A paper in BMC Medicine presents an apparent solution to the economic obstacles to the development and use of vaccines. The solution is the Full Value of Vaccines Assessments (FVVA) framework, intended to “guide the assessment and communication of the value of a vaccine”. It facilitates “alignment” between stakeholders and enhances decision-making. Here we examine the framework as presented in the paper.
Interrelated obstacles and gaps
The authors state that the development, use, and impact of vaccines are “hindered” by several “interrelated obstacles”, many of which have not emerged recently but been emphasised in debates around the “urgent need” to develop and deploy safe, effective, and affordable vaccines. Research has identified a few hurdles, or gaps, to achieving population-level vaccine impact.
The first gap is between discovery and early clinical development; this is known as the translation gap. The second is the gap between early development and licensure. This gap is dramatically referred to as the “second valley of death”. This is a “particular challenge for vaccines for which the public health need is concentrated in low-income settings” due to “uncertainties regarding demand and national uptake”, which can discourage investment. The third gap is between licensure and subsequent introduction. The fourth gap is between the scale-up of implementation and ensuring sustainable and equitable impact.
“While these hurdles represent seemingly distinct problems faced by different stakeholders along the vaccine value chain, they are in fact related and need to be addressed through an over-arching strategy integrated throughout vaccine development, licensure, policy-making, introduction, and sustainable use.”
The paper offers examples such as the vaccines for hepatitis E virus, tuberculosis (TB), and group A Streptococcus (GAS). In the case of hepatitis E, although two vaccines have progressed through Phase III trials and are licensed for use in China and India, the high cost of vaccine development and limited market for these vaccines have been “major challenges to their wider availability”.
The development of new TB vaccines has been a struggle because of the “complex disease course”, vaccine development challenges, and “uncertain national demand”. This is particularly pertinent for a vaccine that is not intended for deployment within childhood immunisation programmes. For GAS there are currently a few candidates in preclinical and early-stage clinical development, but the authors suggest that more research is required to identify optimal targets for protective immunity, particularly in low-income settings.
Pull and push
The authors suggest that to improve coordination and communication across stakeholders, we need mechanisms for the “integration of diverse sets of information” and the “harmonisation of divergent incentives”. Contemporary efforts are categorised in terms of ‘pull’ and ‘push’ mechanisms.
- Examples of financial ‘pull’ incentives: advanced market commitments, market guarantees, prize systems. Providing systematic information on demand preferences or desired product characteristics also helps to incentivise manufacturers and reduce uncertainties in the development of products in LMICs.
- Examples of ‘push’ mechanisms: financial incentives include grants, subsidies, co-financing arrangements, product-development partnerships. Technical assistance for country plan development, partner-coordination mechanisms, and social mobilisation can also help to reduce risks and share costs.
These mechanisms improve coordination but there is no one approach that countries take to assess the value of vaccines. WHO guidelines on the economic evaluation of vaccines suggest that assessments should consider broad population-level effects as well as the effects on long-term human capital development. Although many countries consider “narrow” benefits like health gains and reduced costs, others are moving to assess and quantify the “broader” benefits of vaccination such as herd protection, educational outcomes, equity, and more.
“To facilitate this quantitative assessment of broader benefits there is a need for greater standardisation both between countries and between disease areas to facilitate international and cross-disease comparisons across different stakeholders.”
The proposed framework guides the “assessment and communication of the value of vaccines” and facilitates “alignment” among key stakeholders. These stakeholders include communities, health care workers, vaccine agents, enablers, CEPI and funders, international and multilateral organisations, and multilateral development banks (MDBs).
The framework considers two concepts:
- Adaptions are required in the individualist, welfarist methods of assessment still frequently used.
- The full value of vaccines derives not only from the results of assessments of benefits and costs but also the robustness of the decision-making process itself.
The FVVA framework aims to provide “guiding principles” to promote country ownership of decision-making and priority setting. The target hurdles include those mentioned above but also those that hinder equitable access and desired coverage. The framework aims to integrate LMIC preferences and needs, increasing the likelihood of global health and well-being goals.
The framework incorporates two streams from Enlightenment ethics: consequentialism and proceduralism. The former is a philosophical approach that requires actions to be judged by their outcomes. The latter is a rules-based attitude to decision-making through which decisions are “partially” justified in accordance with stakeholder goals. However, descriptive modelling should structure and make explicit the reasons for preferred decisions. This approach requires greater attention to the decision-making process itself.
Some consider these views to be contradictory, but modern commentary argues that they are both important components of just health policy and governance. Furthermore, the authors call for the incorporation of ethical systems that are not rooted in Enlightenment thought, such as non-Western ethical systems like communitarian values and relationships. In the paper the authors present the arguments that consequentialist frameworks should take a broader perspective and proceduralism must be integrated with consequentialist approaches, especially to promote coordination and alignment of stakeholders.
The figure below illustrates the three elements of the FVVA and their interaction with each other.
The authors conclude that the framework represents a set of “coherent, organising principles guiding the adoption of consequentialist tools while placing the autonomy and agency of stakeholders at the centre of decision-making”.