Measles and rubella micro-array patches (MR-MAPs) are a promising innovation to address limitations of the current needle and syringe (N&S) presentation due to their single-dose presentation, ease of use, and improved thermostability. To direct and accelerate further research and interventions, an initial full value vaccine assessment (iFVVA) was initiated prior to MR-MAPs entering phase I trials to quantify their value and identify key data gaps and challenges. The iFVVA utilized a mixed-methods approach with rapid assessment of literature, stakeholder interviews and surveys, and quantitative data analyses to (i) assess global need for improved MR vaccines and how MR-MAPs could address MR problem statements; (ii) estimate costs and benefits of MR-MAPs; (iii) identify the best pathway from development to delivery; and (iv) identify outstanding areas of need where stakeholder intervention can be helpful. These analyses found that if MR-MAPs are broadly deployed, they can potentially reach an additional 80 million children compared to the N&S presentation between 2030–2040. MR-MAPs can avert up to 37 million measles cases, 400,000 measles deaths, and 26 million disability-adjusted life years (DALYs). MR-MAPs with the most optimal product characteristics of low price, controlled temperature chain (CTC) properties, and small cold chain volumes were shown to be cost saving for routine immunization (RI) in low- and middle-income countries (LMICs) compared to N&S. Uncertainties about price and future vaccine coverage impact the potential cost-effectiveness of introducing MR-MAPs in LMICs, indicating that it could be cost-effective in 16–81% of LMICs. Furthermore, this iFVVA highlighted the importance of upfront donor investment in manufacturing set-up and clinical studies and the critical influence of an appropriate price to ensure country and manufacturer financial sustainability. To ensure that MR-MAPs achieve the greatest public health benefit, MAP developers, vaccine manufacturers, donors, financiers, and policy- and decision-makers will need close collaboration and open communications.

Microarray patches (MAPs) have the potential to increase equitable vaccine coverage in low- and middle-income countries (LMICs). However, MAP developers and vaccine manufacturers have identified a barrier to development of MAPs for global health applications: the need for guidance on which vaccine MAPs would be of value to LMIC immunization programs. To address this gap, the Vaccine Innovation Prioritisation Strategy (VIPS) Alliance conducted a prioritization process to identify high-priority vaccines that could be delivered via MAPs in LMICs. We first compiled a reference list of vaccine targets through desk research, then filtered these targets based on route of administration, market distribution, existing interest from a global/regional health organization, whether the vaccine would address a specific global health priority or stakeholder agenda, development status, and potential MAP use cases. To further down-select the list, we consulted an external advisory group and evaluated the potential regulatory pathway, programmatic impact, and financial sustainability to define two priority levels. From a reference list of 91 vaccine targets, we identified 21 with applicability to LMICs, which were further down-selected to a VIPS priority list of 11 vaccine targets grouped by priority level. Priority group 1 included vaccines against hepatitis B virus, measles-rubella/measles-mumps-rubella viruses, human papillomavirus, rabies virus, yellow fever, influenza virus (seasonal and pandemic), and SARS-CoV-2. Priority group 2 included vaccines against Group B streptococcus, Neisseria meningitidis A,C,W,Y,(X), Salmonella Typhi, and Streptococcus pneumoniae. These vaccine MAP priorities will inform the investment decisions of MAP developers, vaccine manufacturers, donors, and global health partners to better respond to country needs when designing their MAP portfolios. By providing a holistic assessment of the potential drivers for and key risks of developing specific vaccine MAPs, our findings have the potential to promote MAP development activities for vaccines that are priorities for LMICs.

Background: The achievement of the goals of the Immunization Agenda 2030 (IA2030) requires vaccines to be developed and implemented that meet the needs and requirements of the final users: vaccinators and vaccinees. A detailed and shared understanding of these needs should inform policy and programme guidance directing stakeholders’ efforts and investments. Currently, relevant guidance documents only partially capture vaccine users’ perspectives. Method: To help overcome this gap, we propose an operational research method grounded in the principles of the design approach that systematically maps and integrates user perspectives in vaccine development, policy, and implementation decisions. Results: The method, named the seven Ws, guides researchers through a three-step process. First, it clarifies the contribution of a vaccine to solving a public health problem—the solution–problem fit. Second, it maps potential implementation strategies for the vaccine in different settings. Lastly, it describes the relevant vaccine’s use cases across the implementation strategies, elucidating the user requirements for the vaccine to be successfully implemented—the solution–provider and solution–user fits. Conclusions: By explicitly pursuing these three fits, policymakers, vaccine developers, and programme managers will be able to better contribute towards the achievement of the IA2030 goals. This framework is intended as a conceptual contribution rather than an empirical validation study.