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The Journal of Infection Jul 20214CMenB is a broadly protective vaccine against invasive meningococcal capsular group B disease (MenB IMD). Licensed worldwide based on immunogenicity and safety data,... (Review)
Review
OBJECTIVES
4CMenB is a broadly protective vaccine against invasive meningococcal capsular group B disease (MenB IMD). Licensed worldwide based on immunogenicity and safety data, effectiveness and impact data are now available. We comprehensively reviewed all available real-world evidence gathered from use of 4CMenB since licensure.
RESULTS
Data from 7 countries provide evidence of effectiveness and impact across different healthcare settings and age-groups, including national/regional immunization programs, observational studies and outbreak control. At least 2 4CMenB doses reduced MenB IMD by 50%-100% in 2-month to 20-year-olds depending on length of follow-up. Estimates of vaccine effectiveness in fully vaccinated cohorts ranged from 59%-100%. The safety profile of 4CMenB administered in real-world settings was consistent with pre-licensure clinical trial data.
CONCLUSION
MenB IMD is an uncommon but life-threatening disease with unpredictable epidemiology. The substantial body of data demonstrating 4CMenB effectiveness and impact supports its use in IMD prevention. The results reinforce the importance of direct protection of the highest risk groups; infants/young children and adolescents. Direct protection via routine infant immunization with catch-up in young children and routine adolescent vaccination could be the preferred option for MenB disease control. A Video Abstract linked to this article is available on Figshare: https://doi.org/10.6084/m9.figshare.14546790.
Topics: Adolescent; Child; Child, Preschool; Humans; Immunization Programs; Infant; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Vaccination
PubMed: 33933528
DOI: 10.1016/j.jinf.2021.04.031 -
Vaccine Jan 2021Meningococcal disease (MD) presents a substantial public health problem in Brazil. Meningococcal C conjugate (MenC) vaccination was introduced into the routine infant...
BACKGROUND
Meningococcal disease (MD) presents a substantial public health problem in Brazil. Meningococcal C conjugate (MenC) vaccination was introduced into the routine infant immunization program in 2010, followed by adolescent vaccination in 2017. We evaluated changes in national and regional MD incidence and mortality between 2005 and 2018, serogroup distribution and vaccine coverage.
METHODS
Data were obtained from national surveillance systems from 2005 to 2018. Age-stratified incidence and mortality rates were calculated and a descriptive time-series analysis was performed comparing rates in the pre-(2005-2009) and post-vaccination (2011-2018) periods; MD due to specific meningococcal serogroups were analyzed in the pre-(2007-2009) and post-vaccination (2011-2018) periods.
RESULTS
From 2005 to 2018, 31,108 MD cases were reported with 6496 deaths; 35% of cases and deaths occurred in children < 5 years. Incidence and mortality rates declined steadily since 2012 in all age-strata, with significantly lower incidence and mortality in the post-vaccine introduction period in children aged < 1-year, 1-4 years, 5-9 years and 10-14 years. A significant decline in MenC disease in children < 5 years was observed following MenC vaccine introduction; infants < 1 year, from 3.30/100,000 (2007-2009) to 1.08/100,000 (2011-2018) and from 1.44/100,000 to 0.42/100,000 in 1-4-year-olds for these periods. Reductions in MenB disease was also observed. MenW remains an important cause of MD with 748 cases reported across 2005-2018. While initial infant vaccination coverage was high (>95% nationwide), this has since declined (to 83% in 2018); adolescent uptake was < 20% in 2017/18). Regional variations in outcomes and vaccine coverage were observed.
CONCLUSION
A substantial decline in incidence and mortality rates due to MD was seen following MenC vaccine introduction in Brazil, especially among children < 5 years chiefly driven by reductions in MenC serogroup. While these benefits are considerable, the prevalence of MD due to other serogroups such as MenW and MenB remains a concern. A video summary linked to this article can be found on Figshare: https://doi.org/10.6084/m9.figshare.13379612.v1.
Topics: Adolescent; Brazil; Child; Child, Preschool; Humans; Immunization Programs; Incidence; Infant; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccination
PubMed: 33358262
DOI: 10.1016/j.vaccine.2020.11.067 -
Pharmaceutical Medicine Jan 2021The high incidence of error reports received by the US Food and Drug Administration (FDA) involving 2-component vaccines led to collaboration between the United States...
The high incidence of error reports received by the US Food and Drug Administration (FDA) involving 2-component vaccines led to collaboration between the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). This collaborating group sought to further understand errors associated with all 2-component vaccines (i.e. vaccine components provided by the manufacturer in physically separate containers) and to provide safe practice strategies for storing, preparing, dispensing, and administering these vaccines as intended. Fourteen available 2-component vaccines were identified. The ISMP National Vaccine Errors Reporting Program (VERP) and the FDA Vaccine Adverse Event Reporting System (VAERS) were searched from the initiation of each respective reporting system through December 31, 2019. The three vaccines with the most reported reconstitution errors in the VERP and VAERS are Menveo (meningococcal), Pentacel (DTaP, Polio, Haemophilus influenzae type b), and ActHIB [H. influenzae type b (Hib)]. Manufacturers should design labeling and packaging of vaccines to provide ease of storage and fail-safe preparation to prevent 2-component vaccine errors. Implementing risk reduction strategies, such as training healthcare professionals and affixing storage bin labels, remind healthcare professionals to mix the 2-components and facilitate appropriate administration.
Topics: Adverse Drug Reaction Reporting Systems; Bacterial Vaccines; Haemophilus influenzae type b; Meningococcal Vaccines; United States; United States Food and Drug Administration
PubMed: 33151497
DOI: 10.1007/s40290-020-00362-9 -
Human Vaccines & Immunotherapeutics Mar 2021Meningococcal serogroups A and C cause significant numbers of cases in China. The Sanofi Pasteur meningococcal polysaccharide A + C vaccine (Men-AC) was licensed in... (Randomized Controlled Trial)
Randomized Controlled Trial
Safety and immunogenicity of meningococcal (Groups A and C) polysaccharide vaccine in children 2 to 6 y of age in China: a randomized, active-controlled, non-inferiority study.
Meningococcal serogroups A and C cause significant numbers of cases in China. The Sanofi Pasteur meningococcal polysaccharide A + C vaccine (Men-AC) was licensed in China in 1995. Immunogenicity and safety of a single dose of Men-AC against a similar marketed vaccine, the Lanzhou Institute serogroups A and C vaccine (Lanzhou-AC), were evaluated in children 2 to 6 y of age. Antibody titers were determined before and on Day 30 after vaccination using a serum bactericidal assay using baby rabbit complement (SBA-BR). Immunogenicity endpoints included rates of seroconversion (postvaccination antibody titers ≥4-fold higher) and seroprotection (postvaccination titers ≥1:8). Unsolicited systemic adverse events (AEs) within 30 minutes after vaccination, solicited injection site and systemic reactions between Days 0 and 7, unsolicited non-serious AEs within 30 d, and serious adverse events (SAEs) throughout were recorded. Seroconversion rates against serogroups A and C were 97.0% (95% confidence interval [CI], 94.5-98.6) and 94.7% (95% CI, 91.6-97.0), respectively, in the Men-AC group and 97.7% (95% CI, 95.4-99.1) and 94.8% (95% CI, 91.7-97.0), respectively, in the Lanzhou-AC group, while seroprotection rates were 98.0% (95% CI, 95.8-99.3) and 97.0% (95% CI, 94.5-98.6), respectively, in the Men-AC group and 99.0% (95% CI, 97.2-99.8) and 96.8% (95% CI, 94.1-98.4), respectively, in the Lanzhou-AC group. Non-inferiority of Men-AC with regard to immunogenicity was demonstrated since the lower bounds of the 95% CIs of the differences in rates between the two groups were > -5% for both serogroups. Both vaccines were well tolerated.
Topics: Animals; Rabbits; Antibodies, Bacterial; China; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccines, Conjugate; Humans; Child, Preschool; Child; Equivalence Trials as Topic
PubMed: 33270487
DOI: 10.1080/21645515.2020.1801077 -
The Journal of Pediatric Pharmacology... 2022Meningococcal disease, caused by , is associated with severe illness and death. The Centers for Disease Control and Prevention Advisory Committee on Immunization...
OBJECTIVE
Meningococcal disease, caused by , is associated with severe illness and death. The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices have published recommendations for the use of meningococcal vaccines in the United States. The primary objective of this study is to compare meningococcal serogroup B vaccination rates among adolescents at 4 diverse outpatient clinics.
METHODS
In this retrospective chart review, patients between the ages of 16 and 23 years were identified by using automated dispensing cabinet records of meningococcal serogroup ACWY vaccine removal. Immunization records were reviewed to determine if meningococcal serogroup B vaccine had been administered. Patients from 2 pediatric clinics and 2 family medicine clinics were included in our analysis.
RESULTS
Two hundred sixty-five patients were identified for review and 134 patients were included in our study. Of these, 43 (32%) had received the full meningococcal serogroup B vaccine series and 32 (24%) had completed the vaccine series for both meningococcal serogroup B and meningococcal serogroup ACWY series. Most patients who had completed a meningococcal serogroup B vaccine series presented to a pediatric clinic.
CONCLUSIONS
Less than half of adolescent patients completed their meningococcal B vaccine series at 4 diverse outpatient clinics, with a greater number of patients receiving vaccinations at pediatric clinics than family medicine clinics. Our findings highlight a need for increased education to providers regarding the current meningococcal B vaccination recommendations.
PubMed: 36415765
DOI: 10.5863/1551-6776-27.8.703 -
BMC Infectious Diseases May 2022This study aimed to identify differences and similarities among adolescents and parents in various psychosocial factors influencing meningococcal ACWY (MenACWY)...
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 χ 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.
Topics: Adolescent; COVID-19; Cross-Sectional Studies; Humans; Meningococcal Vaccines; Neisseria meningitidis; Pandemics; Parents; Vaccination; Vaccines, Conjugate
PubMed: 35641926
DOI: 10.1186/s12879-022-07473-5 -
Expert Review of Vaccines 2023Serogroups A, B, C, W, X, and Y of Neisseria meningitidis are responsible for almost all cases of invasive meningococcal disease. In Italy, vaccination against serogroup... (Review)
Review
INTRODUCTION
Serogroups A, B, C, W, X, and Y of Neisseria meningitidis are responsible for almost all cases of invasive meningococcal disease. In Italy, vaccination against serogroup B is recommended at 3-13 months, C at 13-15 months, and A, C, Y and W in adolescents (12-18 years). Four quadrivalent meningococcal conjugate vaccines are available. This review describes the available data on a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT; MenQuadfi®; Sanofi).
AREAS COVERED
We identified articles on quadrivalent meningococcal conjugate vaccines indexed on PubMed since 2000. Of the 524 studies identified, 10 human studies investigating the immunogenicity and safety of MenACYW-TT in toddlers, children aged 2-9 years, and individuals 10-55 or ≥56 years are described in detail.
EXPERT OPINION
In Italy, pediatric and public health groups recommend amending the current vaccination schedule to include a booster dose between 6 and 9 years and quadrivalent vaccine in young adults (≥19 years), targeting waning protection after childhood vaccination and the age cohort with the highest carrier prevalence (adolescents and young adults). MenACYW-TT is a suitable meningococcal vaccine for current and pending recommendations based on high seroprotection rates and a low incidence of adverse events in these age groups. Moreover, it does not require reconstitution.
Topics: Adolescent; Young Adult; Humans; Child; Vaccines, Conjugate; Meningococcal Vaccines; Tetanus Toxoid; Expert Testimony; Neisseria meningitidis; Meningococcal Infections; Antibodies, Bacterial
PubMed: 37144288
DOI: 10.1080/14760584.2023.2211162 -
FEBS Letters Aug 2020Factor H binding protein (fHbp) is a key virulence factor of Neisseria meningitidis and a main component of the two licensed vaccines against serogroup B meningococcus... (Review)
Review
Factor H binding protein (fHbp) is a key virulence factor of Neisseria meningitidis and a main component of the two licensed vaccines against serogroup B meningococcus (Bexsero and Trumenba). fHbp is a surface-exposed lipoprotein that enables the bacterium to survive in human blood by binding the human complement regulator factor H (fH). When used as vaccine, the protein induces antibodies with potent bactericidal activity. While the fHbp gene is present in the majority of N. meningitidis serogroup B isolates, the expression level varies up to 15 times between different strains and more than 700 different sequence variants have been described. Antigenically, the protein has been divided into three variants or two subfamilies. The 3D structure of fHbp alone, in combination with fH or in complex with bactericidal antibodies, has been key to understanding the molecular details of the protein. In this article, we will review the biochemical and immunological properties of fHbp, and its key role in meningococcal pathogenesis, complement regulation, and immune evasion.
Topics: Animals; Antigens, Bacterial; Bacterial Proteins; Complement Factor H; Gene Expression Regulation, Bacterial; Humans; Immune Evasion; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Protein Domains
PubMed: 32298465
DOI: 10.1002/1873-3468.13793 -
The American Journal of Managed Care Nov 2019To identify the most important reasons underlying decisions to stock or not stock adult vaccines.
OBJECTIVES
To identify the most important reasons underlying decisions to stock or not stock adult vaccines.
STUDY DESIGN
US physicians, nurses, pharmacists, and administrators of internal medicine, family medicine, obstetrics/gynecology, and multispecialty practices who were involved in vaccine stocking decisions (N = 125) completed a best-worst scaling survey online between February and April 2018.
METHODS
Sixteen potential factors influencing stocking decisions were developed based on key informant interviews and focus groups. Respondents selected factors that were most and least important in vaccine stocking decisions. Relative importance scores for the best-worst scaling factors were calculated. Survey respondents described which vaccines their practice stocks and reasons for not stocking specific vaccines. Subgroup analyses were performed based on the respondent's involvement in vaccine decision making, role in the organization, specialty, and affiliation status, as well as practice characteristics such as practice size, insurance mix, and patient age mix.
RESULTS
Relative importance scores for stocking vaccines were highest for "cost of purchasing vaccine stock," "expense of maintaining vaccine inventory," and "lack of adequate reimbursement for vaccine acquisition and administration." Most respondents (97%) stocked influenza vaccines, but stocking rates of other vaccines varied from 39% (meningococcal B) to 83% (tetanus-diphtheria-pertussis). Best-worst scaling results were consistent across respondent subgroups, although the range of vaccine types stocked differed by practice type.
CONCLUSIONS
Economic factors associated with the purchase and maintenance of vaccine inventory and inadequate reimbursement for vaccination services were the most important to decision makers when considering whether to stock or not stock vaccines for adults.
Topics: Adult; Attitude of Health Personnel; Decision Making; Drug Storage; Female; Focus Groups; Humans; Male; Surveys and Questionnaires; United States; Vaccines
PubMed: 31747238
DOI: No ID Found -
BMJ Global Health May 2021Previous studies identified factors influencing regulatory approval to introduction timelines for individual vaccines. However, introduction and uptake timelines have...
BACKGROUND
Previous studies identified factors influencing regulatory approval to introduction timelines for individual vaccines. However, introduction and uptake timelines have not been comprehensively assessed across the portfolio of Gavi-supported vaccines.
METHODS
We analysed median times between introduction milestones from vaccine licensure to country introduction and uptake across six vaccine-preventable diseases (VPDs), three delivery platforms and 69 Gavi-supported countries. Data were gathered from public, partner and manufacturer records. VPDs and prequalified vaccines analysed included type b (DTwP-HepB-Hib, pentavalent), pneumococcal disease (pneumococcal conjugate vaccine, PCV), rotavirus diarrhoea (rotavirus vaccine, RVV), cervical cancer (human papillomavirus vaccine, HPV), polio (inactivated polio vaccine, IPV) and meningococcal meningitis (meningococcal group A conjugate vaccine, MenA).
RESULTS
Median time from first vaccine licensure to first Gavi-supported country introduction across VPDs at a 'global level' (Gavi-supported countries) was 5.4 years. Once licensed, MenA vaccines reached first introduction fastest (campaign=0.6 years; routine immunisation (RI)=1.7 years). Most introductions were delayed. Country uptake following first introduction was accelerated for more recently Gavi-supported RI vaccines compared with older ones.
CONCLUSION
Factors accelerating timelines across delivery platforms included rapid product prequalifications by WHO, strong initial recommendations by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, achieving target product profiles on first vaccine licensure within a VPD and completing several VPD milestones at a global level prior to licensure. Milestones required for introduction in Gavi-supported countries should start prior or in parallel to licensure to accelerate uptake of vaccines delivered through diverse delivery platforms.
Topics: Humans; Rotavirus Vaccines; Vaccination
PubMed: 34045183
DOI: 10.1136/bmjgh-2021-005032