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This article presents the World Health Organization's (WHO) recommendations on the use of measles vaccines excerpted from the WHO position paper on Measles vaccines: WHO position paper - April 2017, published in the Weekly Epidemiological Record [1]. This position paper replaces the 2009 WHO position paper on measles vaccines [2]. The position paper summarizes the most recent developments in the field of measles and includes removal of introduction criteria for the routine second dose of measles-containing vaccine (MCV2), guidance on when to vaccinate infants from 6months of age, and guidance on re-vaccination of HIV-infected children receiving highly active anti-retroviral therapy (HAART). Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence, and to the evidence-to-recommendation table. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. Recommendations on the use of measles vaccines were discussed by SAGE in November 2013, October 2015 and October 2016; evidence presented at these meetings can be accessed at: www.who.int/immunization/sage/meetings/2013/november/presentations_background_docs/en/, www.who.int/immunization/sage/meetings/2015/october/presentations_background_docs/en/ and www.who.int/immunization/sage/meetings/2016/october/presentations_background_docs/en/.

This article presented the World Health Organization's (WHO) recommendations on the use of Rabies vaccines excerpted from the Rabies vaccines: WHO position paper - April 2018 published in the Weekly Epidemiological Record [1] This position paper replaces the 2010 WHO position paper on rabies vaccines [2]. It presents new evidence in the field of rabies and the use of rabies vaccines, focussing on programmatic feasibility, simplification of vaccination schedules and improved cost-effectiveness. The recommendations concern the 2 main immunization strategies, namely vaccination for post-exposure prophylaxis and vaccination for pre-exposure prophylaxis. In the context of post-exposure prophylaxis, recommendations are also provided on the use of rabies immunoglobulins. Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence, and to the evidence-to-recommendation tables. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. Recommendations on the use of cholera vaccines were discussed by the Strategic Advisory Group of Experts (SAGE) in October 2017; evidence presented at these meetings can be accessed at: http://www.who.int/immunization/sage/meetings/2017/october/presentations_background_docs/en/.

This article presents the World Health Organization's (WHO) recommendations on the use of hepatitis B vaccines excerpted from the Hepatitis B vaccines: WHO position paper, July 2017, published in the Weekly Epidemiological Record (Hepatitis B vaccines, 2017) [1]. This position paper replaces the May 2009 WHO position paper on hepatitis B vaccines (Hepatitis B vaccines, 2009) [2]. The position paper gives updated information on hepatitis B vaccines and their storage, transport and deployment. The recommendations concern the target groups for vaccination and the appropriate schedules. In particular, the recommendations stress the importance of vaccination of all infants at birth as the most effective intervention for the prevention of hepatitis B virus-associated disease worldwide. Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence, and to the evidence-to-recommendation table. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. Recommendations on the use of hepatitis B vaccines were discussed by SAGE in October 2016; evidence presented at these meetings can be accessed at: http://www.who.int/immunization/sage/meetings/2016/October/presentations_background_docs/en/.

When applying for funding, researchers must demonstrate their productivity. For most funding organizations, a key measure of productivity is the number of papers published. The road to publication is rarely straightforward; few journals provide practical guidance to researchers who are struggling to publish their data. Here, we outline the sections of a research paper and describe practical steps in each part of the publication process as an aid to newer authors.

This article presents the World Health Organization's (WHO) recommendations on the use of dengue vaccine excerpted from the WHO position paper on dengue vaccine published in the Weekly epidemiological Record in July 2016 (Dengue vaccine: WHO position paper, 2016) [1]. The current document is the first WHO position paper on dengue vaccination and focuses primarily on the available evidence concerning the only dengue vaccine to have been registered by National Regulatory Authorities. The position paper gives consideration to the epidemiological features of the disease and assesses the potential use of the vaccine for public health benefits. Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence, and to the evidence-to-recommendation table. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. This paper reflects the recommendations of the WHO's Strategic Advisory Group of Experts (SAGE) on immunization. Recommendations on the use of this dengue vaccine were discussed by SAGE in April 2016; evidence presented at that SAGE meeting can be accessed at: http://www.who.int/immunization/sage/previous/en/index.html.

This article presents the World Health Organization's (WHO) recommendations on the use of Japanese Encephalitis (JE) vaccines excerpted from the WHO position paper on Japanese Encephalitis vaccines recently published in the Weekly Epidemiological Record [1]. This updated position paper on JE vaccines replaces the 2006 position paper on this subject [2]; it focuses on new information concerning the availability, safety, immunogenicity and effectiveness of JE vaccines and the duration of protection they confer. Recent data on global prevalence and burden of disease caused by JE and cost-effectiveness considerations regarding JE vaccination are also summarized. Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. This paper reflects the recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization. These recommendations were discussed by SAGE at its October 2014 meeting. Evidence presented at the meeting can be accessed at http://www.who.int/immunization/sage/previous/en/index.html.

This article presents the World Health Organizations (WHO) evidence and recommendations for the use of yellow fever (YF) vaccination from "Vaccines and vaccination against yellow fever: WHO Position Paper - June 2013" published in the Weekly Epidemiological Record. This position paper summarizes the WHO position on the use of YF vaccination, in particular that a single dose of YF vaccine is sufficient to confer sustained life-long protective immunity against YF disease. A booster dose is not necessary. The current document replaces the position paper on the use of yellow fever vaccines and vaccination published in 2003. Footnotes to this paper provide a number of core references. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. This paper reflects the recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization. These recommendations were discussed by SAGE at its April 2013 meeting. Evidence presented at the meeting can be accessed at http://www.who.int/immunization/sage/previous/en/index.html.

Sustainable financing for immunization refers to the sufficient and predictable allocation and use of resources to support the achievement of immunization goals within the framework of overall health financing. The Immunization Agenda 2030 (IA2030) agenda spells out four important focus areas needed for sustainable financing: (1) ensuring sufficient and predictable resources, (2) making optimal use of resources, (3) aligning partnerships, and (4) supporting sustainable transitions from external assistance. This paper summarizes the evidence and proposes interventions under each area. While immunization is one of the best investments and justifies public financing, the COVID-19 pandemic has led to the worst economic recession since the Great Depression and threatens countries' ability to mobilize funding to ensure continuity and access to essential services, including immunization. Strategies for ensuring adequate resources differ by income group but include raising more revenues, reprioritizing the budget towards health, and ensuring that health resources favor Primary Health Care (PHC) and immunization. In low- and lower-middle income countries, support from Gavi, the Vaccine Alliance, which channels the largest amount of external financing, will remain important, but some lower-middle income countries will need to prepare for transition. Countries benefitting from the Global Polio Eradication Initiative (GPEI) are also experiencing a transition from GPEI financing to domestic and other external financing. This paper outlines ways in which countries can improve the use of domestic and external resources to better incentivize high-quality PHC and immunization services and align immunization programs with health sector reforms. While governments must lead, collective action from development partners, the private sector, and civil society is needed to promote health system financing systems that ensure that the world is better prepared for future outbreaks and pandemics, while reinforcing the IA2030 vision and making progress towards universal health coverage and the Sustainable Development Goals.

The influenza A/H1N1 pandemic in 2009 taught us that the monitoring of vaccine benefits and risks in Europe had potential for improvement if different public and private stakeholders would collaborate better (public health institutes (PHIs), regulatory authorities, research institutes, vaccine manufacturers). The Innovative Medicines Initiative (IMI) subsequently issued a competitive call to establish a public-private partnership to build and test a novel system for monitoring vaccine benefits and risks in Europe. The ADVANCE project (Accelerated Development of Vaccine benefit-risk Collaboration in Europe) was created as a result. The objective of this paper is to describe the perspectives of key stakeholder groups of the ADVANCE consortium for vaccine benefit-risk monitoring and their views on how to build a European system addressing the needs and challenges of such monitoring. These perspectives and needs were assessed at the start of the ADVANCE project by the European Medicines Agency together with representatives of the main stakeholders in the field of vaccines within and outside the ADVANCE consortium (i.e. research institutes, public health institutes, medicines regulatory authorities, vaccine manufacturers, patient associations). Although all stakeholder representatives stated they conduct vaccine benefit-risk monitoring according to their own remit, needs and obligations, they are faced with similar challenges and needs for improved collaboration. A robust, rapid system yielding high-quality information on the benefits and risks of vaccines would therefore support their decision making. ADVANCE has developed such a system and has tested its performance in a series of proof of concept (POC) studies. The system, how it was used and the results from the POC studies are described in the papers in this supplementary issue.

In 2016, the Sierra Leone Ministry of Health and Sanitation (MoHS) piloted VaxTrac, an electronic immunization registry (EIR), in an urban district to improve management of vaccination records and tracking of children who missed scheduled doses. We aimed to document lessons learned to inform decision-making on VaxTrac and similar EIRs' future use.Ten out of 50 urban health facilities that implemented VaxTrac were purposively selected for inclusion in a rapid mixed-method assessment from November to December 2017. For a one-month period, records of six scheduled vaccine doses among children 2 years old in VaxTrac were abstracted and compared to three paper-based records (register of under-two children, daily tally sheet, and monthly summary form). We used the under-two register as the reference gold standard for comparison purposes. We interviewed and observed 10 heath workers, one from each selected facility, who were using VaxTrac.Overall, VaxTrac captured 65% of the vaccine doses reported in the paper-based sources, but in the largest health facility VaxTrac captured the highest number of doses. Two additional notable patterns emerged: 1) the aggregated data sources reported higher doses administered compared to the under-two register and VaxTrac; 2) data sources that need real-time data capture during the vaccination session reported fewer doses administered compared to the monthly HF2 summary form. Health workers expressed that the EIR helped them to shorten the time to manage, summarize, and report vaccination records. Workflows for data entry in VaxTrac were inconsistent among facilities and rarely integrated into existing processes. Data sharing restrictions contributed to duplicate records.Although VaxTrac helped to shorten the time to manage, summarize, and report vaccination records, data sharing restrictions coupled with inconsistent and inefficient workflows were major implementation challenges. Readiness-to-introduce and sustainability should be carefully considered before implementing an EIR.

In high-income countries, there is an increased tendency to replace inactivated seasonal trivalent influenza (TIV) vaccines with quadrivalent (QIV) vaccines as these are considered to give a greater public health benefit. In addition, several recent studies from the USA and Europe indicate that replacement with QIV might also be cost-effective; however, the situation in low- and middle-income countries (LMIC) is less clear as few studies have investigated this aspect. The paper by de Boer et al. (2008) describes a dynamic modelling study commissioned by WHO that suggests that in LMICs, under certain conditions, QIV might also be more cost-effective than TIV. In this commentary, we discuss some important aspects that policymakers in LMICs might wish to take into account when considering replacing TIV by QIV. Indeed, from the data presented in the paper by de Boer et al. it can be inferred that replacing QIV for TIV would mean a 25-29% budget increase for seasonal influenza vaccination in South Africa and Vietnam, resulting in an incremental influenza-related health impact reduction of only 7-8% when a 10% symptomatic attack rate is assumed. We argue that national health budget considerations in LMIC might lead decision-makers to choose other investments with higher health impact for a budget equivalent to roughly a quarter of the yearly TIV immunization costs. In addition to an increased annual cost that would be associated with a decision to replace TIV with QIV, there would be an increased pressure on manufacturers to produce QIV in time for the influenza season requiring manufacturers to produce some components of the seasonal vaccine at risk prior to the WHO recommendations for influenza vaccines. Unless the current uncertainties, impracticalities and increased costs associated with QIVs are resolved, TIVs are likely to remain the more attractive option for many LMICs. Each country should establish its context-specific process for decision-making based on national data on disease burden and costs in order to determine whether the health gains out-weigh the additional cost of moving to QIV. For example, immunizing more people in the population, especially those in higher risk groups, with TIV might not only provide better value for money but also deliver better health outcomes in LMICs. Countries with local influenza vaccine manufacturing capacity should include in their seasonal influenza vaccine procurement process an analysis of the pros- and cons- of TIV versus QIV, to ensure both feasibility and sustainability of local manufacturing.

A high level of concern is placed on the storage, handling, transportation, and distribution of vaccines and other pharmaceutical products, particularly those that are time and temperature sensitive. While active and passive cooling equipment and monitoring devices are important, it is the various personnel responsible for executing and writing procedures, designing and operating systems, and investigating problems and helping prevent them who are paramount in establishing and maintaining a "cold chain" for time and temperature sensitive pharmaceutical products (TTSPPs). These professionals must possess the required competencies, knowledge, skills and abilities so they can effectively perform these activities with appropriate levels of expertise. These are complex tasks that require the development of higher cognitive skills that cannot be adequately addressed through professional development opportunities based on simple information delivery and content acquisition. This paper describes two unique learning solutions (one on a bus called the "wheels course" and the other online called "e-learning") that have been developed by WHO Global Learning Opportunities (WHO/GLO) to provide participants with opportunities not just to learn about cold chain systems or vaccine management, but, rather, to develop high levels of expertise in their respective fields through experiential and authentic learning activities. In these interactive learning environments, participants have opportunities to address real-life situations in contexts similar to what they may face in their own work environments and develop solutions and critical thinking skills they can apply when they return to their jobs. This paper further delineates the managerial and operational vaccine management functions encompassed in these two unique learning environments. The paper also describes the alignment of the objectives addressed in the "wheels course" and the e-learning version with effective vaccine management (EVM) criteria as prescribed by WHO. The paper concludes with an example of a real world product developed by course graduates (specifically a decision tree that is now used by some national programmes). These types of products, valuable in their own right, often emerge when learning environments based on authentic learning principles are designed and implemented as they were by WHO/GLO.

Background During the 2009/2010 season, information on adverse events after administration of seasonal and pandemic influenza vaccines was collected by different active surveys in the Netherlands. In the present paper, we compared data from a paper-based questionnaire with data from a web-based questionnaire with respect to outcomes and target population, in order to guide future influenza vaccine safety monitoring. Methods The paper-based survey collected data from patients who attended primary care practices in the province of Utrecht for influenza vaccination. The web-based survey recruited participants from the general population all provinces of the Netherlands. To analyze the association between study approach and the reported local and systemic adverse events, a generalized estimation equation model was applied. We adjusted for age, gender, comorbidity, previous vaccination and socio-economic status score. Results No significant differences were found between the two studies approaches in reporting local reactions (OR: 0.98, 95% CI 0.88–1.10) and systemic AEs (OR: 1.12, 95% CI 0.99–1.27). There were important differences in the age groups that responded. The elderly were more represented in the paper-based survey where participants were recruited via GPs (79% ⩾ 60 years) compared to 37% in the web-based survey where participants were recruited via internet. Conclusion The paper-based survey with recruitment of participants through GPs is more representative for the target group of influenza vaccination compared to the web-based survey with recruitment of participants via internet. A web-based approach with recruitment of participants via internet seems more suitable for situations where information about adverse events on a national level is desirable. We recommend to recruit participants for a web-based survey during mass vaccinations sessions by GPs to comply with the recommendations of the European Centre for Disease Prevention Control.

The authors of Huijbers et al. [1] apologize for not giving sufficient credit to the work presented by Saupe et al. [2], Huijbers et al. [3] and Femel et al. [4]. Below are corrections to the relevant parts of the article. The authors would like to apologize for any inconvenience caused. Page 3054 (Introduction) The sentence: ‘In previous work we have shown that it is possible to break self-tolerance in mice, and to induce antibody responses against the tumor vascular markers extra domain A (EDA) and B (EDB) of the extracellular matrix molecule fibronectin.’, should be replaced by: ‘Previous work of Huijbers et al. [3] and Femel et al. [4] has shown that it is possible to break self-tolerance in mice, and to induce antibody responses against the tumor vascular markers extra domain A (EDA) and B (EDB) of the extracellular matrix molecule fibronectin.’ Page 3056 (Discussion) The sentence: ‘We have previously shown that the anti-self antibody response against EDB is decreased as the amount of TRX is increased.’, should be replaced by: ‘Saupe et al. [2] have previously shown that the anti-self antibody response against EDB is decreased as the amount of TRX is increased.’ Page 3057 (Discussion) The sentence: ‘In this paper we show that the TRX-part is absolutely required to induce an immune response against EDB and that vaccination with EDB alone does not induce an antibody response against EDB.’, should be replaced by: ‘In this paper Saupe et al. [2] show that the TRX-part is absolutely required to induce an immune response against EDB and that vaccination with EDB alone does not induce an antibody response against EDB.’ Page 3058 (Discussion) The sentence: ‘To address this issue, we have previously used the MMTV-PyMT transgenic model of breast cancer. Since EDB is not expressed in this model we approached the question with a vaccine against the extra domain A of fibronectin (EDA).’, should be replaced by: ‘This issue was previously addressed by Femel et al. [4] using the MMTV-PyMT transgenic model of breast cancer. Since EDB is not expressed in this model the question was approached with a vaccine against the extra domain A of fibronectin (EDA).’ The sentence: ‘We have looked into more detail at the immune response induced with the TRX-EDB vaccine [12] and found that the major subclass induced by the vaccine was IgG1, which is characteristic of a Th2-response, thus an antibody mediated immune response in mice. Furthermore, we found macrophages trying to engulf the tumor vessels in the tumors of mice vaccinated with TRX-EDB, increased fibrinogen leakage and increased neutrophil infiltration in these tumors.’, should be replaced by: ‘Huijbers et al. [3] have looked into more detail at the immune response induced with the TRX-EDB vaccine and found that the major subclass induced by the vaccine was IgG1, which is characteristic of a Th2-response, thus an antibody mediated immune response in mice. Furthermore, they found macrophages trying to engulf the tumor vessels in the tumors of mice vaccinated with TRX-EDB, increased fibrinogen leakage and increased neutrophil infiltration in these tumors.’ After the sentence: ‘The current study demonstrates that several alternative non-self fusion partners in conjugate vaccines can elicit strong and specific antibody responses against self-antigens.’, this sentence should be added: ‘This was also observed in a study by Saupe et al. in which VLRB (variable lymphocyte receptor B) conjugate vaccines were used [2]. This study concluded that the foreign antigen should be short (around 41 aa in size), have multimerizing capacity to provide a strong B cell activation signal and be hidden inside the vaccine protein to avoid epitope masking or clearance of the fusion protein.’ Page 3058 (Experimental procedures) The sentence: ‘The pET21-TRX vector was a kind gift of Dr. Anna-Karin Olsson (Uppsala University, Uppsala, Sweden).’, should be replaced by: ‘Both the pET21-TRX vector and the pET21a-TRX-EDB vector were a kind gift of Dr. Anna-Karin Olsson (Uppsala University, Uppsala, Sweden).’

Background Few detailed facility-based costing studies of routine immunization (RI) programs have been conducted in recent years, with planners, managers and donors relying on older information or data from planning tools. To fill gaps and improve quality of information, a multi-country study on costing and financing of routine immunization and new vaccines (EPIC) was conducted in Benin, Ghana, Honduras, Moldova, Uganda and Zambia. Methods This paper provides the rationale for the launch of the EPIC study, as well as outlines methods used in a Common Approach on facility sampling, data collection, cost and financial flow estimation for both the routine program and new vaccine introduction. Costing relied on an ingredients-based approach from a government perspective. Estimating incremental economic costs of new vaccine introduction in contexts with excess capacity are highlighted. The use of more disaggregated System of Health Accounts (SHA) coding to evaluate financial flows is presented. Results The EPIC studies resulted in a sample of 319 primary health care facilities, with 65% of facilities in rural areas. The EPIC studies found wide variation in total and unit costs within each country, as well as between countries. Costs increased with level of scale and socio-economic status of the country. Governments are financing an increasing share of total RI financing. Conclusions This study provides a wealth of high quality information on total and unit costs and financing for RI, and demonstrates the value of in-depth facility approaches. The paper discusses the lessons learned from using a standardized approach, as well as proposes further areas of methodology development. The paper discusses how results can be used for resource mobilization and allocation, improved efficiency of services at the country level, and to inform policies at the global level. Efforts at routinizing cost analysis to support sustainability efforts would be beneficial.

In 2014, the European Medicines Agency (EMA) set out requirements for an enhanced safety surveillance for seasonal influenza vaccines. This paper presents data from the yearly Enhanced Passive Safety Surveillance (EPSS) implemented for Influvac® since season 2014/15 and continued for Influvac® Tetra from season 2018/19 onwards.In seven consecutive seasons, an EPSS, aiming for at least 1,000 vaccinees (additional target of 100 vaccinees per five predefined age groups), was conducted in Germany, where market characteristics were expected to allow for a quick generation of representative data. Reactogenicity data in terms of reporting rates, severity and duration of pre-specified local and systemic adverse events of interest (AEI) were collected using response cards, which were completed by vaccinees and returned seven days after vaccination via regular mail. In addition, response cards contained a call center number to enhance reporting of other than pre-specified adverse events.The primary target of at least 1,000 vaccinees was surpassed in all seasons, as was the additional target of 100 adults and elderly. Reactogenicity data were in line with known safety profile of Influvac® and Influvac® Tetra. In children, the target was mostly met in seasons when the EPSS was conducted for Influvac®, but not in seasons when it was conducted for Influvac® Tetra. Although the data for Influvac® Tetra are based on a low number of paediatric vaccinees, they do not indicate a different reactogenicity profile of Influvac® Tetra compared with Influvac®. No signals were identified.The EPSS set up for Influvac® and Influvac® Tetra proved a robust and effective methodology to comply with the objectives of EMÁ's guidance on enhanced safety surveillance of seasonal influenza vaccines. Safety data from seven consecutive seasons confirmed the favourable safety profile of both vaccines.

Pediatric immunization is important for preventing potentially life-threatening diseases in children. Over time, the number of recommended pediatric vaccines has increased and is likely to increase further as new vaccines are developed. Given the different number of doses for available vaccines and various constraints (e.g., the appropriate age for each dose of a vaccine or the time between doses), it is challenging to develop a recommended vaccination schedule or a catch-up schedule when a child falls behind on one or more vaccinations.We developed an integer programming optimization model, enabled by Python programming and embedded into an Excel-based decision tool, to recommend childhood vaccination schedules or personalized catch-up schedules. The model recommends a vaccination schedule that balances the goal of being as close as possible to the clinically-indicated dosing schedules and the goal of minimizing clinic visits, and gives users the ability to trade off between these two goals. We illustrated the broad applicability of our proposed model with commonly-faced vaccine scheduling challenges in the United States.The illustrative computational case study confirms our model's ability to create personalized schedules based on each child's age and vaccination history, and to adjust appropriately when a new vaccine becomes available.The model presented in this paper fills the need for an easy-to-use tool to recommend vaccination schedules for de novo and catch-up purposes. It provides straightforward recommendations that can be easily used by physicians, is flexible to handle the requirements varying by region, and can be updated as new vaccines are approved for use.

This paper considers the problem of patient scheduling and capacity planning for the vaccination process during the COVID-19 pandemic. The proposed solution is based on a non-linear mathematical modeling approach representing the dynamics of an open Jackson Network and a Generalized Network. To test these models, we proposed three objective functions and analyzed different configurations of the process corresponding to various levels of the models' parameters as well as the conditions present in the case study. To assess the computational performance of the models, we also experimented with larger instances in terms of number of steps or stations used and number of patients scheduled. The computational results show how parameters such as the minimum percentage of patients served, the maximum occupation allowed per station and the objective functions used have an impact on the configuration of the process. The proposed approach can support the decision-making process in vaccination centers to efficiently assign human and material resources to maximize the number of patients vaccinated while ensuring reasonable waiting times, number of patients in queue and servers' utilization rates, which in turn are key to avoid overcrowding and other negative conditions in the system that could increase the risk of infections.

Despite vaccination being one of the most effective public health interventions, there are persisting inequalities and inequities in immunisation. Understanding the differences in subnational vaccine impact can help improve delivery mechanisms and policy. We analyse subnational vaccination coverage of measles first-dose (MCV1) and estimate patterns of inequalities in impact, represented as deaths averted, across 45 countries in Africa. We also evaluate how much this impact would improve under more equitable vaccination coverage scenarios. Using coverage data for MCV1 from 2000-2019, we estimate the number of deaths averted at the first administrative level. We use the ratio of deaths averted per vaccination from two mathematical models to extrapolate the impact at a subnational level. Next, we calculate inequality for each country, measuring the spread of deaths averted across its regions, accounting for differences in population. Finally, using three more equitable vaccination coverage scenarios, we evaluate how much impact of MCV1 immunisation could improve by (1) assuming all regions in a country have at least national coverage, (2) assuming all regions have the observed maximum coverage; and (3) assuming all regions have at least 80% coverage. Our results show that progress in coverage and reducing inequality has slowed in the last decade in many African countries. Under the three scenarios, a significant number of additional deaths in children could be prevented each year; for example, under the observed maximum coverage scenario, global MCV1 coverage would improve from 76% to 90%, resulting in a further 363(95%CrI:299-482) deaths averted per 100,000 live births. This paper illustrates that estimates of the impact of MCV1 immunisation at a national level can mask subnational heterogeneity. We further show that a considerable number of deaths could be prevented by maximising equitable access in countries with high inequality when increasing the global coverage of MCV1 vaccination.

The development of several types of vaccines to avert COVID-19 has taken place. Despite several reports of undesirable reactions noted post-COVID-19 vaccine administration, later remains one of the best prevention and management tools in fighting the spread of the virus and its variants and reducing the harshness of this viral attack. The purpose of the current paper was to explore the side-effects experienced by the females in the Eastern Province of Saudi Arabia directly after receiving the booster dose of the Pfizer-BioNTech/BNT162b2 COVID-19 vaccine.A descriptive cross-sectional study among adults living in the East-ern Province, Saudi Arabia was applied. A survey link was, distributed through WhatsApp, SMS, or e-mail to community members. Respondent's demographic information was acquired, as well as information about any local and systemic side-effects reported following booster dose of BioNTech/BNT162b2 COVID-19 vaccine.A total of 72.36% (432/597) of the respondents who participated in this study reported at least one side-effect. Pain and redness at the injection site (75.93%), myalgia (71.99%), headache (53.24%), fever (33.56%), and fatigue (43.78%) were the highest frequently stated side-effects. Furthermore, 9.25% of the respondents had to see a physician due to side effects, plus merely four participants were admitted to the hospital. The respondents working in the non-healthcare-related sector had a 1.677-fold more possibility of side effects in comparison with the other respondents (adjusted odds ratio = 1.677; 95% CI = 1.363, 2.064).All reported side-effects were mild to moderate. These findings might persuade pessimists and refusers to get the COVID-19 vaccine. Myalgia and pain or redness at the site of injection were the most common reported side-effects in our study.

The World Health Organization (WHO) global strategy to eliminate cervical cancer (CxCa) could result ingt;62 million lives saved by 2120 if strategy targets are reached and maintained: 90% of adolescent girls receiving prophylactic human papillomavirus (HPV) vaccine, 70% of women receiving twice-lifetime cervical cancer screening, and 90% of cervical pre-cancer lesions and invasive CxCa treated. However, the cost and complexity of CxCa screening and treatment approaches has hampered scale-up, particularly in low- and middle-income countries (LMICs), and new approaches are needed. Therapeutic HPV vaccines (TxV), which could clear persistent high-risk HPV infection and/or cause regression of pre-cancerous lesions, are in early clinical development and might offer one such approach. During October 2021 to March 2022, WHO, in collaboration with the Bill and Melinda Gates Foundation, convened a series of global expert consultations to lay the groundwork for understanding the potential value of TxV in the context of current CxCa prevention efforts and for defining WHO preferred product characteristics (PPCs) for TxV. WHO PPCs describe preferences for vaccine attributes that would help optimize vaccine value and use in meeting the global public health need. This paper reports on the main discussion points and findings from the expert consultations. Experts identified several ways in which TxV might address challenges in current CxCa prevention programmes, but emphasized that the potential value of TxV will depend on their degree of efficacy and how quickly they can be developed and implemented relative to ongoing scale-up of existing interventions. Consultation participants also discussed potential use-cases for TxV, important PPC considerations (e.g., vaccine indications, target populations, and delivery strategies), and critical modelling needs for predicting TxV impact and cost-effectiveness.

There is little research to understand reasons for suboptimal influenza vaccination uptake among Aboriginal people of different ages in Australia. This study aimed to better understand the communication needs and preferences of Aboriginal families (Phase 2) in New South Wales, Australia, and their health service providers (Phase 1), to inform future interventions to improve influenza immunisation coverage in Aboriginal communities. This paper reports from Phase 1 of the study.Aboriginal and non-Aboriginal researchers designed and conducted the study, with cultural governance provided by Aboriginal health care professionals and other community members working within health departments or community healthcare settings across Australia. In Phase 1 we conducted interviews and focus groups with 18 Aboriginal immunisation providers and mainstream immunisation co-ordinators from three geographic areas in New South Wales. We used group-based thematic analysis with a cultural lens and sought participants' feedback prior to finalising results.We identified four themes, framed as opportunities for improvement: better supporting Aboriginal Medical Services as providers of influenza vaccinations; improving the accessibility and appropriateness of mainstream services for Aboriginal families; improving health providers' knowledge of Aboriginal people' influenza risk and their willingness to recommend vaccination; and engaging communities to design influenza vaccination resources.To achieve optimal influenza vaccination coverage, all health services must take responsibility for providing culturally responsive clinical care to Aboriginal families. We suggest that, where possible, mainstream services incorporate elements of the family-centred and broader model of health used by Aboriginal Medical Services. This includes creating a welcoming environment, appropriately identifying and getting to know Aboriginal patients, taking a preventative approach, and opportunistically offering and strongly encouraging influenza vaccination to the individual and their family.

The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group has prepared standardized templates to describe the key considerations for the benefit-risk assessment of several vaccine platform technologies, including nucleic acid (RNA and DNA) vaccines. This paper uses the BRAVATO template to review the features of a vaccine employing a proprietary mRNA vaccine platform to develop Moderna COVID-19 Vaccine (mRNA-1273); a highly effective vaccine to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In response to the pandemic the first in human studies began in March 2020 and the pivotal, placebo-controlled phase 3 efficacy study in over 30,000 adults began in July 2020. Based on demonstration of efficacy and safety at the time of interim analysis in November 2020 and at the time of trial unblinding in March 2021, the mRNA-1273 received Emergency Use Authorization in December 2020 and full FDA approval in January 2022.

Childhood Immunization is one of the critical strategies to decrease infant morbidity and mortality due to infectious diseases, but primary immunization schedules for infants in most countries start at 2 months of age. Childhood vaccines therefore begin providing adequate protection later in life, leaving infants vulnerable to infectious diseases and creating an immunity gap that results in higher morbidity and mortality among younger infants. Maternal immunization, the practice of vaccinating individuals during pregnancy, reduces the risk of infant infection primarily through the transfer of protective maternal antibodies to the fetus during late pregnancy. Although much progress has been made in public health policies to support maternal immunization research, inclusion of pregnant individuals and children in clinical trials remains challenging. This has resulted in paucity of evidence regarding safety and effectiveness of vaccines to support licensure of products intended for use during pregnancy and lactation to prevent disease in the infant. In addition, although safeguards for clinical research in pregnancy are supportive, experimental vaccines, e.g., Respiratory Syncytial Virus, are more complicated to study because data on safety, efficacy, and dosing are limited. This requires randomized controlled trials with safety monitoring for the mother, the fetus, and the infant with follow-up for at least 1 year or longer to assess long-term health outcomes that may be associated with peripartum vaccine exposure. The goal of this paper is to discuss the general regulatory considerations for clinical research to evaluate safety and effectiveness of vaccines administered during pregnancy to protect infants from disease. This could be useful to inform future vaccine trials. This discussion is not intended to provide agency guidance nor to articulate agency policy.

Uncertainty surrounding the risk of developing and dying from Thrombosis and Thromobocytopenia Syndrome (TTS) associated with the AstraZeneca (AZ) COVID-19 vaccine may contribute to vaccine hesitancy. A model is urgently needed to combine and effectively communicate the existing evidence on the risks versus benefits of the AZ vaccine. We developed a Bayesian network to consolidate the existing evidence on risks and benefits of the AZ vaccine, and parameterised the model using data from a range of empirical studies, government reports, and expert advisory groups. Expert judgement was used to interpret the available evidence and determine the structure of the model, relevant variables, data to be included, and how these data were used to inform the model.The model can be used as a decision support tool to generate scenarios based on age, sex, virus variant and community transmission rates, making it a useful for individuals, clinicians, and researchers to assess the chances of different health outcomes. Model outputs include the risk of dying from TTS following the AZ COVID-19 vaccine, the risk of dying from COVID-19 or COVID-19-associated atypical severe blood clots under different scenarios. Although the model is focused on Australia, it can be easily adaptable to international settings by re-parameterising it with local data. This paper provides detailed description of the model-building methodology, which can used to expand the scope of the model to include other COVID-19 vaccines, booster doses, comorbidities and other health outcomes (e.g., long COVID) to ensure the model remains relevant in the face of constantly changing discussion on risks versus benefits of COVID-19 vaccination.

A WHO global strategy launched in November 2020 sets out an ambitious pathway towards the worldwide elimination of cervical cancer as a public health problem within the next 100 years. Achieving this goal will require investment in innovative approaches. This review aims to describe integrated approaches that combine human papillomavirus (HPV) vaccination and cervical cancer screening in low- and middle-income countries (LMIC), and their efficacy in increasing uptake of services. A systematic review was conducted analyzing relevant papers from Embase, Medline, CINAHL and CAB Global Health databases, as well as grey literature. Narrative synthesis was performed on the included studies. Meta-analysis was not appropriate due to the heterogeneity and nature of included studies. From 5,278 titles screened, 11 uncontrolled intervention studies from four countries (from Africa and east Asia) were included, all from the past 12 years. Four distinct typologies of integration emerged that either increased awareness of HPV and/or cervical cancer screening, and/or coupled the delivery of HPV vaccination and cervical cancer screening programs. The synthesis of findings suggests that existing HPV vaccination programs can be a useful pathway for educating mothers and other female caregivers about cervical cancer screening; through in person conversations with care providers (preferred) or take-home communications products. Integrated service delivery through outreach and mobile clinics may overcome geographic and economic barriers to access for both HPV vaccination and cervical cancer screening, however these require significant program and system resources. One study promoted HPV vaccination as part of integrated service delivery, but there were no other examples found that examined use of cervical cancer screening platforms to promote or educate on HPV vaccination. This review has demonstrated gaps in published literature on attempts to integrate HPV vaccination and cervical cancer screening. The most promising practices to date seem to relate to integrated health communications for cervical cancer prevention. Future research should further explore the opportunities for integrated health communications to support the efforts towards the new global cervical cancer elimination agenda, and costs and feasibility of integrated service delivery for underserved populations.

The benefits of vaccines have been centred on their specific effects on subsequent infections by target pathogens. Recent studies, however, have opened up new insights into additional effects of vaccines known as non-specific effects (NSEs) or heterologous effects of vaccines. While several articles have reviewed epidemiological and immunological evidence for NSEs of vaccines in humans, similar works on veterinary vaccines are scarce. The objective of this paper was to review the findings of published studies on NSEs of vaccines developed or repurposed for use in animals. In total 8412 titles were retrieved from PubMed and CABI databases on the 30th of April 2021. After the final stage of screening, 45 eligible articles were included in the review. Data from these articles were summarised and presented here. In general, most of the vaccines studied in the reviewed articles have beneficial NSEs against multiple pathogens and disease conditions. There were, however, fewe studies reporting detrimental NSEs from both non-live and live vaccines which is in contrast to the currently existing evidence of beneficial NSEs of live vaccines and detrimental NSEs of non-live vaccines. This review may be used as a complement for future review of RCT studies of NSEs of vaccines in animals and provide a useful addition to the evolving understanding of the NSEs of vaccines.

Vaccine hesitancy can hinder the successful roll-out of vaccines. This paper examines COVID-19 vaccine hesitancy in the European Union, drawing from a large-scale cross-national survey covering all 27 EU Member States, carried out between February and March 2021 (n = 29,755). We study the determinants of vaccine hesitancy, focusing on the role of social media use. In multivariate regression models, we find statistically significant (p 0.05) impacts on vaccine hesitancy of heavy use of social media and using social media as a main source of news. However, the effect of social media and the drivers of vaccine hesitancy vary depending on the reason for hesitancy. Most notably, hesitancy due to health concerns is mainly driven by physical health status and less by social media use, while views that COVID-19 risks are exaggerated (or that COVID-19 does not exist) are more common among men, people in good health, and those using social media as their main source of news.

The introduction of the Human papillomavirus (HPV) vaccine has shown potential to not only prevent cervical cancer but also drive adolescents’ access to other health care services, even in low-income countries. Few studies have been conducted to date to identify best practices and estimate the acceptance, operational challenges and benefits of including broader adolescent health interventions into immunization efforts, knowledge which is essential to supporting widespread integration. In this paper we review the efforts undertaken by the government of Togo to integrate adolescent health programming with the HPV vaccination roll out. With the support of partners (GAVI, WHO, UNFPA and UNICEF), the country successfully completed, in 2017, two years of an HPV vaccine demonstration project, which entailed vaccinating 10-year-old girls against HPV in two selected districts of the country and integrating a health education component focused on puberty education / menstrual hygiene and hand washing practice. Our study is a post-implementation program evaluation, using mixed methods to assess key questions of feasibility and acceptability of an integrated adolescent package of care. It showed that the HPV vaccination in conjunction with the health education sessions was well received by the majority of health care providers, teachers and parents. Our study confirmed that in Togo it proved feasible to combine education and HPV vaccination in school-based service delivery. However, more operational research is neded to understand how to increase the impact and sustainability of the co-delivery of interventions. We did not analyze the health impact and cost implications of the intervention, which will be an important consideration for scaling up such integration efforts alongside routine immunization.

Under the pandemic situation, there is an urgent need to produce and acquire sufficient quantities of prophylactic vaccines. It becomes important to devise a way to achieve reliable immunity with lower doses to distribute limited supplies of vaccines to maximum number of people very quickly. Intradermal (ID) vaccination is one such method to increase the effectiveness of vaccines. However, this method has not been widely used in general clinical practice because it is technically difficult to inject vaccines precisely into the ID tissue. Therefore, new ID delivery systems that allow reliable ID administration are under development. In this paper, we summarize its design and present the results of performance and usability testing for the Immucise™ Intradermal Injection System (Immucise™). This study showed that Immucise™ can reduce dead volume and inject drugs precisely into the ID tissues of subjects from infants to the elderly and can be used correctly and safely by healthcare professionals. This randomized controlled trial compared ID administration with Immucise™ and standard subcutaneous (SC) administration of seasonal influenza vaccine by analyzing the efficacy of the vaccine in the elderly group at 90 days and 180 days after administration. It was found that the vaccine for the ID group was as effective or more effective than that for the SC group up to 180 days later. It was also found that the geometric mean titer values, especially for B strains, were higher in the two-dose ID group than in the two-dose SC group. These findings suggest that Immucise™ is one of the best devices to distribute a small amount of vaccine quickly and widely to a larger number of people with little loss of vaccine during a pandemic.

Infectious diseases may cause serious morbidity and mortality in pregnant women, their foetuses, and infants; the risk associated with any newly emerging infectious disease (EID) is likely unknown at the time of its emergence. While the ongoing SARS-CoV-2 pandemic shows that the development of vaccines against new pathogens can be considerably accelerated, the immunization of pregnant women generally lags behind the general population. Guided by the priority pathogen list for WHO’s R&D Blueprint for Action to Prevent Epidemics, this workshop sought to define the evidence needed for use of vaccines against EIDs in pregnant and lactating women, using Lassa fever as a model. Close to 60 maternal immunization (MI) and vaccine safety experts, regulators, vaccine developers, Lassa fever experts, and investigators from Lassa-affected countries examined the critical steps for vaccine development and immunization decisions for pregnant and lactating women. This paper reports on key themes and recommendations from the workshop. Current practice still assumes the exclusion of pregnant women from early vaccine trials. A shift in paradigm is needed to progress towards initial inclusion of pregnant women in Phase 2 and 3 trials. Several practical avenues were delineated. Participants agreed that vaccine platforms should be assessed early for their suitability for maternal immunization. It was noted that, in some cases, nonclinical data derived from assessing a given platform using other antigens may be adequate evidence to proceed to a first clinical evaluation and that concurrence from regulators may be sought with supporting rationale. For clinical trials, essential prerequisites such as documenting the disease burden in pregnant women, study site infrastructure, capabilities, and staff experience were noted. Early and sustained communication with the local community was considered paramount in any program for the conduct of MI trials and planned vaccine introduction.

Background Analyzing potential benefits of thermostable vaccines delivered through Micro Array Patch (MAP) has received great attention in low and middle-income countries. The experience may or may not be the same in developed countries where the infrastructure is more developed. It is anticipated that transforming the vaccine supply chain from syringe-and-needle to thermostable MAP-delivered vaccines will result in reduced supply chain costs – including manufacturing/supply, logistics/distribution, and administration costs – as well as reduced wastes and improved safety. This paper provides an end-to-end supply chain analysis comparing the key aspects (cost, safety and environmental aspects) of the conventional syringe-and-needle vaccine supply chain with those of the MAP vaccine supply chain for influenza vaccine delivery in Australia. Directions for future research in this area will be provided. Objective To determine the potential supply chain impacts of replacing syringe-and-needle flu vaccine with MAP-enabled thermostable flu vaccine in Australia. Methods We analyze the current flu vaccine supply chain in Australia to identify practical limitations and opportunities for improvement. Data/information is collected through interviewing the key stakeholders across vaccine supply chain including vaccine manufacturers, logistics providers, clinics, hospitals, and pharmacies. Findings A detailed practice-informed analysis is completed on the key operations of the flu vaccine supply chain. Barriers and limitations of the conventional flu vaccine are discussed, along with potential improvements that can be achieved through the implementation of MAP-enabled flu vaccine delivery. We discuss how technology-driven innovations can help advance vaccine supply chains, improve vaccine visibility, reduce wastes, and enable informed decision-making. Conclusion We find that the benefits of moving from syringe-and-needle vaccines to thermostable MAP-delivered vaccines are beyond transportation and storage cost saving. Potential benefits through cost saving, waste reduction, and service level improvement are discussed along with various safety and wellbeing consequences followed by directions for future research in this area.