During the roll out of vaccines during a pandemic, questions regarding vaccine safety often arise. This was surely true during the SARS-CoV-2 pandemic. Different tools and capabilities exist during the pre-authorization phase and post introduction each with its strengths and limitations. Here we review the various tools and their strengths and limitations and discuss what functioned well in high income settings and the limitations that unequal vaccine safety pharmacovigilance capacity imposed upon middle and low income countries.

BACKGROUND: Assessment of COVID-19 vaccines safety during pregnancy is urgently needed. METHODS: We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185). RESULTS: We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49-15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56-2.12). Animal studies showed consistent results with studies in pregnant persons. CONCLUSION: We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.

INTRODUCTION: Intersectionality refers to the interconnectedness of various social locations creating unique experiences for individuals and groups, in the context of systems of privilege and oppression. As part of immunization coverage research, intersectionality allows healthcare professionals and policymakers to become aware of the constellation of characteristics contributing to low vaccine uptake. The objective of this study was to examine the application of intersectionality theory or concepts, and the appropriate use of sex and gender terminology, in Canadian immunization coverage research. MATERIALS AND METHODS: The eligibility criteria for this scoping review included English or French language studies on immunization coverage among Canadians of all ages. Six research databases were searched without date restrictions. We searched provincial and federal websites, as well as the Proquest Dissertations and Theses Global database for grey literature. RESULTS: Of 4725 studies identified in the search, 78 were included in the review. Of these, 20 studies included intersectionality concepts, specifically intersections of individual-level characteristics influencing vaccine uptake. However, no studies explicitly used an intersectionality framework to guide their research. Of the 19 studies that mentioned "gender", 18 had misused this term, conflating it with "sex". CONCLUSIONS: Based on our findings, there is an evident lack of intersectionality framework utilization in immunization coverage research in Canada, as well as misuse of the terms "gender" and "sex". Rather than only focusing on discrete characteristics, research should explore the interaction between numerous characteristics to better understand the barriers to immunization uptake in Canada.

INTRODUCTION: Vaccine hesitancy is complex and multifactorial and a threat to global health. Uptake of some recommended childhood immunisations in Ireland remains below World Health Organisation targets. The aim of this study was to determine factors associated with vaccine uptake in Ireland. METHODS: A cross-sectional, national survey of parental attitudes towards childhood vaccination for children aged 0 to 48 months was conducted between June and August 2021 (N = 855). A descriptive analysis of questionnaire responses was conducted. Univariate and multivariable logistic regression models were constructed to identify the association of demographic parental characteristics and parental vaccine attitude scores with a delay in or lack of parental vaccine acceptance. RESULTS: There was a strongly positive sentiment towards childhood vaccinations. Self-reported uptake of recommended vaccines was 96.1 % with a strong belief in the importance (94.4 %) and safety (89.2 %) of vaccines. Trust in official vaccine information sources was high; 91.5 % and 89.2 % reported trust in the vaccine information provided by healthcare professionals and the Health Service Executive (HSE) respectively. The most commonly identified reasons for missed vaccines were concerns about safety and vaccine side effects. In multivariable regression analysis, parental trust in official vaccine information sources was a significant predictor of vaccine acceptance. For every one unit increase in the median parental trust in official vaccine information score, the odds of a parent having reduced vaccine acceptance decreased significantly (aOR 0.27 95 % CI 0.16, 0.46, p < 0.001). CONCLUSION: Understanding parental attitudes towards vaccination will inform the development of evidence-informed, targeted interventions to increase childhood immunisation uptake. Vaccine information for parents should focus on vaccine safety and public health action should be taken to build trust and engage communities in order to increase and sustain the uptake of childhood vaccines delivered as part of the national childhood primary immunisation programme in Ireland.

BACKGROUND: Immunogenicity to meningococcal serogroup ACWY (MenACWY) conjugate vaccine has not been studied in immunocompromised minors with juvenile idiopathic arthritis (JIA) or inflammatory bowel disease (IBD). We determined immunogenicity of a MenACWY-TT vaccine in JIA and IBD patients at adolescent age and compared results to data from aged-matched healthy controls (HCs). METHODS: We performed a prospective observational cohort study in JIA and IBD patients (14-18 years old), who received a MenACWY vaccination during a nationwide catch-up campaign (2018-2019) in the Netherlands. Primary aim was to compare MenACWY polysaccharide-specific serum IgG geometric mean concentrations (GMCs) in patients with HCs and secondary between patients with or without anti-TNF therapy. GMCs were determined before and 3-6, 12, and 24 months postvaccination and compared with data from HCs at baseline and 12 months postvaccination. Serum bactericidal antibody (SBA) titers were determined in a subset of patients at 12 months postvaccination. RESULTS: We included 226 JIA and IBD patients (66 % and 34 % respectively). GMCs were lower for MenA and MenW (GMC ratio 0·24 [0·17-0·34] and 0·16 [0·10-0·26] respectively, p < 0·01) in patients compared to HCs at 12 months postvaccination. Anti-TNF users had lower MenACWY GMCs postvaccination compared with those without anti-TNF (p < 0·01). The proportion protected (SBA ≥ 8) for MenW was reduced in anti-TNF users (76 % versus 92 % in non-anti-TNF and 100 % in HCs, p < 0.01). CONCLUSION: The MenACWY conjugate vaccine was immunogenic in the vast majority of JIA and IBD patients at adolescent age, but seroprotection was lower in patients using anti-TNF agents. Therefore, an extra booster MenACWY vaccination should be considered.

BACKGROUND: Within-host models describe the dynamics of immune cells when encountering a pathogen, and how these dynamics can lead to an individual-specific immune response. This systematic review aims to summarize which within-host methodology has been used to study and quantify antibody kinetics after infection or vaccination. In particular, we focus on data-driven and theory-driven mechanistic models. MATERIALS: PubMed and Web of Science databases were used to identify eligible papers published until May 2022. Eligible publications included those studying mathematical models that measure antibody kinetics as the primary outcome (ranging from phenomenological to mechanistic models). RESULTS: We identified 78 eligible publications, of which 8 relied on an Ordinary Differential Equations (ODEs)-based modelling approach to describe antibody kinetics after vaccination, and 12 studies used such models in the context of humoral immunity induced by natural infection. Mechanistic modeling studies were summarized in terms of type of study, sample size, measurements collected, antibody half-life, compartments and parameters included, inferential or analytical method, and model selection. CONCLUSIONS: Despite the importance of investigating antibody kinetics and underlying mechanisms of (waning of) the humoral immunity, few publications explicitly account for this in a mathematical model. In particular, most research focuses on phenomenological rather than mechanistic models. The limited information on the age groups or other risk factors that might impact antibody kinetics, as well as a lack of experimental or observational data remain important concerns regarding the interpretation of mathematical modeling results. We reviewed the similarities between the kinetics following vaccination and infection, emphasising that it may be worth translating some features from one setting to another. However, we also stress that some biological mechanisms need to be distinguished. We found that data-driven mechanistic models tend to be more simplistic, and theory-driven approaches lack representative data to validate model results.

BACKGROUND: We evaluated the immunogenicity and safety of a booster dose of NVX-CoV2373 in Japanese adults who had completed a primary series of COVID-19 mRNA vaccine 6-12 months previously. METHODS: This single-arm, open-label, phase 3 study, conducted at two Japanese centres, enrolled healthy adults ≥ 20 years old. Participants received a booster dose of NVX-CoV2373. The primary immunogenicity endpoint was non-inferiority (lower limit of the 95 % confidence interval [CI] ≥ 0.67) of the geometric mean titre (GMT) ratio of titres of serum neutralizing antibodies (nAbs) against the SARS-CoV-2 ancestral strain 14 days after booster vaccination (day 15) in this study, compared with those 14 days after the second primary NVX-CoV2373 vaccination (day 36) in the TAK-019-1501 study (NCT04712110). Primary safety endpoints included local and systemic solicited adverse events (AEs) up to day 7 and unsolicited AEs up to day 28. RESULTS: Between 15 April 2022 and 10 May 2022, 155 participants were screened and 150, stratified by age (20-64 years old [n = 135] or ≥ 65 years old [n = 15]), received an NVX-CoV2373 booster dose. The GMT ratio between titres of serum nAbs against the SARS-CoV-2 ancestral strain on day 15 in this study and those on day 36 in the TAK-019-1501 study was 1.18 (95 % CI, 0.95-1.47), meeting the non-inferiority criterion. Following vaccination, the proportion of participants who reported local and systemic solicited AEs up to day 7 was 74.0 % and 48.0 %, respectively. The most common local and systemic solicited AEs were tenderness (102 participants [68.0 %]) and malaise (39 participants [26.0 %]), respectively. Seven participants (4.7 %) reported unsolicited AEs between vaccination and day 28; all were severity grade ≤ 2. DISCUSSION: A single heterologous NVX-CoV2373 booster induced rapid and robust anti-SARS-CoV-2 immune responses, addressing waning immunity in healthy Japanese adults, and had an acceptable safety profile. CLINICALTRIALS: gov identifier: NCT05299359.

Prior modeling studies showed that current outbreak management strategies are unlikely to stop outbreaks caused by type 1 wild polioviruses (WPV1) or circulating vaccine-derived polioviruses (cVDPVs) in many areas, and suggested increased risks of outbreaks with cocirculation of more than one type of poliovirus. The surge of type 2 poliovirus transmission that began in 2019 and continues to date, in conjunction with decreases in preventive supplemental immunization activities (SIAs) for poliovirus types 1 and 3, has led to the emergence of several countries with cocirculation of more than one type of poliovirus. Response to these emerging cocirculation events is theoretically straightforward, but the different formulations, types, and inventories of oral poliovirus vaccines (OPVs) available for outbreak response present challenging practical questions. In order to demonstrate the implications of using different vaccine options and outbreak campaign strategies, we applied a transmission model to a hypothetical population with conditions similar to populations currently experiencing outbreaks of cVDPVs of both types 1 and 2. Our results suggest prevention of the largest number of paralytic cases occurs when using (1) trivalent OPV (tOPV) (or coadministering OPV formulations for all three types) until one poliovirus outbreak type dies out, followed by (2) using a type-specific OPV until the remaining poliovirus outbreak type also dies out. Using tOPV first offers a lower overall expected cost, but this option may be limited by the willingness to expose populations to type 2 Sabin OPV strains. For strategies that use type 2 novel OPV (nOPV2) concurrently administered with bivalent OPV (bOPV, containing types 1 and 3 OPV) emerges as a leading option, but questions remain about feasibility, logistics, type-specific take rates, and coadministration costs.

Parental hesitancy poses a serious threat to the success of the COVID-19 childhood vaccination campaign. We investigate whether adults' opinions on childhood vaccination can be influenced via two survey experiments in Italy (n = 3,633 participants) and the UK (n = 3,314 participants). Respondents were randomly assigned to: a "risk treatment" that highlighted the potential risks of COVID-19 to a child, a "herd immunity treatment" that emphasized the community benefits of pediatric vaccination, or a control message. Participants' probability of supporting COVID-19 childhood vaccination was then assessed on a 0-100 scale. We find that the "risk treatment" reduced the proportion of Italian parents strongly against vaccination by up to 29.6 %, while increasing the proportion of neutral parents by up to 45.0 %. The "herd immunity treatment", instead, was only effective among non-parents, resulting in a lower proportion of individuals against pediatric vaccination and a higher proportion of individuals in favor (both shifted by around 20 %).

BACKGROUND: In the United States (US), half of new human papillomavirus (HPV) infections occur among young people aged 15-24 years. Despite the effectiveness of HPV vaccination in protecting against HPV-associated cancers, its coverage among adolescents remains suboptimal. This study examined the association of sociodemographic characteristics and HPV vaccination hesitancy with HPV vaccination coverage in five US states with disproportionately low adolescent coverage rates compared to the national average. METHODS: Responses to an online Qualtrics survey from 926 parents of children aged 9-17 years in Arkansas, Mississippi, Missouri, Tennessee, and Southern Illinois in July 2021 were analyzed using multivariate logistic regression to estimate the association of sociodemographic characteristics and HPV vaccination hesitancy with HPV vaccination coverage. RESULTS: Of the parents, 78 % were female, 76 % were non-Hispanic White, 61.9 % lived in rural areas, 22 % were classified as HPV vaccine hesitant, and 42 % had vaccinated their oldest child between the ages of 9-17 years against HPV. Children of vaccine hesitant parents were less likely to have received any doses of the HPV vaccine than children of non-vaccine hesitant parents (AOR: 0.17, 95 % CI:0.11-0.27). Male children were less likely to have initiated the HPV vaccine series than female children (AOR: 0.70, 95 % CI:0.50-0.97). Older children (13-17 vs 9-12 years), receiving the meningococcal conjugate or most recent seasonal influenza vaccine were all associated with higher likelihoods of receiving any doses of the HPV vaccine (AOR: 6.01, 95 % CI:3.98-9.08; AOR: 2.24, 95 % CI:1.27-3.95; AOR: 2.41, 95 % CI:1.73-3.36, respectively). CONCLUSIONS: Adolescent HPV vaccination coverage remains low in our targeted states. Children's age, sex, and parental vaccine hesitancy were significantly associated with likelihood of HPV vaccination. These findings offer the opportunity for targeted interventions among parents in regions with low vaccine uptake and underscore the importance of developing and implementing strategies to address parental HPV vaccination hesitancy to improve uptake in the US.

Although mumps vaccination has been routine in Canada for decades, mumps cases and outbreaks continue to occur periodically. Mumps surveillance, including monitoring of the mumps virus genotype associated with disease activity, is important to document baseline activity and to advance further research into vaccine effectiveness. Here we describe a detailed analysis of mumps cases that have been detected in Canada from 2002 to 2020, with a focus on the mumps molecular epidemiology. In total, 7395 cases of mumps were reported to the surveillance system, with outbreaks occurring in the years 2007, 2010 and 2016 to 2018. Adolescents and young adults aged 15 to 29 years had the highest risk of being a case (rate ratios ranging from 1.50 to 2.29), compared to adults aged 30 to 39. Genotypes of mumps viruses were determined in 3225 specimens. Genotype G was predominantly detected (96% of genotyped specimens) and was first reported in 2005. Other genotypes were more likely to be detected in cases that also reported travel (or were linked to imported cases) than the cases with genotype G detected (p < 0.0001). The genotype G viruses had little sequence diversity in the 316 nucleotide window used for genotyping (the small hydrophobic protein gene) and mainly belonged to a single phylogenetic lineage that included the MuVi/Sheffield.GBR/1.05 reference sequence. The analysis of over ten years of data has demonstrated that mumps genotype G, specifically belonging to a single lineage, the Sheffield lineage, is the endemically circulating virus in Canada. This lineage is seen also in other countries using the genotype A vaccine. Mumps remains endemic despite high MMR vaccination coverage which has been sufficient to eliminate circulation of measles and rubella in Canada, raising the hypothesis of the evolution towards a vaccine escape mumps virus.

BACKGROUND: Vaccines were crucial in controlling the Covid-19 pandemic. As more vaccines receive regulatory approval, stakeholders will be faced with several options and must make an appropriate choice for themselves. We proposed a multi-criteria decision analysis (MCDA) framework to guide decision-makers in comparing vaccines for the Indian context. METHODS: We adhered to the ISPOR guidance for the MCDA process. Seven vaccine options were compared under ten criteria. Through three virtual workshops, we obtained opinions and weights from citizens, private-sector hospitals, and public health organisations. Available evidence was rescaled and incorporated into the performance matrix. The final score for each vaccine was calculated for the different groups. We performed different sensitivity analyses to assess the consistency of the rank list. RESULTS: The cost, efficacy and operational score of the vaccines had the highest weights among the stakeholders. From the six scenario groups, Janssen had the highest score in four. This was driven by the advantage of having a single dose of vaccination. In the probabilistic sensitivity analysis for the overall group, Covaxin, Janssen, and Sputnik were the first three options. The participants expressed that availability, WHO approvals and safety, among others, would be crucial when considering vaccines. CONCLUSIONS: The MCDA process has not been capitalised on in healthcare decision-making in India and LMICs. Considering the available data and stakeholder preference at the time of the study, Covaxin, Janssen, and Sputnik were preferred options. The choice framework with the dynamic performance matrix is a valuable tool that could be adapted to different population groups and extended based on increasing vaccine options and emerging evidence. *ISPOR - The Professional Society for Health Economics and Outcomes Research.

BACKGROUND: Preventive measures applied during the COVID-19 pandemic have modified the age distribution, the clinical severity and the incidence of Respiratory Syncytial Virus (RSV) hospitalisations during the 2020/21 RSV season. The aim of the present study was to estimate the impact of these aspects on RSV-associated hospitalisations (RSVH) costs stratified by age group between pre-COVID-19 seasons and 2020/21 RSV season. METHODS: We compared the incidence, the median costs, and total RSVH costs from the national health insurance perspective in children < 24 months of age during the COVID-19 period (2020/21 RSV season) with a pre-COVID-19 period (2014/17 RSV seasons). Children were born and hospitalised in the Lyon metropolitan area. RSVH costs were extracted from the French medical information system (Programme de Médicalisation des Systémes d'Information). RESULTS: The RSVH-incidence rate per 1000 infants aged < 3 months decreased significantly from 4.6 (95 % CI [4.1; 5.2]) to 3.1 (95 % CI [2.4; 4.0]), and increased in older infants and children up to 24 months of age during the 2020/21 RSV season. Overall, RSVH costs for RSVH cases aged below 2 years old decreased by €201,770 (31 %) during 2020/21 RSV season compared to the mean pre-COVID-19 costs. CONCLUSIONS: The sharp reduction in costs of RSVH in infants aged < 3 months outweighed the modest increase in costs observed in the 3-24 months age group. Therefore, conferring a temporal protection through passive immunisation to infants aged < 3 months should have a major impact on RSVH costs even if it results in an increase of RSVH in older children infected later in life. Nevertheless, stakeholders should be aware of this potential increase of RSVH in older age groups presenting with a wider range of disease to avoid any bias in estimating the cost-effectiveness of passive immunisation strategies.

Pregnant women are often at higher risk for morbidity and mortality due to contracting vaccine-preventable diseases that result in adverse pregnancy outcomes such as spontaneous abortion, preterm births, and congenital fetal defects. For example, health care provider recommendation is correlated with maternal acceptance of influenza vaccination, however, up to 33 % of pregnant women remain unvaccinated irrespective of provider recommendation. Vaccine hesitancy is a multifactorial problem that both the medical and public health systems need to address synergistically. Vaccine education should incorporate balanced perspectives to deliver vaccine education. This narrative review addresses four questions: 1) what are the primary concerns of pregnant women that lead them to be hesitant about receiving vaccinations; 2) to what extent does the source (e.g. provider, friend, family) of vaccine advice and information influence a pregnant person's decision to accept a vaccine; 3) how does the delivery method of vaccine education influence their decision; 4) how can categorizing patients into four distinct groups based on their opinions and behavior regarding vaccines be used to improve provider-patient communication and increase vaccine acceptance. Results from the literature show that the three most common reasons for vaccine hesitancy include: i.) fear of side effects or adverse events; ii.) lack of confidence in vaccine safety; iii.) low perception of being at high risk of infection during pregnancy and/or not having previously received the vaccination when not pregnant. We conclude that vaccine hesitancy is dynamic therefore people do not always hold a static level of vaccine hesitancy. People may move between a continuum of vaccine hesitancy for a multifactorial reasons. A framework, characterized by levels of vaccine hesitancy before and during pregnancy, was constructed to help providers find balance between promoting individual health and public health while providing vaccine education.

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.

Most seasonal influenza vaccines are produced using hemagglutinin (HA) surface antigens from inactivated virions. However, virions are thought to be a suboptimal source for the less abundant neuraminidase (NA) surface antigen, which is also protective against severe disease. Here, we demonstrate that inactivated influenza virions are compatible with two modern approaches for improving protective antibody responses against NA. Using a DBA/2J mouse model, we show that the strong infection-induced NA inhibitory (NAI) antibody responses are only achieved by high dose immunizations of inactivated virions, likely due to the low viral NA content. Based on this observation, we first produced virions with higher NA content by using reverse genetics to exchange the viral internal gene segments. Single immunizations with these inactivated virions showed enhanced NAI antibody responses and improved NA-based protection from a lethal viral challenge while also allowing for the development of natural immunity to the heterotypic challenge virus HA. Second, we combined inactivated virions with recombinant NA protein antigens. These combination vaccines increased NA-based protection following viral challenge and elicited stronger antibody responses against NA than either component alone, especially when the NAs possessed similar antigenicity. Together, these results indicate that inactivated virions are a flexible platform that can be easily combined with protein-based vaccines to improve protective antibody responses against influenza antigens.

INTRODUCTION: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prompted accelerated vaccine development of novel messenger RNA (mRNA)-based vaccines by Moderna and Pfizer, which received FDA Emergency Use Authorization in December 2020. The purpose of this study was to examine trends in primary series administration and multi-dose completion rates with Moderna's mRNA-1273 vaccine administered at a United States retail pharmacy. METHODS: Walgreens pharmacy data were joined to publicly available data sets to examine trends in mRNA-1273 primary series and multi-dose completion across patient race/ethnicity, age, gender, distance to first vaccination, and community characteristics. Eligible patients received their first dose of mRNA-1273 administered by Walgreens between December 18, 2020 and February 28, 2022. Variables significantly associated with on-time second dose (all patients) and third dose (immunocompromised patients) in univariate analyses were included in linear regression models. A subset of patients in selected states were studied to identify differences in early and late vaccine adoption. RESULTS: Patients (N = 4,870,915) who received ≥ 1 dose of mRNA-1273 were 57.0% White, 52.6% female, and averaged 49.4 years old. Approximately 85% of patients received a second dose during the study period. Factors associated with on-time second dose administration included older age, race/ethnicity, traveling ≤ 10 miles for the first dose, higher community-level health insurance, and residing in areas with low social vulnerability. Only 51.0% of immunocompromised patients received the third dose as recommended. Factors associated with third dose administration included older age, race/ethnicity, and small-town residence. Early adopters accounted for 60.6% of patients. Factors associated with early adoption included older age, race/ethnicity, and metropolitan residence. CONCLUSION: Over 80% of patients received their on-time second dose of mRNA-1273 vaccine per CDC recommendations. Patient demographics and community characteristics were associated with vaccine receipt and series completion. Novel approaches to facilitate series completion during a pandemic should be further studied.

BACKGROUND: Accurate determination of COVID-19 vaccination status is necessary to produce reliable COVID-19 vaccine effectiveness (VE) estimates. Data comparing differences in COVID-19 VE by vaccination sources (i.e., immunization information systems [IIS], electronic medical records [EMR], and self-report) are limited. We compared the number of mRNA COVID-19 vaccine doses identified by each of these sources to assess agreement as well as differences in VE estimates using vaccination data from each individual source and vaccination data adjudicated from all sources combined. METHODS: Adults aged ≥18 years who were hospitalized with COVID-like illness at 21 hospitals in 18 U.S. states participating in the IVY Network during February 1-August 31, 2022, were enrolled. Numbers of COVID-19 vaccine doses identified by IIS, EMR, and self-report were compared in kappa agreement analyses. Effectiveness of mRNA COVID-19 vaccines against COVID-19-associated hospitalization was estimated using multivariable logistic regression models to compare the odds of COVID-19 vaccination between SARS-CoV-2-positive case-patients and SARS-CoV-2-negative control-patients. VE was estimated using each source of vaccination data separately and all sources combined. RESULTS: A total of 4499 patients were included. Patients with ≥1 mRNA COVID-19 vaccine dose were identified most frequently by self-report (n = 3570, 79 %), followed by IIS (n = 3272, 73 %) and EMR (n = 3057, 68 %). Agreement was highest between IIS and self-report for 4 doses with a kappa of 0.77 (95 % CI = 0.73-0.81). VE point estimates of 3 doses against COVID-19 hospitalization were substantially lower when using vaccination data from EMR only (VE = 31 %, 95 % CI = 16 %-43 %) than when using all sources combined (VE = 53 %, 95 % CI = 41 %-62%). CONCLUSION: Vaccination data from EMR only may substantially underestimate COVID-19 VE.

The aim of the study was to assess the effect of a booster dose of COVID-19 vaccine on the rates of hospital ward and intensive care unit (ICU) admissions around the time of emergence of the Omicron variant in the Basque Country. A retrospective cohort population-based study was conducted. The population with any records related to COVID-19 vaccination up to 28 February 2022 was classified into four cohorts by vaccination status. For every cohort, the hospital ward and ICU admission rates were calculated for each day between November 2021 and February 2022. Generalized linear models with a negative binomial distribution were used to estimate the age-adjusted hospitalization rate ratio of the cohort of individuals who had received a booster compared to the other cohorts. The age-adjusted rates of hospital ward and ICU admissions were 70.4 % and 72.0 % lower, respectively, in the fully vaccinated plus booster group compared to the fully vaccinated but no booster group. Analysing changes in the 14-day admission incidence rates showed that as the prevalence of the Omicron variant increased, the corresponding rate ratios decreased. The immunity acquired with the booster dose allowed the hospital network to meet all the demand for hospitalization during a period of high incidence of COVID-19, despite the fact that vaccine protection decreased as the prevalence of the Omicron variant increased.

BACKGROUND: The pneumococcal conjugate vaccine (PCV) was introduced to children in Japan in February 2010 for PCV7 and February 2013 for PCV13. This study aimed to investigate the changes in child pneumonia hospitalization in Japan, before and after the introduction of PCV. METHODS: We utilized the JMDC Claims Database, an insurance claims database in Japan, with a cumulative population of approximately 10.6 million as of 2022. We extracted data of approximately 3.16 million children below 15 years of age from January 2006 to December 2019, and evaluated the number of pneumonia hospitalizations per 1,000 persons per year. The primary analysis was a comparison of three categories according to PCVs: before PCV7, before PCV13, and after PCV13 (2006-2009, 2010-2012, and 2013-2019). The secondary analysis was an interrupted time series (ITS) analysis, assessing the slope change in pneumonia hospitalizations per month, with PCV introduction as an intervening factor. RESULTS: The cases of pneumonia hospitalizations during the study period was 19,920 (0.6 %); 25 % of these were 0-1 years, 48 % were 2-4 years, 18 % were 5-9 years, and 9 % were 10-14 years. Pneumonia hospitalizations per 1000 population was 6.10 before PCV7 and 4.03 after PCV13, representing a 34 % decrease (p < 0.001). The reduction by age group was -30.1 % in 0-1 years, -20.3 % in 2-4 years, -41.7 % in 5-9 years, and -52.9 % in 10-14 years, significant reduction in all groups. ITS analysis showed a further reduction of -0.17 % per month after the introduction of PCV13 than that before PCV7 (p = 0.006). CONCLUSION: Our study estimated 4-6 pneumonia hospitalizations per 1000 pediatric population in Japan, with a 34 % decrease after the introduction of PCV. This study examined the nationwide effectiveness of PCV, further studies are needed in all age groups.

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants has significantly reduced the efficacy of some approved vaccines. A fourth dose of NVX-CoV2373 (5 µg SARS-CoV-2 recombinant spike [rS] protein + 50 µg Matrix-M™ adjuvant; Novavax, Gaithersburg, MD) was evaluated to determine induction of cross-reactive antibodies to variants of concern. A phase II randomized study (NCT04368988) recruited participants in Australia and the United States to assess a primary series of NVX-CoV2373 followed by two booster doses (third and fourth doses at 6-month intervals) in adults 18-84 years of age. The primary series was administered when the SARS-CoV-2 ancestral strain was prevalent and the third and fourth doses while the Alpha and Delta variants were prevalent in AUS and US. Local/systemic reactogenicity was assessed the day of vaccination and for 6 days thereafter. Unsolicited adverse events (AEs) were reported. Immunogenicity was measured before, and 14 days after, fourth dose administration, using anti-spike serum immunoglobulin G (IgG) and neutralization assays against ancestral SARS-CoV-2 strain and Omicron sublineages. Among 1283 enrolled participants, 258 were randomized to receive the two-dose primary series, of whom 104 received a third dose, and 45 received a fourth dose of NVX-CoV2373. The incidence of local/systemic reactogenicity events increased after the first three doses of NVX-CoV2373 and leveled off after dose 4. Unsolicited AEs were reported in 9 % of participants after dose 4 (none of which were severe or serious). Anti-rS IgG levels and neutralization antibody titers increased following booster doses to a level approximately four-fold higher than that observed after the primary series, with a progressively narrowed gap in response between the ancestral strain and Omicron BA.5. A fourth dose of NVX-CoV2373 enhanced immunogenicity for ancestral and variant SARS-CoV-2 strains without increasing reactogenicity, indicating that updates to the vaccine composition may not be currently warranted.

BACKGROUND: The epidemiology of circulating seasonal influenza strains changed following the 2009 pandemic influenza A(H1N1). A universal influenza vaccination recommendation has been implemented and new vaccine types have become available post-2009. The objective of this study was to evaluate the cost-effectiveness of routine annual influenza vaccination in the context of this new evidence. METHODS: A state transition simulation model was constructed to estimate the health and economic outcomes of influenza vaccination compared to no vaccination for hypothetical US cohorts stratified by age and risk status. Model input parameters were derived from multiple sources, including post-2009 vaccine effectiveness data from the US Flu Vaccine Effectiveness Network. The analysis used societal and healthcare sector perspectives and a one-year time horizon, except permanent outcomes were also included. The primary outcome was the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life years (QALYs) gained. RESULTS: Compared to no vaccination, vaccination yielded ICERs lower than $95,000/QALY for all age and risk groups, except for non-high-risk adults 18-49 years ($194,000/QALY). Vaccination was cost-saving for adults ≥50 years at higher risk for influenza-related complications. Results were most sensitive to changes in the probability of influenza illness. Performing the analysis from the healthcare sector perspective, excluding vaccination time costs, delivering vaccinations in lower-cost settings, and including productivity losses improved the cost-effectiveness of vaccination. Sensitivity analysis revealed that vaccination remains below $100,000/QALY for older persons ≥65 years at vaccine effectiveness estimates as low as 4 %. CONCLUSIONS: Cost-effectiveness of influenza vaccination varied by age and risk status and was less than $95,000/QALY for all subgroups, except for non-high-risk working-age adults. Results were sensitive to the probability of influenza illness and vaccination was more favorable under certain scenarios. Vaccination for higher risk subgroups resulted in ICERs below $100,000/QALY even at low levels of vaccine effectiveness or circulating virus.

BACKGROUND: Sub-Saharan Africa has the highest rate of cervical cancer cases and deaths worldwide. Kenya introduced a quadrivalent HPV vaccine (GARDASIL, hereafter referred to as GARDASIL-4) for ten-year-old girls in late 2019 with donor support from Gavi, the Vaccine Alliance. As Kenya may soon graduate from Gavi support, it is important to evaluate the potential cost-effectiveness and budget impact of the current HPV vaccine, and potential alternatives. METHODS: We used a proportionate outcomes static cohort model to evaluate the annual budget impact and lifetime cost-effectiveness of vaccinating ten-year-old girls over the period 2020-2029. We included a catch-up campaign for girls aged 11-14 years in 2020. We estimated cervical cancer cases, deaths, disability adjusted life years (DALYs), and healthcare costs (government and societal perspective) expected to occur with and without vaccination over the lifetimes of each cohort of vaccinated girls. For each of the four products available globally (CECOLIN©, CERVARIX©, GARDASIL-4©, and GARDASIL-9 ©), we estimated the cost (2021 US$) per DALY averted compared to no vaccine and to each other. Model inputs were obtained from published sources, as well as local stakeholders. RESULTS: We estimated 320,000 cases and 225,000 deaths attributed to cervical cancer over the lifetimes of the 14 evaluated birth cohorts. HPV vaccination could reduce this burden by 42-60 %. Without cross-protection, CECOLIN had the lowest net cost and most attractive cost-effectiveness. With cross-protection, CERVARIX was the most cost-effective. Under either scenario the most cost-effective vaccine had a 100 % probability of being cost-effective at a willingness-to-pay threshold of US$ 100 (5 % of Kenya's national gross domestic product per capita) compared to no vaccination. Should Kenya reach its target of 90 % coverage and graduate from Gavi support, the undiscounted annual vaccine program cost could exceed US$ 10 million per year. For all three vaccines currently supported by Gavi, a single-dose strategy would be cost-saving compared to no vaccination. CONCLUSION: HPV vaccination for girls is highly cost-effective in Kenya. Compared to GARDASIL-4, alternative products could provide similar or greater health benefits at lower net costs. Substantial government funding will be required to reach and sustain coverage targets as Kenya graduates from Gavi support. A single dose strategy is likely to have similar benefits for less cost.

We prospectively examined the association between COVID-19 vaccination and menstrual cycle characteristics in an internet-based prospective cohort study. We included a sample of 1,137 participants who enrolled in Pregnancy Study Online (PRESTO), a preconception cohort study of couples trying to conceive, during January 2021-August 2022. Eligible participants were aged 21-45 years, United States or Canadian residents, and trying to conceive without fertility treatment. At baseline and every 8 weeks for up to 12 months, participants completed questionnaires on which they provided information on COVID-19 vaccination and menstrual cycle characteristics, including cycle regularity, cycle length, bleed length, heaviness of bleed, and menstrual pain. We fit generalized estimating equation (GEE) models with a log link function and Poisson distribution to estimate the adjusted risk ratio (RR) for irregular cycles associated with COVID-19 vaccination. We used linear regression with GEE to estimate adjusted mean differences in menstrual cycle length associated with COVID-19 vaccination. We adjusted for sociodemographic, lifestyle, medical and reproductive factors. Participants had 1.1 day longer menstrual cycles after receiving the first dose of COVID-19 vaccine (95 % CI: 0.4, 1.9) and 1.3 day longer cycles after receiving the second dose (95 % CI: 0.2, 2.5). Associations were attenuated at the second cycle post-vaccination. We did not observe strong associations between COVID-19 vaccination and cycle regularity, bleed length, heaviness of bleed, or menstrual pain. In conclusion, COVID-19 vaccination was associated with a ∼1 day temporary increase in menstrual cycle length, but was not appreciably associated with other menstrual cycle characteristics.

INTRODUCTION: The BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines have been approved for children and adolescents for protecting against SARS-CoV-2 infection. This longitudinal study aimed to compare adverse outcomes after SARS-CoV-2 vaccination in children with neurodevelopmental disorders (ND) (e.g., attention-deficit/hyperactivity disorder [ADHD], autism spectrum disorder [ASD], communication disorders, intellectual disability, and tic disorders) and healthy control children. METHODS: A total of 1335 children who received the SARS-CoV-2 vaccination (762 children with ND and 573 healthy controls) were recruited. All subjects were followed-up for 180 days, and outcome events were defined as outpatient department (OPD) or emergency department (ER) visits during follow-up. Multivariate Cox proportional hazards regression models were used to identify the potential differences in outcomes between the propensity score-matched ND group (n = 311) and the control group (n = 311), and to explore the factors associated with outcomes among all children with ND (n = 762). RESULTS: Compared with the control group, children with ND exhibited a higher likelihood of subsequent OPD or ER visits and paediatric neurology OPD visits after the first dose of vaccination. However, we found that only a small proportion of the children visited the OPD or ER because of adverse vaccination-related effects. Among all children with ND, those with communication disorders showed a higher likelihood of any OPD or ER visit. Paediatric neurology OPD visits were associated with communication disorders, intellectual disability, and methylphenidate and aripiprazole prescriptions. ADHD and ASD were not associated with adverse outcomes. CONCLUSIONS: No specific ND diagnosis or medication use clearly increased the risk of adverse effects of SARS-CoV-2 vaccination. Children with ND can be reassured that the SARS-CoV-2 vaccination is a safe regimen to protect themselves.

Campylobacter jejuni is a leading global cause of bacterial gastroenteritis in humans, and poultry are a major reservoir. Glycoconjugate vaccines containing the conserved C. jejuni N-glycan have previously been reported to be effective at reducing caecal colonisation of chickens by C. jejuni. These include recombinant subunit vaccines, live E. coli strains expressing the N-glycan on the surface as well as outer membrane vesicles (OMVs) derived from these E. coli strains. In this study, we evaluated the efficacy of live E. coli expressing the C. jejuni N-glycan from a plasmid and glycosylated OMVs (G-OMVs) derived from them against colonisation by different C. jejuni strains. Despite the C. jejuni N-glycan being expressed on the surface of the live strain and the OMVs, no reduction in caecal colonisation by C. jejuni was observed and N-glycan-specific responses were not detected.

INTRODUCTION: The rapid roll-out of novel COVID-19 vaccines made near real-time post-marketing safety surveillance essential to identify rare and long-term adverse events following immunization (AEFIs). In light of the ongoing booster vaccination campaigns, it is key to monitor changes in observed safety patterns post-vaccination. The effect of sequential COVID-19 vaccinations, as well as heterologous vaccination sequences, on the observed post-vaccination safety pattern, remains largely unknown. METHODS: The primary objective of this study was to describe the profile of spontaneously reported AEFIs following COVID-19 vaccination in the Netherlands, including the primary and booster series. Reports from consumers and healthcare professionals were collected via a COVID-19 vaccine-tailored online reporting form by the National Pharmacovigilance Centre Lareb (Lareb) between 6 January 2021 and 31 August 2022. The data were used to describe the most frequently reported AEFIs per vaccination moment, the consumer experienced burden per AEFI, and differences in AEFIs reported for homologous and heterologous vaccination sequences. RESULTS: Lareb received 227,884 spontaneous reports over a period of twenty months. Overall, a high degree of similarity in local and systemic AEFIs per vaccination moment was observed, with no apparent change in the number of reports of serious adverse events after multiple COVID-19 vaccinations. No differences in the pattern of reported AEFIs per vaccination sequence was observed. CONCLUSION: Spontaneous reported AEFIs demonstrated a similar reporting pattern for homologous and heterologous primary and booster series of COVID-19 vaccination in the Netherlands.

BACKGROUND AND OBJECTIVES: Evidence of immune response to COVID-19 vaccine in psoriasis patients on biological agents is lacking. This study aimed to evaluate SARS-CoV-2 antibody levels following vaccination with CoronaVac or Pfizer/BioNTech mRNA in patients using biological agents or methotrexate, high-titer antibody levels achievement rate, and impact of medications on immunogenicity. METHODS: This noninterventional, prospective cohort study included 89 patients and 40 controls vaccinated with two doses of inactivated (CoronaVac) or Pfizer/BioNTech mRNA vaccines. Anti-spike and neutralising antibodies were analysed before and three to six weeks after the second dose. Adverse effects and symptomatic COVID-19 were assessed. RESULTS: Median anti-spike and neutralising antibody titers after CoronaVac were significantly lower in patients than controls (57.92 U/mL vs 125.4 U/mL, and 1/6 vs 1/32, respectively, p < 0.05). Patients were less likely to achieve high-titer anti-spike antibody levels (25.6 % vs 50 %). Infliximab was associated with attenuated vaccine response. Pfizer/BioNTech vaccine induced comparable median anti-spike (2,080 U/mL vs 2,976.5 U/mL,) and neutralising antibody levels (1/96 vs 1/160) in patients and controls, respectively (p > 0.05). High-titer anti-spike and neutralising antibodies development rates were comparable among patients and controls (95.2 % vs 100 %, and 30.4 % vs 50.0 %, respectively, p > 0.05). Nine (10.1 %) COVID-19 cases- all mild - were identified. Psoriasis flare was seen in 6.74 %, mostly after Pfizer/BioNTech vaccine. CONCLUSION: Psoriasis patients treated with biological agents and methotrexate developed similar response to mRNA vaccine but weaker response to inactivated vaccine. Infliximab reduced response to the inactivated vaccine. Adverse effects were more frequent with mRNA vaccine, but none was severe.

We evaluated relative vaccine effectiveness (rVE) of 4- vs. 3-dose mRNA-1273 against SARS-CoV-2 infection, and COVID-19 hospitalization and death in immunocompetent adults aged ≥50 years at Kaiser Permanente Southern California. We included 178,492 individuals who received a fourth dose of mRNA-1273, and 178,492 randomly selected 3-dose recipients who were matched to 4-dose recipients by age, sex, race/ethnicity, and third dose date. Adjusted 4- vs. 3-dose rVE against SARS-CoV-2 infection, COVID-19 hospitalization, and COVID-19 hospitalization death were 25.9 % (23.5 %, 28.2 %), 67.3 % (58.7 %, 74.1 %), and 72.5 % (-35.9 %, 95.2 %), respectively. Adjusted rVE against SARS-CoV-2 infection ranged between 19.8 % and 39.1 % across subgroups. Adjusted rVE against SARS-CoV-2 infection and COVID-19 hospitalization decreased 2-4 months after the fourth dose. Four mRNA-1273 doses provided significant protection against COVID-19 outcomes compared with 3 doses, consistent in various subgroups of demographic and clinical characteristics, although rVE varied and waned over time.

BACKGROUND: Long duration trial data for two-dose COVID-19 vaccines primary series' are uncommon due to unblinding and additional doses. We report one-year follow-up results from a phase 1/2 trial of AZD1222 (ChAdOx1 nCoV-19) in Japan. METHODS: Adults (n = 256) seronegative for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) were stratified by age, 18-55 (n = 128), 56-69 (n = 86) and ≥70-year-old (n = 42), and randomized 3:1 to AZD1222 or placebo. Safety, immunogenicity, and exploratory efficacy data were collected until study Day 365. RESULTS: Safety was consistent with previous reports. In AZD1222 vaccinees, humoral responses against SARS-CoV-2 steadily declined over time. By Day 365, anti-SARS-CoV-2 spike-binding (spike) and receptor-binding domain (RBD) mean antibody titers remained above Day 15 levels and pseudovirus neutralizing antibodies were undetectable in many participants. CONCLUSIONS: AZD1222 is immunogenic and well tolerated in Japanese adults. Expected waning in anti-SARS-CoV-2 humoral responses was observed; spike and RBD antibody titers remained elevated. (ClinicalTrials.gov: NCT04568031).

BACKGROUND: The first COVID-19 vaccination campaign in Thailand began in April 2020, with healthcare workers receiving two doses of inactivated COVID-19 vaccine (CoronaVac). However, the emergence of the delta and omicron variants raised concerns about vaccine effectiveness. The Thai Ministry of Public Health provided the first booster dose (third dose) and second booster dose (fourth dose) of the mRNA vaccine (BNT162b2) for healthcare workers. This study investigated the immunity and adverse reactions elicited by a heterologous second booster dose of BNT162b2 after a two-dose CoronaVac vaccination for COVID-19 in healthcare workers of the Faculty of Medicine, Naresuan University. METHODS: IgG titres against the SARS-CoV-2-spike protein were measured four and 24 weeks after the second booster dose of BNT162b2 in the study participants. Adverse reactions were recorded during the first three days, four weeks and 24 weeks after the second booster dose of BNT162b2. RESULTS: IgG against the SARS-CoV-2-spike protein was positive (>10 U/ml) in 246 of 247 participants (99.6 %) at both four and 24 weeks after the second booster dose of BNT162b2. The median specific IgG titres at four and 24 weeks after the second booster dose of BNT162b2 were 299 U/ml (min: 2, max: 29,161) and 104 U/ml (min: 1, max: 17,920), respectively. The median IgG level declined significantly 24 weeks after the second booster dose of the BNT162b2 vaccine. Of the 247 participants, 179 (72.5 %) experienced adverse reactions in the first three days after the second booster dose of BNT162b2. Myalgia, fever, headache, injection site pain and fatigue were the most common adverse reactions. CONCLUSION: This study demonstrated that a heterologous second booster dose of BNT162b2 after two doses of CoronaVac induced elevated IgG against the SARS-CoV-2-spike protein and caused minor adverse reactions in healthcare workers of the Faculty of Medicine, Naresuan University. This study was registered as Thailand Clinical Trials No. TCTR20221112001.

BACKGROUND: Increasing vaccine hesitancy and refusal poses a challenge to public health as even small reductions in vaccine uptake can result in large outbreaks of infectious diseases. Here we estimate the societal costs of vaccine refusal using measles as a case study. METHODS: We developed a compartmental metapopulation model of measles transmission to explore how the changes in the size and level of social mixing between populations that are "pro-vaccination", and "anti-vaccination" impacts the burden of measles. Using the projected cases and deaths, we calculated the health, healthcare, direct medical costs, and productivity loss associated with vaccine refusal. Using measles in England as a case study, we quantified the societal costs that each vaccine refusal imposes on society. FINDINGS: When there is a high level of mixing between the pro- and anti-vaccination populations, those that refuse to be vaccinated benefit from the herd immunity afforded by the pro-vaccination population. At the same time, their refusal to be vaccinated increases the burden in those that are vaccinated due to imperfect vaccines, and in those that are not able to be vaccinated due to other underlying health conditions. Using England as a case study, we estimate that this translates to a societal loss of GBP 292 million and disease burden of 17 630 quality-adjusted-life-years (sensitivity range 10 594-50 379) over a 20-year time horizon. Of these costs, 26 % are attributable to healthcare costs and 74 % to productivity losses for patients and their carers. This translates to a societal loss per vaccine refusal of GBP 162.21 and 0.01 (0.006-0.03) quality-adjusted-life-years. INTERPRETATION: Our findings demonstrate that even low levels of vaccine refusal can have a substantial and measurable societal burden on the population. These estimates can support the value of investment in interventions that address vaccine hesitancy and vaccine refusal, providing not only improved public health but also potential economic benefits to society.

INTRODUCTION: Inactivated polio virus (IPV) vaccinations are a mainstay of immunization schedules in developed countries, while oral polio vaccine (OPV) is administered in developing countries and is the main vaccine in outbreaks. Due to circulating wild poliovirus (WPV1) detection in Israel (2013), oral bivalent polio vaccination (bOPV) was administered to IPV primed children and incorporated into the vaccination regimen. OBJECTIVES: We aimed to determine the extent and timeframe of fecal and salivary polio vaccine virus (Sabin strains) shedding following bOPV vaccination among IPV primed children. METHODS: Fecal samples were collected from a convenience sample of infants and toddlers attending 11 Israeli daycare centers. Salivary samples were collected from infants and toddlers following bOPV vaccination. RESULTS: 398 fecal samples were collected from 251 children (ages: 6-32 months), 168 received bOPV vaccination 4-55 days prior to sample collection. Fecal excretion continued among 80 %, 50 %, and 20 %, 2, 3, and 7 weeks following vaccination. There were no significant differences in the rate and duration of positive samples among children immunized with 3 or 4 IPV doses. Boys were 2.3-fold more likely to excrete the virus (p = 0.006). Salivary shedding of Sabin strains occurred in 1/47 (2 %) and 1/49 (2 %) samples 4, and 6 days following vaccination respectively. CONCLUSIONS: Fecal detection of Sabin strains among IPV-primed children continues for 7 weeks; additional doses of IPV do not augment intestinal immunity; limited salivary shedding occurs for up to a week. This data can enhance understanding of intestinal immunity achieved by different vaccination schedules and guide recommendations for contact precautions of children following bOPV vaccination.

Vaccine procurement costs comprise a significant share of immunization program costs in low- and middle-income countries, yet not all procured vaccines are administered. Vaccine wastage occurs due to vial breakage, excessive heat or freezing, expiration, or when not all doses in a multidose vial are used. Better estimates of vaccine wastage rates and their causes could support improved management of vaccine stocks and reduce procurement costs. This study examined aspects of wastage for four vaccines at service delivery points in Ghana (n = 48), Mozambique (n = 36), and Pakistan (n = 46). We used prospective data from daily and monthly vaccine usage data entry forms, along with cross-sectional surveys, and in-depth interviews. The analysis found that estimated monthly proportional open-vial wastage rates for vaccines in single-dose vials (SDV) or in multi-dose vials (MDV) that can be kept refrigerated up to four weeks after opening ranged from 0.08 % to 3 %. For MDV where remaining doses are discarded within six hours after opening, the mean wastage rates ranged from 5 % to 33 %, with rates being highest for measles containing vaccine. Despite national-level guidance to open a vaccine vial even when only one child is present, vaccines in MDV that are discarded within six hours of opening are sometimes offered less frequently than vaccines in SDV or in MDV where remaining doses can be used for up to 4 weeks. This practice can lead to missed opportunities for vaccination. While closed-vial wastage at service delivery points (SDPs) was relatively rare, individual instances can result in large losses, suggesting that monitoring closed-vial wastage should not be neglected. Health workers reported insufficient knowledge of vaccine wastage tracking and reporting methods. Improving reporting forms would facilitate more accurate reporting of all causes of wastage, as would additional training and supportive supervision. Globally, decreasing doses per vial could reduce open-vial wastage.

People with cystic fibrosis (pwCF) were considered to be clinically vulnerable to COVID-19 and were therefore given priority in the vaccination campaign. Vaccines induced a humoral response in these patients that was comparable to the response observed among the general population. However, the role of the cell-mediated immune response in providing long-term protection against SARS-CoV-2 in pwCF has not yet been defined. In this study, humoral (antibody titre) and cell-mediated immune responses (interferon-γ release) to the BNT162b2 vaccine were measured at different time points, from around 6-8 months after the 2nd dose and up to 8 months after the 3rd dose, in 118 CF patients and 26 non-CF subjects. Subjects were sampled between November 2021 and September 2022 and followed-up for breakthrough infection through October 2022. pwCF mounted a cell-mediated response that was similar to that observed in non-CF subjects. Low antibody titres (<1st quartile) were associated with a higher risk of breakthrough infection (HR: 2.39, 95 % CI: 1.17-4.88), while there was no significant association with low INF-γ levels (<0.3 IU/mL) (HR: 1.38, 95 % CI: 0.64-2.99). Further studies are needed in subgroup of pwCF receiving immunosuppressive therapy, such as organ transplant recipients. This data is important for tailoring vaccination strategies for this clinically vulnerable population.

BACKGROUND: Older adults are at increased risk of adverse outcomes from pneumococcal disease and COVID-19. Vaccination is an established strategy for preventing both illnesses. This study evaluated the safety and immunogenicity of coadministration of the 20-valent pneumococcal conjugate vaccine (PCV20) and a booster (third dose) of BNT162b2 COVID-19 vaccine. METHODS: This phase 3, randomized, double-blind, multicentre study included 570 participants aged ≥65 years randomized 1:1:1 to PCV20 and BNT162b2 coadministered, or PCV20 or BNT162b2 only (administered with saline for blinding). Primary safety endpoints included local reactions, systemic events, adverse events (AEs) and serious AEs (SAEs). Secondary objectives were immunogenicity of PCV20 and BNT162b2 when administered together or separately. RESULTS: Coadministration of PCV20 and BNT162b2 was well tolerated. Local reactions and systemic events were generally mild-moderate; injection-site pain and fatigue were the most frequent local and systemic events, respectively. AE and SAE rates were low and similar across groups. No AEs led to discontinuation; no SAEs were considered vaccination-related. Robust immune responses were observed, with opsonophagocytic activity geometric mean fold rises (GMFRs; from baseline to 1 month) of 2.5-24.5 and 2.3-30.6 across PCV20 serotypes in Coadministration and PCV20-only groups, respectively. GMFRs for full-length S-binding IgG of 35.5 and 39.0, and for neutralizing titres against SARS-CoV-2-wild type virus of 58.8 and 65.4, were observed in the Coadministration and BNT162b2-only groups, respectively. CONCLUSIONS: Safety and immunogenicity of coadministered PCV20 and BNT162b2 were similar to those of PCV20 or BNT162b2 administered alone, suggesting that the 2 vaccines may be coadministered. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04887948.

OBJECTIVES: The COVID-19 pandemic has disrupted the distribution of routine immunizations globally. Multi-country studies assessing a wide spectrum of vaccines and their coverage rates are needed to determine global performance in achieving vaccination goals. METHODS: Global vaccine coverage data for 16 antigens were obtained from WHO/UNICEF Estimates of National Immunization Coverage. Tobit regression was performed for all country-antigen pairs for which data were continuously available between 2015-2020 or 2015-2021 to predict vaccine coverage in 2020/2021. Vaccines for which multi-dose data were available were assessed to determine whether vaccine coverage for subsequent doses were lower than that of first doses. RESULTS: Vaccine coverage was significantly lower-than-predicted for 13/16 antigens in 2020 and all assessed antigens in 2021. Lower-than-predicted vaccine coverage was typically observed in South America, Africa, Eastern Europe, and Southeast Asia. There was a statistically significant coverage drop for subsequent doses of the diphtheria-tetanus-pertussis, pneumococcus, and rotavirus vaccines compared to first doses in 2020 and 2021. CONCLUSION: The COVID-19 pandemic exerted larger disruptions to routine vaccination services in 2021 than in 2020. Global efforts will be needed to recoup vaccine coverage losses sustained during the pandemic and broaden vaccine access in areas where coverage was previously inadequate.

BACKGROUND: The mechanism for anaphylaxis following mRNA COVID-19 vaccination has been widely debated; understanding this serious adverse event is important for future vaccines of similar design. A mechanism proposed is type I hypersensitivity (i.e., IgE-mediated mast cell degranulation) to polyethylene glycol (PEG). Using an assay that, uniquely, had been previously assessed in patients with anaphylaxis to PEG, our objective was to compare anti-PEG IgE in serum from mRNA COVID-19 vaccine anaphylaxis case-patients and persons vaccinated without allergic reactions. Secondarily, we compared anti-PEG IgG and IgM to assess alternative mechanisms. METHODS: Selected anaphylaxis case-patients reported to U.S. Vaccine Adverse Event Reporting System December 14, 2020-March 25, 2021 were invited to provide a serum sample. mRNA COVID-19 vaccine study participants with residual serum and no allergic reaction post-vaccination ("controls") were frequency matched to cases 3:1 on vaccine and dose number, sex and 10-year age category. Anti-PEG IgE was measured using a dual cytometric bead assay (DCBA). Anti-PEG IgG and IgM were measured using two different assays: DCBA and a PEGylated-polystyrene bead assay. Laboratorians were blinded to case/control status. RESULTS: All 20 case-patients were women; 17 had anaphylaxis after dose 1, 3 after dose 2. Thirteen (65 %) were hospitalized and 7 (35 %) were intubated. Time from vaccination to serum collection was longer for case-patients vs controls (post-dose 1: median 105 vs 21 days). Among Moderna recipients, anti-PEG IgE was detected in 1 of 10 (10 %) case-patients vs 8 of 30 (27 %) controls (p = 0.40); among Pfizer-BioNTech recipients, it was detected in 0 of 10 case-patients (0 %) vs 1 of 30 (3 %) controls (p >n 0.99). Anti-PEG IgE quantitative signals followed this same pattern. Neither anti-PEG IgG nor IgM was associated with case status with both assay formats. CONCLUSION: Our results support that anti-PEG IgE is not a predominant mechanism for anaphylaxis post-mRNA COVID-19 vaccination.

This article explores how preferences for risk reduction during the COVID-19 pandemic are influenced by personal experiences and contextual variables such as having a close friend or relative who has been infected by the virus (closeness), the severity of the illness (severity), people's own perceptions of being in a risky group (risk group), change in employment status due to the pandemic (employment situation), and vaccination status (vaccination status and altruistic vaccination). We conducted a choice experiment (CE) in Chile, Colombia, and Costa Rica. The attributes of the experiment were risk reduction, latency, and cost. Then, we estimated a mixed logit model to capture preference heterogeneity across the countries. The attributes presented in the CE were statistically significant, with the expected sign in each country. The variables closeness and employment situation presented homogeneous behavior in each country; however, severity, risk group, and vaccination status showed mixed results. We found that preferences were more heterogeneous for the attributes of the CE than for the personal experiences and contextual variables. Understanding the impact of these variables is essential for generating more effective risk reduction policies. For instance, methodologies such as the value of statistical life base their calculations on society's valuation of risk reduction. We provide evidence that the preferences for risk reduction vary due to the everyday situations that individuals face in the context of the pandemic. The latter may cause distortions in the values used to evaluate policies aimed at mitigating the outbreak.

OBJECTIVE: To determinate the frequency of Streptococcus pneumoniae nasopharyngeal carriers, serotypes and antimicrobial resistance in healthy children in Lima, Peru, post-PCV13 introduction and to compare the results with a similar study conducted between 2006 and 2008 before PCV7 introduction (pre-PCV7). METHODS: A cross-sectional multicenter study was conducted between January 2018 and August 2019 in 1000 healthy children under two years of age. We use standard microbiological methods to determinate S. pneumoniae from nasopharyngeal swab, Kirby Bauer and minimum inhibitory concentration methods to determinate antimicrobial susceptibility and whole genomic sequencing to determinate pneumococcal serotypes. RESULTS: The pneumococcal carriage rate was 20.8 % vs. 31.1 % in pre-PCV7 (p < 0.001). The most frequent serotypes were 15C, 19A and 6C (12.4 %, 10.9 % and 10.9 % respectively). The carriage of PCV13 serotypes after PCV13 introduction decreased from 59.1 % (before PCV7 introduction) to 18.7 % (p < 0.001). Penicillin resistance was 75.5 %, TMP/SMX 75.5 % and azithromycin 50.0 %, using disk diffusion. Penicillin resistance rates using MIC breakpoint for meningitis (MIC ≥ 0.12) increased from 60.4 % to 74.5 % (p = 0.001). CONCLUSION: The introduction of PCV13 in the immunization program in Peru has decreased the pneumococcal nasopharyngeal carriage and the frequency of PCV13 serotypes; however, there has been an increase in non-PCV13 serotypes and antimicrobial resistance.

BACKGROUND: The incidence of myopericarditis after mRNA COVID-19 vaccination among adolescents aged 12-17 years remains unknown. Therefore, we conducted a study to pool the incidence of myopericarditis following COVID-19 vaccination in this age group. METHODS: We did a meta-analysis by searching 4 electronic databases until February 6, 2023. The following main keywords were used: "COVID-19", "vaccines", "myocarditis", "pericarditis", and "myopericarditis". Observational studies reporting on adolescents aged 12-17 years who had myopericarditis in temporal relation to receiving mRNA COVID-19 vaccines were included. The pooled incidence of myopericarditis and 95 % confidence interval (CI) were calculated using a single-group meta-analysis. RESULTS: Fifteen studies were included. The pooled incidences of myopericarditis after mRNA COVID-19 vaccination among adolescents aged 12-17 years were 43.5 (95 % CI, 30.8-61.6) cases per million vaccine doses for both BNT162b2 and mRNA-1273 (39 628 242 doses; 14 studies), and 41.8 (29.4-59.4) cases for BNT162b2 alone (38 756 553 doses; 13 studies). Myopericarditis was more common among males (66.0 [40.5-107.7] cases) than females (10.1 [6.0-17.0] cases) and among those receiving the second dose (60.4 [37.6-96.9] cases) than those receiving the first dose (16.6 [8.7-31.9] cases). The incidences of myopericarditis did not differ significantly when grouped by age, type of myopericarditis, country, and World Health Organization region. None of the incidences of myopericarditis pooled in the current study were higher than those after smallpox vaccinations and non-COVID-19 vaccinations, and all of them were significantly lower than those in adolescents aged 12-17 years after COVID-19 infection. CONCLUSIONS: The incidences of myopericarditis after mRNA COVID-19 vaccination among adolescents aged 12-17 years were very rare; they were not higher than other important reference incidences. These findings provide an important context for health policy makers and parents with vaccination hesitancy to weight the risks and benefits of mRNA COVID-19 vaccination among adolescents aged 12-17 years.

BACKGROUND: In August 2015, the German Standing Committee on Vaccination (STIKO) changed the pneumococcal conjugate vaccination (PCV) schedule for mature infants from a 3+1 to a 2+1scheme. For premature infants, the 3+1schedule remained unchanged. Aim was to assess vaccination rates, completeness, and timeliness for PCV stratified by premature and mature infants before and after the recommendation change based on real-world data. METHODS: Retrospective claims data analyses were conducted using a comprehensive research database. The study population consisted of all mature and premature infants born in 2013, 2016, or 2018 with an individual follow-up of 24 months using ICD-10-GM codes P07.2 and P07.3 for premature infants. Hexavalent (HEXA) combination vaccination with a consistent 3+1recommendation for premature and mature infants was analyzed as a reference. RESULTS: After follow-up of 24 months, rates of premature and mature infants receiving ≥1PCV and HEXA vaccination steadily increased since the change of STIKO's recommendation. However, in 2018 (2016/2013), only 47 % (41 %/65 %) of premature but 74 % (72 %/68 %) of mature infants obtained the recommended 3+1 respectively 2+1 PCV doses. At the same age, a consistent increase in complete HEXA vaccination with 3+1 doses was observed over time in premature (2013/2016/2018: 66 %/68 %/70 %) and mature (2013/2016/2018: 69 %/72 %/73 %) infants. Timeliness of PCV and HEXA booster administration remained stable with ∼50 % of all premature and mature infants receiving the booster according to recommended timelines. CONCLUSION: There is no proven evidence that the reduced PCV schedule for mature infants induced a higher acceptance of vaccination. The rate of unvaccinated infants remained at a considerable level and vaccinations were often delayed. Although the STIKO still recommends a 3+1 PCV schedule for premature infants in Germany, less than half of children showed a completed vaccination series. To protect these vulnerable groups, efforts are needed to increase adherence to the STIKO recommendation especially for premature infants.

Streptococcus pneumoniae is a common agent of important human diseases such as otitis media, pneumonia, meningitis and sepsis. Current available vaccines that target capsular polysaccharides induce protection against invasive disease and nasopharyngeal colonization in children, yet their efficacy is limited to the serotypes included in the formulations. The virulence factor Pneumococcal Surface Protein A (PspA) interacts with host immune system and helps the bacteria to evade phagocytosis. Due to its essential role in virulence, PspA is an important vaccine candidate. Here we have tested a delivery system based on the adenylate cyclase toxin of Bordetella pertussis (CyaA) to induce immune responses against PspA in mice. CyaA was engineered to express fragments of the N-terminal region of PspAs from clades 2 and 4 (A2 and A4) and the resulting proteins were used in immunization experiments in mice. The recombinant CyaA-A2 and CyaA-A4 proteins were able to induce high levels of anti-PspA antibodies that reacted with pneumococcal strains expressing either PspA2 or PspA4. Moreover, reactivity of the antibodies against pneumococcal strains that express PspAs from clades 3 and 5 (PspA3 and PspA5) was also observed. A formulation containing CyaA-A2 and CyaA-A4 was able to protect mice against invasive pneumococcal challenges with isolates that express PspA2, PspA4 or PspA5. Moreover, a CyaA-A2-A4 fusion protein induced antibodies at similar levels and with similar reactivity as the formulation containing both proteins, and protected mice against the invasive challenge. Our results indicate that CyaA-PspA proteins are good candidates to induce broad protection against pneumococcal isolates.

BACKGROUND: Since 2008 New Zealand has used three different formulations of pneumococcal vaccines on the national infant schedule, PCV7, PCV10 and PCV13, switching between PCV10 and PCV13 twice in 10 years. We have used New Zealand's linkable, administrative health data to examine the comparative risk of otitis media (OM) and pneumonia hospitalisations among children receiving three different pneumococcal conjugate vaccines (PCV). METHODS: This was a retrospective cohort study using linked administrative data. Outcomes were otitis media, all cause pneumonia and bacterial pneumonia related hospitalisation for children in three cohorts representing periods where PCVs transitioned between PCV7, PCV10, PCV13 and back to PCV10 between 2011 and 2017. Cox's proportional hazard regression was used to provide hazard ratio estimates to compare outcomes for children vaccinated with different vaccine formulations and to adjust for different sub population characteristics. RESULTS: Each observation period, where different vaccine formulations coincided, and therefore comparable with respect to age and the environment, included over fifty-thousand infants and children. PCV10 was associated with a reduced risk for OM compared with PCV7 (Adjusted HR 0.89, 95 %CI 0.82-0.97). There were no significant differences between PCV10 and PCV13 in risk of hospitalisation with either otitis media or all-cause pneumonia amongst the transition 2 cohort. In the 18 -month follow-up, after transition 3, PCV13 was associated with a marginally higher risk of all-cause pneumonia and otitis media compared to PCV10. CONCLUSION: These results should offer reassurance about the equivalence of these pneumococcal vaccines against the broader pneumococcal disease outcomes OM and pneumonia.

INTRODUCTION: The COVID-19 pandemic has contributed to declines in routine childhood and adolescent vaccination coverage globally. While the declines in Australia have been less, they are a concern, given steady increases in coverage prior to the pandemic. Given limited evidence on how the experiences of parents during the pandemic affected their attitudes about and intentions towards adolescent vaccinations, with this study we aimed to explore these. METHODS: This was a qualitative study. We invited parents of adolescents eligible for school-based vaccinations in 2021 from metropolitan, regional and rural areas of New South Wales and Victoria (the most affected States) and South Australia (less affected) to half hour-long online semi-structured interviews. We analysed data thematically and applied a conceptual model of trust in vaccination. RESULTS: In July 2022 we interviewed 15 accepting, 4 hesitant and two parents who refused adolescent vaccinations. We identified three themes: 1. Pandemic impacting on professional and personal lives and routine immunisations; 2. Pandemic strengthening preexisting vaccine hesitancy, with perceived lack of clarity in governmental information about vaccination and stigma around non-vaccinating as contributing factors; 3. Pandemic raising awareness of the benefits of COVID-19 and routine vaccinations, with communication campaigns and one's trusted doctor's vaccination recommendations as contributing factors. CONCLUSIONS: For some parents, experiences of poor system readiness and growing distrust towards health and vaccination systems strengthened their pre-existing vaccine hesitancy. We offer recommendations on how trust in the health system and immunisation can be optimised post-pandemic to increase uptake of routine vaccines. These include improving access to vaccination services and clear, timely information about vaccines; supporting immunisation providers in their immunisation consultations; working alongside communities, and building capacity of vaccine champions.

Vast quantities of open-source data from news reports, social media and other sources can be harnessed using artificial intelligence and machine learning, and utilised to generate valid early warning signals of emerging epidemics. Early warning signals from open-source data are not a replacement for traditional, validated disease surveillance, but provide a trigger for earlier investigation and diagnostics. This may yield earlier pathogen characterisation and genomic data, which can enable earlier vaccine development or deployment of vaccines. Early warning also provides a more feasible prospect of stamping out epidemics before they spread. There are several of such systems currently, but they are not used widely in public health practice, and only some are publicly available. Routine and widespread use of open-source intelligence, as well as training and capacity building in digital surveillance, will improve pandemic preparedness and early response capability.

Africa is set to experience a three-fold increase in vaccine demand by 2040, yet the continent possesses few domestic capabilities for vaccine production. This lack of production capacity, heavy reliance on foreign aid, disruptions of hard-won immunization progress due to the effects of the COVID-19 pandemic, and fluctuating vaccine market dynamics threaten to hinder ongoing efforts to increase vaccination rates on the continent. In order meet the vaccine demands of a rapidly growing population, and to be able to provide novel vaccines to its population in the future, the African continent must develop a sustainable vaccine manufacturing infrastructure. The African Union, in partnership with the Africa Centres for Disease Control and Prevention, recently set forth its Program for African Vaccine Manufacturing Framework for Action, which sets the goal of Africa producing 60 % of its vaccine needs by 2040. To meet these goals, African governments and their multinational, philanthropic, and private sector partners must work to secure low-cost financing and provide a favourable regulatory environment for nascent African vaccine manufacturers. Doing so will save lives, safeguard the health of the continent's current and future citizens, and contribute to economic growth through the development of local bioeconomies.

BACKGROUND: Following the authorization and recommendations for use of the U.S. COVID-19 vaccines, the Centers for Disease Control and Prevention (CDC)'s Immunization Safety Office (ISO) responded to inquiries and questions from public health officials, healthcare providers, and the general public on COVID-19 vaccine safety. METHODS: We describe COVID-19 vaccine safety inquiries, by topic, received and addressed by ISO from December 1, 2020-August 31, 2022. RESULTS: Of the 1978 COVID-19 vaccine-related inquiries received, 1655 specifically involved vaccine safety topics. The most frequently asked-about topics included deaths following vaccination, myocarditis, pregnancy, and reproductive health outcomes, understanding or interpreting data from the Vaccine Adverse Event Reporting System (VAERS), and thrombosis with thrombocytopenia syndrome. CONCLUSIONS: Inquiries about vaccine safety generally reflect issues that receive media attention. ISO will continue to monitor vaccine safety inquiries and provide accurate and timely information to healthcare providers, public health officials, and the general public.

This survey aimed to assess the prevalence of intention to receive smallpox vaccine against mpox and its relationship with sexual orientation in Japan. A cross-sectional online survey was conducted in September-October 2022, with 12,900 assigned males and 13,413 assigned females participating. Modified Poisson regression analyses were performed to determine the relationship between vaccine willingness and sexual orientation, adjusting for socioeconomics, trust in government, COVID-19 vaccination status, and frequency of brothel visits. Vaccine willingness was higher in homosexual respondents than heterosexual counterparts, with proportions of 23.1 % among assigned males and 13.4 % among assigned females. Homosexual orientation was significantly associated with vaccine willingness, with prevalence ratios of 1.37 (95 % CI: 1.23-1.54) among assigned males and 1.34 (95 % CI: 1.13-1.59) among assigned females. These findings highlight the need for targeted vaccine promotion campaigns and ongoing monitoring of attitudes towards mpox and vaccine compliance in high-risk groups.

Coronavirus disease-2019 (COVID-19) is an ongoing pandemic caused by the newly emerged virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently, COVID-19 vaccines are given intramuscularly and they have been shown to evoke systemic immune responses that are highly efficacious towards preventing severe disease and death. However, vaccine-induced immunity wanes within a short time, and booster doses are currently recommended. Furthermore, current vaccine formulations do not adequately restrict virus infection at the mucosal sites, such as in the nasopharyngeal tract and, therefore, have limited capacity to block virus transmission. With these challenges in mind, several mucosal vaccines are currently being developed with the aim of inducing long-lasting protective immune responses at the mucosal sites where SARS-COV-2 infection begins. Past successes in mucosal vaccinations underscore the potential of these developmental stage SARS-CoV-2 vaccines to reduce disease burden, if not eliminate it altogether. Here, we discuss immune responses that are triggered at the mucosal sites and recent advances in our understanding of mucosal responses induced by SARS-CoV-2 infection and current COVID-19 vaccines. We also highlight several mucosal SARS-COV-2 vaccine formulations that are currently being developed or tested for human use and discuss potential challenges to mucosal vaccination.

INTRODUCTION: The 2022 global outbreak of Monkeypox virus (Mpox), which has primarily spread through the sexual networks of sexual and gender minority (SGM) individuals, has introduced new public health challenges. While an efficacious Mpox vaccine is in active circulation, few Mpox vaccine studies have examined its uptake among SGM groups. The aims of this study were to investigate (a) the prevalence of Mpox vaccine uptake among SGM and (b) the contextual, Mpox-disease specific, and Mpox-vaccine specific factors associated with Mpox vaccine among SGM. METHODS: We conducted a cross-sectional survey in Illinois, USA in September 2022; 320 young SGM completed self-administered questionnaires. Multinomial logistic regression was used to assess the contextual, Mpox-disease specific, and Mpox-vaccine specific factors associated with Mpox vaccine uptake. Adjusted Odds Ratios (aORs) and 95 % Confidence Intervals (CI) are reported. RESULTS: Approximately 50 % of the SGM participants included in this study had received at least their first dose of the Mpox vaccine. Multinomial regression analysis showed that individuals who had recently experienced food insecurity, had higher degrees of fear of social rejection due to Mpox acquisition, and were more Mpox-vaccine hesitant were more likely to be unvaccinated. Conversely, knowing people who have contracted Mpox, having higher formal educational attainment, having higher degrees of Mpox-related internalized heterosexism, and being more concerned about one's safety regarding Mpox morbidity were more likely to be double-dosers. CONCLUSION: Approximately 50 % of the SGMs included in this study received at least their first dose of the Mpox vaccine; however, only one-quarter of participants completed the recommended 2-dose Mpox regimen. Our findings indicate that socioeconomic stability, fear of social rejection due to disease acquisition, and Mpox-specific vaccine hesitancy may be important structural targets to consider when developing vaccine-uptake prevention and intervention strategies tailored to the needs of sexual and gender minorities.

Delayed release of vaccine coupled with a soluble vaccine acts as a primer and a booster with only a single administration, which would be very beneficial to livestock producers. We developed a subdermal pellet consisting of solid-phase pure stearic acid (SA) or palmitic acid (PA) that was used to encapsulate a small volume liquid vaccine consisting of fluorescently labeled *Ovalbumin (Cy5-*OVA) formulated with Emulsigen-D +/- Poly I:C (EMP) adjuvants. Mice were also immunized via the subcutaneous route with Cy5-*OVA-EMP (soluble liquid). The vaccine leached out of the pellet with very little dissolution of the fat itself resulting in the sustained subdermal delivery of antigens and adjuvants. Cy5-*OVA was still visible 60 days post administration in mice immunized with stearic acid-coated or palmitic acid-coated pellets. In these mice, persistently high IgG1 and IgG2a antibody titres were detected as well as significant IFNγ production at least 60 days post-injection. These responses were significantly higher than those observed after a single subcutaneous injection of the vaccine. A repeat trial with the pellets alone +/- the soluble vaccine showed comparable immune responses after surgical implantation of the pellet, suggesting that pellet alone may be sufficient. The PA-coated vaccines led to dermal inflammation in the mice that would limit usefulness of this vehicle, but this was largely absent when SA was used to coat the pellets. These data suggest that the SA-coated adjuvanted vaccine prolonged the release of the vaccine and triggered a comparable immune response to the mice that received the two liquid injections, and a single pellet vaccine should be tested as a novel immunization method for livestock.

Mosquito-transmitted chikungunya virus (CHIKV) is the causal pathogen of CHIKV disease and is responsible for global epidemics of arthritic disease. CHIKV infection can lead to severe chronic and debilitating arthralgia, significantly impacting patient mobility and quality of life. Our previous studies have shown a live-attenuated CHIKV vaccine candidate, CHIKV-NoLS, to be effective in protecting against CHIKV disease in mice vaccinated with one dose. Further studies have demonstrated the value of a liposome RNA delivery system to deliver the RNA genome of CHIKV-NoLS directly in vivo, promoting de novo production of live-attenuated vaccine particles in vaccinated hosts. This system, designed to bypass live-attenuated vaccine production bottlenecks, uses CAF01 liposomes. However, one dose of CHIKV-NoLS CAF01 failed to provide systemic protection against CHIKV challenge in mice, with low levels of CHIKV-specific antibodies. Here we describe CHIKV-NoLS CAF01 booster vaccination regimes designed to increase vaccine efficacy. C57BL/6 mice were vaccinated with three doses of CHIKV-NoLS CAF01 either intramuscularly or subcutaneously. CHIKV-NoLS CAF01 vaccinated mice developed a systemic immune response against CHIKV that shared similarity to vaccination with CHIKV-NoLS, including high levels of CHIKV-specific neutralising antibodies in subcutaneously inoculated mice. CHIKV-NoLS CAF01 vaccinated mice were protected against disease signs and musculoskeletal inflammation when challenged with CHIKV. Mice given one dose of live-attenuated CHIKV-NoLS developed a long lasting protective immune response for up to 71 days. A clinically relevant CHIKV-NoLS CAF01 booster regime can overcome the challenges faced by our previous one dose strategy and provide systemic protection against CHIKV disease.

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).

INTRODUCTION: The introduction of anti-poliomyelitis vaccines has driven progress toward the global eradication of wild polioviruses, a millennium goal of the World Health Organization. With the vaccination campaigns carried out since 1964, in 2002 Italy was certified polio-free, considering that no cases had been recorded since 1983. Nevertheless, it is crucial to guarantee high level of immunization coverage also in low-endemicity countries, considering that sporadic polio cases can be recorded. To evaluate the presence of susceptible subjects in the population, seroepidemiological studies are key actions. METHODS: We conducted a systematic review of the relevant literature to evaluate the prevalence of anti-PV neutralizing antibodies in Italian population. Seven studies, selected among scientific articles available in MEDLINE/PubMed, ISI Web of Knowledge and Scopus and published from January 1, 2012, to November 15, 2022, were included. RESULTS: The pooled prevalence of subjects without PV1 neutralizing antibodies was 6.4% (95%CI = 0.5-16.9), for PV2 it was 5.3% (95%CI = 0.4-14.2), and for PV3 it was 13.0% (95%CI = 4.0-25.7; I2 = 98.5%). Levels of neutralizing antibodies appears to decrease with increasing age; this decline is a proxy for the real risk factor, which is the time since the last vaccine dose. CONCLUSIONS: Public health institutions must be aware of the risk of reintroduction of wild PV in polio-free countries and therefore they must keep high level of immunization in population and reinforce the active surveillance systems.

Emerging infectious diseases like COVID-19 will remain a concern for the foreseeable future, and determinants of vaccination and other mitigation behaviors are therefore critical to understand. Using data from the first two waves of the Canadian COVID-19 Experiences Survey (CCES; N = 1,958; 66.56 % female), we examined social cognitive predictors of vaccination status, transition to acceptance and mitigation behaviors in a population-representative sample. Findings indicated that all social cognitive variables were strong predictors of mitigation behavior performance at each wave, particularly among unvaccinated individuals. Among those who were vaccine hesitant at baseline, most social cognitive variables predicted transition to fully vaccinated status at follow-up. After controlling for demographic factors and geographic region, greater odds of transitioning from unvaccinated at CCES Wave 1 to fully vaccinated at CCES Wave 2 was predicted most strongly by a perception that one's valued peers were taking up the vaccine (e.g., dynamic norms (OR = 2.13 (CI: 1.54,2.93)), perceived effectiveness of the vaccine (OR = 3.71 (CI: 2.43,5.66)), favorable attitudes toward the vaccine (OR = 2.80 (CI: 1.99,3.95)), greater perceived severity of COVID-19 (OR = 2.02 (CI: 1.42,2.86)), and stronger behavioral intention to become vaccinated (OR = 2.99 (CI: 2.16,4.14)). As a group, social cognitive variables improved prediction of COVID-19 mitigation behaviors (masking, distancing, hand hygiene) by a factor of 5 compared to demographic factors, and improved prediction of vaccination status by a factor of nearly 20. Social cognitive processes appear to be important leverage points for health communications to encourage COVID-19 vaccination and other mitigation behaviors, particularly among initially hesitant members of the general population.

The "risk compensation hypothesis" holds that vaccinated individuals may be less motivated to protect themselves using other COVID-19 mitigation behaviors-e.g., masking, distancing and hand hygiene-given that they may perceive their infection risk to be lower. The current investigation provides an empirical test of the risk compensation hypothesis in the COVID-19 context using prospective data from the Canadian COVID-19 Experiences Survey (CCES). The survey comprised 1,958 unvaccinated and fully vaccinated individuals drawn from a representative sample, using quota sampling to ensure substantial representation of unvaccinated individuals. Two waves of data were collected 6 months apart. Findings revealed that vaccinated individuals performed COVID-19 mitigation behaviors significantly more frequently than their unvaccinated counterparts, and they also showed lower rates of attenuation as the pandemic continued. In summary, our findings do not support the risk compensation hypothesis; instead they support the notion that people adopt vaccination and other protective behaviors in parallel.

BACKGROUND: Given the long-term threat posed by COVID-19, predictors of mitigation behaviors are critical to identify. Prior studies have found that cognitive factors are associated with some COVID-19 mitigation behaviors, but few studies employ representative samples and no prior studies have examined cognitive predictors of vaccination status. The purpose of the present study was to examine associations between cognitive variables (executive function, delay discounting, and future orientation) and COVID-19 mitigation behaviors (mask wearing, social distancing, hand hygiene and vaccination) in a population representative sample. METHODS: A population representative sample of 2,002 adults completed validated measures of delay discounting, future orientation, and executive function. Participants also reported frequency of mitigation behaviors, vaccination status, and demographics. RESULTS: Future orientation was associated with more mask wearing (β = 0.160, 95 % CI [0.090, 0.220], p < 0.001), social distancing (β = 0.150, 95 % CI [0.070, 0.240], p < 0.001), hand hygiene behaviors (β = 0.090, 95 % CI [0.000, 0.190], p = 0.054), and a higher likelihood of being fully vaccinated (OR = 0.80, 95 % CI [0.670, 0.970], p = 0.020). Lower delay discounting predicted more consistent mask wearing (β = -0.060, 95 % CI[-0.120, -0.010], p = 0.032) and being fully vaccinated (OR = 1.28, 95 % CI [1.13, 1.44], p < 0.001), while more symptoms of executive dysfunction predicted less mask wearing (β = -0.240, 95 % CI [-0.320, -0.150] p < 0.001) and hand hygiene (β = -0.220, 95 % CI [-0.320, -0.130], p < 0.001), but not vaccination status (OR = 0.96, 95 % CI [0.80, 1.16], p = 0.690) or social distancing behaviors (β = -0.080, 95 % CI [-0.180, 0.020], p = 0.097). Overall, social distancing was the least well-predicted outcome from cognitive factors, while mask wearing was most well-predicted. Vaccination status was not a significant moderator of these effects of cognitive predictors on mitigation behaviors. CONCLUSIONS: Cognitive variables predict significant variability in mitigation behaviors. regardless of vaccination status. In particular, thinking about the future and discounting it less may encourage more consistent implementation of mitigating behaviors.

BACKGROUND: Maternal pertussis immunization using Tdap vaccine is recommended in many countries to protect newborns from severe post-natal infection. Immunological changes during pregnancy may influence the response to vaccines. The quality of IgG and memory B cell responses to Tdap immunization in pregnant women has not yet been described. METHODS: The impact of pregnancy on the response to Tdap vaccination was assessed by comparing humoral immune responses in 42 pregnant and 39 non-pregnant women. The levels of serum pertussis antigens and tetanus toxoid-specific IgG, IgG subclasses, IgG Fc-mediated effector functions, as well as memory B cell frequencies were assessed before and at several time points after vaccination. RESULTS: Tdap immunization induced similar levels of pertussis and tetanus-specific IgG and IgG subclasses in pregnant and non-pregnant women. Pregnant women produced IgG promoting complement deposition, and neutrophils and macrophages phagocytosis at levels comparable to non-pregnant women. They were also able to expand pertussis and tetanus-specific memory B cells at similar frequencies as non-pregnant women, suggesting equivalent "boostability". Higher levels of vaccine-specific IgG, IgG subclasses, and IgG Fc-mediated effector functions were detected in cord blood as compared to maternal blood, indicating efficient transport across the placenta. CONCLUSIONS: This study demonstrates that pregnancy does not affect the quality of effector IgG and memory B cell responses to Tdap immunization and that polyfunctional IgG are efficiently transferred across the placenta. REGISTRY'S URL AND THE TRIAL'S REGISTRATION NUMBER: ClinicalTrials.Gov (NCT03519373).

Pregnant and lactating women's vaccine decision-making process is influenced by many factors. Pregnant women were at increased risk for severe disease and poor health outcomes from COVID-19 at various time points during the pandemic. COVID-19 vaccines have been found to be safe and protective during pregnancy and while breastfeeding. In this study, we sought to examine key factors that informed the decision-making process among pregnant and lactating women in Bangladesh. We conducted 24 in-depth interviews, with 12 pregnant and 12 lactating women. These women were from three communities in Bangladesh: one urban community, and two rural communities. We used a grounded theory approach to identify emerging themes and organized emerging themes using a socio-ecological model. The socio-ecological model suggests that individuals are influenced by many levels, including individual-level influences, interpersonal-level influences, health care system-level influences, and policy-level influences. We found key factors at each socio-ecological level that influenced the decision-making process of pregnant and lactating women, including perceived benefits of vaccines and vaccine safety (individual-level), the influence of husbands and peers (interpersonal-level), health care provider recommendations and vaccine eligibility (health care system-level), and vaccine mandates (policy-level). As vaccination can reduce the effect of COVID-19 disease in mothers, infants, and unborn children, targeting critical factors that inform the decision-making process is paramount for improving vaccine acceptance. We hope the results of this study will inform vaccine acceptance efforts to ensure that pregnant and lactating women take advantage of this life-saving intervention.

BACKGROUND: NVX-CoV2373 (Nuvaxovid™ or the Novavax COVID-19 Vaccine, Adjuvanted), the first protein-based COVID-19 vaccine, received emergency use authorization (EUA) as a primary series/booster and is available globally. NVX-CoV2373 primary series demonstrated efficacy rates of 89.7-90.4 % and an acceptable safety profile. This article summarizes safety in adult recipients (aged ≥ 18 years) of primary series NVX-CoV2373 in four randomized placebo-controlled trials. METHODS: All participants who received NVX-CoV2373 primary series or placebo (pre-crossover) were included according to actual received treatment. The safety period was from Day 0 (first vaccination) to unblinding/receipt of EUA-approved/crossover vaccine, end of each study (EOS), or last visit date/cutoff date minus 14 days. The analysis reviewed local and systemic solicited adverse events (AEs) within 7 days after NVX-CoV2373 or placebo; unsolicited AEs from after Dose 1 to 28 days after Dose 2; serious AEs (SAEs), deaths, AEs of special interest, and vaccine-related medically attended AEs from Day 0 through end of follow-up (incidence rate per 100 person-years). FINDINGS: Pooled data from 49,950 participants (NVX-CoV2373, n = 30,058; placebo, n = 19,892) were included. Solicited reactions after any dose were more frequent in NVX-CoV2373 recipients (local, 76 %/systemic, 70 %) than placebo recipients (local, 29 %/systemic, 47 %), and were mostly of mild-to-moderate severity. Grade 3+ reactions were infrequent, with greater frequency in NVX-CoV2373 recipients (local, 6.28 %/systemic, 11.36 %) than placebo recipients (local, 0.48 %/systemic, 3.58 %). SAEs and deaths occurred with similarly low frequency in NVX-CoV2373 (SAEs: 0.91 %, deaths: 0.07 %) and placebo recipients (SAEs: 1.0 %, deaths: 0.06 %). INTERPRETATION: To date, NVX-CoV2373 has displayed an acceptable safety profile in healthy adults. FUNDING: Supported by Novavax, Inc.

BACKGROUND: Health care workers (HCW) have a higher exposure to SARS-CoV-2 virus than other professionals and to protect both HCW and patients, HCW have been prioritized for vaccination against SARS-CoV-2 in many countries. Estimating the COVID-19 vaccine effectiveness among HCW is important to provide recommendations to protect risk groups. METHODS: We estimated vaccine effectiveness against SARS-CoV-2 infections using Cox proportional hazard models among HCW with comparisons in the general population, from 1 August 2021 to 28 January 2022. Vaccine status is specified as a time-varying covariate and all models incorporated explicit time and were adjusted for age, sex, comorbidities, county of residence, country of birth, and living conditions. Data from the adult Norwegian population (aged 18-67 years) and HCW workplace data (as registered 1 January 2021) were collated from the National Preparedness Register for COVID-19 (Beredt C19). RESULTS: Vaccine effectiveness was higher for Delta than for the Omicron variant in HCW (71 % compared to 19 %) as well as in non-HCW (69 % compared to -32 %). For the Omicron variant a 3rd dose provides significantly better protection against infection than 2 doses in both HCW (33 %) and non-HCW (10 %). Further, HCW seem to have better vaccine effectiveness than non-HCW for the Omicron, but not for the Delta variant. CONCLUSIONS: Vaccine effectiveness were comparable between HCW and non-HCW for the delta variant, but significantly higher in HCW than non-HCW for the omicron variant. Both HCW and non-HCW got increased protection from a third dose.

Vaccination is crucial for reducing severe COVID-19 cases, hospitalizations, and deaths. However, vaccine access disparities within countries, particularly in low- and middle-income nations, may leave disadvantaged regions and populations behind. This study aimed to investigate potential inequalities in vaccine coverage among Brazilian aged 18 years and older based on demographic, geographic, and socioeconomic characteristics at the municipal level. A total of 389 million vaccination records from the National Immunization Program Information System were analyzed to calculate vaccine coverage rates for the first, second, and booster doses among adults (18-59 years) and elderly (60 + years) vaccinated between January 2021 and December 2022. We analyzed the data by gender and used a three-level (municipalities, states, regions) multilevel regression analysis to assess the association between vaccine coverage and municipal characteristics. Vaccination coverage was higher among the elderly than among adults, particularly for the second and booster doses. Adult women showed higher coverage rates than men (ranging from 118 % to 25 % higher along the analyzed period). Significant inequalities were observed when analyzing the evolution of vaccination coverage by sociodemographic characteristics of municipalities. In the early stages of the vaccination campaign, municipalities with higher per capita Gross Domestic Product (pGDP), educational level, and fewer Black residents reached higher population coverages earlier. In December 2022, adult and elderly booster vaccine coverage was 43 % and 19 %, respectively, higher in municipalities in the highest quintile of educational level. Higher vaccine uptake was also observed in municipalities with fewer Black residents and higher pGDP. Municipalities accounted for most of the variance in vaccine coverage (59.7 %-90.4 % depending on the dose and age group). This study emphasizes the inadequate booster coverage and the presence of socioeconomic and demographic disparities in COVID-19 vaccination rates. These issues must be addressed through equitable interventions to avoid potential disparities in morbidity and mortality.

BACKGROUND: The pentavalent DTwP-HB-Hib (Shan-5) vaccine was first introduced into the Thailand Expanded Program on Immunization (EPI) in 2019. The Shan-5 vaccine is administered to infants at 2, 4, and 6 months of age, after initial vaccination with monovalent hepatitis B (HepB) and Bacillus Calmette-Guérin (BCG) vaccines at birth. This study compared the immunogenicity of the HepB, diphtheria, tetanus, and Bordetella pertussis antigens incorporated in the EPI Shan-5 vaccine versus the optional pentavalent (DTwP-HB-Hib) Quinvaxem and hexavalent (DTaP-HB-Hib-IPV) Infanrix-hexa vaccine. METHODS: Three-dose Shan-5-vaccinated children were prospectively enrolled at the Regional Health Promotion Centre 5, Ratchaburi province, Thailand, between May 2020 and May 2021. Blood sampling was performed at months 7 and 18. The levels of HepB surface antibody (anti-HBs), anti-diphtheria toxoid (DT) IgG, anti-tetanus toxoid (TT) IgG, and anti-pertussis toxin (PT) IgG were evaluated using commercially available enzyme-linked immunoassays. RESULTS: Anti-HBs levels of ≥10 mIU/mL were achieved in 100 %, 99.2 %, and 99.2 % of infants in the Shan-5 EPI group, hexavalent group and Quinvaxem group one month after four dose immunization (at 0, 2, 4, 6 months of age), respectively. The geometric mean concentrations of the EPI Shan-5 and hexavalent groups were comparable but were higher than those of the Quinvaxem group. At one month after primary vaccination (month 7), infants in the Shan-5 EPI group had significantly higher levels of anti-DT IgG, anti-TT IgG, and anti-PT IgG than infants in the hexavalent and Quinvaxem groups. CONCLUSIONS: The immunogenicity of the HepB surface antigen in the EPI Shan-5 vaccine was similar to that achieved by the hexavalent vaccine, but was higher than that achieved by the Quinvaxem vaccine. The Shan-5 vaccine is highly immunogenic and generates robust antibody responses after primary immunization.

BACKGROUND: Many people refuse vaccination and it is important to understand why. Here we explore the experiences of individuals from Gypsy, Roma, and Traveller groups in England to understand how and why they decided to take up or to avoid COVID-19 vaccinations. METHODS: We used a participatory, qualitative design, including wide consultations, in-depth interviews with 45 individuals from Gypsy, Roma, and Traveller, communities (32 female, 13 male), dialogue sessions, and observations, in five locations across England between October 2021 and February 2022. FINDINGS: Vaccination decisions overall were affected by distrust of health services and government, which stemmed from prior discrimination and barriers to healthcare which persisted or worsened during the pandemic. We found the situation was not adequately characterised by the standard concept of "vaccine hesitancy". Most participants had received at least one COVID-19 vaccine dose, usually motivated by concerns for their own and others' health. However, many participants felt coerced into vaccination by medical professionals, employers, and government messaging. Some worried about vaccine safety, for example possible impacts on fertility. Their concerns were inadequately addressed or even dismissed by healthcare staff. INTERPRETATION: A standard "vaccine hesitancy" model is of limited use in understanding vaccine uptake in these populations, where authorities and health services have been experienced as untrustworthy in the past (with little improvement during the pandemic). Providing more information may improve vaccine uptake somewhat; however, improved trustworthiness of health services for GRT communities is essential to increase vaccine coverage. FUNDING: This paper reports on independent research commissioned and funded by the National Institute for Health Research (NIHR) Policy Research Programme. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, the Department of Health and Social Care or its arm's length bodies, and other Government Departments.

BACKGROUND: During the COVID-19 pandemic multiple vaccines were rapidly developed and widely used throughout the world. At present there is very little information on COVID-19 vaccine interactions with primary human immune cells such as peripheral blood mononuclear cells (PBMCs), monocyte-derived macrophages and dendritic cells (moDCs). METHODS: Human PBMCs, macrophages and moDCs were stimulated with different COVID-19 vaccines, and the expression of interferon (IFN-λ1, IFN-α1), pro-inflammatory (IL-1β, IL-6, IL-8, IL-18, CXCL-4, CXCL-10, TNF-α) and Th1-type cytokine mRNAs (IL-2, IFN-γ) were analyzed by qPCR. In addition, the expression of vaccine induced spike (S) protein and antiviral molecules were studied in primary immune cells and in A549 lung epithelial cells. RESULTS: Adenovirus vector (Ad-vector) vaccine AZD1222 induced high levels of IFN-λ1, IFN-α1, CXCL-10, IL-6, and TNF-α mRNAs in PBMCs at early time points of stimulation while the expression of IFN-γ and IL-2 mRNA took place at later times. AZD1222 also induced IFN-λ1, CXCL-10 and IL-6 mRNA expression in monocyte-derived macrophages and DCs in a dose-dependent fashion. AZD1222 also activated the phosphorylation of IRF3 and induced MxA expression. BNT162b2 and mRNA-1273 mRNA vaccines failed to induce or induced very weak cytokine gene expression in all cell models. None of the vaccines enhanced the expression of CXCL-4. AZD1222 and mRNA-1273 vaccines induced high expression of S protein in all studied cells. CONCLUSIONS: Ad-vector vaccine induces higher IFN and pro-inflammatory responses than the mRNA vaccines in human immune cells. This data shows that AZD1222 readily activates IFN and pro-inflammatory cytokine gene expression in PBMCs, macrophages and DCs, but fails to further enhance CXCL-4 mRNA expression.

Tuberculosis (TB) is the leading cause of death from infectious diseases worldwide, and developing a new TB vaccine is a priority for TB control. Combining multiple immunodominant antigens to form a novel multicomponent vaccine with broad-spectrum antigens to induce protective immune responses is a trend in TB vaccine development. In this study, we used T-cell epitope-rich protein subunits to construct three antigenic combinations: EPC002, ECA006, and EPCP009. Fusion expression of purified protein EPC002f (CFP-10-linker-ESAT-6-linker-nPPE18), ECA006f (CFP-10-linker-ESAT-6-linker-Ag85B), and EPCP009f (CFP-10-linker-ESAT-6-linker-nPPE18-linker-nPstS1) and recombinant purified protein mixtures EPC002m (mix of CFP-10, ESAT-6, and nPPE18), ECA006m (mix of CFP-10, ESAT-6, and Ag85B), and EPCP009m (mix of CFP-10, ESAT-6, nPPE18, and nPstS1) were used as antigens, formulated with alum adjuvant, and the immunogenicity and efficacy were analyzed using immunity experiments with BALB/c mice. All protein-immunized groups elicited higher levels of humoral immunity, including IgG and IgG1. The IgG2a/IgG1 ratio of the EPCP009m-immunized group was the highest, followed by that of the EPCP009f-immunized group, which was significantly higher than the ratios of the other four groups. The multiplex microsphere-based cytokine immunoassay revealed that EPCP009f and EPCP009m induced the production of a wider range of cytokines than EPC002f, EPC002m, ECA006f, and ECA006m, which included Th1-type (IL-2, IFN-γ, TNF-α), Th2-type (IL-4, IL-6, IL-10), Th17-type (IL-17), and other proinflammatory cytokines (GM-CSF, IL-12). The enzyme-linked immunospot assays demonstrated that the EPCP009f- and EPCP009m-immunized groups had significantly higher amounts of IFN-γ than the other four groups. The in vitro mycobacterial growth inhibition assay demonstrated that EPCP009m inhibited Mycobacterium tuberculosis (Mtb) growth most strongly, followed by EPCP009f, which was significantly better than that of the other four vaccine candidates. These results indicated that EPCP009m containing four immunodominant antigens exhibited better immunogenicity and Mtb growth inhibition in vitro and may be a promising candidate vaccine for the control of TB.

BACKGROUND: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. METHODS: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experience, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clinical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study characteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selection process. RESULTS: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppression by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in several indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interventional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxoviridae/influenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. CONCLUSIONS: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe.

BACKGROUND: Chikungunya, a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), causes a significant global health burden, and there is currently no approved vaccine to prevent chikungunya disease. In this study, the safety and immunogenicity of a CHIKV mRNA vaccine candidate (mRNA-1388) were evaluated in healthy participants in a CHIKV-nonendemic region. METHODS: This phase 1, first-in-human, randomized, placebo-controlled, dose-ranging study enrolled healthy adults (ages 18-49 years) between July 2017 and March 2019 in the United States. Participants were randomly assigned (3:1) to receive 2 intramuscular injections 28 days apart with mRNA-1388 in 3 dose-level groups (25 μg, 50 μg, and 100 μg) or placebo and were followed for up to 1 year. Safety (unsolicited adverse events [AEs]), tolerability (local and systemic reactogenicity; solicited AEs), and immunogenicity (geometric mean titers [GMTs] of CHIKV neutralizing and binding antibodies) of mRNA-1388 versus placebo were evaluated. RESULTS: Sixty participants were randomized and received ≥ 1 vaccination; 54 (90 %) completed the study. mRNA-1388 demonstrated favorable safety and reactogenicity profiles at all dose levels. Immunization with mRNA-1388 induced substantial and persistent humoral responses. Dose-dependent increases in neutralizing antibody titers were observed; GMTs (95 % confidence intervals [CIs]) at 28 days after dose 2 were 6.2 (5.1-7.6) for mRNA-1388 25 μg, 53.8 (26.8-108.1) for mRNA-1388 50 μg, 92.8 (43.6-197.6) for mRNA-1388 100 μg, and 5.0 (not estimable) for placebo. Persistent humoral responses were observed up to 1 year after vaccination and remained higher than placebo in the 2 higher mRNA-1388 dose groups. The development of CHIKV-binding antibodies followed a similar trend as that observed with neutralizing antibodies. CONCLUSIONS: mRNA-1388, the first mRNA vaccine against CHIKV, was well tolerated and elicited substantial and long-lasting neutralizing antibody responses in healthy adult participants in a nonendemic region. CLINICALTRIALS: gov: NCT03325075.

The advent of mRNA vaccine technology has been vital in rapidly creating and manufacturing COVID-19 vaccines at an industrial scale. To continue to accelerate this leading vaccine technology, an accurate method is needed to quantify antigens produced by the transfection of cells with a mRNA vaccine product. This will allow monitoring of protein expression during mRNA vaccine development and provide information on how changes to vaccine components affects the expression of the desired antigen. Developing novel approaches that allow for high-throughput screening of vaccines to detect changes in antigen production in cell culture prior to in vivo studies could aid vaccine development. We have developed and optimized an isotope dilution mass spectrometry method to detect and quantify the spike protein expressed after transfection of baby hamster kidney cells with expired COVID-19 mRNA vaccines. Five peptides of the spike protein are simultaneously quantified and provide assurance that protein digestion in the region of the target peptides is complete since results between the five peptides had a relative standard deviation of less than 15 %. In addition, two housekeeping proteins, actin and GAPDH, are quantified in the same analytical run to account for any variation in cell growth within the experiment. IDMS allows a precise and accurate means to quantify protein expression by mammalian cells transfected with an mRNA vaccine.

BACKGROUND: Immunization is essential for safeguarding health workers from vaccine-preventable diseases (VPDs) that they may encounter at work; however, information about the prevalence and scope of national policies that protect health workers through vaccination is limited. Understanding the global landscape of health worker immunization programmes can help direct resources, assist decision-making and foster partnerships as nations consider strategies for increasing vaccination uptake among health workers. METHODS: A one-time supplementary survey was distributed to World Health Organization (WHO) Member States using the WHO/United Nations Children's Fund (UNICEF) Joint Reporting Form on Immunization (JRF). Respondents described their 2020 national vaccination policies for health workers - detailing VPD policies and characterising technical and funding support, monitoring and evaluation activities and provisions for vaccinating health workers in emergencies. RESULTS: A total of 53 % (103/194) Member States responded and described health worker policies: 51 had a national policy for vaccinating health workers; 10 reported plans to introduce a national policy within 5 years; 20 had subnational/institutional policies; 22 had no policy for vaccinating health workers. Most national policies were integrated with occupational health and safety policies (67 %) and included public and private providers (82 %). Hepatitis B, seasonal influenza and measles were most frequently included in policies. Countries both with and without national vaccination policies reported monitoring and reporting vaccine uptake (43 countries), promoting vaccination (53 countries) and assessing vaccine demand, uptake or reasons for undervaccination (25 countries) among health workers. Mechanisms for introducing a vaccine for health workers in an emergency existed in 62 countries. CONCLUSION: National policies for vaccinating health workers were complex and context specific with regional and income-level variations. Opportunities exist for developing and strengthening national health worker immunization programmes. Existing health worker immunization programmes might provide a foothold on which broader health worker vaccination policies can be built and strengthened.

Health care providers' recommendations can play an important role in individuals' vaccination decisions. Despite being one of the most popular complementary and alternative medicine (CAM), naturopathy is understudied in relation to vaccination decisions. We sought to address this gap through this study of vaccination perspectives of naturopathy practitioners in the province of Quebec, Canada. We conducted in-depth interviews with 30 naturopaths. Thematic analysis was conducted. Main themes were developed deductively (i.e., based on prior literature) and expanded through inductive coding of the data. Participants noted that they discuss vaccination in their practice, but only when clients asked questions or wanted advice. Naturopaths described refraining from explicitly recommending for or against vaccination. Instead, they focus on empowering their clients to make their own informed decision regarding vaccination. Most participants noted that they direct clients towards sources of information so that clients could decide for themselves, but some mentioned they discussed with clients what they considered to be risks associated with vaccination, as well as its benefits. These discussions were framed through a personalized and individual approach with clients.

BACKGROUND: Immunosuppressive therapy used in the treatment of inflammatory bowel disease (IBD) is known to reduce vaccine immunogenicity. AIMS: This study aimed to 1) predict the humoral response elicited by SARS-CoV-2 vaccination in IBD patients based on their ongoing treatment and other relevant patient and vaccine characteristics and 2) assess the humoral response to a booster dose of mRNA vaccine. METHODS: We conducted a prospective study in adult IBD patients. Anti-spike (S) IgG antibodies were measured after initial vaccination and again after one booster dose. A multiple linear regression model was created to predict anti-S antibody titer following initial complete vaccination in different therapeutic groups (no immunosuppression, anti-TNF, immunomodulators and combination therapy). A two-tailed Wilcoxon test for two dependent groups was performed to compare anti-S values before and after the booster dose. RESULTS: Our study included 198 IBD patients. The multiple linear regression identified anti-TNF and combination therapy (versus no immunosuppression), current smoking, viral vector (versus mRNA) vaccine and interval between vaccination and anti-S measurement as statistically significant predictors of the log anti-S antibody levels (p < 0.001). No statistically significant differences were found between no immunosuppression and immunomodulators (p = 0.349) and between anti-TNF and combination therapy (p = 0.997). Statistically significant differences for anti-S antibody titer before and after the booster dose of mRNA SARS-CoV-2 vaccine were found, both for non-anti-TNF and anti-TNF groups. CONCLUSIONS: Anti-TNF treatment (either alone or in combination therapy) is associated with lower anti-S antibody levels. Booster mRNA doses seem to increase anti-S both in non-anti-TNF and anti-TNF treated patients. Special attention should be paid to this group of patients when planning vaccination schemes.

BACKGROUND: Vaccines against COVID-19 have proven effective in preventing COVID-19 hospitalisation. In this study, we aimed to quantify part of the public health impact of COVID-19 vaccination by estimating the number of averted hospitalisations. We present results from the beginning of the vaccination campaign ('entire period', January 6, 2021) and a subperiod starting at August 2, 2021 ('subperiod') when all adults had the opportunity to complete their primary series, both until August 30, 2022. METHODS: Using calendar-time specific vaccine effectiveness (VE) estimates and vaccine coverage (VC) by round (primary series, first booster and second booster) and the observed number of COVID-19 associated hospitalisations, we estimated the number of averted hospitalisations per age group for the two study periods. From January 25, 2022, when registration of the indication of hospitalisation started, hospitalisations not causally related to COVID-19 were excluded. RESULTS: In the entire period, an estimated 98,170 (95 % confidence interval (CI) 96,123-99,928) hospitalisations were averted, of which 90,753 (95 % CI 88,790-92,531) were in the subperiod, representing 57.0 % and 67.9 % of all estimated hospital admissions. Estimated averted hospitalisations were lowest for 12-49-year-olds and highest for 70-79-year-olds. More admissions were averted in the Delta period (72.3 %) than in the Omicron period (63.4 %). CONCLUSION: COVID-19 vaccination prevented a large number of hospitalisations. Although the counterfactual of having had no vaccinations while maintaining the same public health measures is unrealistic, these findings underline the public health importance of the vaccination campaign to policy makers and the public.

The efficacy of BCG vaccines against Mycobacterium tuberculosis (Mtb) strains of lineage 2 (Beijing) in preclinical models and humans has been questioned. We have developed BCG∆BCG1419c, by deletion of BCG1419c in BCG Pasteur, which improved control of tuberculosis (TB) in preclinical models. Here, we compared the capacity of BCG and BCG∆BCG1419c to induce autophagy in murine macrophages, modify c-di-GMP content and transcript levels of BCG1416c, encoding the enzyme responsible for c-di-GMP synthesis/degradation, and of BCG1419c, encoding the phosphodiesterase involved in c-di-GMP degradation. Furthermore, we evaluated proteomic differences in vitro and compared protection against TB produced by a low dose of the HN878-Beijing strain at 3- and 6-months post-infection. We found that BCG∆BCG1419c induced more autophagy and produced different levels of c-di-GMP as well as different transcription of BCG1416c with no expression of BCG1419c. BCG∆BCG1419c differentially produced several proteins, including some involved in interaction with host cells. Vaccination with either BCG strain led to control of bacillary burden in lungs and spleen at 3- but not 6-months post-infection, whereas it reduced pneumonic areas compared with unvaccinated controls at 6 months post-infection. Vaccination with BCG∆BCG1419c delayed progression of lung necrosis as this was observed only at 6 months post-infection. Taken together, compared with BCG, BCG∆BCG1419c increased autophagy, presented different levels of c-di-GMP and transcription of BCG1416c in vitro in a growth-phase dependent manner, modified its proteome and delayed progression of lung pathology produced by a highly virulent Beijing strain.

BACKGROUND: Patients with autoimmune rheumatic diseases (ARD) are at a potentially higher risk for COVID-19 infection complications. Given their inherent altered immune system and the use of immunomodulatory medications, vaccine immunogenicity could be unpredictable with a suboptimal or even an exaggerated immunological response. The aim of this study is to provide real-time data on the emerging evidence of COVID-19 vaccines' efficacy and safety in patients with ARDs. METHODS: We performed a literature search of the PubMed, EMBASE, and OVID databases up to 11-13 April 2022 on the efficacy and safety of both types of the mRNA-vaccines and the AstraZeneca COVID-19 vaccines in patients with ARD. The risk of bias in the retrieved studies was evaluated using the Quality in Prognostic Studies tool. Also, current clinical practice guidelines from multiple international professional societies were reviewed. RESULTS: We identified 60 prognostic studies, 69 case reports and case series, and eight international clinical practice guidelines. Our results demonstrated that most patients with ARDs were able to mount humoral and/or cellular responses after two doses of COVID-19 vaccine although this response was suboptimal in patients receiving certain disease-modifying medications including rituximab, methotrexate, mycophenolate mofetil, daily glucocorticoids >10 mg, abatacept, as well as in older individuals, and those with comorbid interstitial lung diseases. Safety reports on COVID-19 vaccines in patients with ARDs were largely reassuring with mostly self-limiting adverse events and very minimal post-vaccination disease flares. CONCLUSION: Both types of the mRNA-vaccines and the AstraZeneca COVID-19 vaccines are highly effective and safe in patients with ARD. However, due to their suboptimal response in some patients, alternative mitigation strategies such as booster vaccines and shielding practices should also be followed. Management of immunomodulatory treatment regimens during the peri vaccination period should be individualized through shared decision making with patients and their attending rheumatologists.

Dengue is a growing public health threat, causing approximately 400 million infections annually. In June 2021, the Advisory Committee on Immunization Practices recommended the first dengue vaccine (CYD-TDV) for children aged 9-16 years with a previous dengue infection, living in endemic areas, such as Puerto Rico (PR). As the COVID-19 pandemic affected vaccine intention worldwide, we assessed dengue vaccine intention before (pre-COVID) and after (post-COVID) COVID-19 vaccine availability among participants enrolled in the Communities Organized to Prevent Arboviruses (COPA) cohort to prepare for dengue vaccine implementation in PR. We used logistic regression models to evaluate changes in dengue vaccine intention by interview timing and participant characteristics. Among 2,513 participants pre-COVID, 2,512 answered the dengue vaccine intention question for themselves, and 1,564 answered relative to their children. Post-COVID, dengue vaccine intention in adults increased for themselves from 73.4% to 84.5% (adjusted odds ratio (aOR) = 2.27, 95%CI: 1.90-2.71) and relative to their children from 75.6% to 85.5% (aOR = 2.21, 95%CI: 1.75-2.78). Among all participants, groups with higher dengue vaccine intention included those who reported previous year influenza vaccine uptake and those who reported being frequently bitten by mosquitos, compared to those who did not. Adult males were also more likely to intend to vaccinate themselves than females. Respondents who were employed or in school were less likely to intend to vaccinate compared to those who were not working. The primary reasons for vaccine hesitancy were concerns with side effects and not believing in vaccines, which should be considered during educational strategies prior to dengue vaccine implementation. In general, dengue vaccine intention is high in PR and has increased after COVID-19 vaccine availability, potentially due to increased awareness of vaccine importance during the COVID-19 pandemic.

The importance of vaccination has been proven particularly significant the last three years, as it is revealed to be the most efficient weapon for the prevention of several infections including SARS-COV-2. Parenteral vaccination is the most applicable method of immunization, for the prevention of systematic and respiratory infections, or central nervous system disorders, involving T and B cells to a whole-body immune response. However, the mucosal vaccines, such as nasal vaccines, can additionally activate the immune cells localized on the mucosal tissue of the upper and lower respiratory tract. This dual stimulation of the immune system, along with their needle-free administration favors the development of novel nasal vaccines to produce long-lasting immunity. In recent years, the nanoparticulate systems have been extensively involved in the formulation of nasal vaccines as polymeric, polysaccharide and lipid ones, as well as in the form of proteosomes, lipopeptides and virosomes. Advanced delivery nanosystems have been designed and evaluated as carriers or adjuvants for nasal vaccination. To this end, several nanoparticulate vaccines are undergone clinical trials as promising candidates for nasal immunization, while nasal vaccines against influenza type A and B and hepatitis B have been approved by health authorities. This comprehensive literature review aims to summarize the critical aspects of these formulations and highlight their potential for the future establishment of nasal vaccination. Both preclinical (in vitro and in vivo) and clinical studies are incorporated, summarized, and critically discussed, as well as the limitations of nasal immunization.

Vaccination against hepatitis B using a dissolving microneedle patch (dMNP) could increase access to the birth dose by reducing expertise needed for vaccine administration, refrigerated storage, and safe disposal of biohazardous sharps waste. In this study, we developed a dMNP to administer hepatitis B surface antigen (HBsAg) adjuvant-free monovalent vaccine (AFV) at doses of 5 µg, 10 µg, and 20 µg, and compared its immunogenicity to vaccination with 10 µg of standard monovalent HBsAg delivered by intramuscular (IM) injection either in an AFV format or as aluminum-adjuvanted vaccine (AAV). Vaccination was performed on a three dose schedule of 0, 3, and 9 weeks in mice and 0, 4, and 24 weeks in rhesus macaques. Vaccination by dMNP induced protective levels of anti-HBs antibody responses (≥10 mIU/ml) in mice and rhesus macaques at all three HBsAg doses studied. HBsAg delivered by dMNP induced higher anti-HBsAg antibody (anti-HBs) responses than the 10 µg IM AFV, but lower responses than 10 µg IM AAV, in mice and rhesus macaques. HBsAg-specific CD4+ and CD8+ T cell responses were detected in all vaccine groups. Furthermore, we analyzed differential gene expression profiles related to each vaccine delivery group and found that tissue stress, T cell receptor signaling, and NFκB signaling pathways were activated in all groups. These results suggest that HBsAg delivered by dMNP, IM AFV, and IM AAV have similar signaling pathways to induce innate and adaptive immune responses. We further demonstrated that dMNP was stable at room temperature (20 °C-25 °C) for 6 months, maintaining 67 ± 6 % HBsAg potency. This study provides evidence that delivery of 10 µg (birth dose) AFV by dMNP induced protective levels of antibody responses in mice and rhesus macaques. The dMNPs developed in this study could be used to improve hepatitis B birth dose vaccination coverage levels in resource limited regions to achieve and maintain hepatitis B elimination.

BACKGROUND: Data on the effectiveness of the 3-dose mRNA-1273 primary series are limited, particularly in comparison to 2 doses. Given suboptimal COVID-19 vaccine uptake among immunocompromised populations, it is important to monitor the effectiveness of fewer than the recommended doses in this population. METHODS: We conducted a matched cohort study at Kaiser Permanente Southern California to evaluate the relative vaccine effectiveness (rVE) of the 3-dose series vs 2 doses of mRNA-1273 in preventing SARS-CoV-2 infection and severe COVID-19 outcomes among immunocompromised individuals. RESULTS: We included 21,942 3-dose recipients who were 1:1 matched with randomly selected 2-dose recipients (third doses accrued 08/12/2021-12/31/2021, with follow-up through 01/31/2022). Adjusted rVE of 3 vs 2 doses of mRNA-1273 against SARS-CoV-2 infection, COVID-19 hospitalization, and COVID-19 hospital death were 55.0 % (95 % CI: 50.8-58.9 %), 83.0 % (75.4-88.3 %), and 87.1 % (30.6-97.6 %), respectively. CONCLUSION: Three doses of mRNA-1273 were associated with a significantly higher rVE against SARS-CoV-2 infection and severe outcomes, compared to 2 doses. These findings were consistent across subgroups of demographic and clinical characteristics, and mostly consistent across subgroups of immunocompromising conditions. Our study highlights the importance of completing the 3-dose series for immunocompromised populations.

Prevention of hepatitis B virus (HBV) infection by vaccination can potentially eliminate HBV-related diseases. PreHevbrio™/PreHevbri® is a 3-antigen (S, preS1, preS2) HBV vaccine (3A-HBV) recently licensed for adults in the US, EU and Canada. This study evaluated antibody persistence in a subset of fully vaccinated and seroprotected (anti-HBs ≥ 10 mIU/mL) Finnish participants from the phase 3 trial (PROTECT) of 3A-HBV versus single-antigen HBV vaccine (1A-HBV). 465/528 eligible subjects were enrolled (3A-HBV: 244; 1A-HBV: 221). Baseline characteristics were balanced. After 2.5 years, more 3A-HBV subjects remained seroprotected (88.1 % [95 %CI: 84.1,92.2]) versus 1A-HBV (72.4 % [95 %CI: 66.6,78.3)], p < 0.0001) and had higher mean anti-HBs [1382.9 mIU/mL (95 %CI: 1013.8,1751.9) versus 252.6 mIU/mL (95 %CI: 127.5,377.6), p < 0.0001]. In multiple variable logistic regression analysis including age, vaccine, initial vaccine response, sex and BMI, only higher post dose 3 (Day 196) antibody titers significantly reduced the odds of losing seroprotection.

OBJECTIVE: The burden of COVID-19 pandemic affected the globe, and it is unclear how it has impacted the general perception of other vaccines. We aimed to investigate the public awareness, knowledge, and attitude towards other complementary vaccines after the mandate of the COVID-19 vaccine. METHODS: A cross-sectional study was conducted in Saudi Arabia using a survey distributed via several social media platforms in June 2022. The questionnaire had three main sections; awareness; attitudes; and demographic information. Descriptive analysis was mainly used and supplemented with Chi-square test for correlation. All individuals over the age of 18 were eligible to participate in the study. RESULTS: A total of 1,045 participants from Saudi Arabia completed the survey. Of the respondents, 55.9% were female, and 95% were Saudi citizens. Public awareness towards vaccines after the mandate of COVID-19 vaccine was the highest with the influenza vaccine (98.2%), followed by human papillomavirus (HPV) (40.7%), tetanus, diphtheria, and pertussis (Tdap) (37.2%), and lastly, pneumococcal vaccine (17%). More than 50% of the participants expressed their willingness to receive any of the four vaccines if they knew about the benefits related to these vaccines. CONCLUSION: The study showed that participants were willing to receive the vaccination if they were aware of the general benefits of vaccinations. Therefore, health education and campaigns toward recommended vaccines for high-risk group are essential and needed.

Subunit vaccines for the Hepatitis B virus (HBV) have greatly reduced the prevalence of infection and morbidity through HBV-related liver cirrhosis and cancer. However, strength of immune response to vaccination varies considerably. While it is known that ABO blood types may influence HBV infection risk, the role of ABO and related blood types in strength of immune response to HBV vaccine has not been investigated. We examined 16 polymorphisms in the ABO, FUT2, and FUT3 genes and their related phenotypes for associations with strength of antibody response to HBV vaccine in Black South African infants. Anti-HBc and anti-HBs antibody levels were measured by CMIA assay 1-3 months after the last dose of HBV vaccine. Prior infection occurred in 8/207 individuals (3.86%) who were removed from further study. Of the remaining 199 individuals, 83.4% individuals were strong responders (anti-HBs ≥ 100 mIU/ml, median 973 mIU/ml), another 15.6% were weak responders (anti-HBs < 100 mIU/ml, median 50 mIU/ml) and 1% were non-responders (anti-HBs < 10 mIU/ml). The frequency of weak responders to HBV vaccine was not significantly affected by sex, birthweight, use of an additional booster dose of vaccine or cohort of origin. We characterised patterns of genetic variation present at the ABO, FUT2 and FUT3 loci by use of MassArray genotyping and used these data to predict ABO, Secretor and Lewis phenotypes. We observed significant association of ABO blood type with strength of antibody response to HBV vaccine in a Black South African cohort (p = 0.002). In particular, presence of rs8176747G and expression of B antigen (whether in B blood type or AB blood type) was associated with decreased antibody response to HBV vaccine. Secretor and Lewis blood types were not associated with antibody response to HBV vaccine. This work increases our understanding of the impact that host genetic variation may have on vaccine immunogenicity.

This qualitative study using in-depth interviews and focus group discussions is the first to investigate HPV vaccination in The Gambia; it provides an in-depth analysis of uptake, knowledge, and perceptions of HPV vaccination as well as trust in Ministry of Health vaccination advice. Despite high uptake rates, knowledge of HPV vaccination was low, and the most prominent concern was that the vaccine could cause infertility or is a form of population control. Holistic approaches to addressing HPV vaccine concerns relating to fertility that consider socio-political contexts, including colonial histories, could lead to more positive vaccine perceptions, empowered decisions and to increasing vaccine uptake rates in The Gambia and elsewhere.

BACKGROUND: Histo-blood group antigens (HBGAs) may influence immune responses to rotavirus vaccination. METHODS: HBGA phenotyping was determined by detection of antigens A, B, H and Lewis a and b in saliva using enzyme-linked immunosorbent assay. Secretor status was confirmed by lectin antigen assay if A, B and H antigens were negative or borderline (OD ± 0.1 of threshold of detection). PCR-RFLP analysis was used to identify the FUT2 'G428A' mutation in a subset. Rotavirus seropositivity was defined as serum anti-rotavirus IgA ≥ 20 AU/mL. RESULTS: Of 156 children, 119 (76 %) were secretors, 129 (83 %) were Lewis antigen positive, and 105 (67 %) were rotavirus IgA seropositive. Eighty-seven of 119 (73 %) secretors were rotavirus seropositive, versus 4/9 (44 %) weak secretors and 13/27 (48 %) non-secretors. CONCLUSIONS: Most Australian Aboriginal children were secretor and Lewis antigen positive. Non-secretor children were less likely to be seropositive to rotavirus antibodies following vaccination, but this phenotype was less common. HBGA status is unlikely to fully explain underperformance of rotavirus vaccines among Australian Aboriginal children.

OBJECTIVE: To understand the attitudes towards COVID-19 vaccination and trusted sources of vaccination-related information among persons incarcerated in the Federal Bureau of Prisons. METHODS: From June-July 2021, persons incarcerated across 122 facilities operated by the Federal Bureau of Prisons were invited to participate in a survey asking their reasons for receiving or declining COVID-19 vaccination and the information sources they relied upon to make these decisions. Descriptive analyses were conducted. RESULTS: A total of 130,789 incarcerated persons with known vaccination status were invited to participate in the survey. At the time of survey, 78,496 (62%) were fully vaccinated; 3,128 (3%) were partially vaccinated and scheduled to complete their second dose, and 44,394 (35%) had declined either a first or second dose. 7,474 (9.5%) of the fully vaccinated group and 2,302 (4.4%) of the group declining either a first or second dose chose to participate in the survey; an overall survey return rate of 7.6% (n = 9,905). Among vaccinated respondents, the most common reason given for accepting vaccination was to protect their health (n = 5,689; 76.1%). Individuals who declined vaccination cited concerns about vaccine side effects (n = 1,304; 56.6%), mistrust of the vaccine (n = 1,256; 54.6%), and vaccine safety concerns (n = 1,252; 54.4%). Among those who declined, 21.2% (n = 489) reported that they would choose to be vaccinated if the vaccine was offered again. Those who declined also reported that additional information from outside organizations (n = 1128; 49.0%), receiving information regarding vaccine safety (n = 841; 36.5%), and/or speaking with a trusted medical advisor (n = 565; 24.5%) may influence their decision to be vaccinated in the future. CONCLUSION: As the COVID-19 pandemic continues, it is important to increase vaccine confidence in prisons, jails, and detention facilities to reduce transmission and severe health outcomes. These survey findings can inform the design of potential interventions to increase COVID-19 vaccine uptake in these settings.

OBJECTIVES: Pneumococcal immunization is recommended in dialysis patients. We aimed to estimate pneumococcal vaccination coverage among patients who initiate dialysis in France, and its association with mortality. METHODS: Data were extracted from two prospective national databases, merged using a deterministic linkage method: renal epidemiology and information network (REIN) registry, which includes all patients on dialysis and kidney transplants recipients in France, and the national health insurance information system (SNIIRAM) which collects individual data on health expenditure reimbursement, including vaccines. We enrolled all patients who initiated chronic dialysis in 2015. Data on health status at dialysis initiation, dialysis modalities, and pneumococcal vaccine prescribed from 2 years before to 1 year after dialysis start were collected. Univariate and multivariate Cox proportional hazard models were used to assess one-year all-cause mortality. RESULTS: Among the 8,294 incident patients included, 1,849 (22.3 %) received at least one pneumococcal vaccine before (n = 542, 6.5 %), or after (n = 1,307, 15.8 %) dialysis start, as follows: 13-valent pneumococcal conjugated vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23), n = 938 (50.7 %); only PPSV23, n = 650 (35.1 %); or only PCV13, n = 261 (14.1 %). Vaccinated patients were younger (mean, 66.5 ± 14.8 years vs. 69.0 ± 14.9 years, P ≤ 0.001), more likely to suffer from glomerulonephritis (17.0 % vs. 11.0 %, P ≤ 0.001), and less likely to start dialysis in emergency (27.2 % vs. 31.1 %, P = 0.001). On multivariate analysis, patients who received PCV13 and PPSV23, or only PCV13 were less likely to die (respectively, HR = 0.37; 95 %CI 0.28-0.51, and HR = 0.35; 95 %CI 0.19-0.65). CONCLUSIONS: Pneumococcal immunization with PCV13 followed by PPSV23, or with PCV13 alone, but not with PPSV23 alone, is independently associated with decreased one year-mortality in patients who start dialysis.

PURPOSE: Lower COVID-19 vaccination rates have been observed among some adult immigrant populations in Norway, and there appears to be an association with sociodemographic factors. However, knowledge is lacking on the distribution of vaccination rates and role of sociodemographic factors among adolescents. This study aims to describe COVID-19 vaccination rates among adolescents according to immigrant background, household income, and parental education. METHODS: In this nationwide registry study, we analyzed individual-level data on adolescents (12-17 years) from the Norwegian Emergency preparedness register for COVID-19 until September 15th, 2022. We estimated incidence rate ratios (IRR) for receiving at least one COVID-19 vaccine dose by country background, household income and parental education, using Poisson regression, adjusting for age, sex, and county. RESULTS: The sample comprised 384,815 adolescents. Foreign-born and Norwegian-born with foreign-born parents, had lower vaccination rates (57 % and 58 %) compared to adolescents with at least one Norwegian-born parent (84 %). Vaccination rates by country background varied from 88 % (Vietnam) to 31 % (Russia). Variation and associations by country background, household income, and parental education were greater among 12-15-year-olds than 16-17-year-olds. Household income and parental education were positively associated with vaccination. Compared to the lowest income and education category, IRRs for household income ranged from 1.07 (95 % CI 1.06-1.09) to 1.31 (95 % CI 1.29-1.33) among 12-15-year-olds, and 1.06 (95 % CI 1.04-1.07) to 1.17 (95 % CI 1.15-1.18) among 16-17-year-olds. For parental education, from IRR 1.08 (95 % CI 1.06-1.09) to 1.18 (95 % CI 1.17-1.20) among 12-15-year-olds, and 1.05 (95 % CI 1.04-1.07) to 1.09 (95 % CI 1.07-1.10) among 16-17-year-olds. CONCLUSION: COVID-19 vaccination rates varied by immigrant background and age group, with lower rates especially among adolescents with background from Eastern Europe and among younger adolescents. Household income and parental education were positively associated with vaccination rates. Our results may help target measures to increase vaccination rates among adolescents.