in early 2009 through
donation by manufacturer plus GAVI support
� PCV10 expected to be available in Q1/2010
� PCV13 expected to be available in Q3/2010
� Advanced Market Commitment for PCV10 and PCV13: Agreement pending
� Target Product Profile finalized
NUVI Challenges
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Country Decision-Making & IntroductionCountry Decision-Making & Introduction
� Competing priorities
� Compounded decision-making
� Difficult planning processes
� More complex vaccines
targeting disease syndromes
� Practical introduction challenges
� VPD Prioritization Project
� Improved data on BoD
� Easy-to-use C/E tools
� WHO position papers
� cMYP tools
� Communication to communities,
Training of HCWs
� Post Introduction Evaluations
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Supply, Procurement & LogisticsSupply, Procurement & Logistics
� Multiple formulations
� Uncertain supply and pricing
� Increased cold chain capacity needs
� Waste disposal challenges
� Vaccine Product Menu, PRG
� Supply forecast, studies and
workshops on pooled procurement
� Effective Vaccine Management
� High temperature incineration or safe burial
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Surveillance & Safety MonitoringSurveillance & Safety Monitoring
� Integrate VPDs and other
diseases into one platform
� Standardize indicators and
reporting requirements
� Show that integrated surveillance works
� Monitor and deal with AEFIs
� Surveillance transition
� Global meeting Nov 2008
� Central African Demonstration Project
� Post marketing surveillance, AEFI investigations and
response, GACVS reviews
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NUV Regulatory IssuesNUV Regulatory Issues
� Regulatory pathways and network initiatives for registration and
oversight of clinical trials
� Expedited review for registration of PQ vaccines in receiving countries
� Guidance to manufacturers to facilitate successful submissions for PQ
� Strengthen NRAs and National Control Labs, particularly those from producing countries exporting vaccines through the UN system
� Extend testing capacity to a critical mass of laboratories (regional)
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NUV Advocacy and CommunicationNUV Advocacy and Communication
� Address concerns and anti-
vaccination messages challenging NUVI
� Improve Knowledge Management
� NUVI website, GIN, NUVI news
stories
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Sustained NUV FinancingSustained NUV Financing
� Need for improved financing
data
� Monitor implementation of GAVI
co-financing
� Impact of debt relief
� Impact of International Health
Partnership (IHP+)
� Impact of the financial crisis
� Analysis of cMYPs - database
and website
� GAVI / UNICEF SD monitoring
� Study on immunization and
health system financing
� Assess NUVI in context of
National Health Plans and National Health Reports
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NUV in Lower Middle Income CountriesNUV in Lower Middle Income Countries
LMICs falling behind GAVI countries (example Hib in EMR)
68.526.6Total EMR
100.0100.05.96.5HIC
100.0100.01.32.0UMIC
22.922.935.544.5LMIC
92.819.657.347.0GAVI
% Hib
2009
% Hib
2008
% <1 pop% pop
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NUVI: Old Partners, New StructuresNUVI: Old Partners, New Structures
� ADIPs (Hib, Pneumo, Rota) phasing out in 2008/09
� New Technical Advisory Consortium (TAC) created
� Accelerated Vaccine Introduction Initiative (AVI) for rotavirus and
pneumococcal vaccines in formation
"New" NUV
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Human Papilloma Virus VaccineHuman Papilloma Virus Vaccine
� Two HPV vaccines widely licensed and marketed
� Strong advocacy (and sensitivities)
� SAGE recommendation in Nov 2008
� Included in GAVI investment strategy (subject to financing)
� Lack of existing delivery systems - demonstration projects ongoing
� HPV surveillance to be coordinated
� Cervical screening and treatment to continue
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Japanese Encephalitis VaccineJapanese Encephalitis Vaccine
� SA-14-14-2 most widely used vaccine, not pre-qualified
� Importance of JE control restated by SAGE in Nov 08
� Included in GAVI investment strategy (subject to
financing)
� Surveillance and lab capacity in endemic countries
insufficient
� "JE Coalition" framed - to work on:
– Surveillance and laboratory support
– Vaccine supply and procurement
– Special research
– Financing and Technical Support
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Typhoid VaccineTyphoid Vaccine
� SAGE recommendation for programmatic use of typhoid vaccines for
controlling endemic disease and for outbreak control
� Included in GAVI investment strategy (subject to financing)
� Target high-risk groups and populations
� School-age or pre-school age immunization
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Meningococcal A VaccineMeningococcal A Vaccine
� Yaoundé Declaration of Health Ministers Sept 2008
� Meningitis Vaccine Project (WHO/PATH)
� GAVI investment case approved (subject to financing)
� Vaccine filed for licensing and pre-qualification
� Preparation for first campaigns in 1 – 29 year age groups in Burkina
Faso, Mali, Niger
� Post-introduction safety surveillance with lab confirmation required
NUVI Priorities for 2009
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NUVI – Priorities for 2009 NUVI – Priorities for 2009
� Hib vaccine introduction in remaining countries - focus on countries
with large birth cohorts (e.g. India, Nigeria)
� Extension of rotavirus vaccine WHO recommendation to all
countries and preparation for introduction
� PCV7 introduction in Rwanda and The Gambia
� Preparation for PCV10 & 13 introduction
� Ensure AMC support
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NUVI – Priorities for 2009NUVI – Priorities for 2009
� Surveillance standardisation and creation of integrated surveillance platform and feedback bulletins
� Safety monitoring, AEFI crisis and pre-emptive communication
� Co-financing monitoring and follow-up of defaulter countries
� Accelerated Vaccine Introduction (AVI) Initiative off the ground and working
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AcknowledgementsAcknowledgements
� Thomas Cherian
� Patrick Zuber
� Cristiana Toscano
� Gill Mayers
� Rosalyn O'Loughlin
� Ana Sartori
� Laure Dumolard
� Elsa Dérobert
� and collegues of the Hib Initiative, Rota ADIP, Pneumo ADIP and others …