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With the pandemic, there has been a global reduction in influenza virus circulation, with WHO reporting, during 2021/22 season, laboratory testing positivity rate for influenza of less than 3%. Influenza surveillance systems anticipated a peak of influenza cases in the Northern Hemisphere during 2022/2023 season and the Italian Ministry of Health recommended the routinary co-administration of influenza with bivalent COVID-19 vaccines for the 2022/2023 season. At the Vaccination Hub of the University Hospital (UH) of Palermo, more than 700 subjects received influenza and COVID-19 booster doses in co-administration, during the 2021/2022 season. A cross-sectional study analyzing attitudes and factors associated with adherence to influenza and COVID-19 seasonal vaccines co-administration was conducted at the Vaccination Hub of the UH of Palermo, from October to December 2022. Among the 1,263 respondents, 74.7% ( n  = 944) received the co-administration of seasonal influenza and COVID-19 vaccines. The main reason reported for accepting it was confidence in the recommendations of the Health Ministry (41.3%). At the multivariable analysis, subjects aged ≤ 59 y old (AdjOR: 2.48; CIs95%: 1.89-3.65), male (AdjOR: 1.51; CIs95%: 1.27-1.75), Health-care professionals (HCPs) (AdjOR: 1.66; CIs95%: 1.08-2.57) and those who received co-administration during 2021/2022 (AdjOR: 41.6; CIs95%: 25.5-67.9) were significantly more prone to receive co-administration during 2022/23 season. From data obtained, the role of HCPs in accepting and then promoting co-administration of COVID-19 and influenza vaccines is crucial, as well as receiving co-administration in the previous season that represented the main drive for accepting it in the following seasons, supporting safety and effectiveness of this procedure.

Vaccine co-administration is a useful strategy for improving vaccine coverage and adherence. In Italy, an update to the national immunization program (NIP) in 2023 included recommendations for co-administration of pediatric vaccines, including the four-component vaccine for meningococcus B (4CMenB), pneumococcal conjugate vaccine (PCV), hexavalent vaccines, and oral rotavirus vaccines. Safety is a major concern when considering vaccine co-administration; therefore, a literature review of the available evidence on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines was performed. Of 763 publications screened, two studies were reviewed that reported safety data on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines in infants aged 0-24 months. Overall, these studies supported that there were no significant safety signals when co-administering 4CMenB with PCV, hexavalent/pentavalent, and rotavirus vaccines, compared with individual vaccination. This review provides key insights for healthcare professionals on the tolerability of co-administering 4CMenB with routine vaccines.

Hexavalent (HV) vaccination is a priority for newborn protection and in Italy is included in the National Immunization Plan with a three doses cycle at 61, 121 and 301 days of age. A retrospective clinical study has been conducted to evaluate real life clinical practice of HV vaccination in the fourth most populous Italian Region. Data on the completion of the HV cycle, on the interchangeability between the two HV adopted in 2016-2017 (DTaP3-IPV-HB/Hib) and 2018-2019 (DTaP5-IPV-HB-Hib) and on the use above the established age, were collected in five Sicilian Local Health Authorities. Data showed an average 91.5% completion of the vaccination cycle at 24 months of age. The average age of administration was significantly higher in children who switched between the two hexavalent vaccines compared to those who completed the vaccination cycle with the same product ( p -value <.01). Interchangeability with one or two doses of HV was also documented in 17.8% (2018) and 16% (2019) of vaccinated infants. Co-administration with other vaccines included in the Sicilian Vaccination Schedule was 85% with anti-pneumococcal vaccination and 65% with anti-rotavirus vaccination. Children vaccinated above recommended age (from 15 to >36 months) significantly after the introduction of mandatory vaccination in Italy ( p -value <.001). This retrospective analysis will contribute to manage potential disruptions due to missed routine immunization opportunities, as the pandemic has caused, with strategies such as catch up above recommended age as well as interchangeability. Data could also help to demonstrate the need to optimize vaccine sessions through co-administration, that strongly contribute to increase vaccination coverage rates and respect of timing of vaccination schedules.

Rotavirus (RV) causes up to half of hospital and community acute gastroenteritis (AGE) cases in young children in Italy. Two RV vaccines, available since 2006, are human RV (HRV) and human bovine RV (HBRV). This report looks back at the implementation of RV vaccination with HRV in Italy, and at HRV current and future perspectives. Initial regional policies led to national implementation by 2018, after scientific societies' disease awareness efforts. Following vaccination, RV hospitalizations declined significantly, and cost savings were observed. The two-dose HRV vaccine is easily administered during compulsory vaccine visits, helping increase coverage. Intussusception, a serious event in children <1 year, was reported in Italy with a rate of 33-40 per 100,000 infants. RV vaccination presents a low increased risk of intussusception after the first dose, estimated at 0.6 cases per 100,000 doses in Italy in 2019. Parents should be aware of the intussusception risk and symptoms to ensure prompt treatment. It is widely recognized that the vaccination benefits (large numbers of RV hospitalizations prevented) outweigh the risk. HRV introduction in Italy was supported by epidemiologic burden studies, healthcare provider opinions, and congress debates, which significantly contributed to implementation of RV universal routine infant vaccination in Italy.

Counteract vaccine hesitancy is a public health priority. Main objectives of the cross-sectional study conducted were to evaluate knowledge, attitudes, and behaviors regarding vaccination issues, to estimate the prevalence of vaccine hesitancy and to estimate the effectiveness of vaccination counseling on community advocacy in a sample of general population. An anonymous validated questionnaire was administered in April 2017 at the main shopping center of Palermo and was followed by tailored vaccination counseling interventions. To estimate the effectiveness of the interventions four main connection parameters to the vaccinarsi.org website were evaluated, in the two months before and after the intervention and in the two months before the intervention compared with the same period of previous and following years. Among the 299 subject enrolled 12.7% were hesitant about vaccinations, and 4.7% declared being against vaccinations. General practitioners (GPs) and pediatricians were the most affordable source of information about vaccinations. A higher probability of vaccination hesitancy/refusal was reported among subjects who considered "alternative strategies" the best way for the prevention of infectious diseases (adj-OR = 7.01, IC95% 2.88-17.09, p -value < 0.001). A considerable increase of all the vaccinarsi.org website indicators analyzed was observed, from the area in which survey participants lived. Prevalence of vaccine hesitancy among population surveyed is consistent with the literature data. HCWs, such as GPs and pediatricians, should play a key role in modifying personal convictions and choices about vaccinations. A proper vaccination counseling could improve attitudes regarding vaccination issues, such as quality of web-based research.

Vaccination represents the most effective intervention to prevent infection, hospitalization and mortality due to influenza. This meta-analysis quantifies data reporting influenza vaccine effectiveness (VE) on influenza visits and hospitalizations of case-control and cohort studies among high-risk groups. A systematic literature review including original articles published between 2007 and 2016, using a protocol registered on Prospero with No. 42017054854, and a meta-analysis were conducted. For 3 high-risk groups (subjects with underlying health conditions, pregnant women and health care workers) only a qualitative evaluation was performed. The VE quantitative analysis demonstrated a clear significant overall effect of 39% (95%CI: 32-46%) for visits and 57% (95%CI: 30-74%) for hospitalization among children. Considering the elderly influenza VE had a clear effect of 25% (95%CI: 6-40%) for visits and 14% (95%CI: 7-21%; p<0.001) for hospitalization. This study showed the high VE of influenza vaccination among high-risk groups, representing a tool for public health decision-makers to develop evidence-based preventive interventions to avoid influenza outcomes.

Influenza A and B viruses are responsible for respiratory infections, representing globally seasonal threats to human health. The 2 viral types often co-circulate and influenza B plays an important role in the spread of infection. A 6-year retrospective surveillance study was conducted between 2010 and 2016 in 2 large administrative regions of Italy, located in the north (Liguria) and in the south (Sicily) of the country, to describe the burden and epidemiology of both B/Victoria and B/Yamagata lineages in different healthcare settings. Influenza B viruses were detected in 5 of 6 seasonal outbreaks, exceeding influenza A during the season 2012-2013. Most of influenza B infections were found in children aged ≤ 14 y and significant differences were observed in the age-groups infected by the different lineages. B/Victoria strains prevailed in younger population than B/Yamagata, but also were more frequently found in the community setting. Conversely, B/Yamagata viruses were prevalent among hospitalized cases suggesting their potential role in the development of more severe disease. The relative proportions of viral lineages varied from year to year, resulting in different lineage-level mismatch for the B component of trivalent influenza vaccine. Our findings confirmed the need for continuous virological surveillance of seasonal epidemics and bring attention to the adoption of universal influenza immunization program in the childhood. The use of tetravalent vaccine formulations may be useful to improve the prevention and control of the influenza burden in general population.

Rotavirus is considered the main cause of severe gastroenteritis and nosocomial infections in Pediatric units, especially during late winter and early spring season in temperate region. In 2013 Sicilian Region, for the first time in Italy, introduced universal Rotavirus vaccination. This study aims to estimate health and economic impact on rotavirus Gastroenteritis (RVGE) among children aged 0-59 months in Sicily, after rotavirus vaccine introduction. We analyzed hospital discharge records including a diagnosis of RVGE occurred from 1 st January 2009 to 31 st December 2016 among hospitalized children aged 0 to 59 months, residents in Sicily. RVGEs were defined as all hospitalizations with an ICD-9-CM diagnosis code of 008.61 on first or any diagnosis position. Also an economic impact analysis on Health Regional System was conducted. We observed a consistent decline of hospitalization after rotavirus vaccination introduction from 394 per 100,000 in 2009-2012 to 220 per 100,000 in 2013-2016. We found a change in the peak of reported cases by at least one month from March-April in the pre-vaccination period to May-June in the post-vaccination period. Since 2013, we estimated that the annual average cost saved is 1,134,056 € when considering direct and indirect costs to health care as well as vaccination costs. Our study is the first analysis conducted as far as we are aware in a high-income setting with poor coverage (lower than 50%), demonstrating a significant reduction of RVGE hospitalizations in Sicily after vaccine introduction. Moreover, was observed a consistent impact of vaccination on health care cost saving.

The ESCULAPIO Project aims at increasing awareness on vaccine preventable infectious diseases (VPID) and vaccinations in different target populations and to spread the culture of prevention. Information/training interventions on VPID have been developed and health promotion activities for the general population, students and their parents, teachers and health care workers (HCWs) were set up. In Tuscany, educational courses on VPID in high schools were organized and students were stimulated to prepare informative materials on VPID for lower grade school pupils. In Liguria, an educational card game (named 'Vaccine at the Fair') was presented to children of primary schools. Stands in shopping centers were used in Palermo to distribute the regional vaccination schedule and gadgets, also providing indications on reliable websites where to find correct information on vaccinations. A music video played by health care workers (HCWs) was created and used in the University Hospital of Cagliari to promote the anti-flu vaccination campaign in HCWs. In Apulia, meetings with the general population were organized to collect controversial issues about vaccinations and a national call center was launched to create a direct line from the general population to experts in vaccines and vaccination strategies. In Veneto, meetings in the birth centers and home visits for subjects refusing vaccination have been organized. All activities are useful and effective tools to increase knowledge about VPID and confidence in vaccination, which are crucial aspects in order to increase vaccine uptake. The project was funded by the Italian Ministry of Health, Center for Disease Prevention and Control (CCM) in 2013.

Among solid organ transplant recipients, influenza infection is commonly associated with higher morbidity and mortality than immunocompetent hosts. Therefore, in these subjects influenza vaccination is of paramount importance. The main objective of the study was to assess compliance to vaccination and analyze factors associated with influenza vaccination of solid organ transplant recipients admitted to the Sicilian solid organ transplant Reference Center IRCCS-ISMETT in Palermo during 2014-2015 influenza season. Thirty one (37.8%) out of 82 solid organ transplant recipients were vaccinated against influenza. The main reason for vaccination refusal was fear of adverse reaction (n = 16, 31.4%), impaired health status (n = 14, 27.4%) and low vaccine efficacy (n = 10, 19.6%). Vaccinated solid organ transplant recipients compare with unvaccinated had smaller hospital admissions for infectious respiratory diseases (9.7% Vs 23.5%) during surveillance period. On multivariate analysis the factors positively associated with influenza vaccination were the advice of Reference Center physicians (OR 53.4, p < 0.001) and to perform vaccine against pneumococcus (OR 7.0, p = 0.016). This study showed that Reference Center physicians play a key role on vaccine communication and recommendation for patients at risk and it underlines the effectiveness of influenza vaccination in solid organ transplant recipients. However, it remains that, although physician advice resulted a strong determinant for vaccination, influenza vaccination coverage in this subset of population remains still unsatisfactory.

The real cause of intussusception is not fully understood and a variety of conditions have been associated with it (Meckel diverticulum, polyps, duplication cysts, parasites, Henoch-Schönlein purpura, cystic fibrosis, hemolytic-uremic syndrome and infectious gastroenteritis). Furthermore few European countries, following WHO recommendation to monitor baseline incidence of intussusception before implementation of immunization program for rotavirus, used intussusception rate as a baseline value to compare the same figures in the period before and after introduction of vaccination. In this study, data of intussusception hospitalizations occurred among Italian children aged 0 through 59 months from 2009 to 2014 were analyzed. A total amount of 3,088 children were included, accounting for a hospitalization rate of 20.2 per 100,000. Overall, the hospitalization rate for intussusception had a slight increase in trend from 2009 to 2014 (18%). In particular children 0-11 months had a hospitalization rate higher than 12-59 months with an aggregate value of 36 Vs. 16 per 100,000 respectively. Among all children hospitalized for intussusception a total of 239 (7.7%) had also a previous or concomitant hospitalization for gastroenteritis. This study demonstrates that Italian hospitalizations for intussusception are increasing by time and the role played by different risk factors, including acute gastroenteritis, have to be investigated in the future. These data could be useful to monitor intussusception hospitalization in the perspective of anti-rotavirus vaccination introduction in Italy.

Vaccine knowledge of the general population is shaped by different information sources and strongly influences vaccination attitudes and uptake. The CCM-Italian Ministry of Health ESCULAPIO project attempted to identify the role of such information sources, in order to address adequate strategies to improve information on vaccines and vaccine preventable diseases. In the present study, data on 632 adults from Southern Italy regarding information sources were collected, and their perceived and actual knowledge on vaccinations were compared and analyzed in relation to socio-demographic characteristics and information sources. The main reported reference sources were general practitioners (GPs) (42.5%) and pediatricians (33.1%), followed by mass media (24.1%) and the Internet (17.6%). A total of 45.4% reported they believed to be informed (45.4%), while those estimated to be truly informed were 43.8%. However, as showed in the multivariate logistic regression, people having the perception to be correctly informed ascribed their good knowledge to their profession in the health sector (Adj OR 2.28, CI 1.09-4.77, p < 0.05) and to friends/relatives/colleagues (AdjOR 6.25, CI 2.38-16.44, p < 0.001), while the non-informed population thought the responsibility had to be attributed to mass media (AdjOR 0.45, CI 0.22-0.92, p < 0.05). Those showing the real correct information, instead, were younger (AdjOR 1.64, CI 1.04-2.59, p < 0.05), and their main reference sources were pediatricians (AdjOR 1.63, CI 1.11-2.39, p < 0.05) and scientific magazines (Adj OR 3.39, CI 1.51-7.59, p < 0.01). Only 6% knew the "VaccinarSì" portal, developed to counter the widespred antivaccine websites in Italy. The post-survey significant increase of connections to "VaccinarSi" could be ascribed to the counselling performed during questionnaire administration. Strategies to improve information about vaccination should be addressed to fortifying healthcare workers knowledge in order to make them public health opinion leaders. General population should be provided with correct indications on trustworthy websites on vaccines to contrast false information supplied by anti-vaccinists on their own websites or social networks pages and on the mass media.

As a results of the case report "Post-rotavirus vaccine intussusception in identical twins: a case report" recently published on Human Vaccines & Immunotherapy by La Rosa et al., the principal Sicilian Public Health Authorities decided to specify several points and underline some important details omitted by the authors. In particular, aims to underline the remarkable benefit for Sicilian Regional Health service after the introduction of the rotavirus vaccination. Universal mass vaccination against rotavirus is properly managed by the Regional Health Authorities and is contributing to a consistent increase of public health in the Sicilian pediatric population; any modification of such a program should be based on robust scientific evidences. Finally, a single case report should not be considered as a basis to recommend a change in the clinical practice but instead a possible point of start for discussion and research.

Vaccine hesitancy is an important issue to be addressed, due to the risk of decrease of vaccination coverage and consequent control of preventable diseases. While it is not considered a specific determinant, poor or inadequate communication can contribute to vaccine hesitancy and negatively influence vaccination uptake. As a contribution to the ongoing discussion regarding this theme and in the perspective of the implementation of the upcoming national vaccination plan in Italy, the Erice Declaration was drafted by experts in the field of immunization following a 5-day residential, independent workshop regarding communication topics in vaccinology. The aim of the current letter is to present to the broader international audience such a contribution, proposing the identification of the main actions that should be taken into account and prioritized in order to improve communication in the domain of vaccination.

Low measles, mumps and rubella (MMR) immunization levels in European children highlight the importance of identifying determinants of parental vaccine uptake to implement policies for increasing vaccine compliance. The aim of this paper is to identify the main factors associated with partial and full MMR vaccination uptake in European parents, and combine the different studies to obtain overall quantitative measures. This activity is included within the ESCULAPIO project, funded by the Italian Ministry of Health. ORs and CIs were extracted, sources of heterogeneity explored and publication bias assessed. Forty-five papers were retrieved for the qualitative study, 26 of which were included in the meta-analysis. The following factors were associated with lower MMR vaccine uptake: misleading knowledge, beliefs and perceptions on vaccines (OR 0.57, CI 0.37-0.87); negative attitudes and behaviors toward vaccination (OR 0.71, CI 0.52-0.98); demographic characteristics, such as different ethnicity in Southern populations (OR 0.44, CI 0.31-0.61), higher child's age (OR 0.80, CI 0.76-0.85); low socio-economic status (OR 0.64, CI 0.51-0.80), especially low income (OR 0.39, CI 0.25-0.60) and education (OR 0.64, CI 0.48-0.84), high number of children (OR 0.54, CI 0.42-0.69), irregular marital status (OR 0.80, CI 0.66-0.96). The factors explaining heterogeneity were country location, administration modality, collection setting and responses reported on MMR alone or in combination. Findings from this study suggest policy makers to focus communication strategies on providing better knowledge, correct beliefs and perceptions on vaccines, and improving attitudes and behaviors in parents; and to target policies to people of ethnic minority from Southern Europe, low educated and deprived, with higher number of children and non-married marital status.

In Italy, the introduction of Universal Varicella Vaccination (UVV) has been decided but postponed, as a national programme, until 2015, when data from Regions which have already implemented it will be available. Starting from 2003, eight Italian Regions (Basilicata, Calabria, Friuli Venezia Giulia, Apulia, Sardinia, Sicily, Tuscany and Veneto) have progressively introduced UVV, in their immunization programme, with different schedules in children aged 13-15 months and 5-6 years, currently a two-dose schedule is adopted by all Regions. In June 2013, an Interregional Group on Varicella Vaccination (IGVV) has been established in order to assess the effectiveness of varicella vaccination with standardized and shared tools. The aim of this study was to evaluate the impact of varicella vaccination on the incidence and hospitalizations due to varicella and its complications in the period 2003-2012 in order to support the Italian decision makers on the future national adoption. Preliminary data showed that a general reduction of incidence and hospitalization rates was observed in the study period, resulting in relevant savings for the National Health Service. Immunization coverage with first dose at 24 months of age was high in all Regions (84%-95%) in 2012. Adverse events due to varicella vaccines were rare and without permanent sequelae. Underreporting of varicella cases and delays in the administration of the first dose of varicella vaccines were the main critical issues. In conclusion, solid evidences in support of universal UVV arise from the experiences available today in Italy.

Introduction: Universal varicella vaccination in Sicily was introduced in infant population since 2003, with a rapidly increasing coverage. Aim of the present study was to analyze changes in the epidemiology of varicella since the introduction of universal vaccination., Methods: The study was performed by analyzing Sicilian administrative/clinical data on varicella case notifications and hospitalizations from 2003 to 2012 (ICD-9-CM discharge diagnosis codes 052 and 052.×). MMR+V and V coverage were also calculated for each birth cohort. Moreover, blood samples drawn in 2013/2014 from general population stratified by age were tested for varicella antibodies., Results: From 2003 to 2012, 15 433 varicella cases were notified with a decreasing temporal trend (1.1/1000 population in 2003 to 0.1/1000 in 2012) (P < 0.001). In the same period, a total of 1145 patients were hospitalized with a diagnosis of varicella, with a 6-fold reduced risk of hospitalization over time (from 4.8 to 0.8/100 000 population per year; P < 0.001). Varicella vaccination coverage rates increased from 40% (2001 birth cohort) to 85% (2010 birth cohort), and inversely correlated with both notification and hospitalization rates (P < 0.001). Finally, 80.0% of subjects enrolled in the seroepidemiological survey were positive for varicella and seroprevalence increased significantly with age in both sexes (P < 0.001)., Discussion: The results show the impact of infant universal varicella vaccination in Sicily. Noteworthy, notifications and hospitalizations for varicella have significantly decreased after the introduction of universal vaccination, confirming the effectiveness of the adopted strategy.

Herpes Zoster (HZ) is a viral disease with painful neuro-dermatologic manifestations. Incidence increases with age. In Italy, the estimated incidence is 6.3 cases/1000 person/year; hospital admissions are less than 2%, 69% in patients aged over 65 years. The most frequent complication of HZ is Post-Herpetic Neuralgia (PHN) characterized by metameric pain, allodynia, and hyperalgesia. In Italy 20.6% and 9.2% of HZ patients experience PHN after 3 and 6 months, respectively. Available antiviral and analgesic treatments are relatively unsatisfactory in reducing pain and length of the disease. Prevention has recently become possible with the live attenuated vaccine Oka/Merck. Clinical studies show a reduction of 51% in the incidence of the disease, 61% of its burden and 67% of PHN in vaccinees. Protection seems to be long lasting and vaccine safety matches registration requirements. Available evidence suggests that the costs for QALY (less than € 20 000) and avoided cases is favorable. Due to the heavy burden of disease, it is time to offer this vaccination to elderly population.

Due to median vaccination coverage far from elimination level, Italy is still an European country with high number of measles cases per million of people. In this study we explored potential socioeconomic, medical and demographic factors which could influence the propensity of family members for measles vaccination schedule. A cross-sectional study was performed through a questionnaire administered to the parents of children who received the first dose of MMR vaccine in two different vaccination centers in the Palermo area from November 2012 to May 2013. Overall, the role played by internet (OR 19.8 P = 0.001) and the large number of children in a family (OR 7.3 P ≤ 0.001) were the factors more associated to be unvaccinated, whereas the birth order of the child (OR 0.3 P = < 0.05 for the oldest children vs. the closer young one) and reporting a lack of MMR vaccination as a "personal decision" (OR 0.19 P ≤ 0.01) inversely correlated with the risk of quitting vaccination. These findings can be useful for a better knowledge of disaffection to vaccination practice in local settings and could contribute to improve and maintain timely uptake, suggesting approaches to optimize the uptake of MMR tailored to the needs of local populations.

Although influenza vaccination is recognized to be safe and effective, recent studies have confirmed that immunization coverage among health care workers remain generally low, especially among medical residents (MRs). Aim of the present multicenter study was to investigate attitudes and determinants associated with acceptance of influenza vaccination among Italian MRs. A survey was performed in 2012 on MRs attending post-graduate schools of 18 Italian Universities. Each participant was interviewed via an anonymous, self-administered, web-based questionnaire including questions on attitudes regarding influenza vaccination. A total of 2506 MRs were recruited in the survey and 299 (11.9%) of these stated they had accepted influenza vaccination in 2011-2012 season. Vaccinated MRs were older (P = 0.006), working in clinical settings (P = 0.048), and vaccinated in the 2 previous seasons (P<0.001 in both seasons). Moreover, MRs who had recommended influenza vaccination to their patients were significantly more compliant with influenza vaccination uptake in 2011-2012 season (P<0.001). "To avoid spreading influenza among patients" was recognized as the main reason for accepting vaccination by less than 15% of vaccinated MRs. Italian MRs seem to have a very low compliance with influenza vaccination and they seem to accept influenza vaccination as a habit that is unrelated to professional and ethical responsibility. Otherwise, residents who refuse vaccination in the previous seasons usually maintain their behaviors. Promoting correct attitudes and good practice in order to improve the influenza immunization rates of MRs could represent a decisive goal for increasing immunization coverage among health care workers of the future.

Streptococcus pneumoniae is a major cause of human infectious diseases worldwide. Despite this documented evidence, data on pneumococcal disease rates among general populations are scant because of the frequent lack of cultural identification. In this study we propose a model for estimating the burden of pneumococcal pneumonia on hospitalizations. The study was performed by analyzing administrative and clinical data of patients aged 50 years or older, resident in Sicily, and hospitalized, from 2005 to 2012. Demographic information, admission/discharge dates, discharge status, and up to 6 discharge diagnoses coded according to ICD-9 CM were collected for each hospitalized patient. During the 8-year study period, a total of 72,372 hospitalizations with at least one ICD-9 CM diagnosis code suggestive of all-cause pneumonia were recorded. Of these, 1943 (2.7%) hospitalizations had specific ICD-9 CM diagnosis codes for pneumococcal pneumonia. According to the proposed model, 16,541 (22.9%) pneumonia out of all-cause pneumonia was estimated to be attributable to S. pneumoniae. Pneumococcal pneumonia and model-estimated pneumococcal pneumonia had mean hospitalization rates of 13.4 and 113.3/100,000, respectively, with a decreasing temporal trend. The risk of hospitalization for pneumococcal pneumonia was strongly correlated with age (P<0.001). Our model provides data usable to construct suitable decisional models for the decision-makers and could allow to the responsibles of healthcare facilities to assess the budget impact if they hypothesize to offer vaccination for pneumococcal disease to certain cohorts of subjects aged 50 years or older. In our area, the high estimated hospitalization rates among adults aged ≥65 years suggest the need to implement effective preventive strategies (e.g., vaccination) tailored for these groups.

Infant vaccination using 2-dose priming at 3 and 5 mo of age with a booster at 11-12 mo of age was pioneered in Italy. The 3-5-11 schedule is now used in a growing number of European countries. Infanrix™ hexa (DTPa-HBV-IPV/Hib, GlaxoSmithKline Vaccines) was first licensed for use in 2000 and has been the only pediatric hexavalent vaccine available since 2005. We reviewed available clinical trial data describing the immunogenicity of DTPa-HBV-IPV/Hib when administered at 3, 5, and 11 mo of age, and conducted an analysis of safety using global and Italian post-marketing surveillance data. In Italy, DTPa-HBV-IPV/Hib has a demonstrated safety record extending over a decade of use, it has been associated with record levels of vaccine coverage, and with sustained disease control in vaccinated cohorts. Hexavalent vaccines will continue to contribute to high vaccine coverage in Italy and across Europe.