16:45 - 17:00
Objectives of the meeting: climbing over a brick wall
Estimating the full Public Health Value of vaccines 2016
5 - 7 December 2016 - Les pensieres, Veyrier du Lac (France)
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
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
18:00 - 18:45
Keynote address 2: QALYs or the social rate of return: what’s the right benefit measure?
Session 1 The public health value of vaccines: socio-economic aspects
8:30 - 8:50
Examples of the public value of some health interventions other than vaccines (the example of HIV treatment)
Till BARNIGHAUSENDownload presentation
9:05 - 9:25
Are current cost-effectiveness "thresholds" for low- and middle- income countries useful? An example from the "world of vaccines"
Jessica OCHALEKDownload presentation
9:40 - 9:55
Public health value and broader impact of vaccines
Raymond HUTUBESSYDownload presentation
9:55 - 10:10
WHO activities in immunization implementation research
Ana Maria HENAO-RESTREPODownload presentation
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 RAPPUOLIDownload presentation
11:20 - 11:40
Quantifying the equity and financial risk protection benefits of vaccines using extended cost-effectiveness analysis (ECEA)
Stephan VERGUETDownload presentation
11:55 - 12:15
Vaccination as an essential element of reducing health inequities
Ulla GRIFFITHSDownload presentation
Session 2 Panel discussion: health systems disruption resulting from epidemics: effect on vaccination programmes
14:00 - 14:10
14:10 - 14:25
Impact of the 2014-15 Ebola outbreak on health systems, vaccination programmes and population health
James ELSTONDownload presentation
14:25 - 14:40
Health system disruption by epidemics: the exemple of Zika
Joâo Bosco SIQUEIRADownload presentation
14:40 - 14:55
Flexibility in pandemic planning, preparedness, response and international health regulation (IHR), implementation, H5N1 experience in Indonesia
I Nyoman KANDUNDownload presentation
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
15:50 - 16:10
Unique considerations of public health value of vaccines given to pregnant women
Kathy NEUZILDownload presentation
16:25 - 16:45
Group B streptococcus vaccination of pregnant women: potential for impacting on maternal, fetal and infant health
Shabir MADHIDownload presentation
17:00 - 17:20
Potential public health impact of RSV vaccines
Ruth KARRONDownload presentation
17:35 - 17:55
Rotavirus vaccines: efficacy and public health impact
Umesh PARASHARDownload presentation
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
8:30 - 8:45
How to make best use of an imperfect malaria vaccine
Brian GREENWOODDownload presentation
8:45 - 9:00
Optimal use of Malaria vaccine II
Matthew LAURENSDownload presentation
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 SIQUEIRADownload presentation
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
Session 5 Round table discussion: How do policy makers see the public health value of vaccines
14:00 - 14:15
Vaccination and public health: “a governments’ obligation”; “Every childrens’ right” / Philippines
Janette LORETO GARINDownload presentation
14:15 - 14:30
Vaccination program: governance and policy decision process in Malaysia
Puan Dr. SAFURAH - Binti Hj. JAAFARDownload presentation
14:30 - 14:45
Expanded program on immunization in indonesia and it’s public health implication
I Nyoman KANDUNDownload presentation