Economic evaluation of second measles containing vaccine (MCV) dose: a systematic review of available evidence.

INTRODUCTION: The global measles incidence has decreased from 145 to 49 cases per 1 million population from 2000 to 2018, but evaluating the economic benefits of a second measles-containing vaccine (MCV2) is crucial. This study reviewed the evidence and quality of economic evaluation studies to guide MCV2 introduction. METHODS: The systematic review of model-based economic evaluation studies was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search yielded 2231 articles, with 876 duplicates removed and 1355 articles screened, with nine studies included for final analysis. RESULTS: Six studies reported a positive benefit-cost ratio with one resulting in net savings of $11.6 billion, and two studies estimated a 2-dose MMR vaccination program would save $119.24 to prevent one measles case, and a second dose could prevent 9,200 cases at 18 months, saving $548.19 per case. The most sensitive variables were the discount rate and vaccination administration cost. CONCLUSIONS: Two MCV doses or a second opportunity with an additional dose of MCV were highly cost-beneficial and resulted in substantial cost savings compared to a single routine vaccine. But further research using high-quality model-based health economic evaluation studies of MCV2 should be made available to decision-makers. PROSPERO REGISTRATION: CRD42020200669.

Contribution of vaccination to improved survival and health: modelling 50 years of the Expanded Programme on Immunization.

BACKGROUND: WHO, as requested by its member states, launched the Expanded Programme on Immunization (EPI) in 1974 to make life-saving vaccines available to all globally. To mark the 50-year anniversary of EPI, we sought to quantify the public health impact of vaccination globally since the programme's inception. METHODS: In this modelling study, we used a suite of mathematical and statistical models to estimate the global and regional public health impact of 50 years of vaccination against 14 pathogens in EPI. For the modelled pathogens, we considered coverage of all routine and supplementary vaccines delivered since 1974 and estimated the mortality and morbidity averted for each age cohort relative to a hypothetical scenario of no historical vaccination. We then used these modelled outcomes to estimate the contribution of vaccination to globally declining infant and child mortality rates over this period. FINDINGS: Since 1974, vaccination has averted 154 million deaths, including 146 million among children younger than 5 years of whom 101 million were infants younger than 1 year. For every death averted, 66 years of full health were gained on average, translating to 10·2 billion years of full health gained. We estimate that vaccination has accounted for 40% of the observed decline in global infant mortality, 52% in the African region. In 2024, a child younger than 10 years is 40% more likely to survive to their next birthday relative to a hypothetical scenario of no historical vaccination. Increased survival probability is observed even well into late adulthood. INTERPRETATION: Since 1974 substantial gains in childhood survival have occurred in every global region. We estimate that EPI has provided the single greatest contribution to improved infant survival over the past 50 years. In the context of strengthening primary health care, our results show that equitable universal access to immunisation remains crucial to sustain health gains and continue to save future lives from preventable infectious mortality. FUNDING: WHO.

The Full Value of Vaccine Assessments Concept-Current Opportunities and Recommendations.

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.

Financing for pandemic preparedness and response measures: a systematic scoping review.

Objective: To obtain insights into reducing the shortfall in financing for pandemic preparedness and response measures, and reducing the risk of another pandemic with social and economic costs comparable to those of the coronavirus disease. Methods: We conducted a systematic scoping review using the databases ScienceDirect, Scopus, JSTOR, PubMed® and EconLit. We included articles published in any language until 1 August 2023, and excluded grey literature and publications on epidemics. We categorized eligible studies according to the elements of a framework proposed by the World Health Organization Council on the Economy of Health for All: (i) root/structural causes; (ii) social position/foundations; (iii) infrastructure and systems; and (iv) communities, households and individuals. Findings: Of the 188 initially identified articles, we included 60 in our review. Most (53/60) were published after 2020, when academic interest had shifted towards global financing mechanisms. Most (37/60) addressed two or more of the council framework elements. The most frequently addressed element was infrastructure and systems (54/60), discussing topics such as health systems, financial markets and innovation ecosystems. The roots/structural causes were discussed in 25 articles; communities, households and individuals in 22 articles; and social positions/foundations in 11. Conclusion: Our review identified three important gaps: a formal definition of pandemic preparedness and response, impeding the accurate quantification of the financing shortfall; research on the extent to which financing for pandemic preparedness and response has been targeted at the most vulnerable households; and an analysis of specific financial instruments and an evaluation of the feasibility of their implementation.

National Immunization Program Decision Making Using the CAPACITI Decision-Support Tool: User Feedback from Indonesia and Ethiopia.

To ensure that limited domestic resources are invested in the most effective interventions, immunization programs in low- and middle-income countries (LMICs) must prioritize a growing number of new vaccines while considering opportunities to optimize the vaccine portfolio, as well as other components of the health system. There is a strong impetus for immunization decision-making to engage and coordinate various stakeholders across the health system in prioritization. To address this, national immunization program decision-makers in LMICs collaborated with WHO to structure deliberation among stakeholders and document an evidence-based, context-specific, and transparent process for prioritization or selection among multiple vaccination products, services, or strategies. The output of this effort is the Country-led Assessment for Prioritization on Immunization (CAPACITI) decision-support tool, which supports using multiple criteria and stakeholder perspectives to evaluate trade-offs affecting health interventions, taking into account variable data quality. Here, we describe the user feedback from Indonesia and Ethiopia, two initial countries that piloted the CAPACITI decision-support tool, highlighting enabling and constraining factors. Potential immunization program benefits and lessons learned are also summarized for consideration in other settings.

Vaccine value profile for Chikungunya.

Chikungunya virus (CHIKV) a mosquito-borne alphavirus is the causative agent of Chikungunya (CHIK), a disease with low mortality but high acute and chronic morbidity resulting in a high overall burden of disease. After the acute disease phase, chronic disease including persistent arthralgia is very common, and can cause fatigue and pain that is severe enough to limit normal activities. On average, around 40% of people infected with CHIKV will develop chronic arthritis, which may last for months or years. Recommendations for protection from CHIKV focus on infection control through preventing mosquito proliferation. There is currently no licensed antiviral drug or vaccine against CHIKV. Therefore, one of the most important public health impacts of vaccination would be to decrease burden of disease and economic losses in areas impacted by the virus, and prevent or reduce chronic morbidity associated with CHIK. This benefit would particularly be seen in Low and Middle Income Countries (LMIC) and socio-economically deprived areas, as they are more likely to have more infections and more severe outcomes. This 'Vaccine Value Profile' (VVP) for CHIK is intended to provide a high-level, holistic assessment of the information and data that are currently available to inform the potential public health, economic and societal value of vaccines in the development pipeline and vaccine-like products.This VVP was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships, and multi-lateral organizations. All contributors have extensive expertise on various elements of the CHIK VVP and collectively aimed to identify current research and knowledge gaps.The VVP was developed using only existing and publicly available information.

Systematic review of cost projections of new vaccine introduction.

BACKGROUND: A recent review of guidance documents on vaccine delivery costing revealed current guidance on cost projections for new vaccine introduction has gaps on methods of sampling, data collection and analysis. In preparation for updating the respective guidance, this systematic review was undertaken to qualitatively assess methodologies used in new vaccine cost projection studies. This will inform researchers and stakeholders about the methods of new vaccine introduction cost projections for strategic directions in countries where cost data are not available. METHODS: We systematically searched four search engines (PubMed, Cochrane Open Access, Mendeley and Google Scholar) for articles on cost projections for new vaccines published between 1999 and 15 June 2022. We developed inclusion and exclusion criteria for the selection of articles and analyzed the results using a PRISMA 2020 flow diagram. RESULTS: Out of 1,108 articles identified, 171 met the criteria for inclusion in the study. Half of the articles were from high-income countries (50%), and most cost projections were part of cost-effectiveness analysis (84%). The most common source of cost data was secondary national information (43%), followed by author's assumptions (17%), secondary international information (14%), and primary data collection (7%). 19% of studies didn't include costs to deliver vaccines in their cost estimation. Among studies that included secondary vaccine delivery costs, approximately half only calculated vaccine administration costs (50%), while 35% included incremental system costs and 15% utilized ingredients data. Two thirds of the studies were conducted to inform policymakers of the cost-effectiveness or cost-benefit of introducing the vaccine. CONCLUSIONS: Half of the economic evaluations on new vaccine introductions only included partial vaccine delivery costs. Thus, total costs of vaccine introduction were often being underestimated in economic evaluations. This suggests that guidelines on economic evaluations and journals should recommend that authors include more extensive vaccine delivery costs in their studies.

Benefits, harms and cost-effectiveness of cervical screening, triage and treatment strategies for women in the general population.

In 2020, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer as a public health problem. To support the strategy, the WHO published updated cervical screening guidelines in 2021. To inform this update, we used an established modeling platform, Policy1-Cervix, to evaluate the impact of seven primary screening scenarios across 78 low- and lower-middle-income countries (LMICs) for the general population of women. Assuming 70% coverage, we found that primary human papillomavirus (HPV) screening approaches were the most effective and cost-effective, reducing cervical cancer age-standardized mortality rates by 63-67% when offered every 5 years. Strategies involving triaging women before treatment (with 16/18 genotyping, cytology, visual inspection with acetic acid (VIA) or colposcopy) had close-to-similar effectiveness to HPV screening without triage and fewer pre-cancer treatments. Screening with VIA or cytology every 3 years was less effective and less cost-effective than HPV screening every 5 years. Furthermore, VIA generated more than double the number of pre-cancer treatments compared to HPV. In conclusion, primary HPV screening is the most effective, cost-effective and efficient cervical screening option in LMICs. These findings have directly informed WHO's updated cervical screening guidelines for the general population of women, which recommend primary HPV screening in a screen-and-treat or screen-triage-and-treat approach, starting from age 30 years with screening every 5 years or 10 years.

Scoping review of modelling studies assessing the impact of disruptions to essential health services during COVID-19.

BACKGROUND: Studies assessing the indirect impact of COVID-19 using mathematical models have increased in recent years. This scoping review aims to identify modelling studies assessing the potential impact of disruptions to essential health services caused by COVID-19 and to summarise the characteristics of disruption and the models used to assess the disruptions. METHODS: Eligible studies were included if they used any models to assess the impact of COVID-19 disruptions on any health services. Articles published from January 2020 to December 2022 were identified from PubMed, Embase and CINAHL, using detailed searches with key concepts including COVID-19, modelling and healthcare disruptions. Two reviewers independently extracted the data in four domains. A descriptive analysis of the included studies was performed under the format of a narrative report. RESULTS: This scoping review has identified a total of 52 modelling studies that employed several models (n=116) to assess the potential impact of disruptions to essential health services. The majority of the models were simulation models (n=86; 74.1%). Studies covered a wide range of health conditions from infectious diseases to non-communicable diseases. COVID-19 has been reported to disrupt supply of health services, demand for health services and social change affecting factors that influence health. The most common outcomes reported in the studies were clinical outcomes such as mortality and morbidity. Twenty-five studies modelled various mitigation strategies; maintaining critical services by ensuring resources and access to services are found to be a priority for reducing the overall impact. CONCLUSION: A number of models were used to assess the potential impact of disruptions to essential health services on various outcomes. There is a need for collaboration among stakeholders to enhance the usefulness of any modelling. Future studies should consider disparity issues for more comprehensive findings that could ultimately facilitate policy decision-making to maximise benefits to all.

Modeling the impact of vaccination for the immunization Agenda 2030: Deaths averted due to vaccination against 14 pathogens in 194 countries from 2021 to 2030.

BACKGROUND: The Immunization Agenda 2030 (IA2030) Impact Goal 1.1. aims to reduce the number of future deaths averted through immunization in the next decade. To estimate the potential impact of the aspirational coverage targets for IA2030, we developed an analytical framework and estimated the number of deaths averted due to an ambitious vaccination coverage scenario from 2021 to 2030 in 194 countries. METHOD: A demographic model was used to determine annual age-specific mortality estimates associated with vaccine coverage rates. For ten pathogens (Hepatitis B virus, Haemophilus influenzae type B, human papillomavirus, Japanese encephalitis, measles, Neisseria meningitidis serogroup A, Streptococcus pneumoniae, rotavirus, rubella, yellow fever), we derived single measures of country-, age-, and pathogen-specific relative risk of deaths conditional upon coverage rates, leveraging the data from 18 modeling groups as part of the Vaccine Impact Model Consortium (VIMC) for 110 countries. We used a logistic regression model to extrapolate the relative risk estimates to countries that were not modeled by VIMC. For four pathogens (diphtheria, tetanus, pertussis and tuberculosis), we used estimates from the Global Burden of Disease 2019 study and existing literature on vaccine efficacy. A future scenario defining years of vaccine introduction and scale-up needed to reach aspirational targets was developed as an input to estimate the long-term impact of vaccination taking place from 2021 to 2030. FINDINGS: Overall, an estimated 51.5 million (95 % CI: 44.0-63.2) deaths are expected to be averted due to vaccinations administered between the years 2021 and 2030. With immunization coverage projected to increase over 2021-2030 an average of 5.2 million per year (4.4-6.3) deaths will be averted annually, with 4.4 million (3.9-5.1) deaths be averted for the year 2021, gradually rising to 5.8 million (4.9-7.5) deaths averted in 2030. The largest proportion of deaths is attributed to Measles and Hepatitis B accounting for 18.8 million (17.8-20.0) and 14.0 million (11.5-16.9) of total deaths averted respectively. INTERPRETATION: The results from this global analysis demonstrate the substantial potential mortality reductions achievable if the IA2030 targets are met by 2030. Deaths caused by vaccine preventable diseases disproportionately affect LMICs in the African region.

Estimating the delivery costs of COVID-19 vaccination using the COVID-19 Vaccine Introduction and deployment Costing (CVIC) tool: the Lao People's Democratic Republic experience.

BACKGROUND: The COVID-19 Vaccine Introduction and deployment Costing (CVIC) tool was developed to assist countries to estimate incremental financial costs to roll out COVID-19 vaccines. This article describes the purposes, assumptions and methods used in the CVIC tool and presents the estimated financial costs of delivering COVID-19 vaccines in the Lao People's Democratic Republic (Lao PDR). METHODS: From March to September 2021, a multidisciplinary team in Lao PDR was involved in the costing exercise of the National Deployment and Vaccination Plan for COVID-19 vaccines to develop potential scenarios and gather inputs using the CVIC tool. Financial costs of introducing COVID-19 vaccines for 3 years from 2021 to 2023 were projected from the government perspective. All costs were collected in 2021 Lao Kip and presented in United States dollar. RESULTS: From 2021 to 2023, the financial cost required to vaccinate all adults in Lao PDR with primary series of COVID-19 vaccines (1 dose for Ad26.COV2.S (recombinant) vaccine and 2 doses for the other vaccine products) is estimated to be US$6.44 million (excluding vaccine costs) and additionally US$1.44 million and US$1.62 million to include teenagers and children, respectively. These translate to financial costs of US$0.79-0.81 per dose, which decrease to US$0.6 when two boosters are introduced to the population. Capital and operational cold-chain costs contributed 15-34% and 15-24% of the total costs in all scenarios, respectively. 17-26% went to data management, monitoring and evaluation, and oversight, and 13-22% to vaccine delivery. CONCLUSIONS: With the CVIC tool, costs of five scenarios were estimated with different target population and booster dose use. These facilitated Lao PDR to refine their strategic planning for COVID-19 vaccine rollout and to decide on the level of external resources needed to mobilize and support outreach services. The results may further inform inputs in cost-effectiveness or cost-benefit analyses and potentially be applied and adjusted in similar low- and middle-income settings.

Cost-effectiveness of measles and rubella elimination in low-income and middle-income countries.

BACKGROUND: Since 2000, the incidence of measles and rubella has declined as measles-rubella (MR) vaccine coverage increased due to intensified routine immunisation (RI) and supplementary immunisation activities (SIAs). The World Health Assembly commissioned a feasibility assessment of eliminating measles and rubella. The objective of this paper is to present the findings of cost-effectiveness analysis (CEA) of ramping up MR vaccination with a goal of eliminating transmission in every country. METHODS: We used projections of impact of routine and SIAs during 2018-2047 for four scenarios of ramping up MR vaccination. These were combined with economic parameters to estimate costs and disability-adjusted life years averted under each scenario. Data from the literature were used for estimating the cost of increasing routine coverage, timing of SIAs and introduction of rubella vaccine in countries. RESULTS: The CEA showed that all three scenarios with ramping up coverage above the current trend were more cost-effective in most countries than the 2018 trend for both measles and rubella. When the measles and rubella scenarios were compared with each other, the most cost-effective scenario was likely to be the most accelerated one. Even though this scenario is costlier, it averts more cases and deaths and substantially reduces the cost of treatment. CONCLUSIONS: The Intensified Investment scenario is likely the most cost-effective of the vaccination scenarios evaluated for reaching both measles and rubella disease elimination. Some data gaps on costs of increasing coverage were identified and future efforts should focus on filling these gaps.

The Full Value of Vaccine Assessments (FVVA): a framework for assessing and communicating the value of vaccines for investment and introduction decision-making.

BACKGROUND: Several economic obstacles can deter the development and use of vaccines. This can lead to limited product options for some diseases, delays in new product development, and inequitable access to vaccines. Although seemingly distinct, these obstacles are actually interrelated and therefore need to be addressed through a single over-arching strategy encompassing all stakeholders. METHODS: To help overcome these obstacles, we propose a new approach, the Full Value of Vaccines Assessments (FVVA) framework, to guide the assessment and communication of the value of a vaccine. The FVVA framework is designed to facilitate alignment across key stakeholders and to enhance decision-making around investment in vaccine development, policy-making, procurement, and introduction, particularly for vaccines intended for use in low- and middle-income countries. RESULTS: The FVVA framework has three key elements. First, to enhance assessment, existing value-assessment methods and tools are adapted to include broader benefits of vaccines as well as opportunity costs borne by stakeholders. Second, to improve decision-making, a deliberative process is required to recognize the agency of stakeholders and to ensure country ownership of decision-making and priority setting. Third, the FVVA framework provides a consistent and evidence-based approach that facilitates communication about the full value of vaccines, helping to enhance alignment and coordination across diverse stakeholders. CONCLUSIONS: The FVVA framework provides guidance for stakeholders organizing global-level efforts to promote investment in vaccines that are priorities for LMICs. By providing a more holistic view of the benefits of vaccines, its application also has the potential to encourage greater take-up by countries, thereby leading to more sustainable and equitable impacts of vaccines and immunization programmes.

The Cost Analysis of Human Papillomavirus Vaccination Program in Indonesia.

OBJECTIVES: This study aimed to analyze and describe the cost of HPV vaccination program in Indonesia. METHODS: This study identified the cost-related HPV vaccination program implemented in Makassar, Manado, and Surabaya cities, Indonesia, according to the previous activities performed. Cost information was collected and analyzed in each specific activity for each cost components, using the HPV vaccination module of the World Health Organization Cervical Cancer Prevention and Control Costing tool. RESULTS: According to the Cervical Cancer Prevention and Control Costing tool, the recurrent costs, both financial and economic costs, dominated the HPV vaccination program costs in Surabaya (US dollars [USD] 264 618; USD 268 724), Makassar (USD 166 852; USD 293 300), and Manado (USD 270 815; USD 270 946), with a total cost of USD 702 285 for financial cost and USD 832 970 for economic cost. Vaccine procurement drives the recurrent cost. CONCLUSIONS: The implementation of demonstration program in Surabaya, Makassar, and Manado cities was considerably succeed. Any prediction related to the cost of implementation of HPV vaccination in Indonesia can be calculated and used to advocate regional or national government.

Equity-Informative Economic Evaluations of Vaccines: A Systematic Literature Review.

The Immunization Agenda 2030 prioritizes the populations without access to vaccines. Health equity has been increasingly incorporated into economic evaluations of vaccines to foster equitable access. Robust and standardized methods are needed to evaluate the health equity impact of vaccination programs to ensure monitoring and effective addressing of inequities. However, methods currently in place vary and potentially affect the application of findings to inform policy decision-making. We performed a systematic review by searching PubMed, Embase, Econlit, and the CEA Registry up to 15 December 2022 to identify equity-informative economic evaluations of vaccines. Twenty-one studies were included that performed health equity impact analysis to estimate the distributional impact of vaccines, such as deaths averted and financial risk protection, across equity-relevant subgroups. These studies showed that the introduction of vaccines or improved vaccination coverage resulted in fewer deaths and higher financial risk benefits in subpopulations with higher disease burdens and lower vaccination coverage-particularly poorer income groups and those living in rural areas. In conclusion, methods to incorporate equity have been evolving progressively. Vaccination programs can enhance equity if their design and implementation address existing inequities in order to provide equitable vaccination coverage and achieve health equity.

Delivery cost of the first public sector introduction of typhoid conjugate vaccine in Navi Mumbai, India.

Navi Mumbai Municipal Corporation (NMMC), a local government in Mumbai, India, implemented the first public sector TCV campaign in 2018. This study estimated the delivery costs of this TCV campaign using a Microsoft Excel-based tool based on a micro-costing approach from the government (NMMC) perspective. The campaign's financial (direct expenditures) and economic costs (financial costs plus the monetized value of additional donated or existing items) incremental to the existing immunization program were collected. The data collection methods involved consultations with NMMC staff, reviews of financial and programmatic records of NMMC and the World Health Organization (WHO), and interviews with the health staff of sampled urban health posts (UHPs). Three UHPs were purposively sampled, representing the three dominant residence types in the catchment area: high-rise, slum, and mixed (high-rise and slum) areas. The high-rise area UHP had lower vaccination coverage (47%) compared with the mixed area (71%) and slum area UHPs (76%). The financial cost of vaccine and vaccination supplies (syringes, safety boxes) was $1.87 per dose, and the economic cost was $2.96 per dose in 2018 US dollars. Excluding the vaccine and vaccination supplies cost, the financial delivery cost across the 3 UHPs ranged from $0.37 to $0.53 per dose, and the economic delivery cost ranged from $1.37 to $3.98 per dose, with the highest delivery costs per dose in the high-rise areas. Across all 11 UHPs included in the campaign, the weighted average financial delivery cost was $0.38 per dose, and the economic delivery cost was $1.49 per dose. WHO has recommended the programmatic use of TCV in typhoid-endemic countries, and Gavi has included TCV in its vaccine portfolio. This first costing study of large-scale TCV introduction within a public sector immunization program provides empirical evidence for policymakers, stakeholders, and future vaccine campaign planning.

The impact of alternative delivery strategies for novel tuberculosis vaccines in low-income and middle-income countries: a modelling study.

BACKGROUND: Tuberculosis is a leading infectious cause of death worldwide. Novel vaccines will be required to reach global targets and reverse setbacks resulting from the COVID-19 pandemic. We estimated the impact of novel tuberculosis vaccines in low-income and middle-income countries (LMICs) in several delivery scenarios. METHODS: We calibrated a tuberculosis model to 105 LMICs (accounting for 93% of global incidence). Vaccine scenarios were implemented as the base-case (routine vaccination of those aged 9 years and one-off vaccination for those aged 10 years and older, with country-specific introduction between 2028 and 2047, and 5-year scale-up to target coverage); accelerated scale-up similar to the base-case, but with all countries introducing vaccines in 2025, with instant scale-up; and routine-only (similar to the base-case, but including routine vaccination only). Vaccines were assumed to protect against disease for 10 years, with 50% efficacy. FINDINGS: The base-case scenario would prevent 44·0 million (95% uncertainty range 37·2-51·6) tuberculosis cases and 5·0 million (4·6-5·4) tuberculosis deaths before 2050, compared with equivalent estimates of cases and deaths that would be predicted to occur before 2050 with no new vaccine introduction (the baseline scenario). The accelerated scale-up scenario would prevent 65·5 million (55·6-76·0) cases and 7·9 million (7·3-8·5) deaths before 2050, relative to baseline. The routine-only scenario would prevent 8·8 million (95% uncertainty range 7·6-10·1) cases and 1·1 million (0·9-1·2) deaths before 2050, relative to baseline. INTERPRETATION: Our results suggest novel tuberculosis vaccines could have substantial impact, which will vary depending on delivery strategy. Including a one-off vaccination campaign will be crucial for rapid impact. Accelerated introduction-at a pace similar to that seen for COVID-19 vaccines-would increase the number of lives saved before 2050 by around 60%. Investment is required to support vaccine development, manufacturing, prompt introduction, and scale-up. FUNDING: WHO (2020/985800-0). TRANSLATIONS: For the French, Spanish, Italian and Dutch translations of the abstract see Supplementary Materials section.