As of November 2023, 140 World Health Organization (WHO) member states had introduced human papillomavirus (HPV) vaccination in their routine immunization schedules. Despite a continuously increasing demand from countries across all income groups, supply constraints, COVID-19 pandemic disruptions, and other factors have slowed the pace of introduction, particularly in low-resource settings. Using a population-based forecasting methodology and leveraging the WHO’s yearly vaccine supply data collection, we updated global demand and supply projections for the HPV vaccine for the period of 2022–2031. The analysis aimed at clarifying the magnitude of the challenges to bringing in equitable access to HPV vaccines, which can hinder the achievement of the Global Strategy for the Elimination of Cervical Cancer. The results of this analysis show that the risk of HPV shortages has significantly decreased, and global supply is now, under normal circumstances, sufficient to meet global demand. In the long term, HPV supply will be more than sufficient to meet the Global Strategy’s goal of 90% of girls fully vaccinated with the HPV vaccine by the age of 15 years. Nonetheless, paying attention to the formulation of policies and carefully managing demand and supply will be required to ensure the long-term sustainability of the HPV vaccine program.
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.
Influenza disease continues to have significant global burden. Despite broader use of seasonal influenza vaccines in high resource settings, our understanding of use cases for seasonal influenza vaccines, their relative size, and their relationship to the barriers to adoption in different populations and settings, is limited. This study is a first attempt to identify the use cases for seasonal influenza vaccines to support the design of global influenza vaccination strategies that are better tailored to different implementation contexts and the development of improved influenza vaccines that are more aligned with the different user needs. By applying a design-based user-centric approach, we implemented a process, including a desk review, a survey, and interviews, to define the current use cases for seasonal influenza vaccines. Nine use cases have been identified as relevant across all different countries and immunization programme designs and validated by experts. The identified use cases of seasonal influenza vaccines can support the optimization of vaccination programmes to increase their public health impact. The use cases identified through this work can help signal to policymakers the most important populations and delivery channels to increase the impact of seasonal influenza vaccination programmes and help estimate programmatic requirements necessary for the supportive policy recommendations. The use cases can also support the design of measures aimed at increasing access in low resource settings and coverage in settings where seasonal vaccines are widely used. The use cases can also help to inform the development, of improved influenza vaccines by highlighting the specific product characteristics relevant to their most impactful uses in different programmatic settings.
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.
Seasonal influenza remains a significant global public health challenge, causing substantial morbidity and mortality each year and there remains a need for more effective and durable influenza vaccines. To direct and accelerate research efforts, a full value of vaccine assessment (FVVA) was initiated to quantify the value of next-generation, improved influenza vaccines and identify key challenges that may limit their uptake once available. The FVVA utilized a mixed-methods approach with rapid assessment of literature, stakeholder interviews, and surveys, and quantitative data analysis to estimate the full value of influenza vaccines with improved characteristics. These analyses found that if improved influenza vaccines are broadly employed, depending on their characteristics, using our demand forecast they could avert 6.6-18 billion additional influenza cases, 2.3-6.2 million additional influenza deaths, and 21-57 million disability-adjusted life years (DALYs) between 2025 and 2050 beyond those averted by current seasonal influenza vaccines. Under this scenario, introducing improved influenza vaccines could be cost-effective in 9-48 % of countries at the lowest assumed price point. However, uncertainties about price and future vaccine coverage may impact the potential cost-effectiveness. Furthermore, from the producer perspective, the FVVA highlighted the robust financial value proposition to develop and commercialize improved influenza vaccines, in both established and emerging markets. Strongly tiered prices could make these vaccines cost-effective in more countries and boost impact further. To ensure that improved influenza vaccines achieve the greatest public health benefit, effective collaboration between vaccine developers, vaccine manufacturers, donors, financiers, multilateral organisations, and policy- and decision-makers will be essential.