A Framework for the Systematic Consideration of Ethics, Equity, Feasibility, and Acceptability in Vaccine Program Recommendations

"...evidence-informed tools for the systematic consideration of programmatic factors in order to develop clear, comprehensive recommendations for timely, transparent decision-making, thereby upholding the principles identified by stakeholders..."

Decision-makers and National Immunisation Technical Advisory Groups (NITAGs) around the world increasingly acknowledge the significance of programmatic factors, such as vaccine acceptability, in an era where vaccine hesitancy is emerging as a threat to global health. To help strengthen national capacity to formulate evidence-based immunisation policies, the National Advisory Committee on Immunization (NACI), which is an expert advisory group to the Public Health Agency of Canada (PHAC), has developed an EEFA (Ethics, Equity, Feasibility, Acceptability) Framework - with supporting evidence-informed tools for each EEFA factor - to help decision-makers, including advisory bodies like NITAGs globally, systematically assess programmatic issues. This paper provides a detailed look at the EEFA Framework.

The NACI team carried out work over a 5-year period to develop, test, improve, and implement the EEFA Framework and supporting tools (termed "matrix" or, in the case of Ethics, "integrated filter"). Part of this process involved developing the following definitions of terms in the Framework:

• Ethics: A systematic process to clarify, prioritise, and justify possible courses of action based on ethical principles. Have ethical concerns regarding implementation of the immunisation programme been adequately addressed?
• Equity: The absence of avoidable, unfair, or remediable differences among groups of people, whether those groups are defined socially, economically, demographically, or geographically or by other means of stratification. Is the immunisation programme equitable in terms of accessibility of the vaccine(s) for all groups seeking to be reached?
• Feasibility: The potential for a programme to be successfully implemented in the local setting with available resources. Is programme implementation feasible, given existing resources?
• Acceptability: A marker of desirability or demand for a given product or programme, including intention and behaviours toward vaccination. Does a high level of demand or acceptability exist for the immunisation programme?

The EEFA development process was participatory. Through an iterative process, the team refined the tools based on written and verbal feedback from a range of stakeholder groups and experts in ethics (e.g., Public Health Ethics Consultative Group - PHECG), equity (e.g., Centre for Chronic Disease Prevention and Health Equity), feasibility (e.g., provincial and territorial representatives who implement recommendations), and acceptability (e.g., international expert in vaccine hesitancy Dr. Ève Dubé). They also sought specific feedback from representatives of specific groups to be reached or high-risk groups (e.g., Canadian Indigenous Nurses Association). Over the course of 2 years, the Framework was been evaluated based on feedback from various stakeholder groups receiving and implementing NACI guidance using the EEFA Framework.

As outlined in Table 3 in the paper, the EEFA Framework summarises the minimum threshold for consideration of each programmatic factor and outlines: when further in-depth analysis may be required, which aspects of the factor should be considered, how to assess the factor using evidence-informed tools, and whom should be consulted to assist in the assessment. Various tables in the paper look at each element through specific filers, outlining dimensions, considerations, and tools. For example:

• Ethics - e.g., Based on the principle of respect for persons and communities, one would look at whether the right to exercise informed choice based on all available evidence is being protected: Has all the evidence been presented in acomprehensive manner? Is the guidance accessible to stakeholders? One way forward would be to summarise evidence clearly and post guidance on the internet and directly disseminate it to stakeholders.
• Equity - e.g., With regard to social capital, one would be cognisant of the fact that the lack of support networks (e.g., to remind parents) and trust (e.g., in authorities making recommendations) may lead to differential access to vaccines. One strategy would be to empower trusted healthcare providers to recommend and provide vaccinations during patient visits.
• Feasibility - e.g., Table 7 demonstrates how the feasibility matrix can help identify potential issues with the feasibility of implementing a prospective SARS-CoV-2/COVID-19 vaccine programme. This process can highlight, for example, the fact that clear communication on eligible groups and the vaccine programme to the public will be required.
• Acceptability - e.g., This matrix consolidates the many factors that can influence the acceptability of a vaccine into 4 categories: (i) perceptions of the vaccine (e.g., safety concerns, vaccine efficacy); (ii) perceptions of the disease being vaccinated against (e.g., severity of disease, outbreak, groups at risk, personal risk); (iii) the process of getting vaccinated (e.g., access to the vaccine, opportunity cost to get the vaccine); and (iv) individual/personal factors (e.g., beliefs and values, experiences, trust in healthcare providers and the healthcare system, trust in vaccine experts and vaccine industry, social norms/pressures and media). These factors are considered from the perspective of: the public, healthcare providers, and policymakers. The systematic review of acceptability literature in Canada commissioned during the development of the EEFA Framework identified over 100 factors linked to vaccine acceptability (some common across vaccines and others that are vaccine-specific) that were incorporated into this matrix.

The EEFA Framework and supporting evidence-informed tools have been applied in various NACI guidance documents since 2018. (Figure 2 in the paper demonstrates how the EEFA Framework is applied in the context of the full spectrum of public health science and best practice, including traditional scientific as well as economic factors, when developing immunisation recommendations.) For example, NACI used the Framework and tools in its Updated Recommendations on the Use of Herpes Zoster Vaccines.

Canadian stakeholder feedback has reportedly been positive, and research, particularly in the fields of vaccine acceptability and equity, has validated the utility and comprehensiveness of the matrices. However, the team notes that additional research may be required, for example, for a new vaccine protecting against a novel virus in a pandemic (e.g,. SARS-CoV-2/COVID-19), because acceptability is affected by contextual influences. Yet, they contend that "the EEFA Framework and supporting tools are still effective to systematically consider critical factors, direct additional research where gaps exist, and enable more efficient assessment."

The team concludes that advisory bodies around the world can use the EEFA Framework and supporting tools "to guide the assessment of prospective vaccines for viable inclusion in immunization programs and meet the global objective of practical, evidence-informed immunization guidance."