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1.
Curr Med Res Opin ; 40(7): 1253-1263, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38860982

ABSTRACT

OBJECTIVE: In 2019, the United States Advisory Committee on Immunization Practices (ACIP) updated their meningococcal serogroup B (MenB) vaccination recommendation for 16-|23-year-olds from individual to shared clinical decision-making (SCDM). SCDM recommendations are individually based and informed by a decision process between patients and healthcare providers (HCPs). MenB vaccination among 16-23-year-olds remains low. We examined recorded conversations in which MenB vaccine-related discussions between HCPs and patients/caregivers took place, and how these interactions changed following the updated SCDM recommendation. METHODS: An analysis of recordings where MenB vaccination was discussed between HCPs and patients (16-|23 years old)/caregivers was conducted using retrospective anonymized dialogue data (January 2015-October 2022). Shared decision-making strength was measured using a modified OPTION5 framework. RESULTS: Of 97 included recorded conversations, the average duration was 11.3 min. Within these conversations, MenB disease was discussed for 0.25 min (38.9% of words in total vaccine-preventable diseases discussion) and MenB vaccination was discussed for 1.36 min (60.9% of words in total vaccine discussion), on average. HCPs spoke 78.8% of MenB vaccine-related words and most (99.0%) initiated the MenB vaccination discussion. In 40.2% of recordings, HCPs acknowledged the MenB vaccine without providing a clear recommendation. HCP recommendations often favored MenB vaccination (87.0%) and recommendations were 21.4% stronger post-recommendation change to SCDM. As measured by the modified OPTION5 framework, most recordings did not reflect a high degree of shared decision-making between HCPs and patients/caregivers. CONCLUSIONS: MenB vaccination discussions were brief, and the degree of shared decision-making was low. Targeted education of HCPs and patients/caregivers may improve MenB vaccination awareness, SCDM implementation, and vaccine uptake.


Meningitis is a serious and sometimes deadly disease. In the United States (US), the Centers for Disease Control and Prevention (CDC) recommends that 16­23-year-olds get vaccinated against meningococcal serogroup B (MenB), which causes a specific type of meningitis called invasive meningococcal disease. As of 2019, the CDC recommends that healthcare providers and patients or their caregivers have a shared decision-making discussion about deciding to get vaccinated against MenB. Despite these recommendations, vaccination against MenB among 16­23-year-olds is very low. Only about 3 in 10 17-year-olds had received the MenB vaccine in 2022. We studied conversations between healthcare providers and patients or their caregivers that included discussions of MenB vaccination. These discussions were largely brief and led by the healthcare providers. We found that healthcare providers most often made recommendations that were in favor of their patients getting vaccinated against MenB. However, we also found that healthcare providers missed many opportunities to have these shared decision-making discussions about MenB vaccination with patients or their caregivers. Providing education and resources for patients, caregivers, and healthcare providers focused on increasing awareness about MenB vaccination and the role they can play in having shared decision-making discussions may lead to more adolescents and young adults getting vaccinated against MenB. More research is needed to find out how we can improve MenB vaccination coverage in the US.


Subject(s)
Meningococcal Vaccines , Neisseria meningitidis, Serogroup B , Vaccination , Humans , Neisseria meningitidis, Serogroup B/immunology , Meningococcal Vaccines/administration & dosage , Adolescent , Female , Male , Young Adult , United States , Vaccination/psychology , Retrospective Studies , Meningococcal Infections/prevention & control , Clinical Decision-Making , Adult , Decision Making, Shared , Health Personnel/psychology
2.
Vaccine ; 42(15): 3461-3466, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38653680

ABSTRACT

INTRODUCTION: Meningococcal vaccinations are recommended by Polish public health authorities but lack coverage under health insurance, prompting Local Government Units (LGUs) to implement local health policy programs. This study examines the effectiveness and impact of LGU-driven meningococcal vaccination initiatives in Poland between 2017 and 2021. MATERIAL AND METHODS: A retrospective analysis utilized data from reports on local public health interventions submitted annually to the Ministry of Health in Poland. The study focused on the number of meningococcal vaccination programs, their scope, the vaccinated population, and associated program costs. Additionally, nationwide data on meningococcal disease incidence and vaccine uptake were analyzed. RESULTS: Within LGUs programs, 48,617 individuals received meningococcal vaccinations, constituting approximately 10% of all vaccinations in Poland during the study period. Notably, cities with poviat rights spearheaded programs covering 54% of the total participants. The total cost incurred by these initiatives amounted to EUR 2,553,661. CONCLUSIONS: While LGUs activities positively contributed to increased meningococcal vaccination rates, the overall engagement of local governments remains limited. The findings underscore the importance of expanding local government involvement in meningococcal vaccination programs to address public health needs effectively. Improved collaboration and increased funding may enhance the reach and impact of these initiatives.


Subject(s)
Immunization Programs , Local Government , Meningococcal Infections , Meningococcal Vaccines , Humans , Meningococcal Vaccines/administration & dosage , Meningococcal Vaccines/economics , Meningococcal Infections/prevention & control , Meningococcal Infections/epidemiology , Poland , Immunization Programs/economics , Retrospective Studies , Vaccination/statistics & numerical data , Vaccination/economics , Health Policy , Public Health
3.
Expert Rev Vaccines ; 23(1): 445-462, 2024.
Article in English | MEDLINE | ID: mdl-38517733

ABSTRACT

INTRODUCTION: The epidemiology of invasive meningococcal disease (IMD), a rare but potentially fatal illness, is typically described as unpredictable and subject to sporadic outbreaks. AREAS COVERED: Meningococcal epidemiology and vaccine use during the last ~ 200 years are examined within the context of meningococcal characterization and classification to guide future IMD prevention efforts. EXPERT OPINION: Historical and contemporary data highlight the dynamic nature of meningococcal epidemiology, with continued emergence of hyperinvasive clones and affected regions. Recent shifts include global increases in serogroup W disease, meningococcal antimicrobial resistance (AMR), and meningococcal urethritis; additionally, unvaccinated populations have experienced disease resurgences following lifting of COVID-19 restrictions. Despite these changes, a close analysis of meningococcal epidemiology indicates consistent dominance of serogroups A, B, C, W, and Y and elevated IMD rates among infants and young children, adolescents/young adults, and older adults. Demonstrably effective vaccines against all 5 major disease-causing serogroups are available, and their prophylactic use represents a powerful weapon against IMD, including AMR. The World Health Organization's goal of defeating meningitis by the year 2030 demands broad protection against IMD, which in turn indicates an urgent need to expand meningococcal vaccination programs across major disease-causing serogroups and age-related risk groups.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis , Child , Infant , Adolescent , Young Adult , Humans , Child, Preschool , Aged , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Disease Outbreaks , Serogroup , Vaccines, Combined
4.
J Adolesc Health ; 74(6): 1131-1138, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38363244

ABSTRACT

PURPOSE: The United States Advisory Committee on Immunization Practices (ACIP) recommends vaccination against meningococcal serogroups A, C, W, and Y (MenACWY) for all 11-12-year-olds, with a booster dose for 16-year-olds, and against meningococcal serogroup B (MenB) for 16-23-year-olds under shared clinical decision-making (SCDM). However, uptake of the MenB vaccine and the MenACWY booster dose is low. This study investigated United States physicians' knowledge, attitudes, and practices regarding recommending MenB and MenACWY vaccines to non-high-risk older adolescents and young adults. METHODS: An online survey was conducted in April-May 2022 among pediatricians, family physicians (FPs), general practitioners (GPs), and internists who had recommended the MenB and/or the MenACWY vaccine(s) to at least one 16-23-year-old in the past year. RESULTS: Among 407 participants, 50% correctly identified MenB as the leading cause of meningococcal disease among adolescents and young adults. Furthermore, 46% of physicians (47% of pediatricians, 40% of FPs and GPs, 53% of internists) answered correctly that MenB vaccination is recommended under SCDM, and 82% of physicians (96% of pediatricians, 70% of FPs and GPs, 65% of internists) answered correctly that MenACWY vaccination is routinely recommended. Among MenB-vaccinators, 78% reported having received some training or other information on implementing SCDM, and 65% rated recommending MenB vaccination as very important. DISCUSSION: Knowledge gaps, which varied by specialty, were identified regarding meningococcal disease and vaccine recommendations, particularly regarding MenB. Targeted education of physicians may facilitate discussions about MenB vaccination.


Subject(s)
Health Knowledge, Attitudes, Practice , Meningococcal Infections , Meningococcal Vaccines , Humans , Meningococcal Vaccines/administration & dosage , United States , Male , Adolescent , Female , Meningococcal Infections/prevention & control , Young Adult , Practice Patterns, Physicians'/statistics & numerical data , Adult , Surveys and Questionnaires , Attitude of Health Personnel , Vaccination/statistics & numerical data , Middle Aged
5.
Hum Vaccin Immunother ; 20(1): 2313872, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38348600

ABSTRACT

Meningococcal vaccination strategies in China are intricate, including multiple vaccines targeting different serogroups. The current National Immunization Program (NIP) includes two polysaccharide vaccines for serogroups A and C (MPV-A and MPV-AC), covering limited serogroups and requiring adaptation. This study aims to evaluate the cost-effectiveness of replacing the current strategy with alternative strategies utilizing non-NIP vaccines to inform policy decisions. From a societal perspective, a decision tree-Markov model was constructed to simulate the economic and health consequences of meningococcal disease in a 2019 birth cohort with four vaccination strategies. Epidemiology, vaccine efficacy, cost, and other parameters were derived from previous studies. We conducted sensitivity analyses to assess the robustness of the findings and explored prices for non-NIP vaccines that enable cost-effective strategies. Compared to the current strategy, alternative strategies using quadrivalent polysaccharide vaccine (MPV-4), bivalent conjugate vaccine (MCV-AC), and quadrivalent conjugate vaccine (MCV-4) could avoid 91, 286, and 455 more meningococcal cases. The ICERs were estimated at approximately $250 thousand/QALY, $450 thousand/QALY, and $1.5 million/QALY, all exceeding the threshold of three times GDP per capita. The alternative strategies were not cost-effective. However, if vaccine prices were reduced to $3.9 for MPV-4, $9.9 for MCV-AC, and $12 for MCV-4, the corresponding strategy would be cost-effective. The current meningococcal vaccination strategy in China could effectively prevent the disease at a low cost, but with limited serogroup coverage. Strategies using MPV-4, MCV-AC, or MCV-4 could increase health benefits at a substantial cost, and might become cost-effective if vaccine prices decrease.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Child , Humans , Cost-Effectiveness Analysis , Vaccines, Conjugate , Cost-Benefit Analysis , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Vaccination , China/epidemiology , Polysaccharides
6.
Hum Vaccin Immunother ; 20(1): 2301186, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38173392

ABSTRACT

Invasive meningococcal disease (IMD) is an acute life-threatening infection caused by the gram-negative bacterium, Neisseria meningitidis. Globally, there are approximately half a million cases of IMD each year, with incidence varying across geographical regions. Vaccination has proven to be successful against IMD, as part of controlling outbreaks, and when incorporated into national immunization programs. The South-Eastern Europe Meningococcal Advocacy Group (including representatives from Croatia, the Czech Republic, Greece, Hungary, Poland, Romania, Serbia, Slovenia and Ukraine) was formed in order to discuss the potential challenges of IMD faced in the region. The incidence of IMD across Europe has been relatively low over the past decade; of the countries that came together for the South-Eastern Meningococcal Advocacy Group, the notification rates were lower than the European average for some country. The age distribution of IMD cases was highest in infants and children, and most countries also had a further peak in adolescents and young adults. Across the nine included countries between 2010 and 2020, the largest contributors to IMD were serogroups B and C; however, each individual country had distinct patterns for serogroup distribution. Along with the variations in epidemiology of IMD between the included countries, vaccination policies also differ.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis , Child , Infant , Adolescent , Young Adult , Humans , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Meningococcal Infections/microbiology , Europe/epidemiology , Czech Republic , Vaccination , Serogroup
7.
Preprint in Portuguese | SciELO Preprints | ID: pps-5499

ABSTRACT

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.

8.
Expert Rev Vaccines ; 21(11): 1637-1646, 2022 11.
Article in English | MEDLINE | ID: mdl-36222056

ABSTRACT

INTRODUCTION: Immunization is the best strategy to protect individuals from invasive meningococcal disease (IMD). To support decision-making around immunization, this paper considers what has led four countries and regions of two more to introduce the quadrivalent MenACWY vaccine in toddlers (ages 12-24 months). AREAS COVERED: A narrative literature review was conducted to identify countries that have introduced a MenACWY vaccination program for toddlers. Information from peer-reviewed publications, reports, and policy documents for each identified country was extracted. Australia, Chile, the Netherlands, Switzerland, and regions of Italy and Spain have introduced the MenACWY vaccine in their toddler programs, driven by the rising incidence of MenW and MenY and the vaccine's ability to provide protection against other serogroups. Australia and the Netherlands considered the economic impacts of implementing a MenACWY toddler vaccination program. Vaccination uptake and effects are reported for three countries; however, in two, isolating the vaccine's effect from the collateral effect of COVID-related measures is difficult. EXPERT OPINION: Increased convergence of vaccination policies and programs is needed internationally, as IMD recognizes no borders.PL AIN LANGUAGE SUMMARYVaccination is the best defense against meningitis, a deadly disease. While someone of any age can contract it, children 0-24 months of age are disproportionately affected. The increasing number of cases of meningitis has led four countries plus regions of two more to introduce into their vaccination schedules for toddlers (ages 12-24 months) a vaccine that protects against four different serogroups rather than one serogroup alone. This paper considers what has driven that shift.


Subject(s)
COVID-19 , Meningococcal Infections , Meningococcal Vaccines , Child, Preschool , Humans , Infant , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Policy , Vaccines, Conjugate
9.
Hum Vaccin Immunother ; 18(6): 2110759, 2022 Nov 30.
Article in English | MEDLINE | ID: mdl-36084311

ABSTRACT

Invasive meningococcal disease (IMD) imposes a significant burden on the global community due to its high case fatality rate (4-20%) and the risk of long-term sequelae for one in five survivors. An expert group meeting was held to discuss the epidemiology of IMD and immunization policies in Malaysia, Philippines, Thailand, and Vietnam. Most of these countries do not include meningococcal immunization in their routine vaccination programs, except for high-risk groups such as immunocompromised people and pilgrims. It is difficult to estimate the epidemiology of IMD in the highly diverse Asia-Pacific region, but available evidence indicate serogroup B is increasingly dominant. Disease surveillance systems differ by country. IMD is not a notifiable disease in some of them. Without an adequate surveillance system in the region, the risk and the burden of IMD might well be underestimated. With the availability of new combined meningococcal vaccines and the World Health Organization roadmap to defeat bacterial meningitis by 2030, a better understanding of the epidemiology of IMD in the Asia-Pacific region is needed.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis , Humans , Incidence , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Meningococcal Infections/microbiology , Vaccination , Serogroup , Thailand
10.
Vaccines (Basel) ; 10(4)2022 Apr 12.
Article in English | MEDLINE | ID: mdl-35455341

ABSTRACT

We conducted an age-based risk analysis of meningococcal disease in Spain to provide prospects on a rational vaccine schedule in pediatrics. We used the National Hospital Registry to estimate meningococcal hospitalization rate. Population census for each year was used as the denominator in computing the hospitalization rate. We computed the odds ratio of each age using <1 year old as a reference group. From 1998 to 2017, 13,554 hospitalized cases were diagnosed, with a declining trend across the years. Infants (<1 year, n = 2425) and children (1−14 years, n = 6053) comprised the majority of all hospitalized meningococcal disease in Spain (62.5% or 8474/13,554). The incidence of hospitalization decreased dramatically with age from 56.2/100,000 in <1-year-old children to 1.3/100,000 in >5-year-old children. There was a dramatic decline in risk in 1 year (OR 0.58) to 4 years of age (OR 0.21). The risk continued to decline until 13 years old. Afterward, it had a minimal upward trajectory observed at 14−17 years old (OR 0.08). Infants and adolescents are at continued risk of invasive meningococcal disease in Spain. The highest risk occurs in infants. Surveillance data, together with evidence on long-term immunogenicity and capacity for herd effect, should be considered for a more relevant immunization schedule.

11.
Article in English | MEDLINE | ID: mdl-35409716

ABSTRACT

Meningococcal disease is caused by Neisseria meningitidis; 13 serogroups have been identified and differentiated from each other through their capsular polysaccharide. Serotypes A, B, C, W, X, and Y are responsible for nearly all infections worldwide. The most common clinical manifestations are meningitis and invasive meningococcal disease, both characterized by high mortality and long-term sequelae. The infection rate is higher in children younger than 1 year and in adolescents, who are frequently asymptomatic carriers. Vaccination is the most effective method of preventing infection and transmission. Currently, both monovalent meningococcal vaccines (against A, B, and C serotypes) and quadrivalent meningococcal vaccines (against serogroups ACYW) are available and recommended according to local epidemiology. The purpose of this article is to describe the meningococcal vaccines and to identify instruments that are useful for reducing transmission and implementing the vaccination coverage. This aim could be reached by switching from the monovalent to the quadrivalent vaccine in the first year of life, increasing vaccine promotion against ACYW serotypes among adolescents, and extending the free offer of the anti-meningococcal B vaccine to teens, co-administering it with others proposed in the same age group. Greater awareness of the severity of the disease and increased health education through web and social networks could represent the best strategies for promoting adhesion and active participation in the vaccination campaign. Finally, the development of a licensed universal meningococcal vaccine should be another important objective.


Subject(s)
Meningitis, Meningococcal , Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis , Adolescent , Child , Humans , Immunization Programs , Meningitis, Meningococcal/epidemiology , Meningitis, Meningococcal/prevention & control , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Meningococcal Vaccines/therapeutic use , Vaccination , Vaccines, Conjugate/therapeutic use
12.
J Med Microbiol ; 71(3)2022 Mar.
Article in English | MEDLINE | ID: mdl-35238737

ABSTRACT

Introduction. Only approximately 40 cases of invasive meningococcal diseases are reported annually in Japan, and the dominant strains are serogroup Y meningococci (MenY) followed by serogroup B meningococci (MenB). Within the last 10 years, Neisseria meningitidis strains belonging to clonal complex (cc)2057 have become dominant among Japanese MenB and have not been identified in countries other than Japan.Hypothesis/Gap Statement. The uniqueness of cc2057 N. meningitidis strains was considered to be epidemiologically of importance, and some genetic features could be hidden in the genome of cc2057 meningococci.Method. We investigated 22 cc2057 MenB and one cc2057 MenY using whole genome sequencing (WGS) and also predicted the potential coverage of 4CMenB and bivalent rLP2086 vaccines in silico.Results. cc2057 N. meningitidis strains were phylogenetically assigned to two clades. Three hypothetical genes homologous to those in Neisseria lactamica and sequences related to a new CRISPR Cas9 system were found only in the genome of cc2057 strains. Moreover, one cc2057 MenY strain was presumed to be capsular-switched at the capsule synthesis (cps) locus. The potential coverage of 4CMenB and rLP2086 for cc2057 MenB strains was estimated to be very low.Conclusion. To the best of our knowledge, this is the first study to provide genetic insights from epidemiologically unique N. meningitidis cc2057 strains isolated only in Japan, an island country.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis, Serogroup B , Antigens, Bacterial/genetics , Humans , Japan/epidemiology , Meningococcal Infections/microbiology , Meningococcal Vaccines/immunology , Neisseria meningitidis, Serogroup B/genetics , Neisseria meningitidis, Serogroup B/immunology , Serogroup
13.
Vaccine ; 40(2): 247-254, 2022 01 21.
Article in English | MEDLINE | ID: mdl-34887130

ABSTRACT

BACKGROUND: Bexsero® (GlaxoSmithKline) is a four-component Neisseria meningitidis serogroup B vaccine (MenB-4C). It was licensed in the United States in 2015 for use among individuals ages 10-25 years. We aimed to assess the post-licensure safety profile of MenB-4C by examining reports received in the Vaccine Adverse Event Reporting System (VAERS). METHODS: VAERS is a national passive surveillance system for adverse events (AEs) following immunization that uses the Medical Dictionary for Regulatory Activities to code reported AEs and the Code of Federal Regulations to classify reports by seriousness. In this case series, we analyzed U.S. reports involving MenB-4C received between January 23, 2015 through December 31, 2018. We used Empirical Bayesian data mining to identify MenB-4C/AE combinations reported at least twice as often as expected. RESULTS: VAERS received 1,867 reports following MenB-4C administration, representing 332 reports per million doses distributed. Most reports were for females (59%), with a median age of 17 years (interquartile range: 16-18 years); 40% of reports described simultaneous administration of other vaccines. The majority of reports were classified as non-serious (96%). The most commonly reported AEs were injection site pain (22%), pyrexia (16%), and headache (16%). Data mining identified disproportionate reporting for "injected limb mobility decreased" secondary to injection site reactions, including extensive swelling of the vaccinated limb and injection site pain. CONCLUSIONS: Analysis of passive surveillance data from over 5.6 million doses of MenB-4C distributed in the United States did not reveal new safety concerns. The large majority of reports were classified as non-serious and the reported AEs were generally consistent with the safety experience described in clinical studies and the product's package insert. While our results are reassuring, continued post-marketing surveillance is warranted.


Subject(s)
Meningococcal Vaccines , Neisseria meningitidis, Serogroup B , Adolescent , Adult , Adverse Drug Reaction Reporting Systems , Bayes Theorem , Child , Female , Humans , Meningococcal Vaccines/adverse effects , United States/epidemiology , Young Adult
14.
Vaccine ; 39(52): 7655-7660, 2021 12 20.
Article in English | MEDLINE | ID: mdl-34785099

ABSTRACT

Since serogroup B meningococcal (MenB) vaccines became available in the United States, six serogroup B meningococcal disease cases have been reported in MenB-4C (n = 4) or MenB-FHbp (n = 2) recipients. Cases were identified and characterized through surveillance and health record review. All five available isolates were characterized using whole genome sequencing; four isolates (from MenB-4C recipients) were further characterized using flow cytometry, MenB-4C-induced serum bactericidal activity (SBA), and genetic Meningococcal Antigen Typing System (gMATS). Three patients were at increased meningococcal disease risk because of an outbreak or underlying medical conditions, and only four of the six patients had completed a full 2-dose MenB series. Isolates were available from 5 patients, and all contained sub-family A FHbp. The four isolates from MenB-4C recipients expressed NhbA but were mismatched for the other MenB-4C vaccine antigens. These four isolates were relatively resistant to MenB-4C-induced SBA, but predicted by gMATS to be covered. Overall, patient risk factors, incomplete vaccine series completion, waning immunity, and strain resistance to SBA likely contributed to disease in these six patients.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis, Serogroup B , Antigens, Bacterial , Humans , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Serogroup , United States/epidemiology
15.
Vaccine ; 39(52): 7541-7544, 2021 12 20.
Article in English | MEDLINE | ID: mdl-34802785

ABSTRACT

BACKGROUND: The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with a quadrivalent meningococcal conjugate serogroup A,C,W,Y (MenACWY) vaccine at 11-12 years of age, with a booster dose at 16 years. ACIP also recommends meningococcal vaccination for persons at increased risk of meningococcal disease, including a 2-dose primary series and regular booster doses for persons at increased risk because of underlying medical conditions. U.S. cases of serogroup A, C, W, and Y meningococcal disease in persons previously vaccinated with MenACWY vaccine have not been systematically described since 2008. Characterization of these cases is important to understand potential factors leading to breakthrough disease. METHODS: We analyzed cases of serogroup A,C,W, and Y meningococcal disease reported through the National Notifiable Diseases Surveillance System (NNDSS) from 2014 through 2018. State health departments submitted additional information on risk factors and clinical course. RESULTS: During 2014-2018, 822 cases of serogroup A, C, W, and Y meningococcal disease were reported through NNDSS; 34 (4%) were in patients who previously received ≥ 1 dose of MenACWY vaccine. Twenty-three vaccinated patients were up-to-date on MenACWY vaccine per recommendations, and seven were not up-to-date; four were missing information on the number of doses received. Seventeen cases (50%) occurred > 3 years after the most recent dose. A significantly higher proportion of vaccinated patients were people living with HIV (PLWH) compared to unvaccinated patients. Eight of the 34 vaccinated patients were immunosuppressed, including five PLWH, one taking eculizumab, and two taking other immunosuppressive medications. The case fatality ratio did not differ between vaccinated and unvaccinated patients. CONCLUSIONS: Immunosuppression, incomplete vaccination, and waning immunity likely contributed to breakthrough cases of meningococcal disease among people who received MenACWY vaccine. Continued monitoring of serogroup A, C, W, and Y meningococcal disease in previously vaccinated persons will help inform meningococcal disease prevention efforts.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis , Adolescent , Humans , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Serogroup , United States/epidemiology , Vaccines, Conjugate
16.
Hum Vaccin Immunother ; 17(11): 4675-4688, 2021 11 02.
Article in English | MEDLINE | ID: mdl-34613863

ABSTRACT

Neisseria meningitidis is a bacterial pathogen capable of causing rapidly progressing illness from nonspecific symptoms to end-organ failure or death in a matter of hours to days. Despite the availability of meningococcal vaccines, there remains a notable disease incidence peak among individuals aged 18-19 years, with college students at increased risk for disease relative to non-college students. Between 2007 and 2017, as many as one in five colleges in the United States experienced an outbreak of meningococcal disease at their own or a nearby institution. Evidence-based strategies to promote meningococcal vaccination among students can be adapted for the college setting, but barriers exist that limit widespread implementation of these strategies by colleges. In this article, we review meningococcal disease characteristics and epidemiology among US college students, vaccination indications and coverage levels among US college students, as well as college vaccination policies and practices that can impact students' vaccine uptake.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis , Humans , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Students , United States/epidemiology , Vaccination
17.
Emerg Infect Dis ; 27(9): 2495-2497, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34193335

ABSTRACT

Invasive meningococcal disease incidence in England declined from 1.93/100,000 persons (1,016 cases) in 2010-11 to 0.95/100,000 (530 cases) in 2018-19 and 0.74/100,000 in 2019-20 (419 cases). During national lockdown for the coronavirus disease pandemic (April-August 2020), incidence was 75% lower than during April-August 2019.


Subject(s)
COVID-19 , Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis , Communicable Disease Control , England/epidemiology , Humans , Meningococcal Infections/epidemiology , Pandemics , SARS-CoV-2
19.
mBio ; 12(3)2021 05 18.
Article in English | MEDLINE | ID: mdl-34006659

ABSTRACT

Carriage evaluations were conducted during 2015 to 2016 at two U.S. universities in conjunction with the response to disease outbreaks caused by Neisseria meningitidis serogroup B and at a university where outbreak and response activities had not occurred. All eligible students at the two universities received the serogroup B meningococcal factor H binding protein vaccine (MenB-FHbp); 5.2% of students (181/3,509) at one university received MenB-4C. A total of 1,514 meningococcal carriage isolates were obtained from 8,905 oropharyngeal swabs from 7,001 unique participants. Whole-genome sequencing data were analyzed to understand MenB-FHbp's impact on carriage and antigen genetic diversity and distribution. Of 1,422 isolates from carriers with known vaccination status (726 [51.0%] from MenB-FHbp-vaccinated, 42 [3.0%] from MenB-4C-vaccinated, and 654 [46.0%] from unvaccinated participants), 1,406 (98.9%) had intact fHbp alleles (716 from MenB-FHbp-vaccinated participants). Of 726 isolates from MenB-FHbp-vaccinated participants, 250 (34.4%) harbored FHbp peptides that may be covered by MenB-FHbp. Genogroup B was detected in 122/1,422 (8.6%) and 112/1,422 (7.9%) isolates from MenB-FHbp-vaccinated and unvaccinated participants, respectively. FHbp subfamily and peptide distributions between MenB-FHbp-vaccinated and unvaccinated participants were not statistically different. Eighteen of 161 MenB-FHbp-vaccinated repeat carriers (11.2%) acquired a new strain containing one or more new vaccine antigen peptides during multiple rounds of sample collection, which was not statistically different (P = 0.3176) from the unvaccinated repeat carriers (1/30; 3.3%). Our findings suggest that lack of MenB vaccine impact on carriage was not due to missing the intact fHbp gene; MenB-FHbp did not affect antigen genetic diversity and distribution during the study period.IMPORTANCE The impact of serogroup B meningococcal (MenB) vaccines on carriage is not completely understood. Using whole-genome sequencing data, we assessed the diversity and distribution of MenB vaccine antigens (particularly FHbp) among 1,514 meningococcal carriage isolates recovered from vaccinated and unvaccinated students at three U.S. universities, two of which underwent MenB-FHbp mass vaccination campaigns following meningococcal disease outbreaks. The majority of carriage isolates recovered from participants harbored intact fHbp genes, about half of which were recovered from MenB-FHbp-vaccinated participants. The distribution of vaccine antigen peptides was similar among carriage isolates recovered from vaccinated and unvaccinated participants, and almost all strains recovered from repeat carriers retained the same vaccine antigen profile, suggesting insignificant vaccine selective pressure on the carriage population in these universities.


Subject(s)
Antigens, Bacterial/genetics , Bacterial Proteins/genetics , Carrier State/microbiology , Genetic Variation , Meningococcal Infections/microbiology , Neisseria meningitidis, Serogroup B/genetics , Students/statistics & numerical data , Universities , Antigens, Bacterial/classification , Carrier State/epidemiology , Disease Outbreaks , Genotype , Humans , Meningococcal Infections/epidemiology , Meningococcal Vaccines/administration & dosage , Neisseria meningitidis, Serogroup B/isolation & purification , Serogroup , United States/epidemiology
20.
Hum Vaccin Immunother ; 17(8): 2777-2787, 2021 08 03.
Article in English | MEDLINE | ID: mdl-33631080

ABSTRACT

In Norway, the incidence of invasive meningococcal disease (IMD) is higher among 16-19-year-olds than in the general population. Most IMD cases among teenagers are caused by serogroup Y. Since 2011, one dose of meningococcal ACWY conjugate vaccine (MCV4) has been recommended for teenagers with out-of-pocket payment. The teenagers are usually vaccinated through the school health service at age 18. This study aimed to estimate costs and health gains of introducing MCV4 to Norwegian teenagers through the national immunization program (NIP). A Markov model was used to analyze the cost-effectiveness of universal MCV4 vaccination of either 15-year-olds or 18-years-olds. Occurrences of IMD were simulated from 15 until 23 years of age. Costs were estimated from a healthcare perspective. Sensitivity analyses evaluated the impact of vaccine price, vaccination uptake, IMD incidence and discount rate. Compared to today's practice of vaccinating 18-year-olds with out-of-pocket payment, introducing MCV4 to 15-year-olds in a NIP-setting, with 90% vaccine uptake and 50% rebate on vaccine price, prevented 3.2 hospitalizations, 0.20 sequelae and 0.47 deaths among 15-23-year-olds, annually. Total costs were reduced by €30,000 and 9.7 quality-adjusted life-years (QALYs) were gained per birth cohort. The probability of cost-effectiveness was 99.0%, assuming a willingness-to-pay threshold of €86,000/QALY for severe diseases in Norway. Cost-effectiveness was highly dependent on vaccine price. Vaccination of 18-year-olds in a NIP-setting was also cost-effective, but less than NIP-vaccination of 15-year-olds. Introduction of MCV4 to the 15-year-olds in the Norwegian NIP is likely to be cost-effective given a rebate on the vaccine price.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Adolescent , Cost-Benefit Analysis , Humans , Meningococcal Infections/epidemiology , Meningococcal Infections/prevention & control , Norway/epidemiology , Vaccination , Vaccines, Conjugate
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