50 years in the fight against infectious diseases 1967 – 2017

Estimating the full Public Health Value of vaccines 2016

5 - 7 December 2016 - Les pensieres, Veyrier du Lac (France)

Summary

Several new candidate vaccines have reached a level of efficacy that has triggered discussions in the public health community on how to assess and incorporate the full public health value (FPHV) of preventive vaccines into the evidence-based decision-making process of vaccine licensure and public health use.

In June 2015, a group of experts discussed how to define what criteria should be considered to assess the FPHV of vaccines in addition to efficacy measured in clinical trials. (1) They’ve reached the conclusion that we were entering in an era of a new paradigm in vaccine evaluation where all aspects of public health value of vaccines beyond efficacy should be assessed.

It was clear for this group of experts that assessing the full benefit of vaccines can no longer rely on largescale Phase III trials and vaccine effectiveness studies only. Going a step further and considering additional outcomes, measures, and designs becomes extremely valuable, as does the consideration of vaccines role in facilitating equitable access to public health. They also considered that in addition to benefit-risk assessment based on the information collected through the traditional regulatory process, a substantial body of additional information is needed to inform policy and other required decision-making at the global, national and sub-national levels. Therefore, to assess the wider scope of vaccine benefits, improvement in risk assessment, partnership and coalition building across interventions and data sharing needs to occur. With this new paradigm, alternative regulatory pathways involving stakeholders as a process for low and middle-income countries (LMICs), and conditional licensure of vaccines based on collection of outcome results should both be considered, to lower the financial barriers to development of new vaccines and thus increase portfolio of vaccines to be developed and introduced in these countries.

Now that the components of this new paradigm are well defined, there is a need to evaluate their feasibility for the proper assessment of the FPHV.

This meeting will continue a discussion that has been engaged starting at the Global Vaccine and Immunization Research Forum in 2014 and was continued in 2015 and into 2016 starting with the Health Affairs special issue (HEALTH AFFAIRS, Volume 35, Issue 2: Vaccines), and discussions at the Global Vaccine and Immunization Research Forum (March) and the Geneva Health Forum (April).

Objective of the meeting

To advance discussions on the definition, evidence and communication of the Full Public Health Value (FPHV) of vaccines:

  • To challenge the definition of what constitutes the FPHV of vaccines.

  • TTo review examples of Public Health Value with existing vaccines used in outbreak settings and others used in endemic disease settings.

  • TTo propose designs, measures, and outcomes for assessing the FPHV of vaccines in phase III trials and phase IV assessments and integrated/hybrid phIII/IV strategies.

  • TTo apply these concepts to specific vaccines: malaria, dengue, Group B Streptococcus (GBS), Respiratory syncytial virus (RSV), Neisseria meningitidis B (NMB), and Oral Cholera Vaccine (OCV).

  • TTo strategize on how to communicate the FPHV of vaccines to regulatory and program policy makers.

(1)Saadatian-Elahi M, et al. Beyond efficacy: The full public health impact of vaccines. Vaccine (2016), http://dx.doi.org/10.1016/j. vaccine.2016.01.021

Program

Monday, December 5

Tuesday, December 6

Wednesday, December 7

  • 17:00 - 17:45

    Keynote address 1 The importance of the full public health value of vaccination in decisions of policy makers: where do we stand and where should we go

    Brad GESSNER

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  • 18:00 - 18:45

    Keynote address 2: QALYs or the social rate of return: what’s the right benefit measure?

    JP SEVILLA

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Session 1 The public health value of vaccines: socio-economic aspects

Kathy NEUZIL

  • 8:30 - 8:50

    Examples of the public value of some health interventions other than vaccines (the example of HIV treatment)

    Till BARNIGHAUSEN

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  • 9:05 - 9:25

    Are current cost-effectiveness "thresholds" for low- and middle- income countries useful? An example from the "world of vaccines"

    Jessica OCHALEK

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  • 9:40 - 9:55

    Public health value and broader impact of vaccines

    Raymond HUTUBESSY

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  • 9:55 - 10:10

    WHO activities in immunization implementation research

    Ana Maria HENAO-RESTREPO

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  • 10:45 - 11:05

    The public health value as an important attribute of potential vaccines in a priority-setting aid for new vaccine candidates

    Rino RAPPUOLI

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  • 11:20 - 11:40

    Quantifying the equity and financial risk protection benefits of vaccines using extended cost-effectiveness analysis (ECEA)

    Stephan VERGUET

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  • 11:55 - 12:15

    Vaccination as an essential element of reducing health inequities

    Ulla GRIFFITHS

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Session 2 Panel discussion: health systems disruption resulting from epidemics: effect on vaccination programmes

Jean-Antoine ZINSOU

  • 14:00 - 14:10

    Introduction

    Guenael RODIER

  • 14:10 - 14:25

    Impact of the 2014-15 Ebola outbreak on health systems, vaccination programmes and population health

    James ELSTON

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  • 14:25 - 14:40

    Health system disruption by epidemics: the exemple of Zika

    Joâo Bosco SIQUEIRA

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  • 14:40 - 14:55

    Flexibility in pandemic planning, preparedness, response and international health regulation (IHR), implementation, H5N1 experience in Indonesia

    I Nyoman KANDUN

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  • 14:55 - 15:30

    General discussion: “considerations for vaccination programmes during acute health emergencies”

    Facilitator: Guenael RODIER

Session 3 a) Extending the evaluation of specific vaccines beyond the traditional efficacy measures evaluated in phase III trials: case studies of the full public health value of vaccination against endemic and non-seasonal diseases

Chris NELSON

  • 15:50 - 16:10

    Unique considerations of public health value of vaccines given to pregnant women

    Kathy NEUZIL

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  • 16:25 - 16:45

    Group B streptococcus vaccination of pregnant women: potential for impacting on maternal, fetal and infant health

    Shabir MADHI

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  • 17:00 - 17:20

    Potential public health impact of RSV vaccines

    Ruth KARRON

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  • 17:35 - 17:55

    Rotavirus vaccines: efficacy and public health impact

    Umesh PARASHAR

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Session 3 b) Extending the evaluation of specific vaccines beyond the traditional efficacy measures evaluated in phase III trials: case studies of the public health value of vaccination against seasonal and epidemic/outbreakprone diseases

David KASLOW

  • 8:30 - 8:45

    How to make best use of an imperfect malaria vaccine

    Brian GREENWOOD

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  • 8:45 - 9:00

    Optimal use of Malaria vaccine II

    Matthew LAURENS

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  • 9:00 - 9:30

    Panel discussion: optimal use of Malaria vaccines in relation to other control measures; The role of vaccines in Malaria eradication

    Facilitator : David Kaslow

  • 9:30 - 9:50

    Optimal use of Dengue vaccines

    Joâo Bosco SIQUEIRA

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Session 4 Specific evaluations that should be considered either pre- or postlicensure to extend to the public health impact of vaccines the information obtained from phase III trials

Kate O’BRIEN

  • 10:30 - 10:50

    How undervaluing vaccination can undermine vaccination ecosystem sustainability and diversity

    Michael WATSON

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  • 11:05 - 11:25

    The perceived full public health value of vaccines and vaccine hesitancy among patients and providers

    Pauline PATERSON

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Session 5 Round table discussion: How do policy makers see the public health value of vaccines

Tikki PANG

  • 14:00 - 14:15

    Vaccination and public health: “a governments’ obligation”; “Every childrens’ right” / Philippines

    Janette LORETO GARIN

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  • 14:15 - 14:30

    Vaccination program: governance and policy decision process in Malaysia

    Puan Dr. SAFURAH - Binti Hj. JAAFAR

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  • 14:30 - 14:45

    Expanded program on immunization in indonesia and it’s public health implication

    I Nyoman KANDUN

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