Update on Implementation of NUV

Carsten Mantel WHO/FCH/IVB/EPI

2 | GIM, NYC, 17-19 Feb 2009

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

3 | GIM, NYC, 17-19 Feb 2009

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

5 | GIM, NYC, 17-19 Feb 2009

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

6 | GIM, NYC, 17-19 Feb 2009

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

7 | GIM, NYC, 17-19 Feb 2009

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

8 | GIM, NYC, 17-19 Feb 2009

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

9 | GIM, NYC, 17-19 Feb 2009

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

11 | GIM, NYC, 17-19 Feb 2009

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

12 | GIM, NYC, 17-19 Feb 2009

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

13 | GIM, NYC, 17-19 Feb 2009

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

14 | GIM, NYC, 17-19 Feb 2009

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)

15 | GIM, NYC, 17-19 Feb 2009

NUV Advocacy and CommunicationNUV Advocacy and Communication

� Address concerns and anti-

vaccination messages challenging NUVI

� Improve Knowledge Management

� NUVI website, GIN, NUVI news

stories

16 | GIM, NYC, 17-19 Feb 2009

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

17 | GIM, NYC, 17-19 Feb 2009

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

18 | GIM, NYC, 17-19 Feb 2009

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

20 | GIM, NYC, 17-19 Feb 2009

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

21 | GIM, NYC, 17-19 Feb 2009

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

22 | GIM, NYC, 17-19 Feb 2009

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

23 | GIM, NYC, 17-19 Feb 2009

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

25 | 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

26 | GIM, NYC, 17-19 Feb 2009

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

27 | GIM, NYC, 17-19 Feb 2009

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 …