Tuberculosis (TB) remains a leading cause of morbidity and mortality in South Africa despite substantial progress in diagnosis and treatment. Several candidate vaccines targeting adolescents and adults are now in advanced clinical development, raising the prospect that a new TB vaccine could become available as early as 2029. However, translating clinical trial success into population-level impact will require early policy planning, health system preparedness, and coordinated national action. To support these efforts, the South African National Department of Health and the World Health Organization convened a national TB Vaccine Preparedness Workshop in Johannesburg in July 2025, bringing together policymakers, researchers, regulators, manufacturers, and civil society and community representatives. The workshop aimed to align stakeholders on priority populations and delivery strategies for future TB vaccines, identify evidence needs to inform national policy decision-making, and outline actions required to ensure timely and equitable introduction. Discussions highlighted that successful introduction of a TB vaccine for adolescents and adults will depend on coordinated readiness across delivery systems, regulatory and manufacturing processes, financing mechanisms, and public trust. Participants emphasised pursuing a broad population-level vaccination strategy for adolescents and adults, building on existing immunisation and primary healthcare platforms while adapting delivery strategies to reach these populations. Priorities included generating South Africa-specific evidence to inform policy and financing decisions, engaging early with regulatory authorities and manufacturing partners, strengthening data systems for safety monitoring and evaluation of vaccine impact, developing sustainable financing approaches, and fostering community engagement to build vaccine confidence. These insights provide a foundation for coordinated national planning to ensure timely and equitable introduction of future TB vaccines in South Africa.

In this commentary, we reflect on GAVI's experience incorporating an antimicrobial resistance (AMR) criterion into the Vaccine Investment Strategy to explore how global vaccine policy can more integrate AMR objectives, and identify priority actions for maximizing the AMR impact of vaccines. This article is part of the Royal Society Science+ meeting issue 'Vaccines and antimicrobial resistance: from science to policy'.

Background Measles and rubella continue to be a significant global health challenge, disproportionately impacting marginalised communities in low-and middle-income countries (LMICs). Innovative technologies such as measles-rubella microarray patches (MR-MAPs) are currently in development and can potentially improve immunisation coverage and equity through their unique product characteristics. Nonetheless, the limited evidence around their use cases, optimal implementation, cost-effectiveness, and integration into national immunisation programmes raises the need for the development of a prioritised implementation research agenda. Methods We used the Child Health and Nutrition Research Initiative (CHNRI) methodology to prioritise 36 research questions (RQs), which we identified through a rapid literature assessment and consultations with experts. We then prepared an online survey and asked stakeholders to assess each question considering the selected CHNRI criteria. We calculated research priority scores (RPS) and average expert agreement (AEA) and conducted stratified analyses restricted to: LMIC government representatives, respondents based in middle-income countries, those with at least moderate experience in implementing health products in LMICs, those with at least moderate knowledge of MR-MAPs, and representatives from academic or research institutions. Results A total of 139 respondents identified a diverse range of priorities for MR-MAP implementation research. The 36 RQs had a median RPS of 80%. The key priorities identified included research on vaccine supply chain management, vaccine uptake among underserved populations, and human resource implications for integration in routine immunisation services. Stratified analyses revealed a diversity of scores, with representatives from LMIC governments generally prioritising operational questions related to human resources, vaccine administration, and managing dual delivery mechanisms. Fifteen RQs were prioritised to accommodate different perspectives. Conclusion This exercise prioritised implementation questions that will inform MR-MAPs' research investments and efforts over the next 10 years in order to prepare for their introduction in LMICs. While the questions identified in this exercise were specifically about MR-MAPs, the RQs and potential evidence may apply to other vaccine MAPs. This research addresses critical evidence needed towards the successful roll-out of this innovative technology in LMICs, to ensure equitable access to measles and rubella vaccination and accelerate progress towards measles and rubella control and elimination.

Even though two widely used combination vaccines (measles-rubella- and diphtheria- tetanus-pertussis-containing vaccines) are universally acknowledged as the cornerstones of pediatric immunization programs, the development of new combination vaccines for children has not been a priority for manufacturers, policy bodies, or decision-makers. At the same time, economic evaluations have not assessed the full array of benefits and risks associated with combination vaccines. As part of an effort to identify and prioritize potential new combination vaccines, we aimed to enhance efforts to establish their value, a crucial step toward a more thorough, quantifiable, and realistic assessment of these vaccines.We reviewed the literature on economic evaluations of combination vaccines to more precisely identify and define current gaps in value assessment. We identified a set of (often unvalued) benefits and risks and created a list of value drivers and metrics for potential inclusion in future evaluations. Value drivers were then categorized based on how they resonate with decision-makers' priorities and their contribution to product value. Metrics were categorized based on their quantifiability and their fit within existing economic evaluation frameworks. We developed a prioritized checklist of value drivers and metrics to assess combination vaccines through a consultative process involving numerous immunization stakeholders (e.g., immunization specialists, regional immunization advisors, policy bodies). The checklist was further refined through a convening of health economics experts and ultimately endorsed by the World Health Organization's Immunization and Vaccines-related Implementation Research Advisory Committee.This checklist of prioritized value drivers and metrics is meant to serve as a tool for analysts to value combination vaccines and help ensure these vaccines are more comprehensively assessed by decision-makers to inform investment decisions or adoption.

Invasive disease caused by non-typhoidal Salmonella serovars (iNTS) occurs with increased risk in the presence of other comorbidities such as malaria, HIV, malnutrition, anaemia and sickle cell disease. While infection with non-typhoidal (NTS) serovars often results in self-limited enterocolitis in high-income settings, in sub-Saharan Africa (SSA) where these risk-comorbidities are common, an invasive (iNTS) disease phenotype is seen, associated with up to 20 % case-fatality ratio, and antimicrobial resistance is both significant and growing. The need to evaluate the potential public health value of vaccines against iNTS disease is increasingly being recognized, and several candidate vaccines are in early development. A better understanding of the global burden and epidemiology of iNTS disease, as well as the potential public health and socio-economic benefits that iNTS vaccines may offer is fundamental to support and justify the investments in vaccine development. In addition, the pathways for licensure, policy recommendations and eventual vaccine prioritization and use in low- and middle-income countries (LMICs) need to be defined. Here, we report on the proceedings of an expert consultation held on 29 November - 1 December 2021 as part of an overall project to develop a Full Value of Vaccines Assessment (FVVA) for iNTS vaccines and in addition to more recent iNTS vaccine developments. Experts at the consultation reviewed the current evidence on iNTS disease and discussed knowledge gaps to be addressed to accelerate vaccine development, licensure and introduction, as well as LMIC perspectives on potential iNTS vaccine use and demand. The learnings from this consultation are critical inputs to inform remaining work under the iNTS FVVA project.

Introduction: 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. Methods: 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. Results: 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. Conclusions: 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.

This report summarizes the proceedings of a policy and planning meeting convened in Indonesia, by the Ministry of Health and the World Health Organization, on potential new tuberculosis (TB) vaccines intended for adults and adolescents. Given that Indonesia bears the second highest TB burden globally, and that it is participating in the phase III efficacy study for one of the leading vaccine candidates that could be approved for use by 2028, the meeting aimed to discuss strategies and evidence needs that could accelerate vaccine introduction. The meeting, held in November 2024, was attended by Indonesian policymakers, researchers, health advocates and community representatives, alongside observers from immunization and TB programmes working at the global level, as well as donors. This report offers several key recommendations to ensure new TB vaccines for adults and adolescents are available, accessible and acceptable in Indonesia, as soon as possible after regulatory approval. The vaccine implementation strategy is expected to be through a stratified, geographical approach, initiating in provinces with the highest disease and socio-economic burden. As such, improved data on disease, infection prevalence and acceptability within different age cohorts and populations are needed to inform national and sub-national (e.g., province or district level) health and economic impact modelling. Early studies on knowledge, attitudes and practices of new TB vaccines for adults and adolescents will help to engage community leaders and advocates and ensure effective, culturally acceptable communication to improve acceptability. Of greatest urgency, a national strategic plan for new TB vaccine introduction, including a roadmap of critical activities, responsible entities and a stakeholder engagement plan are needed.

At the 2023 Global Vaccine and Immunization Research Forum (GVIRF), researchers from around the world gathered in the Republic of Korea to discuss advances and opportunities in vaccines and immunization.Many stakeholders are applying the lessons of Covid-19 to future emergencies, by advancing early-stage development of prototype vaccines to accelerate response to the next emerging infectious disease, and by building regional vaccine research, development, and manufacturing capacity to speed equitable access to vaccines in the next emergency.Recent vaccine licensures include: respiratory syncytial virus vaccines, both for the elderly and to protect infants through maternal immunization; a new dengue virus vaccine; and licensure of Covid-19 vaccines previously marketed under emergency use authorizations. Malaria vaccine implementation is expanding and a second malaria vaccine has been recommended by the World Health Organization. In a setback for human immunodeficiency virus vaccine development, the only remaining Phase 3 trial has been discontinued.In immunization, greater clarity is emerging on the challenges of achieving access and equity, along with strategies to address those challenges. A better understanding of behavioral and social determinants of vaccine uptake and a validated toolkit for measuring and modifying the drivers of vaccination is informing program design and service delivery, contributing to improved uptake. Implementation research, which has been essential for human papillomavirus and malaria vaccine delivery, will be critical for delivering the new respiratory syncytial virus vaccines and for many other vaccines currently in development. The growing diversity of vaccines and complexity of immunization programs are leading to greater interest in simplified regimens, combination vaccines, and other innovations to facilitate delivery.Collaboration emerged as the unifying theme of GVIRF 2023, underscoring that the combined efforts of many contributors have enabled progress thus far, and going forward will continue to be essential to ensure equitable access to vaccines for all.

Group B Streptococcus (GBS) is a leading cause of infant mortality, particularly in low- and middle-income countries (LMICs). Several maternal GBS vaccine candidates, aimed at protecting infants, are progressing through clinical trials. The World Health Organisation (WHO) aims to ensure equitable access to safe, effective, and affordable vaccines of assured quality in LMICs, by facilitating regulatory pathways. An alternate approval pathway, based on safety and an immunological endpoint thought to predict clinical benefit (commonly referred to as serological threshold of risk reduction [SToRR]), is being considered for GBS maternal vaccines. Since this approach is new to many LMICs regulators and policymakers, WHO organized consultative meetings at national, regional, and global levels to discuss the feasibility and potential challenges of approving a GBS vaccine based on safety and immunogenicity data alone. These consultations focused on evidence supporting SToRR, their use as endpoints to infer protection, and post-licensure requirements. The aim of the consultations was to reduce the delay between vaccine development, licensure, policy recommendations and use in high-burden LMICs.

Background: Microarray patches (MAPs) are innovative, needle-free vaccine delivery systems, suitable for administration by minimally trained health care workers or trained community health workers. Their introduction may transform immunization programmes, particularly for vaccines where high coverage is required for population immunity, such as measles, and where vaccine delivery is challenging, such as in low- and middle-income countries. Recognizing the need to understand how best to tailor these products to reflect country priorities, workshops on measles and rubella MAPs (MR-MAPs) were conducted in multiple regions to collect insights on needs and preferences from relevant stakeholders at country level. Methods: The CAPACITI Innovation Framework was used to structure stakeholder discussions in nine countries in the period from August 2022 to July 2023. The discussions, building on the findings from a situation analysis on the barriers related to measles and rubella vaccine delivery, followed the four-step process outlined in the framework. Results: Key barriers hindering delivery of measles and rubella vaccines across the countries were in the categories of human resource management, service delivery, and demand generation. MR-MAP attributes that stakeholders believed would reduce or eliminate these barriers included ease of preparation and administration, improved thermostability, fewer (ancillary) components, and single-dose presentation. Some attributes such as the site of administration, wear time, and storage volume could exacerbate certain barriers. Based on an understanding of key barriers, product attributes, and underserved populations, stakeholders identified several potential use cases for MR-MAPs: (i) delivery at a fixed health post, (ii) delivery through outreach sessions conducted by health workers, and (iii) administration by community health workers. To enable robust national decision making about the introduction of MR-MAPs and successful implementation, global and national evidence on feasibility and acceptability of MR-MAPs should be generated. To prepare for the potential introduction of MR-MAPs, immunization programmes should evaluate their immunization policies based on their preferred use cases and modify them if needed, for example, to enable community health workers to administer vaccines, along with making programmatic adjustments to waste management and training. Conclusions: MR-MAPs have the potential to reduce key barriers to MR delivery. Yet, their future impact depends on the ability of global stakeholders to steer the development of MR-MAPs to be responsive to country needs and preferences. The generation of evidence to enable robust decision making, timely modification of vaccine policies, and addressing programmatic considerations will be key to successful uptake.

In 2019, an estimated 4.95 million deaths were linked to antimicrobial resistance (AMR). Vaccines can prevent many of these deaths by averting both drug-sensitive and resistant infections, reducing antibiotic usage, and lowering the likelihood of developing resistance genes. However, their role in mitigating AMR is currently underutilized.This article builds upon previous research that utilizes Vaccine Value Profiles—tools that assess the health, socioeconomic, and societal impact of pathogens—to inform vaccine development. We analyze the effects of 16 pathogens, covered by Vaccine Value Profiles, on AMR, and explore how vaccines could reduce AMR. The article also provides insights into vaccine development and usage.Vaccines are crucial in lessening the impact of infectious diseases and curbing the development of AMR. To fully realize their potential, vaccines must be more prominently featured in the overall strategy to combat AMR. This requires ongoing investment in research and development of new vaccines and the implementation of additional prevention and control measures to address this global threat effectively.

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.

The essence of a vaccine lies in its ability to elicit a set of immune responses specifically directed at a particular pathogen. Accordingly, vaccines were historically designed, developed, registered, recommended, procured, and administered as monopathogen formulations. Nonetheless, the control and elimination of an astonishing number of diseases was realised only after several once-separate vaccines were provided as combinations. Unfortunately, the current superabundance of recommended and pipeline vaccines is now at odds with the number of acceptable vaccine administrations and feasible health-care visits for vaccine recipients and health-care providers. Yet, few new combinations are in development because, in addition to the scientific and manufacturing hurdles intrinsic to coformulation, developers face a gauntlet of regulatory, policy, and commercialisation obstacles in a milieu still largely designed for monopathogen vaccines. We argue here that national policy makers and public health agencies should prospectively identify and advocate for the development of new multipathogen combination vaccines, and suggest ways to accelerate the regulatory pathways to licensure of combinations and other concrete, innovative steps to mitigate current obstacles.

For vaccine development and adoption decisions, the ‘Full Value of Vaccine Assessment’ (FVVA) framework has been proposed by the WHO to expand the range of evidence available to support the prioritization of candidate vaccines for investment and eventual uptake by low- and middle-income countries. Recent applications of the FVVA framework have already shown benefits. Building on the success of these applications, we see important new opportunities to maximize the future utility of FVVAs to country and global stakeholders and provide a proof-of-concept for analyses in other areas of disease control and prevention. These opportunities include the following: (1) FVVA producers should aim to create evidence that explicitly meets the needs of multiple key FVVA consumers, (2) the WHO and other key stakeholders should develop standardized methodologies for FVVAs, as well as guidance for how different stakeholders can explicitly reflect their values within the FVVA framework, and (3) the WHO should convene experts to further develop and prioritize the research agenda for outcomes and benefits relevant to the FVVA and elucidate methodological approaches and opportunities for standardization not only for less well-established benefits, but also for any relevant research gaps. We encourage FVVA stakeholders to engage with these opportunities.

As an innovative vaccine delivery technology, vaccine microarray patches could have a meaningful impact on routine immunization coverage in low- and middle-income countries, and vaccine deployment during epidemics and pandemics. This review of the potential use cases for a subset of vaccine microarray patches in various stages of clinical development, including measles-rubella, measles-mumps-rubella, and typhoid conjugate, highlights the breadth of their applicability to support immunization service delivery and their potential scope of utilization within national immunization programs. Definition and assessment of the use cases for this novel vaccine presentation provide important insights for vaccine developers and policymakers into the strengths of the public health and commercial value propositions, and the preparatory requirements for public health systems for the future rollout of vaccine microarray patches. An in-depth understanding of use cases for vaccine microarray patches serves as a foundational input to overcoming the remaining technical, regulatory, and financial challenges. Additional efforts will help to realize the potential of vaccine microarray patches as part of the global effort to improve the coverage and equity of national immunization programs.