Update on Implementation of NUV Carsten Mantel WHO/FCH/IVB/EPI
Introduction of New Vaccines The continuum of activity REGULATORY NORMS & STANDARDS VACCINE SUPPLY PROCUREMENT PRICING FINANCING SURVEILLANCE & MONITORING Coverage, Disease, Impact AEFI, PIEs INTRODUCTION OF NEW VACCINES INTO NATIONAL IMMUNIZATION PROGRAMMES RESEARCH Clinical & operational POLICY RECOMMENDATIONS COUNTRY DECISION MAKING COUNTRY IMPLEMENTATION Planning, Training, Logistics 2 GIM, NYC, 17-19 Feb 2009
Maintaining the "Big Picture" on NUV Global NUVI Plan of Action regularly updated Global forum provided at annual NUVI Meetings and NUVI Retreats 3 GIM, NYC, 17-19 Feb 2009
NUVI Achievements
Hib 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 5 GIM, NYC, 17-19 Feb 2009
Rotavirus 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 6 GIM, NYC, 17-19 Feb 2009
Rotavirus Vaccine, 2008 In routine immunization schedule in 2008-18 countries (9%) 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 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 7 GIM, NYC, 17-19 Feb 2009
Pneumococcal 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 8 GIM, NYC, 17-19 Feb 2009
PCV 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 9 GIM, NYC, 17-19 Feb 2009
NUVI Challenges
Country 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 11 GIM, NYC, 17-19 Feb 2009
Supply, 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 procuremen Effective Vaccine Management High temperature incineration or safe burial 12 GIM, NYC, 17-19 Feb 2009
Surveillance & 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 13 GIM, NYC, 17-19 Feb 2009
NUV 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) 14 GIM, NYC, 17-19 Feb 2009
NUV Advocacy and Communication Address concerns and antivaccination messages challenging NUVI NUVI website, GIN, NUVI news stories Improve Knowledge Management 15 GIM, NYC, 17-19 Feb 2009
Sustained 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 16 GIM, NYC, 17-19 Feb 2009
NUV in Lower Middle Income Countries LMICs falling behind GAVI countries (example Hib in EMR) GAVI % pop 47.0 % <1 pop 57.3 % Hib 2008 19.6 % Hib 2009 92.8 LMIC 44.5 35.5 22.9 22.9 UMIC 2.0 1.3 100.0 100.0 HIC 6.5 5.9 100.0 100.0 Total EMR 26.6 68.5 17 GIM, NYC, 17-19 Feb 2009
NUVI: 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 18 GIM, NYC, 17-19 Feb 2009
"New" NUV
Human 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 20 GIM, NYC, 17-19 Feb 2009
Japanese 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 21 GIM, NYC, 17-19 Feb 2009
Typhoid 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 22 GIM, NYC, 17-19 Feb 2009
Meningococcal 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 23 GIM, NYC, 17-19 Feb 2009
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 25 GIM, NYC, 17-19 Feb 2009
NUVI 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 26 GIM, NYC, 17-19 Feb 2009
Acknowledgements 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 27 GIM, NYC, 17-19 Feb 2009