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Invasive meningococcal disease is a life-threatening infection preventable through vaccination. Pediatric vaccination rates have declined during the coronavirus disease 2019 (COVID-19) pandemic. This survey aimed to understand how parents' attitudes and behaviors have changed during the pandemic with regard to immunization and, more specifically, meningococcal vaccination. An online survey was emailed to parents of eligible children 0-4 years, following the selection process from UK, France, Germany, Italy, Brazil, Argentina, and Australia; and of adolescents 11-18 years from US. Data collection took place 19 January-16 February 2021. Quotas were set to ensure a representative sample. Eleven questions relating to general perceptions around vaccination and attitudes and behaviors toward meningitis vaccination were displayed. On 4,962 parents (average 35 years) participating in the survey, most (83%) believed important for their child to continue receiving recommended vaccines during the COVID-19 pandemic. Nearly half of routine vaccine appointments were delayed or canceled due to the pandemic, and 61% of respondents were likely to have their children catch up once COVID-19 restrictions were lifted. 30% of meningitidis vaccination appointments were canceled or delayed during the pandemic, and 21% of parents did not intend to reschedule them because of lockdown/stay at home regulations, and fear of catching COVID-19 in public places. It is crucial to communicate clear instructions to health workers and the general population and to provide appropriate safety precautions in vaccination centers. This will help to maintain vaccination rates and limit infections to prevent future outbreaks.

The global invasive meningococcal disease (IMD) landscape changed considerably during the COVID-19 pandemic, as evidenced by decreased incidence rates due to COVID-19 mitigation measures, such as limited social contact, physical distancing, mask wearing, and hand washing. Vaccination rates were also lower during the pandemic relative to pre-pandemic levels. Although policymakers may have shifted their focus away from IMD vaccination programs to COVID-19 vaccination programs, strong arguments support implementation and prioritization of IMD vaccination programs; IMD cases have increased in some countries and IMD rates may even have exceeded pre-pandemic levels. Additional concerns include increased susceptibility due to vaccination coverage gaps, increased incidence of other respiratory pathogens, immunity debt from lockdown restrictions, and increased IMD epidemiologic variability. The full range of benefits of widely available and effective meningococcal vaccines needs to be considered, especially in health technology assessments, where the broad benefits of these vaccines are neither accurately quantified nor captured in implementation policy decisions. Importantly, implementation of meningococcal vaccination programs in the current IMD climate also appeals to broader healthcare principles, including preparedness rather than reactive approaches, generally accepted benefit-risk approaches to vaccination, historical precedent, and the World Health Organization's goal of defeating meningitis by 2030. Countries should therefore act swiftly to bolster existing meningococcal vaccination strategies to provide broad coverage across age groups and serogroups given the recent increases in IMD incidence., (© 2023. The Author(s).)

The four-component meningococcal serogroup B vaccine (4CMenB) is indicated for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B. Co-administering 4CMenB with other vaccines may improve vaccine uptake provided that the safety and immunogenicity of either are not affected. Published literature on the immunogenicity and reactogenicity of 4CMenB co-administered with other routine childhood and adulthood vaccines was reviewed. From 282 publications identified, data were collated from 10 clinical studies, 3 real-world studies, and 3 reviews. The evidence showed that 4CMenB co-administration is not associated with significant safety concerns or clinically relevant immunological interferences. The increased reactogenicity (e.g., fever) associated with 4CMenB co-administration can be adequately managed with prophylactic paracetamol in children. Thus, 4CMenB co-administration has the potential to maximize vaccine coverage and improve protection against IMD globally.

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.

Introduction: The high burden of respiratory syncytial virus (RSV) infection in young children disproportionately occurs in low- and middle-income countries (LMICs). The PROUD (Preventing RespiratOry syncytial virUs in unDerdeveloped countries) Taskforce of 24 RSV worldwide experts assessed key needs for RSV prevention in LMICs, including vaccine and newer preventive measures., Methods: A global, survey-based study was undertaken in 2021. An online questionnaire was developed following three meetings of the Taskforce panellists wherein factors related to RSV infection, its prevention and management were identified using iterative questioning. Each factor was scored, by non-panellists interested in RSV, on a scale of zero (very-low-relevance) to 100 (very-high-relevance) within two scenarios: (1) Current and (2) Future expectations for RSV management., Results: Ninety questionnaires were completed: 70 by respondents (71.4% physicians; 27.1% researchers/scientists) from 16 LMICs and 20 from nine high-income (HI) countries (90.0% physicians; 5.0% researchers/scientists), as a reference group. Within LMICs, RSV awareness was perceived to be low, and management was not prioritised. Of the 100 factors scored, those related to improved diagnosis particularly access to affordable point-of-care diagnostics, disease burden data generation, clinical and general education, prompt access to new interventions, and engagement with policymakers/payers were identified of paramount importance. There was a strong need for clinical education and local data generation in the lowest economies, whereas upper-middle income countries were more closely aligned with HI countries in terms of current RSV service provision., Conclusion: Seven key actions for improving RSV prevention and management in LMICs are proposed., Competing Interests: The reviewer PAP declared a past co-authorship with the author(s) FMT to the handling. XCE and BP have received research funding and/or compensation as advisor/lecturer from AbbVie and AstraZeneca. JF and BRG, working for Violicom and former company, have previously received payment from AbbVie and AstraZeneca for work on various projects. MCN reports grants from the Bill & Melinda Gates Foundation, European & Developing Countries Clinical Trials Partnership, Pfizer, AstraZeneca and Sanofi-Pasteur; and personal fees from Pfizer and Sanofi-Pasteur. RTS has received fees for Advisory Board meetings and lectures for Sanofi-Pasteur, AstraZeneca, Janssen, and AbbVie. QB serves in the Independent Data Monitoring Committee (IDMC) for Respiratory Syncytial Virus (RSV) vaccine development for the protection of infants (since October 2015) (GlaxoSmithKline -GSK). JP reports grants to his institution from MedImmune, Merck, Sanofi Pasteur and AbbVie, and personal fees from AbbVie, Merck and AstraZeneca. JMP reports grants to his institution from MedImmune. HJZ has received funding for RSV-related research studies from Pfizer, AstraZeneca, Merck and the Bill & Melinda Gates Foundation. AM has received research funding from Merck and Janssen and compensation as advisor/lecturer from Sanofi-Pasteur and AstraZeneca. IM has been an investigator on studies funded by MedImmune, Regeneron, and Boehringer. MAS has received research funding from Janssen and compensation as advisor/lecturer from AbbVie, Sanofi-Pasteur and AstraZeneca. All declarations made by authors outside of the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2022 Carbonell-Estrany, Simões, Bont, Gentile, Homaira, Scotta, Stein, Torres, Sheikh, Broor, Khuri-Bulos, Nokes, Munywoki, Bassat, Sharma, Basnet, Garba, De Jesus-Cornejo, Lupisan, Nunes, Divarathna, Fullarton, Rodgers-Gray, Keary, Reñosa, Verwey, Moore, Noordeen, Kabra, do Vale, Paternina-De La Ossa, Mariño, Figueras-Aloy, Krilov, Berezin, Zar, Paudel, Safadi, Dbaibo, Jroundi, Jha, Rafeek, Pinheiro, Bracht, Muthugala, Lanari, Martinón-Torres, Mitchell, Irimu, Pandey, Krishnan, Mejias, Santos Corrêa Da Costa, Shrestha, Pernica, Cotrim de Carvalho, Jalango, Ibrahim, Ewa, Ensinck, Ulloa-Gutierrez, Miralha, Lucion, Hassan, Akhtar, Aleem, Chowdhury, Rojo, Sande, Musau, Zaman, Arlant, Ghimire, Price, Subedi, Brenes-Chacon, Goswami, Rahman, Hossain, Chisti, Vain, Lim, Chiu, Papenburg, Juarez, Senaratne, Arunasalam, Strand, Ayuk, Ogunrinde, Tavares, Garba, Garba, Dawa, Gordon, Osoro, Agoti, Nyawanda, Ngama, Tabu, Mathew, Cornacchia, Rai, Jain, Giongo and Paes.)

Background: More than 325,000 cases of coronavirus disease 2019 (COVID-19) have been reported among pregnant women in the Americas., Aims: This review examines the impact of COVID-19 in pregnant women and describes available evidence on the safety, effectiveness, and immune response(s) to vaccination among pregnant and lactating women., Content: Multiple studies indicate that pregnant women are more susceptible to adverse COVID-19 outcomes, including hospitalization, intensive care unit admission, and invasive ventilation than non-pregnant women with COVID-19. Furthermore, COVID-19 in pregnancy is associated with adverse maternal and neonatal outcomes. Adverse COVID-19 outcomes appear to disproportionately affect pregnant women from low- and middle-income countries, likely reflecting inequities in access to quality healthcare. Despite the absence of safety and efficacy data from randomized clinical trials in this subpopulation, observational studies and data from pregnancy registries thus far have demonstrated that vaccination of pregnant or lactating women against COVID-19 is safe, effective, and results in robust immune responses including transfer of antibodies to the newborn via the placenta and breast milk, respectively., Implications: These data support vaccination recommendations intending to help protect these vulnerable individuals against COVID-19 and its sequelae. Randomized clinical studies will further evaluate the safety and immunogenicity of COVID-19 vaccines in these populations. This review examines the impact of COVID-19 in pregnant women and describes available evidence on the safety, effectiveness, and immune response(s) to vaccination among pregnant and lactating women., (© 2022 Pfizer Inc. American Journal of Reproductive Immunology published by John Wiley & Sons Ltd.)

Introduction: Social deprivation is associated with poorer healthcare access. Vaccination is among the most effective public health interventions and achieving equity in vaccination access is vitally important. However, vaccines are often reimbursed by public funds only when recommended in national immunization programs (NIPs), which can increase inequity between high and low socioeconomic groups. Invasive meningococcal disease (IMD) is a serious vaccination-preventable disease. This review focuses on vaccination strategies against IMD designed to reduce inequity., Areas Covered: We reviewed meningococcal epidemiology and current vaccination recommendations worldwide. We also reviewed studies demonstrating an association between social deprivation and risk of meningococcal disease, as well as studies demonstrating an impact of social deprivation on uptake of meningococcal vaccines. We discuss factors influencing inclusion of meningococcal vaccines in NIPs., Expert Opinion: Incorporating meningococcal vaccines in NIPs is necessary to reduce inequity, but insufficient alone. Inclusion provides clear guidance to healthcare professionals and helps to ensure that vaccines are offered universally to all target groups. Beyond NIPs, cost of vaccination should be reimbursed especially for disadvantaged individuals. These approaches should help to achieve optimal protection against IMD, by increasing access and immunization rates, eventually reducing social inequities, and helping to protect those at greatest risk.

Outbreaks of invasive meningococcal disease (IMD) are unpredictable, can be sudden and have devastating consequences. We conducted a non-systematic review of the literature in PubMed (1997-2020) to assess outbreak response strategies and the impact of vaccine interventions. Since 1997, IMD outbreaks due to serogroups A, B, C, W, Y and X have occurred globally. Reactive emergency mass vaccination campaigns have encompassed single institutions (schools, universities) through to whole sections of the population at regional/national levels (e.g. serogroup B outbreaks in Saguenay-Lac-Saint-Jean region, Canada and New Zealand). Emergency vaccination responses to IMD outbreaks consistently incurred substantial costs (expenditure on vaccine supplies, personnel costs and interruption of other programmes). Impediments included the limited pace of transmission of information to parents/communities/healthcare workers; issues around collection of informed consents; poor vaccine uptake by older adolescents/young adults, often a target age group; issues of reimbursement, particularly in the USA; and difficulties in swift supply of large quantities of vaccines. For serogroup B outbreaks, the need for two doses was a significant issue that contributed substantially to costs, delayed onset of protection and non-compliance with dose 2. Real-world descriptions of outbreak control strategies and the associated challenges systematically show that reactive outbreak management is administratively, logistically and financially costly, and that its impact can be difficult to measure. In view of the unpredictability, fast pace and potential lethality of outbreak-associated IMD, prevention through routine vaccination appears the most effective mitigation tool. Highly effective vaccines covering five of six disease-causing serogroups are available. Preparedness through routine vaccination programmes will enhance the speed and effectiveness of outbreak responses, should they be needed (ready access to vaccines and need for a single booster dose rather than a primary series)., (© 2021. The Author(s).)

In this study, we report the occurrence of multisystemic inflammatory syndrome among 64 children (2 deaths) with recent severe acute respiratory syndrome-related coronavirus 2 (SARS-COV-2) infections in the northeast region of Brazil. The major clinical symptoms and signs reported were exanthema (60.9%), abdominal pain (56.3%), nausea and vomiting (46.9%), diarrhea (37.5%), and dyspnea (37.5%). Laboratory findings revealed that the levels of C-reactive protein (75.0%), hemoglobin (51.6%), D-dimer (48.4%), lymphocytes (43.8%), LDH (45.3%), AST (42.2%), ALT (51.6%), and ferritin (48.4%) were above the reference values for a given age and gender. The clinical findings were similar to those observed in Kawasaki disease, although it represents a separate entity, emphasizing the need for proactive surveillance and early treatment.

Objective: To characterize the clinical-epidemiological profile of multisystem inflammatory syndrome in children temporally associated with COVID-19 (MIS-C), and to identify factors associated with MIS-C deaths in Brazil, 2020., Methods: This was a cross-sectional study, using national MIS-C monitoring data. Logistical regression was performed to estimate crude and adjusted odds ratios (OR)., Results: Median case (n=652) age was 5 years, 57.1% were male, 52.0% were of brown race/skin color and 6.4% died. Likelihood of death was greater among those who presented O2 saturation <95% (ORa=4.35 - 95%CI 1.69;11.20) and altered urea results (ORa=5.18 - 95%CI 1.91;14.04); likelihood of death was lower when red skin blotches were not present (ORa=0.23 - 95%CI 0.09;0.62), when anticoagulants were used (ORa=0.32 - 95%CI 0.12;0.89) and when immunoglobulins were used (ORa=0.38 - 95%CI 0.15;1.01)., Conclusion: Fatality ratios were higher among cases that presented O2 saturation <95% and altered urea results. Fatality ratios were lower among those with red skin blotches, and those who used immunoglobulins and anticoagulants.

Routine childhood vaccinations are key for the protection of children from a variety of serious and potentially fatal diseases. Current pediatric vaccine schedules mainly cover active vaccines. Active vaccination in infants is a highly effective approach against several infectious diseases; however, thus far, for some important viral pathogens, including respiratory syncytial virus (RSV), vaccine development and license by healthcare authorities have not been accomplished. Nirsevimab is a human-derived, highly potent monoclonal antibody (mAb) with an extended half-life for RSV prophylaxis in all infants. In this manuscript, we consider the potential implications for the introduction of an anti-viral mAb, such as nirsevimab, into the routine pediatric vaccine schedule, as well as considerations for coadministration. Specifically, we present evidence on the general mechanism of action of anti-viral mAbs and experience with palivizumab, the only approved mAb for the prevention of RSV infection in preterm infants, infants with chronic lung disease of prematurity and certain infants with hemodynamically significant heart disease. Palivizumab has been used for over two decades in infants who also receive routine vaccinations without any alerts concerning the safety and efficacy of coadministration. Immunization guidelines (Advisory Committee on Immunization Practices, Joint Committee on Vaccination and Immunization, National Advisory Committee on Immunization, Centers for Disease Control and Prevention, American Academy of Pediatrics, The Association of the Scientific Medical Societies in Germany) support coadministration of palivizumab with routine pediatric vaccines, noting that immunobiologics, such as palivizumab, do not interfere with the immune response to licensed live or inactivated active vaccines. Based on the mechanism of action of the new generation of anti-viral mAbs, such as nirsevimab, which is highly specific targeting viral antigenic sites, it is unlikely that it could interfere with the immune response to other vaccines. Taken together, we anticipate that nirsevimab could be concomitantly administered to infants with routine pediatric vaccines during the same clinic visit., Competing Interests: SE: Research support from GSK, Sanofi, and Vifor. Speaker’s fees from GSK, Janssen, Pfizer, Novartis, Sanofi Pasteur, and MSD in the past 3 years. BA is supported by the Canadian Health and Research Institute Vanier Canada scholarship. PB received grants for epidemiological and HTA research projects from GlaxoSmithKline, MSD, Sanofi Pasteur, Pfizer, Seqirus and Astra Zeneca, and fees for taking part in advisory boards on different vaccines from the same companies plus Janssen. FM has received honoraria from GSK, Pfizer, Sanofi Pasteur, MSD, Seqirus, and Janssen for taking part in advisory boards and expert meetings, and for acting as speaker in congresses outside the scope of the submitted work. FM has also acted as principal investigator in RCTs of the above-mentioned companies as well as Ablynx, Regeneron, Roche, Abbot, Novavax, and Medimmune, with honoraria paid to his institution. FM research activities received support from the Instituto de Salud Carlos III (Proyecto de Investigación en Salud, Acción Estratégica en Salud): project ReSVinext ISCIII/PI16/01569/Cofinanciado FEDER and project Enterogen (ISCIII/PI19/01090). KF is a member of the Australian Technical Advisory Group on Immunisation (ATAGI) but the views in this manuscript are her own and not necessarily those of ATAGI. KF has received honoraria as a member of the vaccine advisory boards for Seqiris and Sanofi Pasteur in the last 5 years. AM has received research grants from NIH, Janssen and Merck AND fees for participation in advisory boards from Janssen, Sanofi-Pasteur, Merck and Roche. MS reports research grants and personal fees for advisory boards from GSK, Pfizer, Sanofi-Pasteur, Janssen and Seqirus. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Esposito, Abu-Raya, Bonanni, Cahn-Sellem, Flanagan, Martinon Torres, Mejias, Nadel, Safadi and Simon.)

Therapeutic hypothermia (TH) using servo-controlled cooling devices has proved to be a safe and effective method to reduce mortality and sequelae in neonates with hypoxic-ischemic encephalopathy (HIE). However, such cooling devices can be expensive and have limited availability in low- and middle-income countries. To evaluate the feasibility and effectiveness of low-cost cooling devices (ice packs) to reach and maintain the target temperature in newborns with moderate or severe HIE. Descriptive retrospective cross-sectional study, including newborns with gestational age ≥35 weeks, weight ≥1800 g, with diagnosis of moderate or severe HIE, submitted to whole body hypothermia using ice packs for 72 hr. Data was obtained from medical records and databases. The thermal curves of each patient, time spent at the target temperature and rewarming time were evaluated. Complications directly related to therapeutic hypothermia, evolution, and early outcomes before hospital discharge were analyzed. Seventy-one newborns met the criteria for TH, and 61 completed the entire cooling period and were included in the final analysis. The average time to reach the target temperature was 1.50 ± 1.3 hr. The mean temperature during the cooling period was 33.5°C (±0.62). 82.32% of the measurements were within the target temperature range (from 33 to 34°C). The following adverse events were observed during TH: pulmonary hypertension 11.3%, arrhythmia 4.2%, and coagulopathy 26.7%. Whole body hypothermia using low-cost devices proved to be an effective method in the absence of availability of servo-controlled devices, representing a plausible option in restricted resource settings., (© 2021 American Association for Anatomy.)

Introduction: Vaccination is an effective strategy to combat invasive meningococcal disease (IMD). Vaccines against the major disease-causing meningococcal serogroups are available; however, development of vaccines against serogroup B faced particular challenges, including the inability to target traditional meningococcal antigens (i.e. polysaccharide capsule) and limited alternative antigens due to serogroup B strain diversity. Two different recombinant, protein-based, serogroup B (MenB) vaccines that may address these challenges are currently available. These vaccines have been extensively evaluated in pre-licensure safety and immunogenicity trials, and recently in real-world studies on effectiveness, safety, and impact on disease burden., Areas Covered: This review provides healthcare professionals, particularly pediatricians, an overview of currently available MenB vaccines, including development strategies and evaluation of coverage., Expert Opinion: Overall, recombinant MenB vaccines are valuable tools for healthcare professionals to protect patients against IMD. Their development required innovative design approaches that overcame challenging hurdles and identified novel protein antigen targets; however, important distinctions in the approaches used in their development, evaluation, and administration exist and many unanswered questions remain. Healthcare providers frequently prescribing MenB vaccines are challenged to keep abreast of these differences to ensure patient protection against this serious disease.

Severe acute respiratory syndrome coronavirus 2 related disease (COVID-19) is now responsible for one of the most challenging and concerning pandemics. By August 2020, there were almost 20 million confirmed cases worldwide and well over half-million deaths. Since there is still no effective treatment or vaccine, non-pharmaceutical interventions have been implemented in an attempt to contain the spread of the virus. During times of quarantine, immunization practices in all age groups, especially routine childhood vaccines, have also been interrupted, delayed, re-organized, or completely suspended. Numerous high-income as well as low- and middle-income countries are now experiencing a rapid decline in childhood immunization coverage rates. We will, inevitably, see serious consequences related to suboptimal control of vaccine-preventable diseases (VPDs) in children concurrent with or following the pandemic. Routine pediatric immunizations of individual children at clinics, mass vaccination campaigns, and surveillance for VPDs must continue as much as possible during pandemic.

Introduction: Neisseria meningitidis causes invasive meningococcal disease (IMD), with the highest incidence observed in infants and young children. Meningococcal serogroups A, B, C, W, X, and Y account for almost all IMD cases worldwide. Available meningococcal vaccines targeting serogroups A, C, W, and Y (MenACWY) include those conjugated to diphtheria toxoid (MenACWY-D), diphtheria protein cross-reactive material 197 (MenACWY-CRM 197 ), and tetanus toxoid (MenACWY-TT). MenACWY-TT is indicated for use starting at 6 weeks of age., Areas Covered: This review discusses data from the four primary studies assessing MenACWY-TT safety and immunogenicity in infants, which evaluated a variety of dosing schedules, short-term and long-term outcomes, and impact of coadministration on the immunogenicity of routine childhood vaccines. Remaining gaps in the field are addressed., Expert Opinion: Robust data support the use of MenACWY-TT in infants starting as early as 6 weeks of age. MenACWY-TT was safe and well tolerated in infants, was immunogenic after priming and booster, and demonstrated persistent immunogenicity. Lower persistence for serogroup A relative to other serogroups based on serum bactericidal assays (SBAs) using human complement appears to be a class effect of MenACWY conjugate vaccines. Correlates of protection other than SBA are being explored, including immunologic responses associated with different carrier proteins.

Background: No data are currently available on immunogenicity of higher-valent pneumococcal conjugate vaccines when co-administered with a 4-component meningococcal serogroup B vaccine (4CMenB)., Methods: Post-hoc analysis of pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) immunogenicity when co-administered with 4CMenB (2 + 1 schedule) and/or a CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM) in a trial assessing 4CMenB reduced schedules and co-administration with MenC-CRM (NCT01339923). Infants were randomized to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM (Group 2) at 3, 5, and 12 months (M) of age. Both groups received PHiD-CV (3 + 1 schedule) as part of the Brazilian national immunisation programme at 3 M, 5 M, 7 M, and 12 M of age. Antibody responses were assessed pre-vaccination, 1 M post-dose 2, pre-booster, and 1 M post-booster., Results: Anti-pneumococcal antibody responses were in similar ranges in the two study groups., Conclusions: 4CMenB co-administration did not seem to impact antibody responses to PHiD-CV in infants., (Copyright © 2019 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.)

Background: Varicella and herpes zoster (HZ), diseases both caused by the varicella zoster virus (VZV), are vaccine-preventable. However, the hypothesis that childhood varicella vaccination may increase the incidence of HZ hinders varicella universal routine vaccination (URV) implementation in many countries., Methods: This non-systematic and narrative review of the literature considers the burden of varicella and HZ, and the effectiveness of the respective vaccines. We present the factors involved in the interplay between varicella vaccination and HZ incidence, including the roles of exogenous and endogenous boosting. We review HZ incidence model predictions, and compare these with real-world evidence, which has accumulated since varicella URV was introduced., Conclusion: Although more research and longer surveillance are needed, available real-world evidence has not confirmed the model-predicted increase in HZ incidence, associated with childhood varicella URV. Although there is a rising incidence of HZ globally, this trend appears to be predominantly the result of an aging population. Vaccination against varicella in childhood provides significant benefits with respect to the medical, societal and economic burdens of the disease. Therefore, a theoretical concern of an increased burden of HZ with varicella vaccination programs should not prevent children from being protected against the disease., (Copyright © 2018 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved.)

Background: Meningococcal disease (MD) is a major cause of meningitis and sepsis worldwide, with a high case fatality rate and frequent sequelae. Neisseria meningitidis serogroups A, B, C, W, X and Y are responsible for most of these life-threatening infections, and its unpredictable epidemiology can cause outbreaks in communities, with significant health, social and economic impact. Currently, serogroup B is the main cause of MD in Europe and North America and one of the most prevalent serogroups in Latin America. Mass vaccination strategies using polysaccharide vaccines have been deployed since the 1970s and the use of conjugate vaccines has controlled endemic and epidemic disease caused by serogroups A, C, W and Y and more recently serogroup B using geographically-specific outer membrane vesicle based vaccines. Two novel protein-based vaccines are a significant addition to our armamentarium against N. meningitidis as they provide broad coverage against highly diverse strains in serogroup B and other groups. Early safety, effectiveness and impact data of these vaccines are encouraging. These novel serogroup B vaccines should be actively considered for individuals at increased risk of disease and to control serogroup B outbreaks occurring in institutions or specific regions, as they are likely to save lives and prevent severe sequelae. Incorporation into national programs will require thorough country-specific analysis.

Background: This study evaluated the immunogenicity and safety of a licensed meningococcal serogroup B vaccine (4CMenB) administered alone according to reduced schedules in infants or catch-up series in children., Methods: In this open-label, multicentre, phase 3b study (NCT01339923), infants randomised 1:1:1 received 4CMenB: 2+1 doses at 3½-5-11months or 6-8-11months of age, 3+1 doses at ages 2½-3½-5-11months. Children aged 2-10years received 2 catch-up doses administered 2months apart. Immune responses were measured by hSBA assays against 4 strains specific for vaccine components fHbp, NadA, PorA and NHBA. Sufficiency of immune responses was defined in groups with 2+1 doses schedules as a lower limit ≥70% for the 97.5% confidence interval of the percentage of infants with hSBA titres ≥4, 1month post-dose 2 for fHbp, NadA, PorA. Adverse events were collected for 7days post-vaccination; serious adverse events (SAEs) throughout the study., Results: 754 infants and 404 children were enrolled. Post-primary vaccination, 98-100% of infants across all groups developed hSBA titres ≥4 for fHbp, NadA, PorA, and 48-77% for NHBA. Sufficiency of immune responses in infants receiving 2+1 schedules was demonstrated for fHbp, NadA, PorA after 2 doses of 4CMenB, as pre-specified criteria were met. Following receipt of 2 catch-up doses, 95-99% of children developed hSBA titres ≥4 for 4CMenB components. Similar safety profiles were observed across groups. A total of 45 SAEs were reported, 3 of which were related to vaccination., Conclusion: Reduced infant schedules and catch-up series in children were immunogenic and safe, having the potential to widen 4CMenB vaccine coverage., Funding: GlaxoSmithKline Biologicals SA., (Copyright © 2017. Published by Elsevier Ltd.)