Meningococcal C conjugate vaccine suspension for injection 0.5ml pre-filled syringes

Co-administration of multiple vaccines during a single clinical visit is common in pediatric immunization programs, but administering three or more injections simultaneously has raised safety concerns. This systematic review, conducted in 2023, assessed the safety of administering three or more vaccines at the same time compared with giving fewer or the same vaccines across separate sessions. Data from 26 studies were analyzed using random-effects meta-analyses. The risk of any adverse event (AE) was modestly increased (OR ≈ 1.54), mainly due to expected and transient reactions such as fever, irritability and injection-site pain. Importantly, there was no significant increase in serious adverse events (SAEs) (OR 1.07, 95% CI 0.92-1.25). Differences in systemic (OR 1.19, 95% CI 0.95-1.50) or local AEs (OR 1.37, 95% CI 0.85-2.22) were not statistically significant. These findings support the continued co-administration of multiple vaccines in pediatric programs, providing a nuanced safety profile for policymakers and clinicians.

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Invasive meningococcal disease (IMD) is an uncommon and often fatal disease. Although IMD vaccines are widely available in high-income countries, vaccination access and receipt vary. To identify factors associated with IMD prevention inequalities across high-income countries and Latin America, a systematic literature review (SLR) of four databases (Embase, MEDLINE/MEDLINE In-Process, The Cochrane Library, EconLit; 2012-2023), and recent congress proceedings was conducted. In total, 68 studies reported inequalities in IMD prevention and were included in the analysis, across North America, Latin America, Europe, and the Western Pacific. Despite increased vaccination opportunities, inequalities in IMD prevention remain, associated with demographic and socioeconomic characteristics such as age, sex, income, and quality healthcare access. Poor IMD vaccination rates were associated with low IMD knowledge/awareness, negative attitudes toward vaccination, and low educational attainment. This SLR identified knowledge gaps regarding IMD prevention, highlighted underserved populations, and may inform policy changes to improve IMD-related health equity.

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IntroductionClinical trials are evaluating the efficacy of serogroup B meningococcal (MenB) outer membrane vesicle (OMV) vaccines in preventing gonorrhoea. We assessed the global epidemiology of gonorrhoea and MenB invasive meningococcal disease (IMD) and reviewed national MenB-OMV vaccination policies to inform potential use of these vaccines.MethodsWe included country-specific epidemiologic data from 2015 through October 2025. Gonorrhoea prevalence data for general populations of women were extracted from published systematic reviews and case reports taken from well-established reporting systems. Country-specific MenB IMD incidence rates were drawn from published reviews and surveillance reports. National MenB-OMV immunization policies were obtained from published reviews and databases from the World Health Organization and vaccine manufacturers.ResultsForty-two countries had ≥1 gonorrhoea prevalence study. Mean prevalence was DiscussionEpidemiologic data were lacking in many countries; only a handful had a substantial burden of both gonorrhoea and MenB IMD. Low- and middle-income countries with high gonorrhoea prevalence typically reported no MenB IMD or lacked data, whereas high-income countries with higher MenB IMD incidence and MenB-OMV vaccine use had low gonorrhoea prevalence but high rates in subpopulations like MSM.ConclusionsIf trials confirm MenB-OMV vaccine cross-protection against gonorrhoea, global epidemiology can help identify settings and populations for potential vaccine use against gonococcal infection alone, or for both conditions. Improved data collection and cost-effectiveness analyses across both conditions can further inform decision-making.

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Invasive meningococcal disease (IMD) is a significant but under-recognized public health challenge in India, marked by rapid progression, high mortality, and severe sequelae. This consensus document, developed from literature review, outbreak analyses, and deliberations by 14 Indian experts, highlights outbreaks from 1966 (Delhi: 616 cases, case fatality ration: CFR 20.9%) to 2022-2023 (Kolkata). Serogroup A remains predominant, with emerging serogroups C, W, and Y. Systematic review evidence shows 12.1% prevalence in epidemics (CFR 12.8%) and 0.76% in endemic settings (CFR 3.0%), though true burden is underestimated due to weak surveillance. IMD shows bimodal age distribution, highest in children < 5 y (61.8%) and adolescents. MenACWY conjugate vaccines show 95.7-99.5% seroprotection across serogroups. Experts recommend vaccination at 9-12 months with booster at 10-11 y, mandatory reporting, sentinel surveillance, and clinician awareness. The roadmap stresses awareness, short-term surveillance, and long-term data generation toward National Immunization Program inclusion.

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4CMenB vaccine is authorized for protection against serogroup B invasive meningococcal disease (IMD). This study synthesized real-world evidence (RWE) data on effectiveness and impact of 4CMenB vaccine. A systematic search identified RWE on vaccine effectiveness (VE) and vaccine impact of 4CMenB in infants, children and adolescents. A meta-analysis was conducted of 4CMenB VE against serogroup B-IMD in infants and children. The primary meta-analysis used a random-effects model on data from five studies from five countries reporting VE in fully vaccinated infants and children, and estimated pooled VE at 79.7% (95% confidence interval 70.4, 86.1). In sensitivity analyzes, inclusion/exclusion of studies from the primary analysis did not materially change the results. Age-specific data in adolescents were summarized qualitatively. Data identified from Australia reported high effectiveness and impact in adolescents. This meta-analysis provides evidence of high 4CMenB VE against serogroup B-IMD in fully vaccinated infants and children across different geographic regions. Clinical trial registration: N/A.

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IntroductionGonorrhoea is a major global sexually transmitted infection, with rising incidence and increasing antimicrobial resistance threatening current control strategies. If untreated, Neisseria gonorrhoeae can lead to severe reproductive health sequelae. Gonorrhoea is also linked to increased HIV acquisition and transmission. There is currently no vaccine licensed to prevent gonorrhoea. However, observational evidence suggests that outer membrane vesicle-based serogroup B meningococcal vaccines, including the four-component meningococcal B (4CMenB) vaccine, confer partial cross-protection against gonorrhoea. We discuss observational studies and randomized controlled trials (RCTs) focused on defining the efficacy of 4CMenB against gonorrhoea.DiscussionObservational studies from multiple settings have reported an association between receipt of 4CMenB vaccine and reduced gonorrhoea risk, with a meta-analysis estimating a 38% reduction in risk. Neisseria meningitidis and N. gonorrhoeae are closely related bacteria that share numerous antigens, making cross-protection biologically plausible. Based on observational data, 4CMenB immunization programmes have been implemented in two countries with the aim of preventing gonorrhoea. However, three RCTs have recently shown that 4CMenB is not effective in preventing gonorrhoea in gay, bisexual and other men at high risk of acquisition. Several RCTs are ongoing, looking at efficacy in different populations, including women and people at lower risk of acquisition. The different outcomes between the observational studies and RCTs may be due to a range of known and unknown confounding factors, and differences in the populations considered in the different studies.ConclusionsCurrent evidence from RCTs does not support the use of 4CMenB to prevent gonorrhoea in gay and bisexual men at high risk of acquisition. Results from ongoing RCTs will be critical to determine whether vaccine efficacy varies by population or epidemiological context and to inform future gonorrhoea vaccine policy and development.

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