Antibody persistence and revaccination recommendations of MenACWY-TT: a review of clinical studies assessing antibody persistence up to 10 years after vaccination.

INTRODUCTION: Invasive meningococcal disease (IMD) is potentially fatal and associated with severe sequelae among survivors. It is preventable by several vaccines, including meningococcal vaccines targeting the most common disease-causing serogroups (A, B, C, W, Y). The meningococcal ACWY tetanus toxoid conjugate vaccine (MenACWY-TT [Nimenrix]) is indicated from 6 weeks of age in the European Union and >50 additional countries. AREAS COVERED: Using PubMed, Google Scholar, ClinicalTrials.gov and ad hoc searches for publications to June 2023, we review evidence of antibody persistence for up to 10 years after primary vaccination and up to 6 years after MenACWY-TT revaccination. We also review global MenACWY revaccination recommendations and real-world impact of vaccination policies, focusing on how these data can be considered alongside antibody persistence data to inform future IMD prevention strategies. EXPERT OPINION: Based on clear evidence that immunogenicity data (demonstrated antibody titers above established correlates of protection) are correlated with real-world effectiveness, long-term persistence of antibodies after MenACWY-TT vaccination suggests continuing protection against IMD. Optimal timing of primary and subsequent vaccinations is critical to maximize direct and indirect protection. Recommending bodies should carefully consider factors such as age at vaccination and long-term immune responses associated with the specific vaccine being used.

Modelling the Public Health Impact of MenACWY and MenC Adolescent Vaccination Strategies in Germany.

INTRODUCTION: Invasive meningococcal disease (IMD) causes significant mortality and long-term sequelae. This study assesses the potential public health impact of adolescent vaccination strategies employing MenACWY and MenC vaccines in Germany, where the existing meningococcal immunisation programme predominantly involves MenC administration in toddlers. METHODS: A dynamic transmission model was developed to simulate the carriage of five meningococcal serogroup compartments (AY/B/C/W/Other) from 2019 until 2060 within 1-year age groups from 0 to 99 years of age. IMD cases were estimated based on case-carrier ratios. The model considered vaccine effectiveness against carriage acquisition and IMD. RESULTS: The model predicts that introducing MenACWY adolescent vaccination could lead to a considerable reduction in IMD incidence, with the potential to prevent up to 65 cases per year and a cumulative total of 1467 cases by 2060. This decrease, mainly driven by herd effects, would result in a reduction of IMD incidence across all age groups, regardless of vaccination age. Furthermore, implementing MenACWY vaccination in adolescents is projected to decrease annual MenACWY-related IMD mortality by up to 64%, equating to an overall prevention of 156 IMD deaths by 2060. These protective outcomes are expected to culminate in approximately 2250 life years gained (LYG) throughout the model's projected time horizon. In contrast, the adoption of MenC vaccination in adolescents is predicted to have minimal influence on both IMD incidence and mortality, as well as on LYG. CONCLUSION: The results of this study demonstrate that implementing MenACWY vaccination for adolescents in Germany is likely to notably reduce IMD incidence and mortality across age groups. However, the introduction of MenC adolescent vaccination shows only limited impact. Considering the extensive healthcare resources typically required for IMD management, these findings suggest the potential for economic benefits associated with the adoption of MenACWY adolescent vaccination, warranting further cost-effectiveness analysis.

Meningococcal Vaccination of Adolescents in the United States: Past Successes and Future Considerations.

Invasive meningococcal disease (IMD) is a rare but serious illness, and adolescents and young adults in the United States are at increased risk. Here, we discuss US IMD history and how successful disease prevention through routine vaccination against the most common disease-causing serogroups (A, B, C, W, and Y) can inform future recommendations. Before the introduction of quadrivalent meningococcal conjugate (MenACWY) vaccines, most US cases of IMD were caused by serogroups B, C, and Y. After recommendation by the Advisory Committee on Immunization Practices for routine MenACWY vaccination of 11-12-year-olds in 2005, followed by a 2010 booster recommendation, MenCWY disease incidence declined dramatically, and vaccine coverage remains high. Two serogroup B (MenB) vaccines are licensed in the United States, but uptake is low compared with MenACWY vaccines, likely because Advisory Committee on Immunization Practices recommends MenB vaccination subject to shared clinical decision-making rather than routinely for all adolescents. The proportion of adolescent IMD caused by MenB has now increased. Pentavalent vaccines that protect against serogroups A, B, C, W, and Y may provide an optimal strategy for improving vaccination rates to ultimately reduce MenB incidence while maintaining the historically low rates of IMD caused by serogroups A, C, W, and Y.

Nurses' preferences regarding MenACWY conjugate vaccines attributes: a discrete choice experiment in Spain.

OBJECTIVES: Immunisation against preventable diseases as meningitis is crucial from a public health perspective to face challenges posed by these infections. Nurses hold a great responsibility for these programs, which highlights the importance of understanding their preferences and needs to improve the success of campaigns. This study aimed to investigate nurses' preferences regarding Meningococcus A, C, W, and Y (MenACWY) conjugate vaccines commercialised in Spain. STUDY DESIGN: A national-level discrete choice experiment (DCE) was conducted. METHODS: A literature review and a focus group informed the DCE design. Six attributes were included: pharmaceutical form, coadministration evidence, shelf-life, package contents, single-doses per package, and package volume. Conditional logit models quantified preferences and relative importance (RI). RESULTS: Thirty experienced primary care nurses participated in this study. Evidence of coadministration with other vaccines was the most important attribute (RI = 43.78%), followed by package size (RI = 22.17%), pharmaceutical form (RI = 19.07%), and package content (RI = 11.80%). There was a preference for evidence of coadministration with routine vaccines (odds ratio [OR] = 2.579, 95% confidence interval [95%CI] = 2.210-3.002), smaller volumes (OR = 1.494, 95%CI = 1.264-1.767), liquid formulations (OR = 1.283, 95%CI = 1.108-1.486) and package contents including only vial/s (OR = 1.283, 95%CI = 1.108-1.486). No statistical evidence was found for the remaining attributes. CONCLUSIONS: Evidence of coadministration with routine vaccines, easy-to-store packages, and fully liquid formulations were drivers of nurses' preferences regarding MenACWY conjugate vaccines. These findings provide valuable insights for decision-makers to optimize current campaigns.

Impact of Meningococcal ACWY Vaccination Program during 2017-18 Epidemic, Western Australia, Australia.

The rising incidence of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup W in Western Australia, Australia, presents challenges for prevention. We assessed the effects of a quadrivalent meningococcal vaccination program using 2012-2020 IMD notification data. Notification rates peaked at 1.8/100,000 population in 2017; rates among Aboriginal and Torres Strait Islander populations were 7 times higher than for other populations. Serogroup W disease exhibited atypical manifestations and increased severity. Of 216 cases, 20 IMD-related deaths occurred; most (19/20) were in unvaccinated persons. After the 2017-2018 targeted vaccination program, notification rates decreased from 1.6/100,000 population in 2018 to 0.9/100,000 population in 2019 and continued to decline in 2020. Vaccine effectiveness (in the 1-4 years age group) using the screening method was 93.6% (95% CI 50.1%-99.2%) in 2018 and 92.5% (95% CI 28.2%-99.2%) in 2019. Strategic planning and prompt implementation of targeted vaccination programs effectively reduce IMD.

Real-world impact and effectiveness of MenACWY-TT.

In response to escalating cases of serogroup W (MenW) invasive meningococcal disease (IMD), multiple countries introduced quadrivalent conjugate MenACWY vaccines into their national immunization programs (NIPs). Here, we summarize the real-world impact and vaccine effectiveness (VE) data of MenACWY-TT from Chile, England, the Netherlands, and Australia. Incidence rate reductions (IRRs) and VE from baseline to post-NIP period were extracted from publications or calculated. After the administration of a single dose of MenACWY-TT, substantial IRRs of MenCWY were observed across the countries in vaccine-eligible age groups (83%-85%) and via indirect protection in non-vaccine-eligible age groups (45%-53%). The impact of MenACWY-TT was primarily driven by MenW IRRs, as seen in vaccine-eligible age groups (65%-92%) and non-vaccine-eligible age groups (41%-57%). VE against MenW was reported in vaccine-eligible toddlers (92%) in the Netherlands and in vaccine-eligible adolescents/young adults (94%) in England. These real-world data support the implementation and continued use of MenACWY-TT in NIPs.

National and regional differences in meningococcal vaccine recommendations for individuals at an increased risk of meningococcal disease.

INTRODUCTION: Invasive meningococcal disease (IMD) is a severe, life-threatening condition caused by infection with Neisseria meningitidis. Currently available vaccines offer protection against the five most common meningococcal disease-causing serogroups and include monovalent and quadrivalent conjugate vaccines (MenA, MenC, MenACWY vaccines) and outer membrane vesicle- and/or recombinant protein-based vaccines (MenB vaccines). AREAS COVERED: Country and regional immunization programs target populations susceptible to IMD and typically emphasize the highest-risk age groups (i.e., infants, adolescents/young adults, and the elderly); however, additional groups are also considered at an elevated risk and are the focus of the current review. Specific increased-risk groups include individuals with underlying immunocompromising medical conditions, university/college students, Indigenous people, laboratory workers, military personnel, men who have sex with men, and travelers to areas with hyperendemic IMD. This review compares established meningococcal vaccination recommendations for these vulnerable groups in Europe, the United States, Australia, New Zealand, Israel, Brazil, and Turkey. EXPERT OPINION: Recommendations should be standardized to cover all groups at increased risk of IMD.

Surveillance of Neisseria meningitidis carriage four years after menACWY vaccine implementation in the Netherlands reveals decline in vaccine-type and rise in genogroup e circulation.

Carriage of Neisseria meningitidisis an accepted endpoint in monitoring meningococcal vaccine effects. We applied molecular methods to assess the impact of menACWY vaccine implementation on meningococcal carriage and genogroup-specific prevalence in young adults in Fall of 2022, four years after the introduction of the tetravalent vaccine in the Netherlands. The overall carriage rate of genogroupable meningococci was not significantly different compared to a pre-menACWY cohort investigated in 2018 (20.8 % or 125 of 601 versus 17.4 % or 52 of 299 individuals, p = 0.25). Of 125 carriers of genogroupable meningococci, 122 (97.6 %) were positive for either vaccine-types menC, menW, menY or genogroups, menB, menE, and menX, which are not targeted by the menACWY vaccine. Compared with a pre-vaccine-implementation cohort, there was 3.8-fold reduction (p < 0.001) in vaccine-type carriage rates and 9.0-fold increase (p < 0.0001) in non-vaccine type menE prevalence. We observe a reduction in menW and menY and an increase in menE, which suggest that implementation of menACWY vaccine affected carriage.

Meningococcal ACWY conjugate vaccine immunogenicity in adolescents with primary or secondary immune deficiencies, a prospective observational cohort study.

BACKGROUND: Immunization with meningococcal ACWY conjugate vaccine induces protective antibodies against invasive meningococcal disease (IMD) caused by serogroups A, C, W and Y. We studied MenACWY-TT vaccine immunogenicity in adolescents with a heterogenous group of primary and secondary immune deficiency including patients with systemic lupus erythematosus, mixed connective tissue disease, vasculitis, uveitis, 22Q11 syndrome, sickle cell disease, and patients who underwent stem cell transplantation for bone marrow failure. FINDINGS: We enrolled 69 individuals aged 14-18 years diagnosed with a primary or secondary immune deficiency in a prospective observational cohort study. All patients received a single dose of MenACWY-TT vaccine during the catch-up campaign 2018-19 because of the IMD-W outbreak in the Netherlands. Capsular polysaccharide-specific (PS) IgG concentrations against MenACWY were measured before and 3-6, 12, and 24 months after vaccination. Overall, geometric mean concentrations (GMCs) of MenACWY-PS-specific IgG were lower in patients compared to data from healthy, aged-matched controls (n = 75) reaching significance at 12 months postvaccination for serogroup A and W (adjusted GMC ratios 0.26 [95% CI: 0.15-0.47] and 0.22 [95% CI: 0.10-0.49], respectively). No serious adverse events were reported by study participants. CONCLUSIONS: The MenACWY conjugate vaccine was less immunogenic in adolescent patients with primary or secondary immunodeficiency compared to healthy controls, urging the need for further surveillance of these patients and supporting considerations for booster MenACWY conjugate vaccinations in these patient groups.

Meningococcal ACWY conjugate vaccine immunogenicity and safety in adolescents with juvenile idiopathic arthritis and inflammatory bowel disease: A prospective observational cohort study.

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.

Determinants of Meningococcal Vaccination Coverage and Adherence: A Targeted Literature Review Supporting a 16-year-old Healthcare Visit.

We conducted a targeted literature review to understand the determinants of meningococcal serogroups A, C, W, and Y (MenACWY) and meningococcal serogroup B (MenB) vaccination coverage and adherence to vaccination schedules in the USA, and to identify evidence to support improvement of MenACWY and MenB vaccination coverage and adherence in older adolescents. Sources published since 2011 were considered, with sources published since 2015 given preference. Out of 2355 citations screened, 47 (46 studies) were selected for inclusion. Determinants of coverage and adherence ranging from patient-level sociodemographic factors to policy-level factors were identified. Four determinants identified were associated with improved coverage and adherence: (1) well-child, preventive, or vaccination-only appointments (particularly for older adolescents); (2) provider-initiated, provider-driven vaccine recommendations; (3) provider education about meningococcal disease and vaccine recommendations; and (4) state-level school-entry immunization policies. This robust review of the literature sheds light on the continued low MenACWY and MenB vaccination coverage and adherence among older adolescents (16-23 years of age) compared with that of younger adolescents (11-15 years of age) in the USA. The evidence supports a renewed call to action by local and national health authorities and medical organizations urging healthcare professionals to implement a healthcare visit for 16-year-olds and focus on vaccination as a key component of the visit.

Certain meningococcal vaccines are recommended for young people (ages 11­23) in the USA at specific ages. We analyzed scientific studies to understand how many young people in the USA have received meningococcal vaccines and whether they received them at the recommended ages. We found that a low proportion of young people age 16 or older have received appropriate meningococcal vaccination, compared with those under age 16. We looked at reasons why this might be the case and identified actions that could be taken to increase the proportion of young people age 16 or older who receive appropriate meningococcal vaccination. Overall, the information found confirms the importance of encouraging healthcare professionals to establish routine appointments with 16-year-olds, during which they can administer recommended, age-appropriate vaccines.

Adolescent and parental decision-making for the MenACWY vaccination: influential predictors and parental-adolescent differences among households in the Netherlands.

BACKGROUND: Between 2015 and 2018 The Netherlands experienced increases of invasive meningococcal disease (IMD) serogroup W (MenW). Therefore in 2018 the MenACWY vaccination was introduced in the National Immunisation Programme (NIP) and a catch-up campaign was initiated targeting adolescents. This study aimed to gain insight into what factors played a role in the decision-making process regarding the MenACWY vaccination. The focus was on the differences in the decision-making of parents and adolescents in order to assess what factors influence the decisions made. METHODS: An online questionnaire was offered to adolescents and one of their parents. We used random forest analyses to determine which factors best predict the outcome of the MenACWY vaccination decision. We carried out ROC (receiver-operator characteristics) analyses to confirm the predictive value of the variables. RESULTS: Among parents several factors stand out, centring on the process of the decision, their attitude about the MenACWY vaccination, trust in the vaccination, and ideas of important people around them. Among adolescents the three stand-out predictors are the ideas of important people around them, the process of the decision and trust in the vaccination. Parents have prominent influence in the decision-making, while the adolescent's influence in the household decision-making is more limited. Adolescents tend to be less engaged and spend less time thinking about the decision compared to parents. Opinions of parents and adolescents from the same households concerning the factors that are influential do not differ a lot in the final decision-making. CONCLUSIONS: Information about MenACWY vaccination might be mainly addressed to the parents of the adolescents and whereby the dialogue about MenACWY vaccination between parents and adolescents will be stimulated. With regard to the predictor trust in vaccination, raising the frequency of use of certain sources, especially those deemed very reliable among households such as conversations with a GP or the provider of the vaccination (GGD/JGZ), might prove a useful strategy to solidify vaccination uptake numbers.

A phase 3, randomized, controlled, open-label study to evaluate the persistence up to 5 years of 1 or 2 doses of meningococcal conjugate vaccine MenACWY-TT given with or without 13-valent pneumococcal conjugate vaccine in 12-14-month-old children.

BACKGROUND: Immunogenicity and safety up to 5 years after administration of 1 or 2 doses of quadrivalent meningococcal serogroup A, C, W, and Y tetanus toxoid conjugate vaccine (MenACWY-TT) given alone or with 13-valent pneumococcal conjugate vaccine (PCV13) in children was investigated. METHODS: This phase 3 study randomized healthy 12-24-month-olds to MenACWY-TT at Month 0 (ACWY1d), MenACWY-TT at Months 0 and 2 (ACWY2d), MenACWY-TT and PCV13 at Month 0 (Co-Ad), or PCV13 at Month 0 and MenACWY-TT at Month 2 (PCV13/ACWY). Immune responses 1, 3, and 5 years after primary vaccination were evaluated with serum bactericidal activity using rabbit complement (rSBA) titers ≥ 1:8 and geometric mean titers (GMTs). Evaluation of serious adverse events up to 5 years after primary vaccination are reported. RESULTS: Of the 802 children randomized in the study, 619 completed the study through Year 5. Immune responses after vaccination declined over time but were higher 5 years after vaccination compared with levels before vaccination. At Year 5, the percentages of children with rSBA titers ≥ 1:8 across all serogroups were 20.5 %-58.6 %, 28.4 %-65.8 %, 23.9 %-52.8 %, and 19.4 %-55.8 % in the ACWY1d, ACWY2d, Co-Ad, and PCV13/ACWY groups, respectively. Comparable antibody persistence at Year 5 was observed for participants receiving 1 or 2 doses of MenACWY-TT, although GMTs were elevated in those who received 2 versus 1 dose. The percentage of children with protective antibody titers at Year 5 was similar in participants who received PCV13 and MenACWY-TT compared with that observed for participants who only received 1 or 2 MenACWY-TT doses. No new safety concerns were identified during the study period. CONCLUSION: Antibody responses persisted in the majority of children up to 5 years after primary vaccination with MenACWY-TT administered in a 1- or 2-dose regimen with or without PCV13, with no new safety concerns identified. CLINICALTRIALS: gov Identifier NCT01939158; EudraCT number 2013-001083-28.

Economic evaluation of meningococcal vaccination with vaccine for serogroups A, C, W e Y: A systematic revision / Avaliação económica da vacinação meningocócica com a vacina para os serogrupos A, C, W e Y: Uma revisão sistemática

Introduction: Meningococcal disease, caused by infection due to Neisseria meningitidis, have a high burden of disease and entails excess costs for countries. The purpose of this paper is to analyse meningococcal disease, the preventive strategies adopted, and to analyse economic evaluations of the meningococcal vaccine for serogroups A, C, W and Y (MenACWY). Methods: A narrative literature review and a systematic literature review were conducted, in which these databases were used: B-ON, PUBMED, EBSCO, Cochrane, NHS EED, Science Direct, Scopus and Web of Science. The inclusion criteria were based on the PICO methodology, the articles included were full economic evaluations and excluded partial. Results: Meningococcal disease still presents a high incidence in the World and in Portugal. The systematic review identified that in seven of the thirteen articles, MenACWY was not cost-effective considering the incidence of disease and the price of the vaccine. The strategies considered cost-effective had high cost-effectiveness thresholds and some even considered cost-effective despite being above. Conclusion: Incidence of this disease in Portugal is higher than in the European Union, due to serogroups B, C, W, and Y. The cost-effectiveness of the MenACWY is still dubious, so the incidence and the price are important to the introduction in the Portuguese National Vaccination Programme.

Introdução: A doença meningocócica, causada por infeção por Neisseria meningitidis, constitui uma elevada carga de doença e acarreta elevados custos aos países. Os objetivos gerais deste artigo são: analisar a doença meningocócica, as estratégias de prevenção adotadas, e analisar as avaliações económicas na utilização da vacina meningocócica para os serogrupos A, C, W e Y (MenACWY). Métodos: Foram realizadas uma pesquisa bibliográfica e uma revisão sistemática da literatura, na qual foram utilizadas as bases de dados B-ON, PUBMED, EBSCO, Cochrane, NHS EED, Science Direct, Scopus e Web of Science. Os critérios de inclusão foram construídos com metodologia PICO e incluíam avaliações económicas completas, tendo sido excluídas as parciais. Resultados: A doença meningocócica apresenta uma elevada incidência no Mundo e em Portugal. A revisão sistemática identificou em sete dos treze artigos, que a MenACWY não era custo-efetiva considerando a incidência no país e o preço da vacina. Nas estratégias que consideraram custo-efetiva, os limiares de custo-efetividade eram muito elevados e em alguns foi considerada custo-efetiva apesar de o ultrapassar. Conclusão: A incidência desta em Portugal está acima da média da União Europeia devido aos serogrupos B, C, W, e Y. A relação custo-efetividade da MenACWY é ainda dúbia, pelo que incidência e preço são importantes para a introdução no Programa Nacional de Vacinação Português.

Overview of meningococcal epidemiology and national immunization programs in children and adolescents in 8 Western European countries.

Background: In Europe, meningococcal (Men) vaccines are available against 5 of the 6 serogroups responsible of nearly all cases of invasive meningococcal disease (IMD). Meningococcal vaccination has been introduced in the national immunization programs (NIPs) for children and adolescents of numerous European countries, but with no consistent strategy across countries. Objectives: To describe IMD epidemiology, NIPs, and vaccination coverage rates (VCRs) in children and adolescents in 8 Western European countries. Methods: Epidemiological data (from 1999 to 2019), NIPs regarding meningococcal vaccination status, and VCRs were collected from the European Centre for Disease Prevention and Control (ECDC) and/or national websites. Results: MenB was the most common serogroup. In Belgium, Spain, France, the Netherlands, the United Kingdom (UK), and Portugal, incidence was greater for MenW than MenC. In 2019, MenB risk was covered in 2 countries (Italy, UK). MenC risk was covered in all countries, via MenC only (countries: N = 3), MenACWY only (N = 2), or MenC (infants/children) and MenACWY (adolescents) (N = 3) vaccination. VCRs were higher in children than adolescents. Conclusion: Our study confirmed the diversity of NIPs, including in neighboring European countries with similar factors like economic resources and epidemiological risk, thus indicating that other factors underlie NIPs. Convergence toward a more common immunization program including MenACWY and MenB vaccination would promote equity and safe travel regarding infectious diseases for young people, and possibly improve the understanding of vaccination by patients and healthcare professionals.

Clinical trial and postmarketing safety experience with MenACWY-TT, a meningococcal group A, C, W, and Y tetanus conjugate vaccine.

BACKGROUND: The meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix®; Pfizer Ltd, Sandwich, Kent, UK) is licensed in more than 80 countries worldwide for the prevention of meningococcal disease caused by serogroups A, C, W, and Y in individuals throughout their lifespans. This report summarizes safety data from the MenACWY-TT clinical development program and postmarketing experience. METHODS: Within the clinical study program, reactogenicity data were based on 3 primary studies, including a large pooled analysis across multiple age groups, and long-term safety data were derived from 3 studies evaluating long-term antibody persistence. Postmarketing safety data through April 19, 2021, were collected and analyzed in connection with the MenACWY-TT Periodic Safety Update Report. RESULTS: Approximately 32 million doses of MenACWY-TT have been administered worldwide, with more than 21,530 additional individuals receiving MenACWY-TT as part of clinical trials. The safety profile of MenACWY-TT was consistent between the clinical study program and the postmarketing experience, as well as with other licensed meningococcal vaccines. The most commonly observed adverse events (AEs) were pyrexia/fever, headache, injection site pain/reactions, nausea/vomiting, and fatigue; serious AEs were rare relative to the number of doses administered. Several cases of serogroup replacement/lack of efficacy were observed in the 1-year postmarketing period but did not appear to be related to MenACWY-TT use. CONCLUSION: Extensive data derived from clinical trials and postmarketing experience indicate a consistently favorable safety profile for MenACWY-TT across a wide range of age groups.

Public health perspective of a pentavalent meningococcal vaccine combining antigens of MenACWY-CRM and 4CMenB.

OBJECTIVES: Invasive meningococcal disease (IMD) is a life-threatening disease that can rapidly progress to death or leave survivors with severe, life-long sequelae. Five meningococcal serogroups (A, B, C, W and Y) account for nearly all IMD. Meningococcal serogroup distribution fluctuates over time across the world and age groups. Here, we consider the potential public health impact of a pentavalent MenABCWY vaccine developed to help further control meningococcal disease and improve immunisation rates. RESULTS: The GSK MenABCWY vaccine combines the antigenic components of MenACWY-CRM (Menveo®) and 4CMenB (Bexsero®), building on a wide body of clinical experience and real-world evidence. Both approved vaccines have acceptable safety profiles, demonstrate immunogenicity, and are broadly used, including in national immunisation programmes in several countries. Since the advent of quadrivalent vaccines, public health in relation to IMD has improved, with a decline in the overall incidence of IMD and an increase in vaccine coverage. CONCLUSION: A pentavalent MenABCWY has the potential to provide further public health benefits through practical, broad IMD protection programmes encompassing serogroups A, B, C, W and Y, and is currently in late-stage development.

Immunogenicity and safety of MenACWY-TT, a quadrivalent meningococcal tetanus toxoid conjugate vaccine recently licensed in the United States for individuals ≥2 years of age.

Vaccination offers the best way to prevent invasive meningococcal disease (IMD). As demonstrated in countries with national immunization programs (NIPs) against IMD, meningococcal conjugate vaccines have contributed to significant declines in incidence. Since some meningococcal vaccines are associated with modest immunogenicity in infants, possible immunological interference upon concomitant administration with some pediatric vaccines, and administration errors resulting from improper reconstitution, opportunities for improvement exist. A quadrivalent conjugate vaccine, MenQuadfi® (Meningococcal [Serogroups A, C, Y, and W] Conjugate Vaccine; Sanofi, Swiftwater, Pennsylvania), was approved in 2020 for the prevention of IMD caused by meningococcal serogroups A, C, W, and Y in individuals ≥2 years of age in the United States. Five pivotal studies and one ancillary study supported approval in the United States; clinical trials in infants are ongoing. Data on the immunogenicity and safety of this vaccine are presented, and its potential value in clinical practice is discussed.

Psychosocial and organizational barriers and facilitators of meningococcal vaccination (MenACWY) acceptance among adolescents and parents during the Covid-19 pandemic: a cross-sectional survey.

BACKGROUND: This study aimed to identify differences and similarities among adolescents and parents in various psychosocial factors influencing meningococcal ACWY (MenACWY) vaccination acceptance. Besides, the impact of the Covid-19 pandemic was assessed as well as resulting organizational adjustments. METHODS: We conducted a cross-sectional survey among adolescents that attended the appointment for the MenACWY vaccination in South Limburg between May and June 2020, and their parents. Independent t-tests and χ2 test were performed to explore differences in psychosocial and organisational factors between adolescents and parents. RESULTS: In total, 592 adolescents (20%) and 1197 parents (38%) filled out the questionnaire. Adolescents scored lower on anticipated negative affect towards MenACWY vaccination refusal [t (985.688) = - 9.32; ρ < 0.001], moral norm towards MenACWY vaccination acceptance [t (942.079) = - 10.38; ρ < 0.001] and knowledge about the MenACWY vaccination and meningococcal disease [t (1059.710) = - 11.24; ρ < 0.001]. Both adolescents and parents reported a social norm favouring accepting childhood vaccinations, but adolescent scored higher [t (1122.846) = 23.10; ρ < 0.001]. The Covid-19 pandemic did barely influence the decision to accept the MenACWY vaccination. Only 6% of the participants indicated that Covid-19 influenced their decision. In addition, the individual vaccination appointment was rated very positive. Most adolescents (71.5%) and parents (80.6%) prefer future vaccinations to be offered individually rather than having mass vaccinations sessions. CONCLUSIONS: This study provides an indication of which psychosocial and organisational factors should be addressed in future MenACWY vaccination campaigns. Individual vaccination appointments for adolescents should be considered, taking the costs and logistical barriers into account.

Factors associated with human papillomavirus and meningococcal vaccination among adolescents living in rural and urban areas.

Background: Studies have shown that adolescent vaccination rates with human papillomavirus (HPV) and quadrivalent meningococcal conjugate (MenACWY) vaccines are lower in rural areas of the U.S. than in urban areas. We sought to determine factors associated with vaccine acceptance in these two settings. Methods: We conducted a cross-sectional survey of 536 parents or guardians of teens age 13 through 15 years in select rural and urban counties of Minnesota and Wisconsin. We collected information on demographic variables, receipt of adolescent vaccines, and attitudes toward HPV vaccine in particular. Multivariable logistic regression models were used to assess associations between covariates and outcomes of interest (HPV vaccine receipt and MenACWY receipt). Results: Of the 536 respondents, 267 (50%) resided in a rural county. Most respondents were female (78%) and non-Hispanic White (88%). About half (52%) of teens of the surveyed parents received the three vaccines recommended specifically for adolescents: 90% received tetanus-diphtheria-acellular pertussis (Tdap), 84% received MenACWY, and 60% received one or more doses of HPV vaccine. Rural and urban parents surveyed differed on several covariates relating to teen's health services, parent's demographics, and household characteristics. Parent's perception of the importance that their healthcare providers placed on vaccination with HPV and MenACWY were independently associated with receipt of each of those vaccines (odds ratio [OR] 6.37, 95% confidence interval [CI] 2.90-13.96 and OR 2.15, 95% CI 1.07-4.31, respectively). Parents of vaccinated teens were less likely to report concerns about potential harm from the HPV vaccine or having heard stories about health problems caused by the HPV vaccine. Conclusion: Teen receipt of HPV vaccine and MenACWY appears to be influenced by parents' perception of vaccine importance, provider recommendations, and concerns regarding potential harm from the HPV vaccine. Continued education of providers and parents of the importance of adolescent vaccinations is warranted.