50 years in the fight against infectious diseases 1967 – 2017

Fondation Mérieux Event

Beyond efficacy: the full public health impact of vaccines in addition to efficacy measures in trials

June 22 - 24, 2015 - Les Pensieres, Veyrier-du-Lac - France

Background

Vaccine efficacy reflects the proportionate reduction in disease incidence between unvaccinated and vaccinated individuals. While vaccines are typically licensed on the basis of demonstrated efficacy, the ultimate goal of vaccination is to achieve a significant public health impact in addition to the prevention of infection in an individual.

In this respect, there is a need to provide a broader perspective that encompasses the capacity of a vaccination program to reduce microbial transmission; avert disease, disability and premature deaths; to lessen the pressure on health systems, and to reduce health inequities between populations. These issues are particularly relevant for some of the newer vaccines (e.g., rotavirus, dengue, and malaria vaccines) that demonstrate lower efficacy in high burden settings than traditional vaccines, but nevertheless could have a substantial overall public health impact in these settings.

Data on a vaccine’s public health benefits are often not available or may be incomplete. As a consequence, decision-makers and target populations may underestimate the justification for vaccine use, leading to delays in public immunization program introduction and to ongoing preventable disease burden. The slow introduction of a rotavirus vaccine in developing countries despite evidence of enormous decreases in severe disease and hospital utilization is one example.

In addition to helping inform decision-makers and target populations, measures beyond efficacy may have a role in vaccine licensure. Specifically, there is no a priori reason why regulatory agencies would notconsider the total disease burden preventable by vaccine as a complement to vaccine efficacy.

Programme

Monday 22 June

Tuesday 23 June

Wednesday 24 June

  • 18:50 - 19:30

    Key-note address : The costs and effectiveness of large pre-licensure phase III clinical trials: time for a new paradigm?

    Steve BLACK

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Session 1 Public Health impact of Vaccination: General concept and methodological approaches

Jean-Antoine ZINSOU

  • 08:30-08:50

    Assessing public health impact through "vaccine probe" analyses

    Robert BREIMAN

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  • 09:05-09:25

    Importance of measuring baseline vaccine preventable disease incidence (against clinical disease syndromes, with clear case definition) in addition to vaccine efficacy in clinical trials

    Umesh PARASHAR (on behalf of Brad GESSNER)

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  • 09:40-10:00

    Herd protection-efficacy vs effectiveness

    Ana Lena LOPEZ

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  • 10:45-11:05

    Cost effectiveness of vaccines: assessment of the decision-making tools

    John EDMUNDS

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  • 11:20- 11:40

    What modeling can and cannot bring to impact assessment of vaccines

    Ira LONGINI

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  • 11:55- 12:15

    Corrolaries of vaccine introduction: benefits beyond vaccine efficacy

    Annelies WILDER-SMITH

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Session 2 Appraisal of the effect of vaccines on the Vaccine Preventable Disease incidence against different outcomes or in different settings: case study examples

Olaf HORSTICK and Umesh PARASHAR

  • 14:35 - 14:55

    Rotavirus vaccine: assessing the risk and benefits

    Umesh PARASHAR

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  • 15:05- 15:25

    Possible effect of a malaria vaccine on the preventable burden

    Kevin MARSH

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  • 16:10-16:30

    Can partially effective vaccines be safely used to prevent and control Dengue?

    Duane GUBLER

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Session 3 Expanding the Regulatory and Immunization Policy decision-making from an Individual Benefit/Risk to a population-level (Public Health Impact) Benefit/Risk

Chris NELSON

Session 3 : Continued

  • 09:00-09:20

    A usa perspecive on regulatory requirments for vaccine efficacy

    Norman BAYLOR

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  • 09:35- 09:50

    Regulatory challenges for registration of novel vaccines

    Nora DELLEPIANE

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  • 10:35- 10:55

    New paradigms in vaccine evaluation and promotion: a view from a developing country

    Helder MARTINS

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  • 11:10-11:30

    A funder’s perspective: the Bill and Melinda Gates Foundation

    Peter DULL

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Contact

Cindy GRASSO - Conference Coordinator

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