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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., (Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: 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., Method: 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., Results: 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., Conclusion: 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., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: A.S. and M.I.G. were part of an external evaluation team contracted to evaluate different aspects of MyChild Solution including data quality in 2019., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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/., (Copyright © 2018 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

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/., (Copyright © 2017. Published by Elsevier Ltd.)

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/., (Copyright © 2017. Published by Elsevier Ltd.)

This article presents the World Health Organization's (WHO) recommendations on the use of tetanus toxoid (TT) vaccines excerpted from the WHO position paper on tetanus vaccines - February 2017, published in the Weekly Epidemiological Record [1]. This position paper replaces the May 2006 WHO position paper on tetanus vaccines (Tetanus vaccines: WHO position paper, 2006). The position paper summarizes the recent developments in the field of tetanus prevention and provides revised guidance on the optimal timing of recommended tetanus vaccine booster doses. 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 TT-containing vaccines (TTCVs) were discussed by SAGE in October 2016; evidence presented at the meeting can be accessed at: http://www.who.int/immunization/sage/meetings/2016/october/presentations_background_docs/en/., (Copyright © 2017 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

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/., (Copyright © 2018. Published by Elsevier Ltd.)

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/., (Copyright © 2018 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

This article presents the World Health Organization's (WHO) recommendations on the use of malaria vaccine excerpted from the WHO position paper on malaria vaccine published in the Weekly epidemiological Record in January 2016 [1]. The current document is the first WHO position paper on malaria vaccination and focuses primarily on the available evidence concerning the only malaria vaccine having received a positive regulation assessment from the European Medicines Agency (EMA) [2]. 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 joint recommendation of the WHO's Strategic Advisory Group of Experts (SAGE) on immunization and the Malaria Policy Advisory Committee (MPAC). These recommendations were discussed by SAGE and MPAC at the October 2015 SAGE meeting. Evidence presented at the meeting can be accessed at http://www.who.int/immunization/sage/previous/en/index.html., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

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/., (Copyright © 2017 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

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/., (Copyright © 2017 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

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/., (Copyright © 2017. Published by Elsevier Ltd.)

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/., (Copyright © 2018 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

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/., (Copyright © 2017. Published by Elsevier Ltd.)

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., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

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/., (Copyright © 2017. Published by Elsevier Ltd.)

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., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2015 The World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

This article presents the World Health Organization's (WHO) recommendations on the use of hepatitis E vaccine excerpted from the WHO position paper on hepatitis E vaccines - May 2015 recently published in the Weekly Epidemiological Record [1]. The current document is the first WHO position paper on hepatitis E vaccination and focuses primarily on the available evidence concerning the only hepatitis E vaccine that is currently licensed. The position paper gives consideration to the epidemiological features of the disease and assesses the 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. 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., (Copyright © 2015 The World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

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., (Copyright © 2015 The World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

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., (Copyright © 2015 The Author. Published by Elsevier Ltd.. All rights reserved.)

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., (Copyright © 2014. Published by Elsevier Ltd.)

This article presents the World Health Organization's (WHO) recommendations for pain mitigation at the time of vaccination from the WHO position paper on reducing pain at the time of vaccination: WHO position paper-September 2015, recently published in the Weekly Epidemiological Record [1]. This position paper summarizes the evidence and integrates information pertaining to the reduction of pain, distress and fear during immunization across all age groups. 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, and on vaccination-related policy questions particularly concerning the use of vaccines in large-scale immunization programmes. They summarize essential background information and conclude with the current WHO position. This position paper addresses a cross-cutting issue which is relevant for all injectable vaccines and reflects the recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization. These recommendations were discussed by SAGE at its April 2015 meeting. The evidence presented at the meetings can be accessed at http://www.who.int/immunization/sage/previous/en/index.html., (Copyright © 2016 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

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., (Copyright © 2016 The World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available evidence strongly supported the safety of the currently recommended schedule as a whole, additional observational research was warranted to compare health outcomes between fully vaccinated children and those on a delayed or alternative schedule. In addition, the IOM identified the Vaccine Safety Datalink (VSD) as an important resource for conducting this research. Guided by the IOM findings, the Centers for Disease Control and Prevention (CDC) commissioned a White Paper to assess how the VSD could be used to study the safety of the childhood immunization schedule. Guided by subject matter expert engagement, the resulting White Paper outlines a 4 stage approach for identifying exposure groups of undervaccinated children, presents a list of health outcomes of highest priority to examine in this context, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias. In light of these considerations, decisions about conducting studies of the safety of the schedule will also need to assess epidemiological evidence of potential adverse events that could be related to the schedule, the biological plausibility of an association between an adverse event and the schedule, and public concern about the safety of the schedule., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Most influenza vaccines are generally safe, but influenza vaccines can cause rare serious adverse events. Some adverse events, such as fever and febrile seizures, are more common in children than adults. There can be differences in the safety of vaccines in different populations due to underlying differences in genetic predisposition to the adverse event. Live attenuated vaccines have not been studied adequately in children under 2 years of age to determine the risks of adverse events; more studies are needed to address this and several other priority safety issues with all influenza vaccines in children. All vaccines intended for use in children require safety testing in the target age group, especially in young children. Safety of one influenza vaccine in children should not be extrapolated to assumed safety of all influenza vaccines in children. The low rates of adverse events from influenza vaccines should not be a deterrent to the use of influenza vaccines because of the overwhelming evidence of the burden of disease due to influenza in children., (Copyright © 2016. Published by Elsevier Ltd.)

Background: The antigen VAR2CSA plays a pivotal role in the pathophysiology of pregnancy-associated malaria (PAM) caused by Plasmodium falciparum. A VAR2CSA-based vaccine candidate, PAMVAC, is under development by an EU-funded multi-country consortium (PlacMalVac project). As part of PAMVAC's clinical development, we quantified naturally acquired vaccine antigen-specific memory B and T cell responses in Beninese primigravidae recruited at the beginning of pregnancy and followed up to delivery and beyond., Methods: Clinical and parasitological histories were compiled from monthly clinic visits. On 4 occasions (first and fifth month of pregnancy, delivery, 6months post-delivery) peripheral blood mononuclear cells were isolated for in vitro assays. PAMVAC-specific memory B cells as well as those specific for a PAM unrelated P. falciparum antigen (PfEMP1-CIDR1a) and for tetanus toxoid were quantified by ELISpot. Memory T cell responses were assessed by quantifying cytokines (IL-5, IL-6, IL-10, IL-13, IFN-γ, TNF-α) in supernatants of cells stimulated in vitro either with PAMVAC, or mitogen (PHA)., Results: Both tetanus toxoid- and PAMVAC-specific memory B cell frequencies increased to reach peak levels in the 5th month and at delivery, respectively and persisted post-delivery. The frequency of CIDR1a-specific memory B cells was stable during pregnancy, but declined post-delivery. The cumulated prevalence of infection with P. falciparum during pregnancy was 61% by microscopy. In women with a history of such infections, a significantly higher frequency of PAMVAC-specific memory B cells was observed at delivery. PAMVAC-specific pro-inflammatory (IFN-γ, TNF) responses tended to be higher at delivery in those with a history of infection. Mitogen-induced IL-5/IL-13 responses were significantly enhanced in the same women., Conclusions: PAMVAC-specific memory B cells are induced during first pregnancies and are maintained post-delivery. Women with a T helper cell profile biased towards production of Th2-type cytokines have a greater risk of infection with P. falciparum., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Edward Jenner's discovery of the smallpox vaccine spread rapidly across Europe. In Spain, vaccinations first took place in December 1800 and the practice flourished upon the private initiative of doctors, surgeons, state officials and members of the nobility in different parts of the country. Ignacio María Ruiz de Luzuriaga, secretary of the Royal Academy of Medicine of Madrid, is considered in medical historiography as a key figure of the introduction of the smallpox vaccine in Spain. Ruiz de Luzuriaga had a major role as a disseminator of the Jennerian technique and as a distributor of the vaccine fluid. Given his prestige as a doctor and his position in the Royal Academy, he was commissioned to establish a scientific and academic corpus on preventive measures to foster their understanding, uptake and good practice among Spanish vaccinators. He also attempted to create a Central Vaccine Committee, such as that existing in other European countries. The Royal Academy kept records of his activity which have been filed and catalogued in a documentary set entitled 'Papeles sobre la vacuna' [Vaccine Papers]. This archive has not been studied in depth to date. These documents allow identifying a network of correspondents set up by Ruiz de Luzuriaga. He provided these correspondents with the vaccine and asked them to report back on the vaccination progress made in their municipalities. This correspondence provides an account of how the first immunisations in Spain unravelled, as well as of the initial concerns that accompanied the introduction of the vaccine., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

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%⩾60years) 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., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Introduction: Vaccination during febrile illness (FI) is often regarded as a contraindication, leading to its postponement in most cases. Considering the doubts about the immunogenicity, efficacy and safety of the procedure among physicians and patients, we sought in this review to assess the data in the literature and international recommendations in terms of vaccination during FI., Methods: This review was conducted according to the methodological structure for systematic-narrative hybrid reviews, using PubMed and Cochrane library databases until March 2024. Inclusion criteria were studies dealing with vaccination during FI in children or adults, and exclusion criteria were studies related to post-vaccination fever or animal experiments. A review of international recommendations was also carried out. Articles included were fully examined by the authors for eligibility., Results: Our literature search enabled us to identify six studies about the immunogenicity and safety of vaccination during FI in children. All have shown no significant differences in seroconversion rates, protective antibody levels or adverse events between children vaccinated during FI and controls. Nine articles on physicians and patients' attitudes regarding immunization during FI were also included in this review. Vaccination was frequently postponed in cases of fever, primarily to avoid potential complications. Review of international recommendations allowed us to classify countries into three categories: those recommending vaccination regardless of the body temperature, those recommending vaccination within a temperature limit, and those with unclear recommendations., Discussion: The immunogenicity and safety studies were only conducted in children, yet results were reassuring. Despite using the same evidence, recommendations differed from country to another. This situation may explain the reluctance of physicians and patients to embrace this practice. Postponing vaccination is however associated with low vaccine coverage and could be considered a missed opportunity to vaccinate. A higher level of evidence seems needed for a firm conclusion., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Elisabeth BOTELHO-NEVERS is the coordinator and principal investigator of a clinical trial about the immunogenicity and safety of the PCV-20 vaccine during a febrile illness (PHRC-N 2019 PREVHOSPIT). The study is not yet recruting. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Reports of coronavirus disease 2019 (COVID-19) vaccine-induced autoimmune hepatitis (AIH) have been largely limited to case reports and case series. To further investigate the association between COVID-19 mRNA vaccination and AIH, we conducted a nationwide study using observed-over-expected (O/E) and Self-Controlled Case Series (SCCS) analyses for acute presentations of AIH (AAIH) warranting admission. Patients were included if they had one or more of the following hepatitis-related signs and symptoms (fever, lethargy, jaundice or abdominal pain) reported up to 3 months prior to admission, deranged liver function tests [alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of laboratory reference ranges], as well as biopsy results characteristic of AIH or response to steroid treatment for cases which did not undergo biopsy. Seventy-six patients fulfilled our case definition of AAIH within the study period from 1 January 2019 to 28 February 2023, with 6 patients having an estimated onset of AAIH within 42 days of COVID-19 mRNA vaccination. All 6 patients were females aged 40 years and above. In the O/E analysis, the rate ratios of AAIH among females aged 40 years and above in the primary cohort were 1.12 (95% confidence interval (CI) 0.14-9.40) and 1.06 (95% CI 0.24-4.74) in the 21 days and 42 days following vaccination respectively. In the SCCS analysis, we did not observe any statistically significant increase in incidence of AAIH in the 21 and 42 days following COVID-19 mRNA vaccination for both the primary and supplementary cohorts, as well as in the subgroup analysis involving females aged 40 years and above. Our findings suggest that COVID-19 mRNA vaccination does not appear to be associated with increased risk of AAIH requiring admissions in the population, although larger studies are required to confirm these findings., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. In May 2023, two subunit RSV vaccines (Arexvy [GSK] and Abrysvo [Pfizer]) received approval from the U.S. Food and Drug Administration (FDA). In June 2023, ACIP recommended that adults aged ≥60 years may receive a single dose of RSV vaccine, using shared clinical decision-making. In support of development of this policy, our objective was to assess the cost-effectiveness of RSV vaccination in the general population in this age group. We used a decision-analytical model of RSV over a two-year timeframe using data from published literature, FDA documents, epidemiological databases, and manufacturer data. We tracked RSV-associated outpatient, emergency department, inpatient healthcare utilization, RSV-attributable deaths, quality-adjusted life-years lost (QALYs), and societal costs. The societal cost per QALY saved from RSV vaccination depended on age group and product: adults aged ≥60 years, $196,842 for GSK's vaccine and $176,557 for Pfizer's vaccine; adults ≥65 years, $162,138 for GSK and $146,543 for Pfizer; adults 60- <65 years, $385,829 for GSK and $331,486 for Pfizer. Vaccine efficacy, incidence of RSV hospitalization, and vaccine cost had the greatest influence on cost per QALY. Cost per QALY saved decreased as the age of those vaccinated increased. Inputs such as long-term efficacy are uncertain. RSV vaccination in adults aged ≥60 years may be cost-effective, particularly in those of more advanced age. Lower vaccine acquisition costs and persistent efficacy beyond two RSV seasons would render RSV vaccination more cost-effective for a broader target population. PRIMARY FUNDING SOURCE: US Centers for Disease Control and Prevention., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: David W. Hutton, Lisa A. Prosser, Angela M. Rose, and Kerra Mercon report financial support was provided by Centers for Disease Control and Prevention. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Bacille Calmette-Guérin (BCG) remains the only licensed vaccine against tuberculosis (TB). While BCG protects against TB in children, its protection against pulmonary TB in adults is suboptimal, and the development of a better TB vaccine is a global health priority. Previously, we reported two recombinant BCG strains effective against murine TB with low virulence and lung pathology in immunocompromised mice and guinea pigs. We have recently combined these two recombinant BCG strains into one novel vaccine candidate (BCGΔBCG1419c::ESAT6-PE25SS) and evaluated its immunogenicity, efficacy and safety profile in mice. This new vaccine candidate is non-inferior to BCG in protection against TB, presents reduced pro-inflammatory immune responses and displays an enhanced safety profile., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Andreas Kupz reports financial support was provided by National Health and Medical Research Council. Ana Maria Valencia-Hernandez reports financial support and travel were provided by VALIDATE Network. Mario Alberto Flores Valdez reports financial support was provided by VALIDATE Network. Socorro Miranda-Hernandez reports financial support was provided by VALIDATE Network. Guangzu Zhao reports financial support was provided by VALIDATE Network. Andreas Kupz reports a relationship with Bill and Melinda Gates Foundation CTVD that includes: board membership, funding grants, and travel reimbursement. Andreas Kupz has a patent 'Recombinant strains of Mycobacterium bovis BCG' issued to James Cook University. Mario Alberto Flores Valdez has patent Patent number: #363576 issued to CIATEJ. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Vasovagal syncope, or fainting, can be triggered by various stimuli, including medical procedures. Syncope after vaccination has been reported, most commonly among adolescents, and can result in injuries. Using the Vaccine Adverse Event Reporting System (VAERS), we reviewed and summarized reports of syncope after live attenuated influenza vaccine, intranasal (LAIV) administered as the sole vaccine (i.e., no concomitant injections). From June 17, 2003 (date of LAIV licensure in the US) through May 31, 2024, VAERS received 50 reports of syncope after LAIV. Nearly half (23; 46 %) pertained to individuals 10-19 years of age. While the vast majority of reports (35; 70 %) did not describe any injuries, 15 people (30 %) were injured, most commonly by falling and hitting their head or face. Twenty-two people (44 %) required evaluation in the emergency department or doctor's office, including an individual who lost consciousness while he was driving home from the vaccination appointment. He did not report any injuries, but the car was severely damaged. Nearly three-quarters of people (37; 74 %) developed syncope within 15 min after vaccination, but fewer than half of reports (24; 48 %) stated that the patient had waited in the observation area for at 15 min. Based on approximately 111.9 million doses of LAIV distributed in the US during the same time period, the reporting rate is approximately 0.4 per million doses, suggesting that syncope following LAIV is rare. The information summarized here may enable clinicians, patients, and caregivers to make a more informed decision regarding preventing injuries that may occur following LAIV-related syncope., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)

Background: There are known disparities in U.S. COVID-19 vaccination but there is limited information on national vaccine uptake in a large, racially diverse, all-age population. Here, we describe COVID-19 vaccination coverage in a large U.S. population accessing care in OCHIN (not an acronym), a national network of community-based healthcare organizations., Methods: Within OCHIN, we identified patients aged 6 months and older with ≥1 completed clinical encounter since becoming age-eligible for the COVID-19 vaccine between December 13, 2020 and December 31, 2022. Patients' COVID-19 vaccination status was assessed from OCHIN's Epic® electronic health record which includes data from state immunization information systems. Patients were considered vaccinated if they received ≥1 dose of a monovalent vaccine product; coverage was categorized by age groups (6 months-4 years; 5-11 years, 12-15 years, 16+ years). Multivariate analyses assessed factors associated with COVID-19 vaccination across age groups., Results: The cohort included 3.3 million Hispanic (37 %), non-Hispanic (NH) White (31 %), NH Black (15 %), and NH Asian (7 %) patients; 45 % of whom were Medicaid-enrolled, 19 % uninsured, and 53 % with a household income below 100 % of the federal poverty level. The proportion with ≥1 COVID-19 vaccine dose increased with age, from 11.7 % (6 months through 4 years) to 72.3 % (65 years and older). The only factors associated with significantly higher COVID-19 vaccine coverage across age groups were prior receipt of an influenza vaccine and having private insurance. In adjusted modeling, when compared to NH whites, COVID-19 vaccine coverage was significantly higher among Hispanic, NH Asian, and NH multiple-race patients aged ≥5 years and significantly lower among NH Black and NH Native Hawaiian/Other Pacific Islander patients aged 6 months-4 years old., Conclusions: We identified disparities in primary series COVID-19 vaccine coverage by age, race and ethnicity, household income, insurance status, and prior influenza vaccination within this large, diverse population accessing care in community-based healthcare organizations., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Bradley Crane reports a relationship with Centers for Disease Control and Prevention that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Frances Biel reports financial support was provided by Centers for Disease Control and Prevention. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Joanna Georgescu reports financial support was provided by Centers for Disease Control and Prevention. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Holly Groom reports financial support, administrative support, and statistical analysis were provided by Centers for Disease Control and Prevention. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Allison Naleway reports financial support was provided by Centers for Disease Control and Prevention. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Ning Smith reports financial support was provided by Centers for Disease Control and Prevention. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Evelyn Sun reports financial support was provided by Centers for Disease Control and Prevention. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Teresa Schmidt reports financial support was provided by Centers for Disease Control and Prevention. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

The COVID-19 Biorepository at Beth Israel Deaconess Medical Center in Boston was initiated in 2020 to address questions about COVID-19 infection and vaccination in a time of urgent need. From April 2020 through July 2024, we enrolled 1018 participants and collected thousands of biospecimens. We enrolled participants from the general population as well as from specific populations that were not well represented in clinical trials, including immunosuppressed, pregnant, and lactating individuals. Our observational study was designed to accommodate the rapidly changing landscape of the pandemic, including the introduction of new vaccines and boosters, breakthrough infections, and emerging variants. Reflecting on the past four years of this experience, we believe that teamwork, collaboration, and flexibility were key factors for the success of this effort, which generated data in real time about COVID-19 vaccine responses in multiple populations, hybrid immunity following breakthrough infections, immune evasion of emerging variants, and immune imprinting following booster immunizations. Rapid dissemination of data through preprints, peer-reviewed publications, and public communications allowed for the real time use of our findings to address public health issues and to inform vaccine policies. The dedication of the study participants, clinical investigators, and laboratory investigators made this research program possible., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dan Barouch reports financial support was provided by Massachusetts Consortium on Pathogen Readiness. Dan Barouch, Ai-ris Collier reports financial support was provided by National Institutes of Health. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Repeated exposure of animals to Ixodes scapularis ticks can result in acquired tick resistance (ATR). The first manifestation of ATR is erythema at the tick bite site, however, the specific peptide targets and mechanisms associated with this early aspect of ATR are not understood. In this study, we immunized guinea pigs with a lipid nanoparticle containing the mRNA encoding 25 amino acids in the carboxyl terminus of Salp14 (Salp14-C mRNA-LNP), an I. scapularis salivary protein. The animals produced high titers of IgG directed at the carboxyl terminus of Salp14. Guinea pigs immunized with Salp14-C mRNA-LNP and then exposed to I. scapularis, developed erythema at the tick bite site. Transcriptomics of the skin of guinea pigs at the I. scapularis bite sites elucidated selected pathways, including histamine activation, that are associated with the development of erythema. The study demonstrates that an mRNA vaccine encoding a small peptide can induce the initial phase of ATR in guinea pigs., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Erol Fikrig reports financial support was provided by National Institutes of Health (NIH). Erol Fikrig reports financial support was provided by Steven & Alexandra Cohen Foundation. Erol Fikrig reports financial support was provided by Howard Hughes Medical Institute. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Risk communication tools based on epidemiological models can help inform decision-making, but must be responsive to health literacy needs to be effective. To facilitate informed choice about risks and benefits of COVID-19 vaccination, an epidemiological model called the COVID-19 Risk Calculator (CoRiCal) tool was developed by a multi-disciplinary team., Aim: This paper demonstrates how to use health literacy principles to improve consumer understanding of COVID-19 and vaccine effects, using a range of methods that could be applied to any health emergency., Methods: Stage 1: Health literacy optimisation and user testing to reduce improve understandability (n = 19). Stage 2: Experiments to explore the effect of risk communication formats on perceived understanding including probability, graphs, evaluative labels and comparison risks (n = 207). Stage 3: Randomised controlled trial (n = 2005) with 4 arms: 1) standard government information; 2) standard CoRiCal output based on bar graphs; 3) animation explaining bar graphs in "x per million" format; 4) animation explaining bar graphs in "1 in x chance" format. The primary outcome was knowledge about COVID-19 risk., Results: Stage 1 reduced the complexity of the text and graphs. Stage 2 showed that different risk communication formats change perceived understanding, with a preference for evaluative labels across 2 experiments and some indication people with lower health literacy had a greater preference for bar graphs. Stage 3 showed both animations increased knowledge compared to standard government information. There was no difference between the probability formats, or by health literacy level., Discussion: The results showed that simple explanations of complex epidemiological models improve knowledge about COVID-19 and vaccination. This demonstrates how health literacy design principles and short animations can be used to support informed decision making about health emergencies., Competing Interests: Declaration of Competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Carissa Bonner reports financial support was provided by Public Health Association of Australia (GSK Immunisation Award; CDIC 2022). Colleen Lau and John Litt report a relationship with Immunisation Coalition that includes: funding grants and non-financial support. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Tuberculosis (TB) is one of the leading causes of death from infectious diseases, killing approximately 1.3 million people worldwide in 2022 alone. The current vaccine for TB contains a live attenuated bacterium, Mycobacterium bovis BCG (Bacille Calmette-Guérin). The BCG vaccine is highly effective in preventing severe forms of childhood TB but does not protect against latent infection or disease in older age groups. A new or improved BCG vaccine for prevention of pulmonary TB is urgently needed. In this study, we infected murine bone marrow derived dendritic cells from C57BL/6 mice with M. bovis BCG followed by elution and identification of BCG-derived MHC class I and class II-bound peptides using tandem mass spectrometry. We identified 1436 MHC-bound peptides of which 94 were derived from BCG. Fifty-five peptides were derived from MHC class I molecules and 39 from class II molecules. We tested the 94 peptides for their immunogenicity using IFN- γ ELISPOT assay with splenocytes purified from BCG immunized mice and 10 showed positive responses. Seven peptides were derived from MHC II and three from MHC class I. In particular, MHC class II binding peptides derived from the mycobacterial surface lipoprotein Mpt83 were highly antigenic. Further evaluations of these immunogenic BCG peptides may identify proteins useful as new TB vaccine candidates., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

This study aimed to quantify U.S. jurisdiction-level costs related to the COVID-19 Vaccination Program by estimating the per-dose-administered cost during December 20, 2020-May 31, 2021, from a combined federal and local government perspective. Costs were limited to vaccine purchase, administration (including operations and wastage), and local redistribution by jurisdictions. Data were collected through publicly available sources, published literature, and a survey of 62 jurisdictions (38 responded). A total of 284.6 million doses of COVID-19 vaccine were distributed to jurisdictions during the study period, of which 284.2 million doses were administered, and 0.4 million doses were wasted. The estimated cost per-dose-administered among the 38 jurisdictions that responded to study survey was $57.45 and imputed cost across all jurisdictions was $63.11. The findings on jurisdiction-level cost per-dose-administered and vaccination cost during the initial period of U.S. COVID-19 Vaccination Program, when demand exceeded supply, may be considered in future pandemic preparedness planning., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: While hepatitis B virus (HBV) infection in children has declined dramatically in China due to the vaccination strategy for newborns, HBV infection in high-risk adults is receiving an increasing attention. The number of people who use drugs (PWUD) in China is huge, but their status of HBV infection and vaccination is less reported, especially from large samples. The related knowledge can help decision makers develop the further strategy of HBV prevention and control., Methods: A seroepidemiological survey was conducted in all four compulsory isolated detoxification centers (CIDCs) and all eight methadone maintenance treatment (MMT) clinics located in Xi'an, China. All PWUD who were undergoing detoxification or treatment in these settings were included. A questionnaire was designed to obtain the information of HBV vaccination history of participants, and sociodemographic and behavioral data of participants were obtained from the registration records of their respective CIDCs or MMT clinics., Results: A total of 4705 PWUD participated in the survey. Positive rates of HBsAg (current infection) and HBsAg or anti-HBc (current/past infection) were 5.50% and 58.02%, notably higher than those reported for the general adult population in the same province during the same period. As age increased, the anti-HBc positive rate increased with statistically significant trend. The all-negative for HBsAg, anti-HBc, and anti-HBs accounted for 28.82%. Only 18.49% were identified by the questionnaire as having received HBV vaccine. The logistic regression found that compared with identified vaccinated PWUD, those unsure if having been vaccinated and those identified non-vaccinated had a significantly higher HBV current/past infection rate, with an increasing trend., Conclusion: PWUD are a high-risk adult group of HBV infection in China. Of them, more than half have not received HBV vaccine, and a significant portion are susceptible to HBV. Catch-up vaccination is need for this population to prevent and control HBV transmission., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: The demand for COVID-19 vaccines has diminished as the pandemic lingers. Understanding vaccine hesitancy among essential workers is important in reducing the impact of future pandemics by providing effective immunization programs delivered expeditiously., Method: Two surveys exploring COVID-19 vaccine acceptance in 2021 and 2022 were conducted in cohorts of health care providers (HCP) and education workers participating in prospective studies of COVID-19 illnesses and vaccine uptake. Demographic factors and opinions about vaccines (monovalent and bivalent) and public health measures were collected in these self-reported surveys. Modified multivariable Poisson regression was used to determine factors associated with hesitancy., Results: In 2021, 3 % of 2061 HCP and 6 % of 3417 education workers reported hesitancy (p < 0.001). In December 2022, 21 % of 868 HCP and 24 % of 1457 education workers reported being hesitant to receive a bivalent vaccine (p = 0.09). Hesitance to be vaccinated with the monovalent vaccines was associated with earlier date of survey completion, later receipt of first COVID-19 vaccine dose, no influenza vaccination, and less worry about becoming ill with COVID-19. Factors associated with hesitance to be vaccinated with a bivalent vaccine that were common to both cohorts were receipt of two or fewer previous COVID-19 doses and lower certainty that the vaccines were safe and effective., Conclusion: Education workers were somewhat more likely than HCP to report being hesitant to receive COVID-19 vaccines but reasons for hesitancy were similar. Hesitancy was associated with non-receipt of previous vaccines (i.e., previous behaviour), less concern about being infected with SARS-CoV-2, and concerns about the safety and effectiveness of vaccines for both cohorts. Maintaining inter-pandemic trust in vaccines, ensuring rapid data generation during pandemics regarding vaccine safety and effectiveness, and effective and transparent communication about these data are all needed to support pandemic vaccination programs., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brenda L Coleman reports financial support was provided by Canadian Institutes of Health Research. Allison McGeer reports financial support was provided by Canadian Institutes of Health Research. Allison McGeer reports financial support was provided by Physicians' Services Inc. Foundation. Dawn Bowdish reports financial support was provided by Weston Family Foundation. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: COVID-19 vaccination has been inconsistently associated with an increased risk of heavy menstrual bleeding in previous studies. This study aimed to assess the risk of heavy menstrual bleeding requiring hospital care following COVID-19 vaccination according to the number of doses received and the time elapsed since vaccination., Methods: Using comprehensive data of the French National Health Data System, we carried out a case-control study. Non-pregnant 15-50 years old women who had a hospital discharge diagnosis of heavy menstrual bleeding between May 12, 2021, and August 31, 2022 (cases) were randomly matched to up to 30 controls of same age, place of residence, social deprivation index, and contraceptive use profile at the date of case hospital admission (index date). Conditional logistic regression models were used to estimate the risk of hospital care for heavy menstrual bleeding associated with primary or booster doses and delay since last COVID-19 vaccination at index date, adjusting for socio-demographic characteristics, comorbidities, healthcare use indicators, and recent SARS-CoV-2 infection., Results: A total of 4610 cases and 89,375 matched controls were included (median age, 42 years). Compared to unvaccinated women, the risk of hospital care for heavy menstrual bleeding was increased in those having received a last dose of primary vaccination in the preceding 1-3 months (Odds Ratio, 1.20 [95% confidence interval, 1.07-1.35]). This association was marked among women residing in the most deprived municipalities (1.28 [1.07-1.52]) and those who were not using hormonal contraception (1.28 [1.11-1.48]). Assuming a causal relationship, a total of 103 cases [54-196] were estimated to be attributable to primary vaccination in France., Conclusion: These findings provide evidence of an increased risk of heavy menstrual bleeding during the three-month period following primary COVID-19 mRNA vaccination. No increased risk was found beyond 3 months after primary vaccination nor following booster doses., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Conflict of interest statement. None., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Lung transplant recipients (LTRs) are particularly at risk of developing severe coronavirus disease-2019 (COVID-19), but are also difficult to protect by vaccination due to their immunocompromised state. Here, we investigated the immunogenicity of mRNA-based COVID-19 vaccines in LTRs who had a prior natural SARS-CoV-2 infection. At a median of 184 days after SARS-CoV-2 infection, LTRs were vaccinated twice with the mRNA-1273 COVID-19 vaccine, with a 28-day interval. Blood samples were obtained pre-vaccination, 28 days after the first dose, and 28 days and 6 months after the second dose. Spike (S-) and nucleocapsid (N-) specific antibodies were measured, as well as neutralization of the ancestral and Omicron BA.5 variant. S-specific T cell responses were evaluated using IFN-γ ELISpot，IGRA, and activation markers by flow cytometry. Phenotyping of T cells was performed by using high-resolution spectral flow cytometry. Most LTRs with prior infection had detectable S-specific antibodies and T cells at baseline. After the first vaccination, S-specific antibody levels increased significantly; an additional increase was observed after the second vaccination. N-specific antibodies decreased during the study period, indicative of the fact that no further breakthrough infections occurred. An increase in IFN-γ producing T cells was observed after the first vaccination, but no additional boost could be detected after the second vaccination. Antibody levels and virus-specific T cell responses remained significantly higher compared to pre-vaccination levels at 6 months post-vaccination, indicating an additive and durable effect of vaccination after infection in LTRs. Neutralizing antibodies were detected against the ancestral strain and retained cross-reactivity with Omicron BA.5, albeit at lower levels. Moreover, the quantity and phenotype of SARS-CoV-2 spike-specific T cells were similar in LTRs compared to controls with hybrid immunity. In conclusion, mRNA-based COVID-19 vaccines are immunogenic in LTRs with prior immunity, and antibody and T cell responses are durable up to 6 months post-vaccination., Competing Interests: Declaration of competing interest The authors declare the following financial support was received for the research. Coretta Van Leer Buter reports financial support was provided by the Netherlands Organization for Health Research and Development (ZonMW), projectnumber: 10430072010003. Siqi Liu reports financial support was provided by Chinese Scholarship Council (CSC NO.201909110111). All authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)