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Additional file 1: Appendix 1. Timeline for the development and key milestones of the COVID-19 Vaccine Introduction and deployment Costing (CVIC) tool. Appendix 2. Prepopulated data and sources in the COVID-19 Vaccine Introduction and deployment Costing (CVIC) tool.

Additional file 1. Consensus Statement on Vaccine Delivery Costs which includes a review of vaccine delivery cost guidance documents and costing tools as well as a consensus statement on the terminology and methodological principles to be used for vaccine delivery costing. It includes two figures and 6 tables. Figure S1. Major current workstreams in vaccine delivery costing identified by working group. Figure A1 ��� Timeline for developing a Consensus Statement on Vaccine Delivery Costs. Table A2a. List of guidelines by publication year, target interventions, and purposes. Table A2b. List of costing tools for vaccine delivery or immunization program. Table A3. Definitions of costing terms in guidance documents. Table A4. Comparison of costing principles among guidance. Table A5. Characteristics of costing workstreams. Table 6A. Data sources, sampling and characterization of uncertainty, and terminology by workstreams.

OBJECTIVE: To undertake a cost-effectiveness analysis of a Community-based Hypertension Improvement Project (ComHIP) compared with standard hypertension care in Ghana. DESIGN: Cost-effectiveness analysis using a Markov model. SETTING: Lower Manya Krobo, Eastern Region, Ghana. INTERVENTION: We evaluated ComHIP, an intervention with multiple components, including: community-based education on cardiovascular disease (CVD) risk factors and healthy lifestyles; community-based screening and monitoring of blood pressure by licensed chemical sellers and CVD nurses; community-based diagnosis, treatment, counselling, follow-up and referral of hypertension patients by CVD nurses; telemedicine consultation by CVD nurses and referral of patients with severe hypertension and/or organ damage to a physician; information and communication technologies messages for healthy lifestyles, treatment adherence support and treatment refill reminders for hypertension patients; Commcare, a cloud-based health records system linked to short-message service (SMS)/voice messaging for treatment adherence, reminders and health messaging. ComHIP was evaluated under two scale-up scenarios: (1) ComHIP as currently implemented with support from international partners and (2) ComHIP under full local implementation. MAIN OUTCOME MEASURES: Incremental cost per disability-adjusted life-year (DALY) averted from a societal perspective over a time horizon of 10 years. RESULTS: ComHIP is unlikely to be a cost-effective intervention, with current ComHIP implementation and ComHIP under full local implementation costing on average US$12 189 and US$6530 per DALY averted, respectively. Results were robust to uncertainty analyses around model parameters. CONCLUSIONS: High overhead costs and high patient costs in ComHIP suggest that the societal costs of ensuring appropriate hypertension care are high and may not produce sufficient impact to achieve cost-effective implementation. However, these results are limited by the evidence quality of the effectiveness estimates, which comes from observational data rather than from randomised controlled study design.

Background Mortality from cryptoccocal meningitis remains high. The ACTA trial demonstrated that, compared with 2 weeks of amphotericin B (AmB) plus flucystosine (5FC), 1 week of AmB and 5FC was associated with lower mortality and 2 weeks of oral flucanozole (FLU) plus 5FC was non-inferior. Here, we assess the cost-effectiveness of these different treatment courses. Methods Participants were randomized in a ratio of 2:1:1:1:1 to 2 weeks of oral 5FC and FLU, 1 week of AmB and FLU, 1 week of AmB and 5FC, 2 weeks of AmB and FLU, or 2 weeks of AmB and 5FC in Malawi, Zambia, Cameroon, and Tanzania. Data on individual resource use and health outcomes were collected. Cost-effectiveness was measured as incremental costs per life-year saved, and non-parametric bootstrapping was done. Results Total costs per patient were US $1442 for 2 weeks of oral FLU and 5FC, $1763 for 1 week of AmB and FLU, $1861 for 1 week of AmB and 5FC, $2125 for 2 weeks of AmB and FLU, and $2285 for 2 weeks of AmB and 5FC. Compared to 2 weeks of AmB and 5FC, 1 week of AmB and 5FC was less costly and more effective and 2 weeks of oral FLU and 5FC was less costly and as effective. The incremental cost-effectiveness ratio for 1 week of AmB and 5FC versus oral FLU and 5FC was US $208 (95% confidence interval $91–1210) per life-year saved. Clinical Trials Registration ISRCTN45035509. Conclusions Both 1 week of AmB and 5FC and 2 weeks of Oral FLU and 5FC are cost-effective treatments., Compared to 2 weeks of amphotericin B (AmB) and flucystosine (5FC), both 1 week of AmB/5FC and 2 weeks of oral fluconazole (FLU) and 5FC save costs; 1 week of AmB/5FC reduces mortality rates more and is somewhat more costly.

Background Social mobilisation during new vaccine introductions encourages acceptance, uptake and adherence to multi-dose schedules. Effective communication is considered especially important for human papillomavirus (HPV) vaccine, which targets girls of an often-novel age group. This study synthesised experiences and lessons learnt around social mobilisation, consent, and acceptability during 55 HPV vaccine demonstration projects and 8 national programmes in 37 low and middle-income countries (LMICs) between January 2007 and January 2015. Methods A qualitative study design included: (i) a systematic review, in which 1,301 abstracts from five databases were screened and 41 publications included; (ii) soliciting 124 unpublished documents from governments and partner institutions; and (iii) conducting 27 key informant interviews. Data were extracted and analysed thematically. Additionally, first-dose coverage rates were categorised as above 90 %, 90–70 %, and below 70 %, and cross-tabulated with mobilisation timing, message content, materials and methods of delivery, and consent procedures. Results All but one delivery experience achieved over 70 % first-dose coverage; 60 % achieved over 90 %. Key informants emphasized the benefits of starting social mobilisation early and actively addressing rumours as they emerged. Interactive communication with parents appeared to achieve higher first-dose coverage than non-interactive messaging. Written parental consent (i.e., opt-in), though frequently used, resulted in lower reported coverage than implied consent (i.e., opt-out). Protection against cervical cancer was the primary reason for vaccine acceptability, whereas fear of adverse effects, exposure to rumours, lack of project/programme awareness, and schoolgirl absenteeism were major reasons for non-vaccination. Conclusions Despite some challenges in obtaining parental consent and addressing rumours, experiences indicated effective social mobilisation and high HPV vaccine acceptability in LMICs. Social mobilisation, consent, and acceptability lessons were consistent across world regions and HPV vaccination projects/programmes. These can be used to guide HPV vaccination communication strategies without additional formative research.

BACKGROUND: Introduction of new vaccines in low- and lower middle-income countries has accelerated since Gavi, the Vaccine Alliance was established in 2000. This study sought to (i) estimate the costs of introducing pneumococcal conjugate vaccine, rotavirus vaccine and a second dose of measles vaccine in Zambia; and (ii) assess affordability of the new vaccines in relation to Gavi's co-financing and eligibility policies. METHODS: Data on 'one-time' costs of cold storage expansions, training and social mobilisation were collected from the government and development partners. A detailed economic cost study of routine immunisation based on a representative sample of 51 health facilities provided information on labour and vaccine transport costs. Gavi co-financing payments and immunisation programme costs were projected until 2022 when Zambia is expected to transition from Gavi support. The ability of Zambia to self-finance both new and traditional vaccines was assessed by comparing these with projected government health expenditures. RESULTS: 'One-time' costs of introducing the three vaccines amounted to US$ 0.28 per capita. The new vaccines increased annual immunisation programme costs by 38%, resulting in economic cost per fully immunised child of US$ 102. Co-financing payments on average increased by 10% during 2008-2017, but must increase 49% annually between 2017 and 2022. In 2014, the government spent approximately 6% of its health expenditures on immunisation. Assuming no real budget increases, immunisation would account for around 10% in 2022. Vaccines represented 1% of government, non-personnel expenditures for health in 2014, and would be 6% in 2022, assuming no real budget increases. CONCLUSION: While the introduction of new vaccines is justified by expected positive health impacts, long-term affordability will be challenging in light of the current economic climate in Zambia. The government needs to both allocate more resources to the health sector and seek efficiency gains within service provision.

Selected descriptive characteristics of included studies. (DOCX 208 kb)

Search strategies for the included databases. (DOCX 54 kb)

Quality assessment tool. (DOCX 14 kb)

OBJECTIVE: To synthesise lessons learnt and determinants of success from human papillomavirus (HPV) vaccine demonstration projects and national programmes in low- and middle-income countries (LAMICs). METHODS: Interviews were conducted with 56 key informants. A systematic literature review identified 2936 abstracts from five databases; after screening 61 full texts were included. Unpublished literature, including evaluation reports, was solicited from country representatives; 188 documents were received. A data extraction tool and interview topic guide outlining key areas of inquiry were informed by World Health Organization guidelines for new vaccine introduction. Results were synthesised thematically. RESULTS: Data were analysed from 12 national programmes and 66 demonstration projects in 46 countries. Among demonstration projects, 30 were supported by the GARDASIL® Access Program, 20 by Gavi, four by PATH and 12 by other means. School-based vaccine delivery supplemented with health facility-based delivery for out-of-school girls attained high coverage. There were limited data on facility-only strategies and little evaluation of strategies to reach out-of-school girls. Early engagement of teachers as partners in social mobilisation, consent, vaccination day coordination, follow-up of non-completers and adverse events was considered invaluable. Micro-planning using school/ facility registers most effectively enumerated target populations; other estimates proved inaccurate, leading to vaccine under- or over-estimation. Refresher training on adverse events and safe injection procedures was usually necessary. CONCLUSION: Considerable experience in HPV vaccine delivery in LAMICs is available. Lessons are generally consistent across countries and dissemination of these could improve HPV vaccine introduction.

There are marked differences in methods used for undertaking economic evaluations across low-income, middle-income, and high-income countries. We outline the most apparent dissimilarities and reflect on their underlying reasons. We randomly sampled 50 studies from each of three country income groups from a comprehensive database of 2844 economic evaluations published between January 2012 and May 2014. Data were extracted on ten methodological areas: (i) availability of guidelines; (ii) research questions; (iii) perspective; (iv) cost data collection methods; (v) cost data analysis; (vi) outcome measures; (vii) modelling techniques; (viii) cost-effectiveness thresholds; (ix) uncertainty analysis; and (x) applicability. Comparisons were made across income groups and odds ratios calculated. Contextual heterogeneity rightly drives some of the differences identified. Other differences appear less warranted and may be attributed to variation in government health sector capacity, in health economics research capacity and in expectations of funders, journals and peer reviewers. By highlighting these differences, we seek to start a debate about the underlying reasons why they have occurred and to what extent the differences are conducive for methodological advancements. We suggest a number of specific areas in which researchers working in countries of differing environments could learn from one another.

OBJECTIVES: To estimate the cost-effectiveness of Haemophilus influenzae type b (Hib) conjugate vaccine in low- and middle-income countries and identify the model variables, which are most important for the result. STUDY DESIGN: A static decision tree model was developed to predict incremental costs and health impacts. Estimates were generated for 4 country groups: countries eligible for funding by the GAVI Alliance in Africa and Asia, lower middle-income countries, and upper middle-income countries. Values, including disease incidence, case fatality rates, and treatment costs, were based on international country estimates and the scientific literature. RESULTS: From the societal perspective, it is estimated that the probability of Hib conjugate vaccine cost saving is 34%-53% in Global Alliance for Vaccines and Immunization eligible African and Asian countries, respectively. In middle-income countries, costs per discounted disability adjusted life year averted are between US$37 and US$733. Variation in vaccine prices and risks of meningitis sequelae and mortality explain most of the difference in results. For all country groups, disease incidence cause the largest part of the uncertainty in the result. CONCLUSIONS: Hib conjugate vaccine is cost saving or highly cost-effective in low- and middle-income settings. This conclusion is especially influenced by the recent decline in Hib conjugate vaccine prices and new data revealing the high costs of lost productivity associated with meningitis sequelae.

For over 100 years, large epidemics of meningococcal meningitis have occurred every few years in areas of the African Sahel and sub-Sahel known as the African meningitis belt. Until recently, the main approach to the control of these epidemics has been reactive vaccination with a polysaccharide vaccine after an outbreak has reached a defined threshold and provision of easy access to effective treatment but this approach has not prevented the occurrence of new epidemics. Meningococcal conjugate vaccines, which can prevent meningococcal carriage and thus interrupt transmission, may be more effective than polysaccharide vaccines at preventing epidemics. Because the majority of African epidemics have been caused by serogroup A meningococci, a serogroup A polysaccharide/tetanus toxoid protein conjugate vaccine (PsA-TT) has recently been developed. Results from an initial evaluation of the impact of this vaccine on meningococcal disease and meningococcal carriage in Burkina Faso have been encouraging. To review how the research agenda for meningococcal disease in Africa has been changed by the advent of PsA-TT and to define a new set of research priorities for study of meningococcal infection in Africa, a meeting of 41 scientists was held in Dakar, Senegal on April 24th and 25th 2012. The research recommendations developed during the course of this meeting are presented in this paper. The need for enhanced surveillance for meningitis in defined populations with good diagnostic facilities in African countries at risk of epidemics was identified as the highest priority. This is needed to determine the duration of protection against serogroup A meningococcal disease provided by PsA-TT and to determine the risk of disease and carriage caused by meningococci of other serogroups. Other research areas given high priority included identification and validation of serological correlates of protection against meningococcal disease and carriage, development of improved methods for detecting carriage and epidemiological studies aimed at determining the reasons underlying the peculiar epidemiology of meningococcal disease in the African meningitis belt. Minutes and working papers from the meeting are provided in supplementary tables and some of the presentations made at the meeting are available on the MenAfriCar consortium website (www.menafricar.org) and on the web site of the Centers for Disease Control (www.cdc.gov).

OBJECTIVES: To evaluate effectiveness of a structured one-to-one behaviour change programme on weight loss in obese and overweight individuals. DESIGN: Randomised controlled trial. SETTING: 23 general practices in Camden, London. PARTICIPANTS: 381 adults with body mass index ≥25 kg/m(2) randomly assigned to intervention (n=191) or control (n=190) group. INTERVENTIONS: A structured one-to-one programme, delivered over 14 visits during 12 months by trained advisors in three primary care centres compared with usual care in general practice. OUTCOME MEASURES: Changes in weight, per cent body fat, waist circumference, blood pressure and heart rate between baseline and 12 months. RESULTS: 217/381 (57.0%) participants were assessed at 12 months: missing values were imputed. The difference in mean weight change between the intervention and control groups was not statistically significant (0.70 kg (0.67 to 2.17, p=0.35)), although a higher proportion of the intervention group (32.7%) than the control group (20.4%) lost 5% or more of their baseline weight (OR: 1.80 (1.02 to 3.18, p=0.04)). The intervention group achieved a lower mean heart rate (mean difference 3.68 beats per minute (0.31 to 7.04, p=0.03)) than the control group. Participants in the intervention group reported higher satisfaction and more positive experiences of their care compared with the control group. CONCLUSIONS: Although there is no significant difference in mean weight loss between the intervention and control groups, trained non-specialist advisors can deliver a structured programme and achieve clinically beneficial weight loss in some patients in primary care. The intervention group also reported a higher level of satisfaction with the support received. Primary care interventions are unlikely to be sufficient to tackle the obesity epidemic and effective population-wide measures are also necessary. CLINICAL TRIAL REGISTRATION NUMBER: Trial registrationClincaltrials.gov NCT00891943.