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).