The Full Value of Vaccine Assessments (FVVA): a framework for assessing and communicating the value of vaccines for investment and introduction decision-making

Abstract

Background Several economic obstacles can deter the development and use of vaccines. This can lead to limited product options for some diseases, delays in new product development, and inequitable access to vaccines. Although seemingly distinct, these obstacles are actually interrelated and therefore need to be addressed through a single over-arching strategy encompassing all stakeholders. Methods To help overcome these obstacles, we propose a new approach, the Full Value of Vaccines Assessments (FVVA) framework, to guide the assessment and communication of the value of a vaccine. The FVVA framework is designed to facilitate alignment across key stakeholders and to enhance decision-making around investment in vaccine development, policy-making, procurement, and introduction, particularly for vaccines intended for use in low- and middle-income countries. Results The FVVA framework has three key elements. First, to enhance assessment, existing value-assessment methods and tools are adapted to include broader benefits of vaccines as well as opportunity costs borne by stakeholders. Second, to improve decision-making, a deliberative process is required to recognize the agency of stakeholders and to ensure country ownership of decision-making and priority setting. Third, the FVVA framework provides a consistent and evidence-based approach that facilitates communication about the full value of vaccines, helping to enhance alignment and coordination across diverse stakeholders. Conclusions The FVVA framework provides guidance for stakeholders organizing global-level efforts to promote investment in vaccines that are priorities for LMICs. By providing a more holistic view of the benefits of vaccines, its application also has the potential to encourage greater take-up by countries, thereby leading to more sustainable and equitable impacts of vaccines and immunization programmes.

New Vaccine Platforms—Novel Dimensions of Economic and Societal Value and Their Measurement

“…The proper clinical and economic evaluation of vaccination programs recognizes their broadly administered use and resulting population-wide benefits [ 1 , 5 , 6 , 11 , 78 , 89 ]. These include reduced disease transmission, reduced fear of contagion, increased health system resilience, and a broad range of non-health economic benefits such as of lower indirect costs, human capital accumulation, and labor market productivity.…”

“…The proper clinical and economic evaluation of vaccination programs necessitates recognition of both the direct clinical value, as well as the broader societal benefits conferred beyond healthcare systems or sectors—such as health system resilience and a broad range of non-health macroeconomic benefits (such as of human capital accumulation and labor market productivity) [ 1 , 2 , 3 , 4 ]. These considerations were reflected in the Professional Society for Health Outcomes and Research (formerly International Society of Pharmacoeconomics and Outcomes Research, ISPOR) 2018 Task Force Report on best practices in the economic assessment of vaccination programs, as well as in the World Health Organization’s (WHO) recently published Full Value of Vaccine Assessments (FVVA) framework and the Asia-Pacific Economic Cooperation (APEC) Regional Dashboard on Vaccination Across the Life-Course [ 5 , 6 , 7 ]. Failing to include such elements in CEAs or formal Health Technology Assessments (HTAs) risks undervaluing vaccine technologies, ultimately reducing manufacturer incentives to invest in research and development (R&D) to develop vaccines for diseases with sustained unmet need [ 8 ].…”

National Immunization Program Decision Making Using the CAPACITI Decision-Support Tool: User Feedback from Indonesia and Ethiopia

“…The decision-making environment for new vaccine introduction in LMICs is complex given the range of immunization strategies and activities available to countries, combined with economic and financial constraints many LMICs face [ 9 ]. Decision-making about new vaccine introductions, including strategic decisions about medium- to short-term priority vaccines for introduction, requires the simultaneous consideration of multiple criteria that collectively capture the broader value of vaccines in terms of benefits and impact across the vaccine life cycle, referred to by WHO as the “full value of vaccines” [ 9 , 10 ]. A recent systematic review of criteria considered in national decision-making for the introduction of new vaccines showed that, indeed, many criteria are considered, noting that programmatic and acceptability aspects were not as often considered and that NITAGs increasingly take into consideration economic evaluations [ 11 ].…”

An mRNA technology transfer programme and economic sustainability in health care

“…7 , 28 , 29 For instance, the value of a vaccine includes individual health benefits and broader socioeconomic and indirect impact(s) that the vaccine or vaccination might have, as reflected in WHO’s full vaccine value assessment, an analysis to inform priority-setting for investment in and uptake of vaccines. 30 For epidemic preparedness and response in particular, the capacity of countries or regions to rapidly develop and make available health technologies to control outbreaks when and where they occur is an important asset for health security. This capacity needs to be valued as such, even if it is not profitable for individual companies.…”