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MyChild Solution is an innovative Electronic Immunisation Register (EIR) reliant on Smart Paper Technology, thereby eliminating the need for electronic devices and internet connectivity at the point-of-care. The goal of this study is to characterise the quality of routine immunisation data generated using MyChild Solution compared to data obtained through the conventional health management information system (HMIS) used in The Gambia. We used the World Health Organization's (WHO) Data Quality Review (DQR) Toolkit to evaluate MyChild Solution's data quality in the 19 health facilities across two regions implementing MyChild Solution in The Gambia at the time of the evaluation. We evaluated all applicable data quality metrics as well as additional metrics of interest, including the incidence of recording errors, the incidence of incomplete indicator level data, and implausible dates. Where possible, we compared results to those of the conventional HMIS. Both MyChild Solution and the conventional HMIS produced 100% complete and timely data in their reference years. Both systems had no moderate or extreme outliers and showed the expected Penta 1 to Penta 3 dropout direction. However, the proportion of verification factors that are not acceptable was higher in the conventional HMIS. MyChild Solution was found to near perfectly (99.98%) digitise scanned documents. These and other data quality indicators evaluated demonstrate that MyChild Solution produces high quality data with high completeness, timeliness, and consistency compared to the conventional HMIS system. MyChild Solution produces high quality data as per the DQR Toolkit metrics and other metrics of interest of interest. The more internally consitent data produced through MyChild Solution compared to the conventional HMIS demonstrates its potential for supporting data-driven decision-making in immunisation. [ABSTRACT FROM AUTHOR]

Seasonal influenza has a significant impact on global public health each year, especially in older adults 65 years of age and above. This paper presents the evolution of high-dose influenza vaccine and the quantity as well as quality of evidence on this vaccine. Its introduces other peer-reviewed manuscripts included in this supplement covering the benefits high-dose influenza vaccine over ten consecutive influenza seasons. The development of the high-dose influenza vaccine represents an important step in the evolution of influenza vaccines, offering an advancement in prevention of influenza and a step in encouraging healthy aging in older adults. A video summary of the article can be accessed via the Supplementary data link at the end of this article. [ABSTRACT FROM AUTHOR]

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/ . [ABSTRACT FROM AUTHOR]

Abstract 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 6 months 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%5fbackground%5fdocs/en/ , www.who.int/immunization/sage/meetings/2015/october/presentations%5fbackground%5fdocs/en/ and www.who.int/immunization/sage/meetings/2016/october/presentations_background_docs/en/. [ABSTRACT FROM AUTHOR]

Abstract 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/. [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization’s (WHO) recommendations on the use of cholera vaccines excerpted from the Cholera vaccines: WHO position paper, August 2017 , published in the Weekly Epidemiological Record (Cholera vaccine, 2017) [1] . This position paper replaces the 2010 WHO position paper on cholera vaccines (Cholera vaccine, 2010) [2] . It incorporates the most recent evidence on cholera vaccination and provides revised recommendations on the target populations for cholera immunization. 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 cholera vaccines were discussed by the Strategic Advisory Group of Experts (SAGE) in April 2017; evidence presented at these meetings can be accessed at: www.who.int/immunization/sage/meetings/2017/April/presentations_background_docs/en/ . [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization’s (WHO) recommendations on the use of diphtheria vaccines excerpted from the Diphtheria vaccines: WHO position paper, August 2017 , published in the Weekly Epidemiological Record (Diphtheria vaccine, 2017) [1] . This position paper replaces the 2006 WHO position paper on diphtheria vaccine (Diphtheria vaccine, 2006) [2] . The position paper incorporates recent evidence on diphtheria and provides revised recommendations on the optimal number of doses and timing of diphtheria vaccination. In view of the widespread use of combination vaccines, it provides guidance on the alignment of vaccination schedules for different antigens included in routine childhood immunization programmes. 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 diphtheria vaccines were discussed by SAGE in April 2017; evidence presented at these meetings can be accessed at: www.who.int/immunization/sage/meetings/2017/april/presentations_background_docs/en/ . [ABSTRACT FROM AUTHOR]

Rotavirus is the leading cause of severe diarrhea in infants and young children. Live attenuated vaccines can lead to horizontal transmission with the risk of vaccine-derived disease in contacts. Transmission of pentavalent human-bovine reassortant rotavirus vaccine (RV5) strains leading to clinical disease was not well evaluated in the pivotal clinical trials, and only a few case reports have been described in the literature. We performed a systematic literature review to investigate secondary transmission of RV5 strains to unvaccinated subjects globally. We searched Embase, Medline for English papers, CNKI, Wan Fang for Chinese papers, and other resources (i.e., conference papers with full text) from January 2005 to June 2021. Eligibility criteria for inclusion were original articles based on non-interventional studies (case-control studies, cohort studies, cross-sectional studies) using RV5 strain transmission as outcomes. Other study or publication types were excluded, such as pre-clinical studies, interventional studies and case reports. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was used, and study quality was assessed using the Newcastle-Ottawa Scale (NOS) for cohort studies and the JBI checklist for cross-sectional studies to assess the risk of bias. The search generated 2,089 articles in total. Seven articles met all inclusion criteria, including six cohort studies and one cross-sectional study. All studies underwent quality assessment and complied with the quality criteria of the NOS or JBI checklist, respectively. Overall, none of the seven studies identified RV5 vaccine-type transmission to an unvaccinated population, in either hospitals or nurseries under a close contact environment. One study reported that 1% of unvaccinated infants had gastrointestinal symptoms, but all symptoms were attributed to other clinical conditions. We found no evidence of horizontal transmission of RV5 strains to unvaccinated infants in a context of a limited amount and the descriptive nature of the identified studies. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective To develop and evaluate a paper-based point-of-care HPV serology test to determine if an individual has received two or more HPV immunizations. Methods The paper-based immunoassay was constructed using a nitrocellulose lateral flow strip with adsorbed HPV16 virus-like particles serving as the capturing moiety. Three capture zones containing virus-like particles were placed in series to allow for visual discrimination between high and low HPV16 plasma antibody concentrations. A plasma separation membrane was used to allow whole blood to be applied directly to the assay. All reagents were dried on glass fiber pads during device fabrication and were rehydrated with buffer at the time of use. A pilot study consisting of 35 subjects with a history of zero, one, two or three HPV vaccines was conducted to evaluate the immunoassay. The completed paper-based immunoassays were scanned for visual interpretation by three researchers who were blinded to the true results and separately evaluated quantitatively using MATLAB. Results For the 28 tests valid for analysis, fifteen subjects reported receiving two or more HPV vaccines, three reported receiving one, and ten reported having no HPV vaccinations. The paper-based immunoassays for all fifteen subjects who reported having received two or more HPV vaccines were judged positive by all researchers. Twelve of the thirteen tests from individuals reporting one or zero vaccinations were deemed negative by all observers. One test from an unvaccinated individual was judged positive by two out of three reviewers. Quantitatively, all tests were correctly separated between the two groups. Conclusions We successfully designed and tested a HPV serology test amenable to the point-of-care. The device showed promising results in a pilot study for discriminating between those who received two or more HPV vaccinations and those who did not. Furthermore, this device offers a platform for producing other semi-quantitative point-of-care serological tests. [ABSTRACT FROM AUTHOR]

Abstract This article presented the World Health Organization's (WHO) recommendations on the use of Typhoid vaccines excerpted from the Typhoid vaccines: WHO position paper – March 2018 published in the Weekly Epidemiological Record (World Health Organization, 2018) [1]. This position paper replaces the 2008 WHO position paper on typhoid vaccines (WHO, 2008) [2]. It re-emphasizes the importance of vaccination to control typhoid fever and presents the WHO recommendations on the use of a new generation of typhoid conjugate vaccines. 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/. [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization’s (WHO) recommendations on the use of human papillomavirus (HPV) vaccines excerpted from the WHO position paper on Human papillomavirus vaccines: WHO position paper, May 2017, published in the Weekly Epidemiological Record [1] . This position paper replaces the 2014 WHO position paper on HPV vaccines [2] . The position paper focuses primarily on the prevention of cervical cancer, but also considers the broader spectrum of cancers and other diseases preventable by HPV vaccination. It incorporates recent developments concerning HPV vaccines, including the licensure of a nonavalent (9-valent) vaccine and recent data on vaccine effectiveness, and provides guidance on the choice of vaccine. New recommendations are proposed regarding vaccination strategies targeting girls only or both girls and boys, and vaccination of multiple birth cohorts [3] . 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 HPV vaccines were discussed by SAGE in October 2016; evidence presented at these meetings can be accessed at: www.who.int/immunization/sage/meetings/2016/october/presentations_background_docs/en/ . [ABSTRACT FROM AUTHOR]

• Proposed a Multi Criteria Decision Making based Reverse Vaccinology model for predicting Bacterial Protective Antigens. • The proposed model tested on extracted physicochemical features from bacterial protein sequence. • Applied four strategies of Synthetic Minority Oversampling Technique and Edited Nearest Neighbour to handle the data imbalance problem. • Consider MCDM-based TOPSIS and CRITIC methods for order preference with soft and hard ranking model. Reverse vaccinology (RV) is a significant step in sensible vaccine design. In recent years, many machine learning (ML) methods have been used to improve RV prediction accuracy. However, there are still issues with prediction accuracy and programme accessibility in ML-based RV. This paper presents a supervised ML-based method to classify bacterial protective antigens (BPAgs) and identify the model(s) that consistently perform well for the training dataset. Six ML classifiers are used for testing with physiochemical features extracted from a comprehensive training dataset. Selecting the best performing model from different performance metrics (accuracy, precision, recall, F1-score, and AUC-ROC) has not been easy, because all the metrics has the same importance to predict BPAgs. To fix this issue, we propose a soft and hard ranking model based on multi-criteria decision-making (MCDM) approach for selecting the best performing ML method that classifies BPAgs. First, our proposed model uses homologous proteins (positive and negative samples) from Protegen and Uniprot databases. Second, we applied four strategies of Synthetic Minority Oversampling Technique and Edited Nearest Neighbour (SMOTE-ENN) to handle the data imbalance problem and train the model using ML methods. Third, we consider MCDM-based technique for order preference by similarity to the ideal solution (TOPSIS) method integrated with soft and hard ranking model. The entropy is used to obtain weighted evaluation criteria for ranking the models. Our experimental evaluations show that the proposed method with best performing models (Random Forest and Extreme Gradient Boosting) outperforms compared to existing open-source RV methods using benchmark datasets. [ABSTRACT FROM AUTHOR]

A global shift to bivalent mRNA vaccines is ongoing to counterbalance the diminishing effectiveness of the original monovalent vaccines due to the evolution of SARS-CoV-2 variants, yet substantial variation in the bivalent vaccine effectiveness (VE) exists across studies and a complete picture is lacking. We searched papers evaluating absolute or relative effectiveness of SARS-CoV-2 BA.1 type or BA.4/5 type bivalent mRNA vaccines on eight publication databases published from September 1st, 2022, to November 8th, 2023. Pooled VE against Omicron-associated infection and severe events (hospitalization and/or death) was estimated in reference to unvaccinated, ≥2 original monovalent doses, and ≥ 3 original monovalent doses. From 630 citations identified, 28 studies were included, involving 55,393,303 individuals. Bivalent boosters demonstrated higher effectiveness against symptomatic or any infection for all ages combined, with an absolute VE of 53.5 % (95 % CI: –22.2–82.3 %) when compared to unvaccinated and relative VE of 30.8 % (95 % CI: 22.5–38.2 %) and 28.4 % (95 % CI: 10.2–42.9 %) when compared to ≥ 2 and ≥ 3 original monovalent doses, respectively. The corresponding VE estimates for adults ≥ 60 years old were 22.5 % (95 % CI: 16.8–39.8 %), 31.4 % (95 % CI: 27.7–35.0 %), and 30.6 % (95 % CI: −13.2–57.5 %). Pooled bivalent VE estimates against severe events were higher, 72.9 % (95 % CI: 60.5–82.4 %), 57.6 % (95 % CI: 42.4–68.8 %), and 62.1 % (95 % CI: 54.6–68.3 %) for all ages, and 72.0 % (95 % CI: 51.4–83.9 %), 63.4 % (95 % CI: 41.0–77.3 %), and 60.7 % (95 % CI: 52.4–67.6 %) for adults ≥ 60 years old, compared to unvaccinated, ≥2 original monovalent doses, and ≥ 3 original monovalent doses, respectively. The bivalent boosters demonstrated superior protection against severe outcomes than the original monovalent boosters across age groups, highlighting the critical need for improving vaccine coverage, especially among the vulnerable older subpopulation. [ABSTRACT FROM AUTHOR]

This article presented the World Health Organization’s (WHO) recommendations on the use of on Bacille Calmette-Guérin (BCG) vaccine excerpted from the BCG vaccines: WHO position paper – February 2018 published in the Weekly Epidemiological Record [1] . This position paper replaces the 2004 WHO position paper on Bacille Calmette-Guérin (BCG) vaccine [2] and the 2007 WHO revised BCG vaccination guidelines for infants at risk for human immunodeficiency virus (HIV) infection [3] . It incorporates recent developments in the tuberculosis (TB) field, provides revised guidance on the immunization of children infected with HIV, and re-emphasizes the importance of the birth dose. This position paper also includes recommendations for the prevention of leprosy. 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/ [ABSTRACT FROM AUTHOR]

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 – September 2018, published in the Weekly Epidemiological Record [1]. This position paper replaces the July 2016 WHO position paper concerning the first licensed dengue vaccine, CYD-TDV [2]. The position paper presents new evidence that became available in November 2017. A retrospective analysis of data from clinical trials, using a new serological assay classified trial participants according to their dengue serostatus prior to receipt of the first vaccine dose. The analysis revealed an excess risk of severe dengue in seronegative vaccine recipients compared to seronegative non-vaccinated individuals, while confirming long-term protection in seropositive individuals [3]. The paper provides revised guidance on dengue vaccination strategies from a population health perspective. 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 dengue vaccine CYD-TDV were discussed by SAGE in April 2018; evidence presented at the meeting can be accessed at: http://www.who.int/immunization/sage/meetings/2018/april/presentations_background_docs/en/ [ABSTRACT FROM AUTHOR]

The vaccine coverage against human papillomavirus (HPV) vaccination remains low in France. The objective of this study was to study adolescent perceptions by comparing boys and girls, in order to build effective school-based interventions. This paper presents a cross-sectional study in French middle school pupils. They completed online questionnaires on their knowledge and attitudes toward the HPV vaccine, HPV vaccination status, their intention, reasons to vaccinate or not to vaccinate, and psychological antecedents of vaccination. A structural equation modeling (SEM) analysis was used to test the hypothesized model. The participants are 818 pupils aged from 12 to 16 years (M age = 13.78). Most pupils were in the pre-contemplative stage (62.7 % of boys and 40.8 % of girls). SEM analysis indicated that the relationship between the level of HPV knowledge, the representations of vaccines in general, and vaccine intention was mediated by attitudes towards the HPV vaccine among both boys and girls. These findings reveal a high percentage of boys who do not feel concerned by the HPV vaccine and highlight the need to consider the psychological antecedents of vaccination in general in addition to the specific attitudes to the HPV vaccine. [ABSTRACT FROM AUTHOR]

• Lack of expertise, integrating policy recommendations, and visibility were challenges. • Collaboration, linkages to policymakers, and effective communication were opportunities. • Optimizing the Regional NITAG Network is one of the most promising ways forward. Following the COVID-19 pandemic, the Americas faced a significant decline in vaccination coverage as well as increased vaccine hesitancy. The objective of this paper is to summarize the challenges and opportunities outlined by the National Immunization Technical Advisory Groups (NITAGs) in Latin America and the Caribbean (LAC) and prioritize targeted interventions. The exploratory survey included open-ended questions on two primary components: challenges, and opportunities. Free-text comments presented by each NITAG were collated and classified using indicators and sub-indicators of the NITAG Maturity Assessment Tool (NMAT). Opportunities were classified thematically, and priority actions were generated from the responses. All 21 NITAGs in LAC, representing 40 countries, 76 % of which have been active for over a decade, responded to the survey. The most common challenges were establishment and composition (62 %), integration into policymaking (62 %), resources and secretariat (52 %), and stakeholder recognition (48 %). The distribution of responses was seen across the whole sample and did not suggest a more pronounced need in relation to year of establishment. Opportunities included maximizing the Regional NITAG Network of the Americas (RNA) to facilitate collaboration, information sharing, visibility, and communication; existing global, regional, and systemic analyses; the World Health Organization/Pan American Health Organization (WHO/PAHO) templates for standard operating procedures; twinning programs with mature NITAGs; and NITAGs in governance structures. Action plans were outlined to formalize the establishment of NITAGs and broaden their composition; strengthen decision-making and access to data resources; and enhance the credibility of evidence-based recommendations and their uptake by policymakers and the public. NITAG challenges are not unique to LAC. NITAGs have outlined a short-term prioritized action plan which is critical to enhancing NITAG value and importance in countries. [ABSTRACT FROM AUTHOR]

• Parents' migration status is associated with infant's timely vaccination. • Having a foreign-born mother is positively associated with infant's timely vaccination. • Having a foreign-born father is positively associated with infant's timely vaccination. • Among migrant population, odds of timely vaccination decreases as length of stay increases. • Future research may explore factors behind lower rates of timely vaccination among settled migrants. Migration has been recognized as an important determinant of child health outcomes including childhood vaccination status. This paper aims to examine the association between parental migration status and a less studied aspect of child immunization outcomes, namely timeliness, within the context of New Zealand (NZ), a country characterized by a substantial proportion of its resident population born overseas. Additionally, the study explored the impact of residential duration on children's immunization timeliness. The data was taken from a large, representative population-based cohort study in NZ (Growing Up in NZ study). A total of 6156 children and their parents, comprising 2241 foreign-born and 3915 NZ-born mothers and a sub-group of their partners were included in the analysis. The survey data was linked with the National Immunization Register dataset. Timely immunization was defined as receiving two vaccines at each scheduled vaccination point (at six-week, three-month, and five-month, totaling six doses of vaccines) within 30 days of their due date. We examined the associations between parental migration status, maternal residential duration, and child immunization timeliness while controlling for socio-economic variations. The results were presented as adjusted odds ratios (AORs) with 95 % confidence intervals (CIs). The findings revealed that after adjustment for socioeconomic differences, children of foreign-born mothers exhibited higher odds of receiving all six studied vaccine doses on time compared to children of native-born mothers (AOR 1.51, 95 %CI:1.27–1.78). Similarly, having a foreign-born father was also significantly associated with timely completion of all six vaccine doses. Children of recent immigrants who had resided in the country for less than five years demonstrated higher odds of timely vaccination of all six vaccine doses compared to children of settled immigrants who had lived in the country for five or more years (AOR 1.65, 95 %CI: 1.25–2.19). This study revealed a significant pattern in NZ where immigrants exhibited higher rates of timely immunization for their children compared to native-born parents. However, the findings also underscore the importance of providing support to settled immigrants, as their children experienced declines in timely vaccination rates compared to children of recent immigrants and even those born to NZ-born parents. [ABSTRACT FROM AUTHOR]

The development of an effective combined vaccine represents a crucial strategy for preventing outbreaks of infectious diseases and reducing the burden on healthcare resources. Developing a combined vaccine against both influenza and the coronavirus is a promising approach, but it is still in the early stages of development. This paper reports on a novel combined pentavalent candidate vaccine that has shown promising results in mice, with statistically significant differences in mean antibody titer against the coronavirus and the influenza antigens compared to placebo. We have shown that the coronavirus antigen is capable of inducing an immune response autonomously, regardless of the presence of the influenza antigens in a combined vaccine. On the other hand, the presence of the coronavirus antigen in a combined vaccine showed to enhance the immune response against some of the studied influenza antigens, suggesting that these antigens may act in synergy and elicit an enhanced immune response. The absence of dose-dependent difference in mean antibody titer within the same antigenic groups of vaccine preparations suggested that even small amounts of the coronavirus and the influenza antigens could induce an immune response just as good as high-dose vaccine preparations, which certainly has important safety and cost implications. The vaccine is soon to be ready for clinical trials and mass production. [ABSTRACT FROM AUTHOR]

The U.S. Centers for Disease Control and Prevention (CDC) developed and implemented the CDC COVID-19 Vaccine Pregnancy Registry (C19VPR) to monitor vaccine safety. Potential participants who received a COVID-19 vaccine in pregnancy or up to 30 days prior to their pregnancy-associated last menstrual period were eligible to participate in the registry, which monitored health outcomes of participants and their infants through phone interviews and review of available medical records. Data for select outcomes, including birth defects, were reviewed by clinicians. In certain cases, medical records were used to confirm and add detail to participant-reported health conditions. This paper serves as a description of CDC C19VPR protocol. We describe the development and implementation for each data collection aspect of the registry (i.e., participant phone interviews, clinical review, and medical record abstraction), data management, and strengths and limitations. We also describe the demographics and vaccinations received among eligible and enrolled participants. There were 123,609 potential participants 18–54 years of age identified from January 2021 through mid-June 2021; 23,339 were eligible and enrolled into the registry. Among these, 85.3 % consented to medical record review for themselves and/or their infants. Participants were majority non-Hispanic White (79.1 %), residents of urban areas (93.3 %), and 48.3 % were between 30 and 34 years of age. Most participants completed the primary series of vaccination by the end of pregnancy (89.7 %). Many participants were healthcare personnel (44.8 %), possibly due to the phased roll-out of the vaccination program. The registry continues to provide important information about the safety of COVID-19 vaccination among pregnant people, a population with higher risk of poor outcomes from COVID-19 who were not included in pre-authorization clinical trials. Lessons learned from the registry may guide development and implementation of future vaccine safety monitoring efforts for pregnant people and their infants. [ABSTRACT FROM AUTHOR]

The Sisonke 2 study provided a homologous boost at least 6 months after administration of the priming dose of Ad26.COV2.S for healthcare workers enrolled on the Sisonke phase 3b implementation study. Safety monitoring was via five reporting sources: (i.) self-report through a web-link; (ii.) paper-based case report forms; (iii.) a toll-free telephonic reporting line; (iv.) healthcare professionals-initiated reports; and (v.) active linkage with National Disease Databases. A total of 2350 adverse events were reported by 2117 of the 240 888 (0.88%) participants enrolled; 1625 of the 2350 reported events are reactogenicity events and 28 adverse events met seriousness criteria. No cases of thrombosis with thrombocytopaenia syndrome were reported; all adverse events including thromboembolic disorders occurred at a rate below the expected population rates apart from one case of Guillain Barre Syndrome and one case of portal vein thrombosis. The Sisonke 2 study demonstrates that two doses of Ad26.COV2.S is safe and well tolerated; and provides a feasible model for national pharmacovigilance strategies for low- and middle-income settings. [ABSTRACT FROM AUTHOR]

• Background rates of maternal foetal and neonatal adverse events in South Africa have been assessed to support safety assessment of vaccines. • Retrospective review of paper-based medical records is challenging and time-consuming. • Missing data hampered alignment between clinically-reported adverse events and adverse events confirmed with GAIA case definitions. • Brighton Collaboration GAIA case definitions are useful, but some require amendments to improve utilization in real world settings. Background epidemiologic population data from low- and middle-income countries (LMIC), on maternal, foetal and neonatal adverse outcomes are limited. We aimed to estimate the incidence of maternal, foetal and neonatal adverse outcomes at South African maternal vaccine trial sites as reported directly in the clinical notes as well as using the 'Global Alignment of Immunization Safety Assessment in Pregnancy' case definitions (GAIA-CDs). GAIA-CDs were utilized as a tool to standardise data collection and outcome assessment, and the applicability and utility of the GAIA-CDs was evaluated in a LMIC observational study. We conducted a retrospective record review of maternity and neonatal case records for births that occurred in Soweto, Inner City- Johannesburg and Metro-East Cape Town, South Africa, between 1st July 2017 and 30th June 2018. Study staff abstracted data from randomly selected medical charts onto standardized study-specific forms. Incidence (per 100,000 population) was calculated for adverse maternal, foetal and neonatal outcomes, which were identified as priority outcomes in vaccine safety studies by the Brighton Collaboration and World Health Organization. Outcomes reported directly in the clinical notes and outcomes which fulfilled GAIA-CDs were compared. Incidence of outcomes was calculated by combining cases which were either reported in clinical notes by attending physicians and/ or fulfilled GAIA-CDs. Of 9371 pregnant women enrolled, 27·6% were HIV-infected, 19·9% attended antenatal clinic in the 1st trimester of pregnancy and 55·3% had ≥1 ultrasound examination. Fourteen percent of women had hypertensive disease of pregnancy, 1·3% had gestational diabetes mellitus and 16% experienced preterm labour. There were 150 stillbirths (1·6%), 26·8% of infants were preterm and five percent had microcephaly. Data available in clinical notes for some adverse outcomes, including maternal- & neonatal death, severe pre-eclampsia/ eclampsia, were able to fulfil GAIA-CDs criteria for all of the clinically-reported cases, however, missing data required to fulfil other GAIA-CD criteria (including stillbirth, gestational diabetes mellitus and gestational hypertension) led to poor correlation between clinically-reported adverse outcomes and outcomes fulfilling GAIA-CDs. Challenges were also encountered in accurately ascertaining gestational age. This study contributes to the expanding body of data on background rates of adverse maternal and foetal/ neonatal outcomes in LMICs. Utilization of GAIA-CDs assists with alignment of data, however, some GAIA-CDs require amendment to improve the applicability in LMICs. This study was funded by Pfizer (Inc). [ABSTRACT FROM AUTHOR]

During the height of the global COVID-19 pandemic, the test-negative design (TND) was extensively used in many countries to evaluate COVID-19 vaccine effectiveness (VE). Typically, the TND involves the recruitment of care-seeking individuals who meet a common clinical case definition. All participants are then tested for an infection of interest. To review and describe the variation in TND methodology, and disclosure of potential biases, as applied to the evaluation of COVID-19 VE during the early vaccination phase of the pandemic. We conducted a systematic review by searching four biomedical databases using defined keywords to identify peer-reviewed articles published between January 1, 2020, and January 25, 2022. We included only original articles that employed a TND to estimate VE of COVID-19 vaccines in which cases and controls were evaluated based on SARS-CoV-2 laboratory test results. We identified 96 studies, 35 of which met the defined criteria. Most studies were from North America (16 studies) and targeted the general population (28 studies). Outcome case definitions were based primarily on COVID-19-like symptoms; however, several papers did not consider or specify symptoms. Cases and controls had the same inclusion criteria in only half of the studies. Most studies relied upon administrative or hospital databases assembled for a different (non-evaluation) clinical purpose. Potential unmeasured confounding (20 studies), misclassification of current SARS-CoV-2 infection (16 studies) and selection bias (10 studies) were disclosed as limitations by some studies. We observed potentially meaningful deviations from the validated design in the application of the TND during the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

According to recent regulatory guidance, clinical trial objectives should be translated into estimands, i.e., precise descriptions of that what is to be estimated. Hence, estimands are to be formulated for influenza vaccine immunogenicity (IVI) trials, notably for one of the most popular immunogenicity trials, the non-inferiority trial. In this paper an estimand for this trial design is proposed. An estimand should state how intercurrent events are handled. Intercurrent events are events that occur after the start of the trial and that affect the endpoint's measurement or interpretation or prevent its observation. In IVI trials the intercurrent events of interest are immunological intercurrent events (IIEs). Major IIEs are identified, i.e., protocol deviations occurring during the trial that affect immunogenicity endpoints, and the consequences for the trial data collection are discussed. In the statistical analysis endpoint values that are missing or excluded from the analysis due to IIEs are to be substituted by plausible values, by means of multiple imputing. Replacing values are based on predictors of the endpoint. A distinction is made between mandatory and non-mandatory predictors. Mandatory predictors are predictors necessary to prevent biased prediction. Non-mandatory predictors are predictors that limit the additional variance due to the imputing. The four steps of the multiple imputing are explained, and available software is listed. [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization's (WHO) recommendations for the use of vaccines against Bordetella pertussis from the WHO position paper on Pertussis vaccines: WHO position paper—August 2015, recently published in the Weekly Epidemiological Record (Pertussis vaccines: WHO position paper. Wkly Epidemiol Rec 2015;90(August(35)):433–60). This position paper summarizes the most recent developments in the field of pertussis disease and its prevention by vaccination. It includes the WHO position on the choice of Pertussis vaccine as well as on the use of additional strategies, particularly vaccination during pregnancy, for prevention of early infant mortality. This document replaces the first WHO position paper on vaccines against disease caused by Pertussis published in 2010 (Pertussis vaccines: WHO position paper. Wkly Epidemiol Rec 2010;85(October(40)):385–400) and incorporates the revised guidance on the choice of pertussis vaccines published in July 2014 (Pertussis vaccines: WHO position paper. Wkly Epidemiol Rec 2014;89(July(30)):337–44). 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 2014 and April 2015 meetings. The evidence presented at the meetings can be accessed at http://www.who.int/immunization/sage/previous/en/index.html . [ABSTRACT FROM AUTHOR]

Abstract: This article presents the WHO recommendations on the use of rabies vaccines excerpted from the recently published Rabies vaccines: WHO position paper. This document replaces the WHO position paper entitled Rabies vaccines WHO position paper published in the Weekly Epidemiological Record in December 2007. Footnotes to this paper provide a limited number of core references; their abstracts as well as a more comprehensive list of references may be found at http://www.who.int/immunization/documents/positionpapers/en/index.html. Grading tables which assess the quality of scientific evidence for key conclusions are also available through this link and are referenced in the position paper. 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 updated paper reflects the recent recommendations of WHO''s Strategic Advisory Group of Experts on immunization, or SAGE. [Copyright &y& Elsevier]

• We compared the perceptions of patients regarding vaccination and the evaluation of these perceptions by their general practitioners. • Three axes were explored: vaccine safety; vaccine efficacy; 'being in favour of vaccination'. • We observed a correlation between the patient perceptions and their evaluation by the physicians. • The median difference (in absolute values) between physician evaluations and patient perceptions was between 9 and 11 (0–100 scale) for the three axes. • Physicians identified most of the patients with good perceptions regarding vaccination but only a fraction of those with poor perceptions. • This result suggests that doctors need to bear in mind that what they perceive to be their patients' attitudes to vaccination may be wrong, although this should not prevent them from making the case for vaccines. The high level of vaccine hesitancy reported in the French population may lead general practitioners to anticipate difficult discussions on this topic. We aimed to assess the extent to which general practitioners' evaluation of their patients' vaccine hesitancy was correlated with the real vaccine hesitancy expressed by these patients. The study was based on two brief paper questionnaires completed in private by the general practitioner and the patient at the beginning of a medical appointment: one for the physician to evaluate on three quantitative and non-graduated visual scales (then analysed as a 0–100 scale) their patients' perceptions regarding vaccine safety, vaccine efficacy and 'being in favour of vaccination'; and one for the patient to express their perceptions for the same three axes using the same scales. Overall, 31 physicians participated in the study, with 540 physician-patient pairs being included. The physicians' evaluation of patient perceptions was more positive when the physician was male (vs female), when the patient was male (vs female) and when both were males (vs both females). The median differences (in absolute values) between the physician evaluations and the patient perceptions were between 9 and 11 (on the 0–100 scale) for the three axes (vaccine safety, vaccine efficacy and 'being in favour'). A correlation was observed between the physicians' evaluation and the patients' declaration (Kendall test: vaccine efficacy: tau = 0.199, p < 0.001; vaccine safety: tau = 0.234, p < 0.001; being in favour of vaccination: tau = 0.365, p < 0.001). Physicians correctly classified 83.4 % of the patients with high perceptions of vaccine safety and efficacy (>75/100 for both scales) but only 54.5 % of those with low perceptions (<75/100 for both scales). Physicians tend to correctly identify patients with the most favourable perceptions about vaccination but not those with the least favourable perceptions. [ABSTRACT FROM AUTHOR]

Conducting a vaccine trial in a low- and middle-income country (LMIC) can present unique challenges and lessons learned. This Ebola vaccine trial, enrolling 699 healthcare providers and frontliners and jointly set up by the University of Antwerp (Sponsor) and the University of Kinshasa (Principal Investigator (PI)), was conducted in Boende, a remote city in the Democratic Republic of the Congo (DRC), between December 2019 and October 2022 (ClinicalTrials.gov : NCT04186000). While being bound by strict ICH-GCP and international funder regulations, this trial, exemplary for being a public–private partnership, required collaboration between several international stakeholders (e.g., two universities, a pharmaceutical company, and a clinical research organization), local communities and government agencies. Here we address several logistical and administrative challenges, cultural differences, language barriers and regulatory, political, and ethical considerations over the trial's 2.5-year duration, while tailoring and adapting the study to the specific local context. Lessons learned include the importance of clear communication with participants in all phases of the study, but also within the study team and among different stakeholders. Challenges, mitigations, and lessons learned are presented in nine categories (e.g., safety management; trial documentation, tools, and materials; communication, staff training and community engagement/sensitization; financial and administrative hurdles; and more). Ultimately, to reach the successful end of the vaccine trial in this remote Ebola endemic area in the DRC, careful planning, collaboration, and great flexibility and adaptability was often required from all involved partners. Despite the encountered challenges, the vaccine trial discussed in this paper was able to obtain high participant retention rates (i.e., 92% of participants completed the study). We hope that other international teams aspiring to conduct similar trials in remote areas of LMICs can learn from the way our challenges were addressed, mitigations developed, and lessons were learned. [ABSTRACT FROM AUTHOR]

• HIV+ individuals are an important subpopulation in areas at risk of an Ebola outbreak. • The Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen induced antibodies that persisted 4·5 years. • Ad26.ZEBOV booster dose is safe and highly immunogenic in previously immunized HIV+ adults. • Ad26.ZEBOV boosters can be deployed safely to HIV+ adults with well-controlled infection. People living with HIV constitute an important part of the population in regions at risk of Ebola virus disease outbreaks. The two-dose Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen induces strong immune responses in HIV-positive (HIV+) adults but the durability of this response is unknown. It is also unclear whether this regimen can establish immune memory to enable an anamnestic response upon re-exposure to antigen. This paper describes an open-label, phase 2 trial, conducted in Kenya and Uganda, of Ad26.ZEBOV booster vaccination in HIV+ participants who had previously received the Ad26.ZEBOV, MVA-BN-Filo primary regimen. HIV+ adults with well-controlled infection and on highly active antiretroviral therapy were enrolled, vaccinated with booster, and followed for 28 days. The primary objectives were to assess Ad26.ZEBOV booster safety and antibody responses against the Ebola virus glycoprotein using the Filovirus Animal Non-Clinical Group ELISA. The Ad26.ZEBOV booster was well-tolerated in HIV+ adults with mostly mild to moderate symptoms. No major safety concerns or serious adverse events were reported. Four and a half years after the primary regimen, 24/26 (92 %) participants were still classified as responders, with a pre-booster antibody geometric mean concentration (GMC) of 726 ELISA units (EU)/mL (95 %CI 447–1179). Seven days after the booster, the GMC increased 54-fold to 38,965 EU/mL (95 %CI 23532–64522). Twenty-one days after the booster, the GMC increased 176-fold to 127,959 EU/mL (95 %CI 93872–174422). The responder rate at both post-booster time points was 100 %. The Ad26.ZEBOV booster is safe and highly immunogenic in HIV+ adults with well-controlled infection. The Ad26.ZEBOV, MVA-BN-Filo regimen can generate long-term immune memory persisting for at least 4·5 years, resulting in a robust anamnestic response. Trial Registration: Pan African Clinical Trial Registry (PACTR202102747294430). Clinicaltrials.gov (NCT05064956). [ABSTRACT FROM AUTHOR]

While Canada has had relatively high vaccination rates against COVID-19, specifically during earlier waves of the pandemic, vaccine hesitancy has continued to serve as a significant barrier to adequate protection against the virus and, more recently, booster vaccine uptake. This paper explores the processes underlying Canadians' perceptions of COVID-19 vaccines and their decisions to take or refuse them, as well as how public policy and health messaging about vaccination has influenced vaccination attitudes and behaviors. Our focus group interviews with 18 vaccinated and unvaccinated adult Canadians conducted during October 2021 reveal that, in some respects, COVID-19 vaccine hesitancy conforms to prior knowledge about some of the factors that affect vaccine attitudes (e.g., the influence of known medical providers) but deviates from current theoretical frameworks regarding general vaccine hesitancy. Specifically, these frameworks emphasize a lack of scientific knowledge and literacy ("knowledge deficit" accounts) or individuals' inability to incorporate rational risk perceptions into initial emotional responses to vaccines ("emotionality/irrationality" accounts). In contrast to the knowledge deficit account, we find that expressions of COVID-19 vaccine hesitancy were most frequently associated with an information surplus or inability to prioritize information from multiple and often contradictory sources. Furthermore, top-down pro-vaccination messaging often triggered significant pushback against what participants perceived as moral shaming of the unvaccinated. Our findings demonstrate the necessity for a new framework to understand and address vaccine hesitancy. A better theoretical account of vaccine hesitancy has important implications for future vaccination efforts, specifically within the context of new variants and low booster vaccination rates in Canada. [ABSTRACT FROM AUTHOR]

• 43 % of WHO member states have school vaccine mandates, but policy details vary. • Some mandates have begun to include education components for non-vaccinating parents/guardians. • Currently, education components are used only in Canada and the U.S.; most are online modules. • Evidence suggests in-person counseling is associated with decreased non-medical exemptions. • Additional research, especially on online module education components, is required. School vaccine mandates (SVMs) are population health interventions that require monitoring and communicating about vaccination of school-aged children, with an aim of controlling infectious disease outbreaks. While 43 % of World Health Organization member states report having some sort of SVM, their details vary. A newer element of some SVMs is an "education component" requiring compulsory information, education, or counseling of parents/guardians who decline to vaccinate their children for non-medical reasons. This environmental scan sought, mapped, and synthesized evidence on the existence, format, and impacts of education components of SVMs in 18 affluent Organization for Economic Co-operation and Development comparator countries. We found current SVMs in nine of the 18 comparator countries, but education components to those SVMs only in Canada (n = 2) and the U.S. (n = 9), where such policies were made at the provincial/state level. The earliest was implemented in 2011 and most recent has not yet been implemented. Education components were used as requirements for obtaining non-medical exemptions from SVMs, and involved either an informational paper to be read and signed, a counseling or information session from a health professional (public health worker or licensed provider such as family doctor), or an online module to be completed. Peer-reviewed research on in-person sessions suggests association with at least short-term increased vaccine uptake and reduction of non-medical exemptions. Available data on online module education components suggests similar impacts, but research to date is limited. SVMs with educational components are uncommon but have been increasing since 2011. The details of these education components vary, although topics covered in online modules are relatively consistent. Evidence to date suggests at least short-term reduction in non-medical exemptions associated with implementation of SVM education components, but additional research is required to follow-up and confirm, especially as regards online education modules. [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization’s (WHO) updated recommendations on the use of meningococcal vaccines excerpted from the WHO position paper on Meningococcal A conjugate vaccine: updated guidance, February 2015, published in the Weekly Epidemiological Record [1] . A position paper on meningococcal vaccines was published in 2011 and its recommendations remain valid [2] . This update adds to the previous recommendations specifically concerning routine immunization of infants and young children in the African meningitis belt with meningococcal A conjugate vaccine. 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. Recommendations on the use of the Meningococcal A conjugate vaccine were discussed by SAGE in October 2014; evidence presented at these meetings can be accessed at: http://www.who.int/immunization/sage/meetings/2014/october/presentations_background_docs/en/ . [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization’s (WHO) recommendations on the use of fractional doses of yellow fever vaccines excerpted from the “Yellow fever vaccine: WHO position on the use of fractional doses – June 2017, Addendum to Vaccines and vaccination against yellow fever WHO: Position Paper – June 2013 ″, published in the Weekly Epidemiological Record [1,2] . This addendum to the 2013 position paper pertains specifically to use of fractional dose YF (fYF) vaccination (fractional dose yellow fever vaccination refers to administration of a reduced volume of vaccine dose, which has been reconstituted as usual per manufacturer recommendations) in the context of YF vaccine supply shortages beyond the capacity of the global stockpile. The current WHO position on the use of yellow fever (YF) vaccine is set out in the 2013 WHO position paper on vaccines and vaccination against YF and those recommendations are unchanged. 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 Yellow Fever vaccines were discussed by SAGE in October 2016; evidence presented at these meetings can be accessed at: www.who.int/immunization/sage/meetings/2016/October/presentations_background_docs/en/ . [ABSTRACT FROM AUTHOR]

• The COVID-19 pandemic has challenged traditional vaccine guidance infrastructure. • NACI made many strategic adaptations to facilitate timely vaccine advice in Canada. • The pandemic highlighted critical roles for NITAGs in vaccine program design. • Learning from COVID-19 pandemic adaptations, we see a roadmap for future pandemics. The COVID-19 pandemic has challenged traditional vaccine guidance infrastructure and frameworks, and added urgency and complexity to the operation of National Immunization Technical Advisory Groups (NITAGs). Canada's National Advisory Committee on Immunization (NACI) provides immunization guidance to the Public Health Agency of Canada (PHAC) who publicly shares expert and evidence-informed guidance with Canadian provinces and territories. Throughout the pandemic, NACI and PHAC implemented many adaptations to meet urgent needs for pandemic vaccine guidance. In this paper, we describe: structural adaptations in response to the accelerated pace and amount of work required to issue recommendations that were timed around product authorizations and dynamic epidemiology; technical adaptations in response to rapidly evolving evidence of variable quality which required close monitoring, and which promoted reliance on basic vaccine principles due to incomplete direct evidence; the need to provide nimble advice (e.g., off-label recommendations, preferential recommendations); communications adaptations (e.g. identify sustainable spokespeople for the committee, receive stakeholder feedback, and ensure urgent nuanced advice was communicated to a diverse audience); and research adaptations focussing on solutions to constrained supply (e.g. prioritisation, extended intervals, and heterologous schedules). The early pandemic vaccine experience has created a roadmap of lessons and adaptations that should be leveraged in future pandemic vaccine programs, and has highlighted the essential role of NITAGs to complement regulatory structures during pandemics to ensure timely, impactful, and evidence-informed public health vaccine guidance. [ABSTRACT FROM AUTHOR]

• Overall levels of vaccine uptake in England are high. • Children from London or of Black ethnicity show different vaccine uptake patterns in comparison to children from other regions or other ethnicities. • The later a vaccine was recommended within the vaccination schedule, the more likely it was not given in time. • Delay of previous vaccine doses was an indicator of delaying subsequential doses. Vaccine surveillance for children in England focuses on coverage at ages 1, 2, and 5 years. Previous studies exploring vaccine timeliness have used different arbitrary categories to define whether vaccines were received 'late' or 'on time'. This paper aims to provide more detailed and holistic information on timing and patterns of vaccine uptake across the childhood immunisation schedule in England. We included all children born in England between 2006 and 2014 and registered in the Clinical Practice Research Datalink (CPRD) Aurum, a primary care electronic health record. We described vaccine uptake for representative antigens (pertussis, pneumococcus, measles) by age in days and stratified by ethnicity, region and birth cohort. Alluvial diagrams were used to illustrate common journeys through the vaccination schedule, and we applied survival analysis using accelerated failure time models (AFT) to predict age of vaccine receipt based on timing of previous doses. 573,015 children were followed up until their fifth birthday, when they had 90.16 % coverage for two doses of measles, mumps, rubella (MMR) vaccine and 88.78% coverage for four doses of diphtheria, tetanus, pertussis (DTP) vaccine. Overall, the later the age at which a vaccine was due, the more delay in vaccination. Children of Black Ethnicity or from London showed deviating uptake patterns. If a child received their third DTP dose more than a year later than recommended, they would receive the next dose 2.7 times later than a child who was vaccinated on time. A smaller delay was found for children who did not receive first MMR dose on time. We showed that the risk of vaccination delay increased with the age of the child and significant delay of previous doses. Primary care data can help to promptly identify children at higher risk of delayed vaccination. [ABSTRACT FROM AUTHOR]

• COVID-19 vaccine hesitancy was heterogeneous both in terms of time and magnitude. • Following COVID-19 news, trust levels, risk preferences, and vaccine confidence predicted intention reversals. • Lowering the cost of following the news for the population may raise vaccine uptake. This paper investigates the prevalence and determinants of three main states of people's willingness to be vaccinated (WTBV) against COVID-19 – willing, unwilling and hesitant – and the occurrence and predictors of shifts between these states over time. Understanding the dynamics of vaccine intentions is crucial for developing targeted campaigns to increase uptake and emergency response preparedness. A panel survey consisting of 9 quarterly waves of data collected between April 2020 and January 2022. Baseline data included 24 952 adults from Germany, UK, Denmark, the Netherlands, France, Portugal, and Italy recruited from online panels to construct census-matched nationally representative samples. Self-reported COVID-19 vaccine intention was the main outcome. Multinomial logit random effects models were used to analyze the relationships of interest. All results reported as relative risk ratios (RRR). Hesitancy to get vaccinated was the most unstable vaccine intention, with on average 42% of ever hesitant respondents remaining in this state through future waves, followed by the 'unwilling' (53%) and 'willing (82%). Following COVID-19 news, trust in information from the government, GPs and the WHO, risk preferences, risk perceptions, and confidence in vaccines (or lack thereof) predicted vaccination intention reversals. Risk preferences acted both as an impediment and as a facilitator for the vaccine uptake depending on the initial vaccine intention. This study revealed the dynamic nature of COVID-19 vaccine intentions and its predictors in 7 European countries. The findings provide insights to policymakers for designing more effective communication strategies, particularly targeted at hesitant and unwilling to vaccinate population groups, to increase vaccine uptake for future public health emergencies. [ABSTRACT FROM AUTHOR]

• The pandemic pushed vaccine mandates to the forefront of global public health policy. • This special issue synthesises the findings of research in the field. • Scholars employ a range of methodologies to study speculative and real mandates. • Scholars study vaccine mandates at different stages of the policy cycle. • Scholars analyse mandates' impact on vaccine coverage rates and wider experiences. A workshop on mandatory vaccination was pitched to the World Public Health Congress in 2019 and the resultant special issue was pitched to Vaccine in 2020. During this project, the COVID-19 pandemic pushed vaccine policy to the forefront of global public health policy, and the imposition of vaccine mandates prompted a new wave of scholarship in the field. This introductory article employs the heuristic of Lasswell's (1956) policy cycle to synthesise the findings of the articles in the special issue. It considers the temporal lifetime of mandates and highlights findings regarding: the emergence of mandates as a policy option, public support and policy instrument design, what matters in the implementation of mandates, and what we can learn from evaluating them. The second half of the paper categorizes the included papers in terms of what aspects of mandates they study and the methods they employ to do so, in order to formulate a guide for future researchers of vaccine mandates. Scholars study either speculative or existing mandates – research can address several stages of the policy cycle or just one of them, ranging from attitudinal research to implementation studies and impact studies. Historical and contextual studies that take deep dives into a particular mandate are a much needed resource for studying emerging mandates, too, and scoping and framework- building work will undoubtedly be valuable in understanding and appreciating the wealth of knowledge production in this growing field. This special issue can serve as a roadmap for a consolidation of this interdisciplinary research agenda, and provide a helpful resource for decisionmakers at this historical juncture. [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization's (WHO) recommendations for the use of varicella and herpes zoster vaccination from the WHO position paper on varicella and herpes zoster vaccines – June 2014, published in the Weekly Epidemiological Record [1] . This position paper summarizes the WHO position on the use of varicella and herpes zoster vaccines. The current document replaces the position paper on the use of varicella vaccines published in 1998 [2] . 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 2014 meeting. Evidence presented at the meeting can be accessed at http://www.who.int/immunization/sage/previous/en/index.html . [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization’s (WHO) recommendations on the use of polio vaccine excerpted from the WHO position paper on polio vaccines – March 2016, published in the Weekly Epidemiological Record [1] . This position paper on polio vaccines replaces the 2014 WHO position paper [2] . The position paper summarizes the WHO position on the introduction of at least one dose of inactivated polio vaccine (IPV) into routine immunization schedules as a strategy to mitigate the potential risk of re-emergence of type 2 polio following the withdrawal of Sabin type 2 strains from oral polio vaccine (OPV) [3] . 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 position paper reflects the global switch from trivalent to bivalent OPV which took place in April 2016. Recommendations on the use of polio vaccines have been discussed on multiple occasions by SAGE, most recently in October 2016; evidence presented at these meetings can be accessed at: http://www.who.int/immunization/sage/previous/en/index.html . [ABSTRACT FROM AUTHOR]

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 [1] . 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 [2] . 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 . [ABSTRACT FROM AUTHOR]

Social media spreads information about vaccines and can be used to better understand public attitudes about them. Using American crowdfunding campaigns that mentioned COVID-19 vaccines from January 2020 to March 2021, this paper investigates public attitudes towards vaccines, specifically the perceived role vaccines could (or couldn't) play in ending the pandemic. We identified 776 crowdfunding campaigns and coded each for their aims and whether they valued vaccines as returning their community to a pre-pandemic state (utopian), helping some but not all people (cautious), and doubtful about the likely positive impacts of vaccines (skeptical). Cautious and skeptical valuations increased over time whereas utopian views declined. This paper uniquely situates attitudes toward COVID-19 vaccines in the context of financial need (as characterized by the campaigners). It offers insight into the "vaccine class gap" in America and demonstrates the usefulness of crowdfunding campaigns for assessing public views on vaccines. [ABSTRACT FROM AUTHOR]

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 . [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization's (WHO) recommendations for the use of vaccines against diseases caused by human papillomaviruses (HPV) from the WHO position paper on Human papillomavirus vaccines: WHO position paper – October 2014, recently published in the Weekly Epidemiological Record [1] . This position paper summarizes the most recent developments in the field of HPV vaccines and the WHO position on HPV vaccine schedules in females. This document replaces the first WHO position paper on vaccines against diseases caused by HPV published in 2009 [2] . 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 2014 meeting. Evidence presented at the meeting can be accessed at http://www.who.int/immunization/sage/previous/en/index.html . [ABSTRACT FROM AUTHOR]

Influenza causes excessive morbidity and mortality among older adults. While influenza vaccine provides protection against its infection, the vaccination coverage in China among older adults has been very low. Previous evidence on the cost-effectiveness of government-sponsored free influenza vaccination programs in China was primarily based on literature data, which might not always reflect real-world patient populations. The Yinzhou Health Information System (YHIS) is a regional database that captures electronic health records, insurance claims data, etc. for all residents in Yinzhou district, Zhejiang province, China. We will use YHIS to study the effectiveness, influenza-related direct medical cost and cost-effectiveness analysis (CEA) of the free influenza vaccination program for older adults. In this paper, we describe the study design and innovations in detail. We will establish a retrospective cohort of permanent older residents aged 65 and over, using YHIS between 2016 and 2021. We will estimate the vaccine coverage rate, influenza incidence rate and influenza-related direct medical cost from 2016 to 2021. Regression discontinuity will be used to estimate vaccine effectiveness for the 2020/2021 season. We will build a decision tree model to compare the cost-effectiveness of three influenza vaccination options (free trivalent influenza vaccine, free quadrivalent influenza vaccine, and no policy) from both societal and health system perspectives. Parameter inputs will be gathered from both YHIS and published literature. We will calculate the incremental cost-effectiveness ratio with cost and quality-adjusted life years (QALYs) discounted at 5 % annually. Our CEA solidifies multiple sources including regional real-world data and literature for a rigorous evaluation of the government-sponsored free influenza vaccination program. The results will provide real-world evidence from real-world data on the cost-effectiveness of a real-world policy. Our findings are expected to support evidence-based policy making and to promote health for older adults. [ABSTRACT FROM AUTHOR]

• Examine vaccine hesitancy after COVID-19 vaccines became widely available for Americans. • Focus on individual trust in the COVID-19 vaccine, government, and value orientation. • Distinct decision-making patterns for three contrasting pairs of vaccine hesitancy. • Reducing scepticism on vaccine breakthrough and boosters to increase vaccine rate. • Shifting from personal choice to social responsibility to increase the vaccination rate. COVID-19 vaccine hesitancy studies, most of which were completed prior to the release of the vaccine, speculated on factors that might influence inoculation intention when a vaccine was introduced. This paper examines actual vaccination decisions among US residents after COVID-19 vaccines were approved, with a focus on trust in vaccine effectiveness, increased trust in government pandemic response, and individual-versus-collective value orientation. The data set was from the Kaiser Family Foundation COVID-19 Vaccine Monitor, a nationally representative sample reflecting the opinions of 1519 American adults aged 18 and above. Data were collected in September 2021—approximately nine months after the first COVID-19 vaccines were approved for distribution. Indicators of trust in vaccine effectiveness included individual opinions regarding breakthrough infections and vaccine boosters. Increased trust in government indicated approval of official COVID-19 responses, and value orientation denoted respondent emphasis on personal choice versus protecting the health of others. We established three categories of a vaccine hesitancy dependent variable: none, some , and full rejection. A multinomial regression analysis was employed to compare vaccine hesitancy in three pairs of contrasting groups. While we noted distinct patterns in decision-making factors for each of the contrasting pairs, we also observed strong effects for trust in vaccine effectiveness and value orientation on vaccine decisions across all three. Both effects were more substantial than those associated with three control variables—social-demographic characteristics, political party affiliation, and health risk. Our findings suggest that in order to increase vaccination rates, policymakers and influencers should focus on reducing individual scepticism over breakthrough infections and vaccine boosters, and on influencing a value orientation shift from personal choice to social responsibility. [ABSTRACT FROM AUTHOR]

• VAX-ID, a novel drug delivery device, allowed for reliable intradermal injections. • The device was rated as easy to use by healthcare professionals. • The dead space volume of 24 µL was below the set volume of 35 µL as defined by EMA. • Piglets of 12 kg were demonstrated to be a good model to mimic human skin. The recent SARS-Cov2 pandemic and mpox health emergency have led to renewed interest in intradermal vaccination due to its dose sparing potential. Indeed, intradermal vaccination is particularly of interest for use in mass vaccination campaigns, pandemic preparedness programs, and/or for vaccines that are expensive or in short supply. Moreover, the rich immune network in the skin makes it an attractive target not only for prophylactic vaccination, but also for therapeutic vaccination, like immunotherapy and (dendritic) cell-based therapies. The aim of the current paper was to provide an overview of preclinical data generated with VAX-ID®, a novel intradermal drug delivery device, to allow assessing it performance, safety and usability. The device can overcome challenges seen with the Mantoux technique whereby the needle needs to be inserted under a shallow angle. Various parameters of VAX-ID® were evaluated, including dead-space volume, dose accuracy, penetration depth & liquid deposit in piglets, as well as usability by healthcare professionals. The device has shown to have a low dead volume and a high dose accuracy. Importantly, the device performed successful injections at a predefined depth into the dermis with a high safety profile as confirmed by visual and histological evaluation in piglets. Moreover, the device was rated as easy to use by healthcare professionals. The combined preclinical performance and usability findings indicate that VAX-ID® can provide reliable, standardized and accurate drug delivery in the dermal layer of the skin with a high ease of use. The device offers a solution for injection of various prophylactic as well as therapeutic vaccines. [ABSTRACT FROM AUTHOR]

• Heterologous mRNA boost following GLS-5310 DNA vaccination was well tolerated. • Neutralizing antibody responses were enhanced 110 fold to GMT of 1244.8. • Binding antibody responses were enhanced 1,187-fold to GMT of 405,920. • Boosted antibody responses similar to other vaccine combinations. • Boosted T cell responses were many-fold higher than other vaccine combinations. Heterologous boost regimens are being increasingly considered against SARS-CoV-2. We report results for the 32 of 45 participants in the Phase 1 CoV2-001 clinical trial (Kim et al., Int J Iinfect Dis 2023, 128:112–120) who elected to receive an EUA-approved SARS-CoV-2 mRNA vaccine 6 to 8 months following a two-dose primary vaccination with the GLS-5310 bi-cistronic DNA vaccine given intradermally and followed by application of suction using the GeneDerm device. Receipt of EUA-approved mRNA vaccines after GLS-5310 vaccination was well-tolerated, with no reported adverse events. Immune responses were enhanced such that binding antibody titers, neutralizing antibody titers, and T-cell responses increased 1,187-fold, 110-fold, and 2.9-fold, respectively. This paper is the first description of the immune responses following heterologous vaccination with a DNA primary series and mRNA boost. [ABSTRACT FROM AUTHOR]

Even though the immediate urgency of the COVID-19 pandemic seems to have passed, many countries did not reach the vaccination rates they initially aimed for. The stagnation in vaccine uptake during the height of the pandemic presented policy makers with a challenge that remains unresolved and is paramount for future pandemics and other crises: How to convince the (often not insubstantial) unvaccinated proportion of the population of the benefits of a vaccination? Designing more successful communication strategies, both in retrospect and looking ahead, requires a differentiated understanding of the concerns of those that remain unvaccinated. Guided by the elaboration likelihood model, this paper has two objectives: First, it explores by means of a latent class analysis how unvaccinated individuals might be characterized by their attitudes towards COVID-19 vaccination. Second, we investigate to what extent (i) varying types of evidence (none/anecdotal/statistical) can be employed by (ii) different types of communicators (scientists/politicians) to improve vaccination intentions across these subgroups. To address these questions, we conducted an original online survey experiment among 2145 unvaccinated respondents from Germany where a substantial population share remains unvaccinated. The results suggest three different subgroups, which differ regarding their openness towards a COVID-19 vaccination: Vaccination opponents (N = 1184) , sceptics (N = 572) and those in principle receptive (N = 389) to be vaccinated. On average, neither the provision of statistical nor anecdotal evidence increased the persuasiveness of information regarding the efficacy of a COVID-19 vaccine. However, scientists were, on average, more persuasive than politicians (relatively increase vaccination intentions by 0.184 standard deviations). With respect to heterogeneous treatment effects among the three subgroups, vaccination opponents seem largely unreachable, while sceptics value information by scientists, particularly if supported by anecdotal evidence (relatively increases intentions by 0.45 standard deviations). Receptives seem much more responsive to statistical evidence from politicians (relatively increases intentions by 0.38 standard deviations). [ABSTRACT FROM AUTHOR]