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• In this study, high maternal educational level was associated with vaccine hesitancy. • Hesitancy was associated with incomplete MMR and HPV immunization series. • We identified three domains: Benefits , Harms and Confidence in the Health System. • Vaccine Hesitancy Scale is a reliable and valid tool. The WHO SAGE Working Group on Vaccine Hesitancy developed the Vaccine Hesitancy Scale (VHS) to identify and compare hesitancy in different global settings. The objectives of the study were to describe and analyze vaccine hesitancy and to validate the VHS in a group of parents in Buenos Aires city, Argentina. A cross-sectional survey was conducted in parents of 1–3 and 12–15 year-old children at three health centres in Buenos Aires City, between June 2018 and May 2019. Sociodemographic data were collected together with history of refusal and/or delay in children's vaccination (defined as hesitancy). The 10-item VHS using 5-point Likert-scale (higher scores indicating lower hesitancy) was administered and children's immunization record cards were verified. Link between hesitancy and socio-demographic variables, and hesitancy and vaccination status was analyzed for five specific vaccines. Cronbach's α was used to determine internal consistency reliability and factor analysis to confirm survey subdomains. Simple and multiple regression analysis was used to examine associations between VHS scores and hesitancy, and VHS scores and vaccination status. Six hundred parents were surveyed and 469 immunization cards verified; 11.5% (n = 69) parents were hesitant. High maternal educational level showed significant association with hesitancy (OR 2.66 95% CI: 1.20–5.9) in the adjusted model. Hesitancy was significantly associated with incomplete MMR vaccination in children (OR 4.43 95% CI: 1.08–8.20) and HPV vaccination in adolescents (OR 3.75 95% CI: 1.54–9.12). Cronbach's α was 0.66 and factor analysis identified three underlying constructs: "Benefits", "Harms" and "Confidence in healthcare system". High scores in VHS were associated with lack of hesitancy (OR 1.2 95% CI: 1.13–1.27) and complete vaccination status (OR 1.07 95% CI: 1.02–1.12). Hesitancy was associated with high maternal educational level, and incomplete MMR and HPV immunization status in children and adolescents. VHS was a reliable and valid tool in this population. [ABSTRACT FROM AUTHOR]

Introduction: In 2015, varicella vaccine was introduced to the National Immunization Programme in a one-dose regimen for infants aged 15 months. The aim of this study was to describe and compare the epidemiologic characteristics, management strategies and costs of varicella outbreaks in Ricardo Gutierrez Children's Hospital (HNRG) from 2000 to 2019, before (PreV period) and after (PostV period) the introduction of the varicella vaccine. Methods: A retrospective, analytic study of the impact of nosocomial varicella outbreaks at the HNRG, based on active epidemiologic surveillance. We compared nosocomial varicella outbreaks rates (per 10,000 discharges) between PreV and PostV, excluding the intervention year (2015). Results: During PreV, an average of 15.87 (13.91–18.02) outbreaks per year was observed and in PostV 5.5 per year (3.44–8.32). Outbreaks adjusted by all cause discharges showed a reduction of 59.13% (-36.68%, -73.62%) after vaccine introduction. Considering that in PreV the average of susceptible cases per outbreak was 5.0 and in PostV 7.8, with a cost per susceptible of AR$ $6,522 (80.27 USD) PreV and 6,708 PostV the economic impact on the reduction of outbreaks after the introduction of the vaccine, showed an estimated average savings per year of AR$ -252,128 AR$ (-3,103.11 USD). Conclusions: The number of annual varicella hospital outbreaks at the HNRG decreased significantly after varicella vaccine was introduced to NIP in Argentina with a relevant reduction in terms of costs. [ABSTRACT FROM AUTHOR]

Background: Neisseria meningitidis (Nm) pharyngeal carriage is a necessary condition for invasive disease. We present the first carriage study in children in Buenos Aires, Argentina, considering 2017 as a transition year. Aims: to assess the rate of Nm carriage, to determine genogroup, clonal complex and outer membrane protein distribution, to determine carriage risk factors by age. Methods: Cross-sectional study including children 1–17 yrs, at Ricardo Gutiérrez Children's Hospital in Buenos Aires 2017. Oro-pharyngeal swabs were taken and cultured within a short time after collection. Genogroup was determined by PCR and clonal complex by MLST. Categorical variables were analyzed. Results: A total of 1,751 children were included. Group 1: 943 children 1–9 yrs, 38 Nm were isolated; overall carriage 4.0%. Genogroup distribution: B 26.3%, W 5.3%, Y 2.6%, Z 5.3%, other groups 7.9% and capsule null (cnl) 52.6%. Participating in extracurricular activities was the only independent predictor of Nm carriage. Group 2: 808 children 10–17 yrs, 76 Nm were isolated; overall carriage 9.4%. Genogroup distribution: B 19.7%, C 5.3%, W 7.9%, Y 9.2%, Z 5.3%, other groups 7.9% and cnl 44.7%. Independent predictors of carriage: attending pubs/night clubs and passive smoking (adjusted OR: 0.55, 95%CI = 0.32–0.93; p = 0.025). Conclusions: Overall carriage was higher in 10–17 yrs. The isolates presenting the cnl locus were prevalent in both age groups and genogroup B was the second most frequent. [ABSTRACT FROM AUTHOR]

• Most Latin American countries have seasonal influenza policies in place (73). • Influenza seasonality in tropical Latin America often challenges optimal vaccination (86). • Influenza surveillance has improved in Latin America since 2009, but more is needed (85). • Standardization of case definitions is recommended across Latin American countries (84). • Seasonal influenza vaccination during pregnancy is increasing in Latin America (76). The Global Influenza Initiative (GII) is a global expert group that aims to raise acceptance and uptake of influenza vaccines globally and provides recommendations and strategies to address challenges at local, national, regional, and global levels. This article provides a consolidated estimation of disease burden in Latin America, currently lacking in published literature, and delivers the GII recommendations specific to Latin America that provide guidance to combat existing vaccination challenges. While many countries worldwide, especially in the tropics and subtropics, do not have a seasonal influenza policy, 90% of Latin American countries have a seasonal influenza policy in place. Local governments in the Latin American countries and The Pan American Health Organization's Technical Advisory Group on Vaccine-preventable Diseases play a major role in improving the vaccination coverage and reducing the overall disease burden. Influenza seasonality poses the biggest challenge in deciding on optimal timing for vaccination in Latin America, as in temperate climates seasonal influenza activity peaks during the winter months (November–February and May–October) in the northern and southern hemispheres, respectively, while in the tropics and subtropical regions it usually occurs throughout the year, but especially during the rainy season. Besides this, vaccine mismatch with circulating strains, misconception concerning influenza vaccine effectiveness, and poor disease and vaccine awareness among the public are also key challenges that need to be overcome. Standardization of clinical case definitions is important across all Latin American countries. Surveillance (mostly passive) has improved substantially in the Latin American countries over the past decade, but more is still required to better understand the disease burden and help inform policies. [ABSTRACT FROM AUTHOR]

Highlights • 4CMenB and MenACWY-CRM were (co)administered at ages 3, 5, 7, 13 months (M) • At 14 M, immune responses to co-administration were non-inferior to single administration of each vaccine. • Across groups, 68–100% (8 M) and 87–100% (14 M) of children had hSBA titers ≥5 for serogroup B test strains. • Across groups, ≥96% (8 M) and ≥98% (14 M) of children had hSBA titers ≥4 for serogroups ACWY. • Co-administration of 4CMenB and MenACWY-CRM was well tolerated. Abstract Background Invasive meningococcal disease has its highest incidence in infants. Co-administration of serogroup B (4CMenB) and quadrivalent conjugate (MenACWY-CRM) vaccines could protect against 5 clinically-relevant meningococcal serogroups. Methods This phase 3b, open, multicenter study (NCT02106390), conducted in Mexico and Argentina, enrolled and randomized (1:1:1) 750 healthy infants to receive either 4CMenB co-administered with MenACWY-CRM (4CMenB/MenACWY group), 4CMenB (4CMenB group), or MenACWY-CRM alone (MenACWY group) at ages 3, 5, 7 and 13 months. Non-inferiority of immune responses of co-administration to single administration of vaccines was assessed at 1 month post-booster dose (primary objective). Immunogenicity was evaluated pre- and 1 month post-primary and booster vaccinations using human serum bactericidal assay (hSBA). Safety was assessed. Results At 1 month post-booster vaccination, between-group hSBA geometric mean titer (GMT) ratios ranged from 0.89 to 1.03 for serogroup B strains (group 4CMenB/MenACWY over 4CMenB), and from 1.05 to 2.48 for ACWY serogroups (group 4CMenB/MenACWY over MenACWY). The lower limit of the 2-sided 95% confidence intervals for all GMT ratios was >0.5; the primary objective was demonstrated. Across all groups and serogroup B strains, 68–100% and 87–100% of children had hSBA titers ≥5 at 1 month post-primary and booster vaccination, respectively. For serogroups ACWY, ≥96% (post-primary vaccination) and ≥98% (post-booster vaccination) of children in all groups had hSBA titers ≥4. Post-booster vaccination, GMTs increased ≥5.99-fold from pre-booster values for each strain/serogroup. Solicited adverse events (AEs) were more frequent in groups 4CMenB/MenACWY and 4CMenB than in MenACWY; incidence of all other AEs was similar between groups. Serious AEs were reported for 6, 13, and 11 participants in groups 4CMenB/MenACWY, 4CMenB, and MenACWY, respectively; 1 (group 4CMenB) was considered vaccine-related. Conclusion Immune responses elicited by co-administration of 4CMenB and MenACWY-CRM was non-inferior to single immunization. Co-administration of vaccines was immunogenic and well tolerated in infants. ClinicalTrials.gov: NCT02106390. [ABSTRACT FROM AUTHOR]

Introduction: In 2012, PCV13 was introduced into the National Immunization Program in Argentina, 2+1 schedule for children <2 years. Coverage rates for 1st and 3rd doses were 69% and 41.0% in 2012, 98% and 86% in 2013; 99% and 89% in 2014, respectively. The aims of this study were to evaluate impact of PCV13 on Consolidated Pneumonia (CP) and Pneumococcal Pneumonia (PP) burden, and to describe epidemiological-clinical pattern of PP during the three-year period following vaccine introduction. Methods: Hospital-based study at 10 pediatric surveillance units in Argentina. CP and PP discharge rates per 10,000 hospital discharges were compared between the pre-vaccination period 2007–2011 (preVp), the year of intervention (2012) and the post-vaccination period 2013–2014 (postVp). Results: Significant reduction in CP and PP discharge rates was observed in patients <5 years [% reduction (95%CI)]: 10.2% (6.3; 14.0) in 2012 and 24.8% (21.3; 28.2) in postVp for CP discharge rate; 59.5% (48.0; 68.5) in 2012 and 68.8% (58.3; 76.6) in postVp for PP discharge rate. Significant changes were also observed in children ≥5 years, mainly in PP discharge rate. A total of 297 PP cases were studied; 59.3% male; 31.3% <2 years; 42.9% had received PCV13 in 2012 and 84.5% in posVp. Case fatality rate was 3.4%. PCV13 serotypes decreased from 83.0% (39/47) in 2012 to 64.2% (52/81) in postVp, p = 0.039. Conclusions: After PCV13 introduction, significant reduction in CP and PP discharge rates was observed in hospitalized children <5 years. In patients ≥5 years, PP discharge rate also decreased significantly. [ABSTRACT FROM AUTHOR]

Background: Influenza is an important cause of acute lower respiratory tract infection (aLRTI), hospitalization, and mortality in children. This study aimed to describe the clinical and epidemiologic patterns and infection factors associated with influenza, and compare case features of influenza A and B. Methods: In a prospective, cross-sectional study, patients admitted for aLRTI, between 2000 and 2015, were tested for respiratory syncytial virus, adenovirus, influenza, or parainfluenza, and confirmed by fluorescent antibody (FA) or real-time polymerase chain reaction (RT-PCR) assay of nasopharyngeal aspirates. Results: Of 14,044 patients, 37.7% (5290) had FA- or RT-PCR-confirmed samples that identified influenza in 2.8% (394/14,044; 91.4% [360] influenza A, 8.6% [34] influenza B) of cases. Influenza frequency followed a seasonal epidemic pattern (May–July, the lowest average temperature months). The median age of cases was 12 months (interquartile range: 6–21 months); 56.1% (221/394) of cases were male. Consolidated pneumonia was the most frequent clinical presentation (56.9%; 224/394). Roughly half (49.7%; 196/394) of all cases had previous respiratory admissions; 9.4% (37/394) were re-admissions; 61.5% (241/392) had comorbidities; 26.2% (102/389) had complications; 7.8% (30/384) had nosocomial infections. The average case fatality rate was 2.1% (8/389). Chronic neurologic disease was significantly higher in influenza B cases compared to influenza A cases (p = 0.030). The independent predictors for influenza were: age ≥6 months, odds ratio (OR): 1.88 (95% confidence interval [CI]: 1.44–2.45); p<0.001; presence of chronic neurologic disease, OR: 1.48 (95% CI: 1.01–2.17); p = 0.041; previous respiratory admissions, OR: 1.71 (95% CI: 1.36–2.14); p<0.001; re-admissions, OR: 1.71 (95% CI: 1.17–2.51); p = 0.006; clinical pneumonia, OR: 1.50 (95% CI: 1.21–1.87); p<0.001; immunodeficiency, OR: 1.87 (95% CI: 1.15–3.05); p = 0.011; cystic fibrosis, OR: 4.42 (95% CI: 1.29–15.14); p = 0.018. Conclusion: Influenza showed an epidemic seasonal pattern (May–July), with higher risk in children ≥6 months, or with pneumonia, previous respiratory admissions, or certain comorbidities. [ABSTRACT FROM AUTHOR]

Introduction Whooping cough continues to be a major cause of morbidity and mortality in infants younger than 1 year. In 2012, Argentina introduced Tdap in pregnancy to prevent infant mortality. The aim of this study is to describe the impact of maternal immunization on the hospitalization and mortality rates of confirmed Bordetella pertussis (Bp) cases by comparing pre- and post-Tdap vaccine recommendation periods. Material and Methods All PCR-confirmed Bp cases from “R. Gutierrez” Children's Hospital identified between December 2003 and December 2016 were included in. Analysis was performed comparing hospitalization rates (per 10,000 discharges) between pre-vaccination (PreV) 2003–2011 and post-vaccination (PostV) 2013–2016 time periods, excluding the intervention year (2012). Results During the study time frame, there were 1046 suspected Bp cases, of which 337 (32.2%) were confirmed. Three-hundred eight cases were analyzed (excluding year 2012): 237 in PreV and 71 in PostV. In comparison with PreV, PostV cases were older (3 vs 9 months; p < 0.001), and required less hospitalization (86.9% vs 67.6%; p < 0.001). Bp hospitalization rate (HR) decreased (22.3 vs 11.6; p < 0.001). The mortality rate in PreV 5.9% (14 cases); there were not deaths during PostV (p = 0.036). Conclusions Confirmed cases were among infants younger than 1 year In PostV, Bp cases were older and there was a significant decrease in the hospitalization rate. There were no fatal cases in our center after the pregnancy Tdap recommendation was implemented. [ABSTRACT FROM AUTHOR]

The delivery of DNA to mammalian cells is of critical importance to the development of genetic vaccines, gene replacement therapies and gene silencing. For these applications, targeting, effective DNA transfer and vector safety are the major roadblocks in furthering development. In this report, we present a novel DNA delivery vehicle that makes use of protoplasted, achromosomal bacterial minicells. Transfer of plasmid DNA as measured by green fluorescent protein expression was found to occur in as high as 25% of cultured Cos-7 cells when a novel chimeric protein containing the D2–D5 region of invasin was expressed and displayed on the surface of protoplasted minicells. Based on endoplasmic reticulum stress and other responses, protoplasted minicells were non-toxic to recipient eukaryotic cells as a consequence of the transfection process. Taken together, these results suggest that bacterial minicells may represent a novel and promising gene delivery vehicle. [ABSTRACT FROM AUTHOR]

Background: RNA polymerase III (POLR3)-related leukodystrophy is a rare, neurodegenerative disorder characterized by hypomyelination, hypodontia, and hypogonadotropic hypogonadism. Despite the challenges of caring for a child with POLR3-related leukodystrophy, few studies have examined parents' disease burden. We sought to investigate quality of life and stress levels amongst parents of children with POLR3-related leukodystrophy. Methods: 43 parents of 32 children completed questionnaires on demographics, stress, quality of life, coping mechanisms, and experience of injustice. Detailed clinical data was collected from all patients. Results: Mothers (t [27] = –8.66, P <.001) and fathers (t[16] = –4.47, P <.001) had lower quality of life scores compared to the normative population, yet 80% of parents' stress scores fell within the normal stress range. Parents' experience of injustice scores were high (>60). Correlations were found between and within parents' scores. Years since disease onset and certain life circumstances correlated to mothers' quality of life scores; however, no correlation was found between modifiable factors and fathers' quality of life scores. Helpful coping mechanisms included those that allowed parents to be involved in their child's life. Conclusions: This is the first study to assess stress and quality of life in this population. These results shed light on the importance of implementing services and social support to improve the well-being of parents. [ABSTRACT FROM AUTHOR]

Background Neisseria meningitides (Nm) cause different types of invasive infections.Nm pharyngeal carriage is a necessary condition for invasive meningococcal disease. In 2017 Argentina introduced a tetravalent meningococcal conjugated vaccine (MenACYW) to the National Immunization Program.Aims To assess the rate of Nm carriage in healthy children and adolescents attending a public hospital in Buenos Aires city, to determine genogroup and clonal complex distribution,to describe genogroup distribution of Nm isolated from ID in Argentina, during the same period. Methods Between March and December 2017, a single-center, cross-sectional study was performed among 1,751 children 1–17 years old attending Ricardo Gutiérrez Children Hospital in Buenos Aires, Argentina. From oro-pharyngeal swabs, genogroup and clonal complex (CC) were identified. We analyzed Nm ID genogroups data reported to the Regional Surveillance Program (SIREVA II) in the same year. at the same period were relevated. Results 114Nm were isolated from the carriage study, with an overall carriage of 6.5%.Genogroups distribution: B 25(21.9%), W 9(7.8%), Y 7(6.1%), Z 6(5.2%), C 4(3.5%), non-groupable 9(7.8%) and non-capsulated (NC)54 (47.3%). 105 Clonal complex (CC) were determined: Genogroup B isolates belonged to ST-41/44, ST-35, ST-32 and ST-865. Genogroup W was associated to ST-11 and ST-35. SIREVA reported 76 strains of Nminvasive infections in 2017, 53.9% meningitis, 11.8% meningitis and sepsis, 22.4% sepsis, and 11.8% others. Genogroupsdistribution: B59.2% (45), W 23.6% (18), C 10.5% (8), Y 6.5% (5). Conclusion Genogroup B is the most frequent cause of ID followed by W in our country. In the pharyngeal carriage study we found that NmNC was prevalent and genogroup B was the most frequent among the encapsulated.Genogroup B CCs detected in our carriage study coincided with those found previously in ID in Argentina. Genogroup W carriage was low and hypervirulent CC ST-11 was detected. Although genogroup Z does not cause ID in our country it was found in carriage. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Background Acute diarrhea is one of the leading causes of infant morbidity and mortality. Argentina introduced massive rotavirus vaccination in 2015. In several countries, this introduction has changed the distribution of enteropathogens. The decrease in the prevalence of rotavirus has been described at the expense of an increase in Norovirus (NoV) activity worldwide. The aim of this study was to analyze the role of NoV in acute diarrhea cases in outpatient children under 5 years of age and their epidemiological profile. Methods A prospective and cross-sectional study in <5 years outpatients attended for acute diarrhea in Children's Hospital "Dr. Ricardo Gutiérrez" in Buenos Aires, Argentina, between July 2017 and March 2019 was conducted. Active epidemiological surveillance was performed with a specific case reporting form. Stool samples were tested for NoV (RT-qPCR). Clinical and epidemiological data were recorded. Results A total of 252 patients were enrolled and 235 stools samples were tested. Median of age was 22.3 months (IQR: 11–30), 58.7% were male. The most frequent symptoms were fever and vomiting in 63.1% and 53%, respectively; 52% had watery diarrhea, 45.2% had moderate diarrhea according to Vesikari Scale, 95.6% were normohydrated and 22% had a household member with diarrhea. There were no immunocompromised children. A 72% had received rotavirus vaccine, 86% of them with full scheme. From samples tested, 27% (n = 63) were NoV positive. NoV was found throughout the year and the frequency of detection was higher in January and June (summer and winter in Argentina). Regarding genetic diversity the most frequent genogroup was GII (65%; 41/63) and genotype GII.P16-GII.4 Sydney (48%; 20/41). Bacterial co-infection was observed in 35%. Compared with negative cases, NoV were younger (18 vs. 20 months; P < 0.001) and were associated with higher prevalence of rotavirus vaccination (88% vs. 66%; P = 0.001). No statistically difference was found regarding to gender, clinical outcome and severity. Conclusion NoV was detected at high frequency (27%) in children presenting moderate acute diarrhea, mainly in those who received rotavirus vaccine. Regarding sporadic acute diarrhea cases in children, it is important to consider NoV as a frequent etiological agent. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Background Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infection (ALRI) in children. We aimed to describe the clinical–epidemiological pattern and risk factors for mortality associated with RSV infection. Methods Prospective, cross-sectional study of ALRI in children admitted to a Children's Hospital among 2000–2018. Viral diagnosis was made by fluorescent antibody techniques or real-time PCR. We compared clinical–epidemiological characteristics of RSV infection in nonfatal vs. fatal cases. Multiple logistic regression was used to identify independent predictors of mortality. Results From a total 16,018 patients with ALRI, 13,545(84.6%) were tested for respiratory viruses, 6047 (45%) were positive: RSV 81.1% (4,907), influenza 7.5% (456), parainfluenza 6.9% (419) and adenovirus 4.4% (265). RSV had a seasonal epidemic pattern coinciding with months of lowest average temperature. RSV mortality rate: 1.7% (83/4,855). Fatal cases had a higher proportion of: prematurity (P < 0.01), perinatal respiratory history (P < 0.01), malnourishment (P < 0.01), congenital heart disease (P < 0.01), chronic neurological disease (P < 0.01) and pneumonia as clinical presentation (<0.01). No significant difference between gender was observed. The annual mortality rate distribution was not stable over the study period with the highest mortality in the year 2002. Most deaths occurred among children who had complications: respiratory distress (80.7%), sepsis (31.3%) and atelectasis (13.2%). Independent predictors of RSV mortality were: moderate to severe malnourishment OR 3.64 (95% CI 1.96–6.74) P < 0.01, chronic neurological disease OR 3.99 (95% CI 2.04–7.79) P < 0.01, congenital heart disease OR 4.10 (95% CI 2.36–7.15) P < 0.01 and age under 6 months OR 1.96 (95% CI 1.23–3.11) P < 0.01. Conclusion RSV showed an epidemic seasonal pattern. Malnourishment, chronic neurological disease, congenital heart disease, age under 6 months and pneumonia were the independent risk factors for RSV mortality. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Summary: Background: This systematic review evaluated the incidence, etiology, and use of resources in bacterial, non-tuberculosis community-acquired pneumonia (CAP) in immune-competent children aged <5 years. Methods: Systematic searches (1980–2008) were performed using MEDLINE, Cochrane Library, EMBASE, LILACS, generic, and academic Internet searches. Regional health ministries, the Pan American Health Organization (PAHO), regional proceedings, doctoral theses, and the reference lists of included studies were also searched, and experts were consulted. Arcsine transformations and the DerSimonian–Laird random-effects model were used for proportion meta-analyses. Results: The search yielded 1220 references; 60 were included in the meta-analysis, giving a total 23 854 CAP episodes with an incidence of 919/100 000 child-years in children aged <5 years. Streptococcus pneumoniae was the most frequently isolated agent (11.08%; 95% confidence interval (CI) 7.63−15.08), and pneumococcal serotype 14 was most prevalent (33.00%; 95% CI 25.95−40.45). Other common agents were Haemophilus influenzae and Mycoplasma pneumoniae. Health economics data on CAP in the region were scarce. About one-fourth of CAP patients required hospitalization (median length of stay 11 days, range 5−13.5 days). Conclusions: The burden of CAP was substantial, with S. pneumoniae, H. influenzae, and M. pneumoniae being the most common pathogens identified. High quality primary studies on disease incidence, use of health resources, and standardized data collection on disease burden and circulating strains are essential to provide baseline data for the future evaluation of vaccine impact. [ABSTRACT FROM AUTHOR]

Abstract: The Millennium Development Goals (MDGs), adopted by world leaders in the year 2000 with an aim to accomplish them by 2015, provide concrete benchmarks for tackling extreme poverty in its many dimensions. One aim is to reduce by two thirds the mortality rate among children <5 years of age. The deaths of nearly 3 million children under 5 each year worldwide can be attributed to diarrhea and pneumonia. Pneumonia, one form of pneumococcal disease, causes almost 1 in 5 deaths of children under 5 worldwide—more than 1.6 million children each year. Pneumococcal disease is preventable by vaccination; because antibiotic resistance is a growing problem worldwide, there is a great need to promote effective pneumococcal vaccines. Vaccines differ from other types of drugs, because they are administered to healthy individuals. Therefore, a good safety profile is required, there is a large governmental regulatory role, and low efficacy is unacceptable. Other important considerations are as follows: vaccines are often used in infants, are typically given in multiple doses, the manufacturing is a larger part of cost, requires high regulatory and quality control burden and minimization of costs. From a biological standpoint, the induction of vaccine-mediated protection is a complex procedure. Long-term protection typically requires the persistence of anti-microbial antibodies and/or the generation of immune memory cells capable of rapid and effective reactivation after microbial re-exposure. Appreciation of the predominant role of B cells in the efficacy of current vaccines should not minimize the importance of generating a T cell response, as this is essential for the induction of high affinity antibodies and immune memory. Pneumococcal capsular polysaccharides typically elicit B cell responses in a T-independent manner. Because of this, capsular polysaccharides are poorly immunogenic in children below 2 years of age and will generate an IgM isotype-based primary response with only short-lived protection. The conjugation of capsular polysaccharides to a protein carrier provides an antigenic complex in a form that can be presented to the immune system and thus recruit antigen specific CD4+ cells (T-dependent antibody). Pneumococcal conjugate vaccines (PCVs), comprising pneumococcal polysaccharides conjugated to a protein carrier, not only induce antibodies but also prime the immune system for protective memory response. These vaccines provide protection in children below 2 years of age, generate long-term protection (highly specific IgG antibodies), generate herd immunity (indirect protection of nonimmunized individuals) and have demonstrated effectiveness in regions that have incorporated them into the national immunization schedules. Global implementation of PCVs has contributed to substantial progress toward reducing childhood mortality, but increased vaccine uptake in developing regions such as Latin America and the Caribbean is necessary to continue toward accomplishing the goals outline in the MDGs. [Copyright &y& Elsevier]

Summary: Objectives: In this open-label, non-randomized phase II study, the safety and immunogenicity of a fully liquid diphtheria–tetanus–whole cell pertussis–hepatitis B–Haemophilus influenzae type b (DTPw–HepB–Hib) combination vaccine (Quinvaxem®) were assessed in infants who had or had not received a birth dose of hepatitis B (HepB) vaccine. Study design: Two groups of infants, ‘HepB at birth’ (n =110) and ‘no HepB at birth’ (n =108), were enrolled and received a primary vaccination course using a 2–4–6 months schedule. Results: Seroprotection/seroconversion rates of >95% were achieved against all antigens included in the combination vaccine for both study groups. Although significantly higher anti-hepatitis B virus (p <0.001) and anti-tetanus (p =0.031) antibody titers were achieved in group ‘HepB at birth’ when compared with group ‘no HepB at birth’, the proportion of ‘no HepB at birth’ subjects achieving protective titers was non-inferior to the proportion of subjects in group ‘HepB at birth’. The birth dose of HepB vaccine did not seem to influence the safety pattern of the DTPw–HepB–Hib combination vaccine. Conclusions: The present study demonstrated that the fully liquid DTPw–HepB–Hib vaccine was safe and immunogenic when administered using a 2–4–6 months immunization schedule, regardless of whether or not infants had received a dose of HepB vaccine at birth. [ABSTRACT FROM AUTHOR]

Abstract: Background: Diphtheria (D), tetanus (T), pertussis (P), hepatitis B (HepB), invasive Haemophilus influenzae type b (Hib) disease, and measles cause substantial global morbidity and mortality. Methods: This unique review highlights geographic differences in disease burden across certain countries in the African, Americas, Mediterranean, South-East Asian, and Western Pacific World Health Organization (WHO) regions, and relates this to vaccination coverage and local vaccine recommendations using the authors’ countries as illustrations. Results: Substantial differences were observed in the incidence of these diseases and in vaccination coverage between the countries studied. Disease incidence often reflected inadequate surveillance, but also variable or poor vaccination coverage. Vaccination coverage against HepB was particularly low in the African and South-East Asian WHO regions; vaccination coverage against invasive Hib disease was low in these regions and in the Eastern Mediterranean and Western Pacific WHO regions. Vaccination schedules within some countries in these regions do not include, or have only recently included, vaccinations against HepB and Hib disease. The use of DTwP–HepB–Hib (diphtheria, tetanus, whole-cell pertussis, HepB, Hib) combination vaccines has now been adopted by some countries to help increase vaccination coverage. Conclusions: Vaccination coverage and vaccination schedules vary markedly between the countries studied, often according to the resources available. DTwP–HepB–Hib combination vaccines represent a cost-effective option, with the potential to substantially reduce the burden associated with these diseases by increasing coverage and compliance. [Copyright &y& Elsevier]

Lassa fever is a serious epidemic viral disease in West Africa affecting an estimated 2 million people annually with about 5000–10,000 deaths, although supporting data is sparse. Lassa fever significantly affects neonates, children, and pregnant women, however, comprehensive data on its impact in these populations are lacking. We reviewed the available literature on Lassa fever to assess its prevalence and impact in these populations and implications for vaccine development. Clinical features in children were similar to those observed in adults, with complications such as bleeding. Altered mental status, anasarca (swollen baby syndrome), bleeding, and poor urine output were risk factors for death. The case fatality rate (CFR) in 16 paediatric studies ranged from 6 % to 63 % and was 66.7 % and 75.0 % in two neonatal studies. In a systematic review of studies on pregnant women the CFR was 33.73 %. The adverse foetal outcomes included miscarriage, stillbirth, and intrauterine death associated with maternal death. Since Lassa fever significantly affects neonates, children, and pregnant women, developing a safe and effective, single-dose vaccine for these high-risk populations is vital. Currently, there are four clinical trials assessing Lassa virus vaccines. Only one of these trials is enrolling children aged ≥18 months, and exclude pregnant and breast-feeding women. It is essential that pregnant and breast-feeding women and young children are included in clinical trials that incorporate robust safety surveillance and risk mitigation measures. In our review, potential approaches to address the specific gaps in the areas of diagnosis, management, and prevention of Lassa fever in these specific populations, such as disease surveillance systems and vaccine development, were identified. A comprehensive strategy with investment focused on addressing specific knowledge gaps will be essential in protecting the health of these specific populations in Lassa virus endemic regions. [ABSTRACT FROM AUTHOR]

Background: Respiratory syncytial virus (RSV) is the most common cause of acute lower respiratory infection in young children. We previously estimated that in 2015, 33·1 million episodes of RSV-associated acute lower respiratory infection occurred in children aged 0-60 months, resulting in a total of 118 200 deaths worldwide. Since then, several community surveillance studies have been done to obtain a more precise estimation of RSV associated community deaths. We aimed to update RSV-associated acute lower respiratory infection morbidity and mortality at global, regional, and national levels in children aged 0-60 months for 2019, with focus on overall mortality and narrower infant age groups that are targeted by RSV prophylactics in development.Methods: In this systematic analysis, we expanded our global RSV disease burden dataset by obtaining new data from an updated search for papers published between Jan 1, 2017, and Dec 31, 2020, from MEDLINE, Embase, Global Health, CINAHL, Web of Science, LILACS, OpenGrey, CNKI, Wanfang, and ChongqingVIP. We also included unpublished data from RSV GEN collaborators. Eligible studies reported data for children aged 0-60 months with RSV as primary infection with acute lower respiratory infection in community settings, or acute lower respiratory infection necessitating hospital admission; reported data for at least 12 consecutive months, except for in-hospital case fatality ratio (CFR) or for where RSV seasonality is well-defined; and reported incidence rate, hospital admission rate, RSV positive proportion in acute lower respiratory infection hospital admission, or in-hospital CFR. Studies were excluded if case definition was not clearly defined or not consistently applied, RSV infection was not laboratory confirmed or based on serology alone, or if the report included fewer than 50 cases of acute lower respiratory infection. We applied a generalised linear mixed-effects model (GLMM) to estimate RSV-associated acute lower respiratory infection incidence, hospital admission, and in-hospital mortality both globally and regionally (by country development status and by World Bank Income Classification) in 2019. We estimated country-level RSV-associated acute lower respiratory infection incidence through a risk-factor based model. We developed new models (through GLMM) that incorporated the latest RSV community mortality data for estimating overall RSV mortality. This review was registered in PROSPERO (CRD42021252400).Findings: In addition to 317 studies included in our previous review, we identified and included 113 new eligible studies and unpublished data from 51 studies, for a total of 481 studies. We estimated that globally in 2019, there were 33·0 million RSV-associated acute lower respiratory infection episodes (uncertainty range [UR] 25·4-44·6 million), 3·6 million RSV-associated acute lower respiratory infection hospital admissions (2·9-4·6 million), 26 300 RSV-associated acute lower respiratory infection in-hospital deaths (15 100-49 100), and 101 400 RSV-attributable overall deaths (84 500-125 200) in children aged 0-60 months. In infants aged 0-6 months, we estimated that there were 6·6 million RSV-associated acute lower respiratory infection episodes (4·6-9·7 million), 1·4 million RSV-associated acute lower respiratory infection hospital admissions (1·0-2·0 million), 13 300 RSV-associated acute lower respiratory infection in-hospital deaths (6800-28 100), and 45 700 RSV-attributable overall deaths (38 400-55 900). 2·0% of deaths in children aged 0-60 months (UR 1·6-2·4) and 3·6% of deaths in children aged 28 days to 6 months (3·0-4·4) were attributable to RSV. More than 95% of RSV-associated acute lower respiratory infection episodes and more than 97% of RSV-attributable deaths across all age bands were in low-income and middle-income countries (LMICs).Interpretation: RSV contributes substantially to morbidity and mortality burden globally in children aged 0-60 months, especially during the first 6 months of life and in LMICs. We highlight the striking overall mortality burden of RSV disease worldwide, with one in every 50 deaths in children aged 0-60 months and one in every 28 deaths in children aged 28 days to 6 months attributable to RSV. For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community. RSV passive immunisation programmes targeting protection during the first 6 months of life could have a substantial effect on reducing RSV disease burden, although more data are needed to understand the implications of the potential age-shifts in peak RSV burden to older age when these are implemented.Funding: EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe (RESCEU). [ABSTRACT FROM AUTHOR]

Background: Diphtheria-tetanus-whole-cell pertussis (DTPw)-based combination vaccines are an attractive option to rapidly achieve high coverage and protection against other important pathogens, such as hepatitis B virus (HBV) and Haemophilus influenzae type B (Hib). To ensure adequate antigen supply, GlaxoSmithKline Biologicals has introduced a new DTPw antigen source and developed a new DTPw-HBV/Hib combination vaccine containing a reduced amount of Hib polyribosylribitol phosphate (PRP). This study was undertaken to compare the immunogenicity and reactogenicity of this new DTPw-HBV/Hib vaccine with a licensed DTPw-HBV/Hib vaccine (Tritanrix™-HBV/Hib). Methods: This was a randomized, partially-blind, multicenter study in three countries in Latin America (Argentina, Chile and Nicaragua). Healthy children received either the new DTPw-HBV/Hib vaccine (1 of 3 lots; n = 439; double-blind) or Tritanrix™-HBV/Hib (n = 146; single-blind) co-administered with oral poliovirus vaccine (OPV) at 2, 4 and 6 months, with a booster dose at 18-24 months. Results: One month after the end of the 3-dose primary vaccination course, the new DTPw-HBV/Hib vaccine was non-inferior to Tritanrix™-HBV/Hib in terms of seroprotection/vaccine response rates for all component antigens; ≥97.3% and ≥93.9% of subjects in the two groups, respectively, had seroprotective levels of antibodies against diphtheria, tetanus, hepatitis B and Hib and a vaccine response to the pertussis component. Persistence of antibodies against all vaccine antigens was comparable between groups, with marked increases in all antibody concentrations after booster administration in both groups. Both vaccines were generally well-tolerated as primary and booster doses. Conclusions: Results confirm the suitability of this new DTPw-HBV/Hib vaccine comprising antigens from a new source and a reduced PRP content for inclusion into routine childhood vaccination programs. Trial registration: http://www.clinicaltrials.gov NCT00332566. [ABSTRACT FROM AUTHOR]

Abstract: Sphingosine-1-phosphate (S1P) is a pleiotropic lysolipid that has recently been implicated in the regulation of tissue fibrosis. However, the fibrogenic potential of S1P in the eye has not previously been investigated. In the current study, we evaluated cells from the anterior and posterior segments of the eye for the presence of S1P and their potential ability to produce and respond to S1P. In addition, we investigated the regulatory role of S1P as a mediator of proliferation, cellular transformation and pro-fibrotic protein expression in human retinal pigmented epithelial cells. Expression of S1P receptors and sphingosine kinases (the enzymes that produce S1P) was examined using RT-PCR, and intracellular localization of S1P was examined using immunoblotting, immunohistochemistry and ELISA in primary human retinal pigmented epithelial (RPE) cells, primary human conjunctival fibroblasts (ConF), and primary human corneal fibroblasts (CF). RPE cell proliferation was determined using an MTT-based cell proliferation assay, and RPE myofibroblast transformation, collagen type I production and profibrotic protein expression were assessed using immunofluorescence, ELISA and immunoblot. S1P1–3, 5 receptors and sphingosine kinases 1 and 2 were expressed and intracellular pools of S1P were detected in RPE cells, ConF and CF. S1P stimulated RPE cell proliferation in a dose- and time-dependent manner. S1P induced myofibroblast transformation of RPE cells, as indicated by increased α-smooth muscle actin (α-SMA) expression and its incorporation into prominent stress fibers, and promoted collagen type I production. S1P stimulated the expression of plasminogen activator inhibitor-1 (PAI-1) and heat shock protein 47 (HSP47), two proteins that are linked to increased tissue fibrosis. Combined, these data demonstrate that RPE cells, ConF and CF from the human eye not only have the molecular ability to produce and respond to S1P, but also contain S1P. Furthermore, S1P promotes proliferation, myofibroblast transformation, collagen production and pro-fibrotic protein expression by human RPE cells. These data suggest that S1P is a previously unrecognized mediator of profibrotic cellular function and signaling in the eye. [Copyright &y& Elsevier]

Abstract Background In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines. Methods We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009. Results No changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03. Conclusions Other than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study. [ABSTRACT FROM AUTHOR]

Summary Objective Some medical conditions constitute important risk factors for the development of invasive pneumococcal diseases in children and adolescents aged from 5 to 19 years. Conjugate vaccines have potential efficacy in this scenario, but are not available in many Latin American public healthcare systems for this age group. This study aimed to estimate the preventable fraction of invasive pneumococcal diseases among individuals aged from 5 to 19 years with associated risk factors for its development. Methods Data regarding the Latin America population, risk factors prevalence and conjugate vaccines efficacy were obtained from the literature. Results Total population at risk ranged from 17.3 to 64.6 million of individuals and asthma was the most impacting risk factor. According to SIREVA, PCV13 provided a 62.9% serotypes coverage in individuals from 5 to 29 years in 2012, potentially increasing the covered population from [8,338,457-31,057,620] with PCV10 to [10,906,356-40,622,078] with PCV13. To date, according to available efficacy data, the hypothetically immunized population ranged from 11.4 to 42.4 million, representing 7.0% to 26.0% of the total population in this age group. Conclusions Vaccination in risk groups should be encouraged, as it potentially contributes to the reduction in the number of cases of invasive pneumococcal disease. [ABSTRACT FROM AUTHOR]

The article discusses research which analyzes global and regional pediatric mortality and hospital admissions due to severe acute lower respiratory infections (ALRI) recorded in 2010. It is said that ALRI which include pneumonia and bronchiolitis remain as leading cause of morbidity and death among children. Aside from searching for relevant studies published online, the research also looked into Chinese language databases to collect necessary ALRI-related statistics in the concerned period.

Abstract: Streptococcus pneumoniae continues to be the most important causative agent of invasive bacterial infections in children and is the most common cause of vaccine-preventable deaths in children less than 5 years of age. Due to some conditions in the Latin America region, economic assessments of pneumococcal conjugate vaccines (PCVs) have unique characteristics. First, distribution of S. pneumoniae serotypes, and thus coverage by vaccines that incorporate certain serotypes, varies within the region and compared with other parts of the world. Second, the mortality rate of pneumococcal infections in developing countries is significantly higher than in the US and Europe. Third, the economies of the Latin American region are very different from those of developed countries. For these reasons, the Pan American Health Organization (PAHO) is promoting the need for economic valuation studies of the impact of pneumococcal vaccines Latin America. Given the importance of pneumonia in the burden of pneumococcal disease in Latin America, the number of pneumonia cases prevented by the vaccine has a large impact on the economic valuation of PCVs, due to a strong correlation with numbers of deaths averted, quality-adjusted life-years (QALYs) gained or disability-adjusted life-years (DALYs) avoided. In terms of cost, analysis of impact on acute otitis media (short-term) and sequelae (long-term) show a significant and important expenditure avoided by vaccination. Cost-effectiveness is significantly modified by vaccine cost, mortality due to pneumonia, vaccine efficacy/effectiveness and herd immunity. Finally the validity of certain assumptions based on the uncertainty of the data should be considered in economic assessments of new PCVs. These include assumptions related to the impact on otitis media, estimates of efficacy/effectiveness based on measured antibody levels and the extrapolation to PCV10 and PCV13 of previous experience with PCV7. [Copyright &y& Elsevier]

Background: The apparent high number of deaths in Argentina during the 2009 pandemic led to concern that the influenza A H1N1pdm disease was different there. We report the characteristics and risk factors for influenza A H1N1pdm fatalities. Methods: We identified laboratory-confirmed influenza A H1N1pdm fatalities occurring during June-July 2009. Physicians abstracted data on age, sex, time of onset of illness, medical history, clinical presentation at admission, laboratory, treatment, and outcomes using standardize questionnaires. We explored the characteristics of fatalities according to their age and risk group. Results: Of 332 influenza A H1N1pdm fatalities, 226 (68%) were among persons aged <50 years. Acute respiratory failure was the leading cause of death. Of all cases, 249 (75%) had at least one comorbidity as defined by Advisory Committee on Immunization Practices. Obesity was reported in 32% with data and chronic pulmonary disease in 28%. Among the 40 deaths in children aged <5 years, chronic pulmonary disease (42%) and neonatal pathologies (35%) were the most common co-morbidities. Twenty (6%) fatalities were among pregnant or postpartum women of which only 47% had diagnosed comorbidities. Only 13% of patients received antiviral treatment within 48 hours of symptom onset. None of children aged <5 years or the pregnant women received antivirals within 48 h of symptom onset. As the pandemic progressed, the time from symptom-onset to medical care and to antiviral treatment decreased significantly among case-patients who subsequently died (p<0.001). Conclusion: Persons with co-morbidities, pregnant and who received antivirals late were over-represented among influenza A H1N1pdm deaths in Argentina, though timeliness of antiviral treatment improved during the pandemic. [ABSTRACT FROM AUTHOR]

Abstract: To inform World Health Organization recommendations regarding use of Haemophilus influenzae type b (Hib) vaccines in national immunization programs, a multi-country evaluation of trends in Hib meningitis incidence and prevalence of nasopharyngeal Hib carriage was conducted in four South American countries using either a primary, three-dose immunization schedule without a booster dose or with a booster dose in the second year of life. Surveillance data suggest that high coverage of Hib conjugate vaccine sustained low incidence of Hib meningitis and low prevalence of Hib carriage whether or not a booster dose was used. [Copyright &y& Elsevier]

Abstract: Background: Acute otitis media (AOM) is one of the most common childhood diseases requiring antimicrobial prescription in pre-school children. This systematic review aimed to estimate the AOM incidence, bacterial etiology and use of resources in children aged <6 years in Latin America and the Caribbean (LA&C). Methods: A systematic search using keywords otitis or middle ear and inflammation was performed for articles published during 1988-2008 in MEDLINE, Cochrane Library, EMBASE, LILACS, generic and academic internet searches, Ministries of Health, PAHO, regional proceedings, reference lists and consulting experts. Pairs of reviewers independently selected articles and assessed their methodological quality with a checklist of essential items from the STROBE statement according to pre-specified criteria. Studies involving immune-competent children with AOM were considered. Arcsine transformations were used for proportion meta-analyses. Results: Annual AOM incidence in four studies in children aged <5 years ranged from 1,171–36,000 episodes/100,000 children. Meta-analysis on etiology and pneumococcal serotypes included 18 studies and 125, 519 children with AOM from six LA&C countries. Meta-analysis per serotype showed that Streptococcus pneumoniae (32.4%; 95%CI=27.1-38.0%) and Haemophilus influenzae (26%; 95%CI=19.5-33.1%), including non-typeable H. influenzae (18.3%; 95%CI=9.5-33.1%) were the most prevalent. The most commonly observed pneumococcal serotype was 19F (24.0%; 95% CI 17.0-32.0%). Data on use of health resources were scarce. Conclusions: Streptococcus pneumoniae and H. influenzae were the most frequent AOM bacterial pathogens, consistent with the international literature from other regions. Future studies on AOM incidence and health resources usage will help better define the impact of this disease. [Copyright &y& Elsevier]

Abstract: Objective: Since the 10-valent pneumococcal conjugate vaccine (PCV-10) and 13-valent pneumococcal conjugate vaccine (PCV-13) were recently licensed for use in Argentina, both vaccines were evaluated to estimate the costs, health benefits and cost-effectiveness of adding a PCV to the routine child immunization schedule. Methodology: The integrated TRIVAC vaccine cost-effectiveness model from Pan American Health Organization''s ProVac Initiative (Version 1.0.65) was used to assess the health outcomes of 20 successive cohorts from birth to 5 years of age. PCV-10 and PCV-13 were each compared to a scenario assuming no PCV vaccination. A 3+1 (three doses+booster) schedule and a vaccination price of US$ 20.75 per dose was assumed in the base case for both vaccines. Results: Introduction of PCV-13 rather than PCV-10 would increase the number of life years gained (LYG) by at least 10%. The number of LYG (and LYG after adjustment for DALY morbidity weights) was 56,882 (64,252) for PCV-10 compared to 65,038 (71,628) for PCV-13. From the health system perspective, the cost per DALY averted was US$ 8973 and US$ 10,948 for PCV-10 and PCV-13 respectively, and US$ 8546 and US$ 10,510 respectively, after incorporating costs saved by households. When PCV13 was compared to PCV10 directly, the additional benefits of PCV-13 was conferred at a cost of US$ 28,147 per DALY averted. Cost-effectiveness was influenced mainly by vaccine price, serotype replacement, pneumonia mortality and discount rate. Conclusion: Routine vaccination against S. pneumoniae in Argentina would be cost-effective with either PCV-10 or PCV-13. PCV-13, with higher coverage of local serotypes, would prevent more cases of pneumonia, invasive pneumococcal disease, sequelae and deaths with a higher number of LYG and DALYs averted, but PCV-10, due its higher impact in the prevention of AOM, would save more costs to the healthcare system. [Copyright &y& Elsevier]

Abstract: Due to the region''s own conditions, universal vaccination with pneumococcal conjugate heptavalent vaccine (PCV-7) in Latin American countries is still controversial. Objective: To compare projected economic costs and health benefits associated with pneumococcal conjugate heptavalent vaccine as a routine immunization in healthy children in Argentina. Design: A decision analytic model of Markov simulated lifetime evolution of a birth cohort (n 696,451) was developed and compared costs and health benefits of pneumococcal disease in the presence and absence of vaccination. Main outcome measures: Cost per life year (LY) gained, reduce in diseases burden and costs of vaccination. Results: From the society''s perspective, the incremental cost per LY gained was US$ 5599.42 and the purchase of the 4 doses of vaccine for the entire cohort with a cost of US$ 26.5 dose requires an investment of US$ 73,823,806.00. The model estimated that vaccination reduce the number of death by 159 cases of meningitis, 756 cases of bacteriemias 4594 cases of pneumonias about 84,769 cases of otitis media and 20 meningitis sequelae. The value of the cost per LY gained was considerably modified by the variation in the cost of the vaccine dose, efficacy/effectiveness of the vaccine for pneumonia the mortality from pneumonia and herd immunity. Conclusions: Our analysis predicted that routine vaccination of healthy infants <2 years could prevent an important number of pneumococcal infectious and reduce related mortality and morbidity. This strategic could be highly cost-effective in Argentina. [Copyright &y& Elsevier]

Abstract: In Argentina, the National Technical Advisory Group on Immunizations is represented by the National Immunization Commission (CoNaIn), an organization created by the Ministry of Health in 2000. Recently, the Argentine government has decided to prioritize vaccination as a state policy, emphasizing this strategy as a sign of social equity so CoNaIn was restructured to increase its capacity to formulate sound and evidence-based recommendations. The commission shall consist of a group of immunization experts, representatives of scientific societies, the immunization program and the Ministry of Health. Its functions include the formulation of recommendations on the introduction of vaccines into the immunization program. The recommendations are based on technical, programmatic and social criteria. This decision-making process transparent with the support and advice of experts and scientific societies and guided by available evidence decisions help strengthen the Ministry of Health immunization policy generating greater confidence and support from the population and health professionals. [Copyright &y& Elsevier]