18:50 - 19:30
Key-note address : The costs and effectiveness of large pre-licensure phase III clinical trials: time for a new paradigm?
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
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.
Monday 22 June
Tuesday 23 June
Wednesday 24 June
Session 1 Public Health impact of Vaccination: General concept and methodological approaches
Assessing public health impact through "vaccine probe" analyses
Robert BREIMANDownload presentation
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)Download presentation
Herd protection-efficacy vs effectiveness
Ana Lena LOPEZDownload presentation
Cost effectiveness of vaccines: assessment of the decision-making tools
John EDMUNDSDownload presentation
What modeling can and cannot bring to impact assessment of vaccines
Ira LONGINIDownload presentation
Corrolaries of vaccine introduction: benefits beyond vaccine efficacy
Annelies WILDER-SMITHDownload presentation
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 PARASHARDownload presentation
Possible effect of a malaria vaccine on the preventable burden
Kevin MARSHDownload presentation
Can partially effective vaccines be safely used to prevent and control Dengue?
Duane GUBLERDownload presentation
Session 3 Expanding the Regulatory and Immunization Policy decision-making from an Individual Benefit/Risk to a population-level (Public Health Impact) Benefit/Risk
Session 3 : Continued
A usa perspecive on regulatory requirments for vaccine efficacy
Norman BAYLORDownload presentation
Regulatory challenges for registration of novel vaccines
Nora DELLEPIANEDownload presentation
New paradigms in vaccine evaluation and promotion: a view from a developing country
Helder MARTINSDownload presentation
A funder’s perspective: the Bill and Melinda Gates Foundation
Peter DULLDownload presentation
Cindy GRASSO - Conference Coordinator