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The exchange of knowledge and best practices in adult immunization are essential to improve vaccination strategies across the European region. Italy has made groundbreaking progress in the field, being one of the first countries to propose a life-course vaccination schedule, broadening the traditional focus on childhood immunization to include adults. All vaccines included in Italy's vaccination schedule are free of charge. Moreover, the country's National Immunization Plan sets clear coverage targets, immunization priorities, and actions to reduce disparities. However, the fragmentation of its National Health System following the constitutional reform of 2001 has led to an increased complexity and regional inequalities regarding immunization. Other challenges the country faces include growing vaccine hesitancy, data gaps and underserved populations. This review describes Italy's adult immunization system, from policy to implementation. The successes, challenges and lessons learned were shared during the first Adult Immunization Board country meeting in Italy, where local experts, healthcare providers, public health representatives, and policymakers engaged in collaborative discussions and shared insights through case studies and presentations (December 2023). These insights are reviewed and discussed in this manuscript.

Objectives: We conducted a cost-benefit analysis of the pediatric National Immunization Program (NIP) in Italy., Methods: An economic model evaluated the benefit-cost ratio (BCR) of the Italian pediatric NIP, including 10 pathogens for mandatory vaccines and 4 pathogens for recommended vaccines for children aged 0-10 years from the healthcare-sector and societal perspectives. Separate decision trees were used to model each vaccine-preventable disease (VPD). The 2020 birth cohort ( n  = 420,084) was followed over their lifetime; the model projected and compared discounted disease cases, life-years, quality-adjusted life-years (QALYs), and costs (2021 euros) with and without immunization (based on current and pre - vaccine era disease incidence estimates, respectively)., Results: The pediatric NIP was estimated to prevent 1.8 million cases of VPDs and 3,330 deaths, resulting in 45,900 fewer life-years lost and 57,000 fewer QALYs lost. Vaccination costs of €285 million were offset by disease cost savings of €1.6 billion, resulting in a BCR of 5.6 from a societal perspective (BCR = 1.7 from a healthcare-sector perspective). When QALYs gained were valued, the BCR increased to 15.6., Conclusions: The benefits of the Italian pediatric NIP, including averted disease-related morbidity, mortality, and associated costs, highlight the value of continued investment in pediatric immunization.

Introduction: Diabetic patients are at a higher risk of getting pneumococcal disease and are therefore recommended to get vaccinated. The aim of our systematic review is the retrieval and analysis of all available evidence on the effect of pneumococcal vaccination on the risk of hospitalization and death in adult patients with diabetes., Research Design and Methods: MEDLINEand EMBASE were searched from inception until January 2023. We included all studies investigating whether pneumococcal vaccination reduces the risk of dying or being hospitalized in diabetic patients. The Newcastle-Ottawa scale was used to assess risk of bias., Results: Only two studies, encompassing a total of 68,246 subjects, were considered eligible for inclusion and of high quality. In both studies polysaccharide pneumococcal vaccination was associated with a reduction of the risk of hospitalization or death in adult diabetic patients (aHR: 0.76 in one study, aOR: 0.97 in the other one). However, in neither of the two included studies the lower risk was statistically significant., Conclusions: Further research is needed due to the potentially major clinical implications for diabetic patients. The results of this systematic review can serve as a foundation for future studies, indicating the importance of continuing research in this area to improve patient outcomes.

Introduction: Two vaccine formulations are available to prevent diphtheria, tetanus, pertussis, and poliomyelitis: the pediatric full-dose (DTaP-IPV) and the reduced dose formulation (dTap-IPV). Different immunization schedules are internationally recommended for the pre-school booster dose., Areas Covered: International and Italian recommendations, scientific evidence on immunogenicity and safety of DTaP/dTap vaccines to support the full dose as a pre-school booster and Italian vaccination coverage (VC) up to adolescence., Expert Opinion: The WHO recommends a '3+1' schedule with DTaP vaccine for primary immunization, followed by a pre-school booster with DTaP or dTap vaccine. In Italy, a '2+1' schedule, with no booster in the second year, and a pre-school booster dose are recommended with DTPa-IPV vaccines. Studies showed a non-inferior immunogenicity in dTap vaccinees in pre-school age; nevertheless, the antibody titers were usually greater in children vaccinated with DTaP, while lower frequencies of adverse events were recorded in children receiving dTap. Italian VCs for pre-school and adolescent boosters have not been satisfactory, which further reduced during the COVID-19 period. In Italy, the pre-school booster offers the last chance to receive a full dose of DTaP vaccine, thus, representing the most suitable intervention to provide lasting protection in children.

Introduction : Influenza can be a significant public health problem. Nevertheless, it is preventable through vaccination. Concerning the pediatric population, the recommendation of influenza vaccination is under-represented in many European countries. The aim of this systematic review is to evaluate the cost-effectiveness of universal childhood vaccination against influenza in Europe. Areas covered : We conducted a systematic review of original article assessing the cost-effectiveness of influenza vaccination by searching PubMed, Embase and Scopus databases for studies in English, starting from January 1 st , 2010 up to October 21 st , 2020. Expert opinion : Our literature review showed that all studies identified highlight that pediatric vaccinations using a live vaccine, especially in the quadrivalent formulation, are cost-effective compared to current vaccinations (elderly and at-risk groups) with TIV or no vaccination. A significant contribution to this positive economic profile is due to the indirect protection. Already many clinical data report the relevant direct and indirect impact of vaccination against influenza for younger subjects. The recent studies collected in this review showed also that the pediatric vaccination is also cost-effective. Therefore, decision-makers should now consider this new favorable evidence.

Both our research and that published by Sticchi et al. on immunological memory against hepatitis B virus (HBV) in health-care workers (HCWs) vaccinated as infants or adolescents confirm that in those testing negative after the primary course, one additional (fourth) booster dose is able to elicit an anti-HBs response in >85% subjects. The fifth and the sixth doses further contribute substantially to a high overall response rate. The rate of subjects showing an anamnestic response after the booster dose was almost six-fold higher in HCWs compared to chronic patients. Since universal vaccination in Italy resulted in a significant decrease in HBV infections, special attention and testing should be addressed to those affected by chronic diseases.

Introduction: Italy (in pilot regions) and Germany (nationwide) were the first European countries to introduce universal varicella vaccination (UVV) programs., Areas Covered: A systematic review was performed to assess varicella epidemiology before UVV programs and the impact of 1-dose and 2-dose UVV programs in Italy and Germany., Expert Opinion: Italy implemented 1- or 2-dose UVV programs successively in eight pilot regions between 2003 and 2011 and nationwide in 2017. Germany implemented 1- and 2-dose UVV programs in 2004 and 2009, respectively. While Italy had two nationwide surveillance systems in place for varicella in the pre-vaccination era, in Germany, a mandatory notification system for varicella was only introduced in the New Federal States 2 years before the 1-dose UVV implementation. Substantial reductions in moderate/severe varicella and varicella-related hospitalization incidence occurred during the 1-dose era. Further reductions were reported in Italy and Germany after the recommendation of a second dose in a long or short schedule, respectively. Different benefit-risk evaluations of a tetravalent varicella-containing vaccine (MMRV) used as a first dose led to different recommendations (MMRV versus MMR+V) in these countries. Vaccination strategies in both countries tailored to country-specific needs and goals led to a reduction in varicella-related health care hospitalization costs.

Simultaneous administration of different vaccines is a strategy to increase the possibility to receive vaccines at appropriate age, safely and effectively, reducing the number of sessions and allowing a more acceptable integration of new vaccines into National Immunization Programs (NIPs). Co-administration can be performed when there are specific indications in the Summary of Product Characteristics (SmPC) of the vaccines; but, in absence of these indications, the practice is possible if there are no specific contraindications nor scientific evidence to discourage simultaneous administration. The aim of this work is to review the safety and efficacy of co-administration of the tetravalent measles, mumps, rubella, and varicella (MMRV) and the meningococcal C (Men C) conjugate vaccines after 12 months of age. Several studies demonstrated that MMRV and Men C conjugate vaccines can be administered concomitantly without a negative impact on the safety and immunogenicity of either vaccines, inducing highly immunogenic responses.

Healthcare workers (HCWs) are considered high-risk subjects for Hepatitis B Virus (HBV) infection due to occupational exposure to blood and body fluids. Vaccination represents the core strategy for HBV infection prevention. Following our previous publication on this topic, we aimed to assess the effectiveness of booster vaccine doses in eliciting the immunological response in seronegative (<10 mIU/mL) HCWs and students of Careggi Teaching Hospital, Florence (Italy). All subjects received primary vaccination course, and they were tested for serum anti-HBs antibodies. In seronegative subjects, a challenge dose of vaccine was administered and the test was repeated 1 month later. Six hundred and ninety-eight (87.8%) of 795 HCWs and students tested responded to the challenge dose. After this challenge dose, males more often had negative anti-HBs titer compared with females (15.9% vs 10.2%; p < .05). The completion of the second vaccination course was offered to subjects with persistently negative anti-HBs titer. 76.2% (32) of those who accepted the fifth dose, and 3 of the 5 who accepted the sixth dose seroconverted. This report shows the importance to convey a strong message to negative subjects at the initial anti-HBs dosage: accepting all the three additional vaccine doses allows the vast majority of them to obtain protection.

Introduction : Vaccination is a crucial tool for the primary prevention of infectious diseases. Thanks to widespread vaccination, in the last century smallpox has been eradicated, and the Americas and Europe have become polio-free. Areas covered : The aim of our study was to assess vaccination coverage in childhood up to booster preschool age in order to update the analysis on European trends of immunization coverage in the last nine years (2009-2017) and to assess the impact of different national policies on vaccine uptake. Expert opinion : Despite the good results, several EU countries are going through unprecedented outbreaks of vaccine-preventable diseases due to insufficient coverage. The increase of vaccine hesitancy has made it difficult to reach and maintain high rates of vaccination coverage. Enforcing mandatory vaccinations is one of the strategies adopted by some countries, like Italy and France, to increase coverage. However, each country should find the most suitable way to keep up with vaccination coverages according to own cultural and organizational background.

Introduction : Influenza vaccination is recommended for caregivers of elderly people. In a study aimed at assessing the level of health literacy (HL) in a sample non-familial caregivers in the Florence Health District (Tuscany), data were collected regarding access and adherence to the flu vaccination campaigns. Methods : The sample consists of 47 non-familial paid caregivers. We collected information regarding socio-demographic characteristics, services provided and daily work time, whether or not influenza vaccination was administered for the 2016/2017 season and in the previous three years. The level of HL was assessed through the Newest Vital Sign. Results : 63.8% of non-familial caregivers have not joined the flu campaigns over the last four years, 14.9% have been vaccinated only sometimes (in some epidemic seasons), and 21.3% have received a flu shot in all the seasons investigated. Most of the non-familial caregivers who do not get vaccinated (27.7%) do not perceive that they are in direct contact with a person at-risk; those who get the vaccine regularly (12.8%) reported they want to protect the assisted person as motivation for vaccine uptake. Vaccination was not associated with HL. Conclusion : Adhesion to anti-flu vaccination campaigns for these homecare workers has been resulted rather poor. Coverage does not seem to be related with HL level. It seems appropriate to promote extensively flu vaccination among family carers by actively offering the vaccination in appropriate forms, places and times, to avoid serious consequences on elderly people with higher risk of comorbidity and frailty.

Influenza is one of the major infectious causes of excess mortality, hospitalization, and an increase in healthcare expenditure in all countries. In an increasingly ageing population, many members are exposed to flu-related complications. Vaccination coverage rates for the elderly in most European countries, such as Italy, are not satisfactory, and have been decreasing with time due to a sense of skepticism toward vaccination. Nowadays, many types of vaccines are available on the Italian market to prevent influenza illness. Many studies have proven their effectiveness in preventing influenza-related complications in specific risk groups. Any vaccine can be crucial to avoid complications, hospitalizations and death, but use of the most appropriate vaccine could optimize the result at a very modest cost. General practitioners (GPs) should encourage their patients to take the influenza vaccination to prevent complications or deaths. Health authorities should give GPs the opportunity to choose the appropriate vaccines tailored to specific patients.

This systematic review describes the current relationship between health literacy (HL) and vaccination (including attitude to vaccines, intention to vaccinate, and vaccine uptake). The aim is to comprehend the role of HL as a determinant of vaccine hesitancy. For this purpose, the following databases were explored from 1 January 2007 to 15 January 2017: PubMed, Embase, PsycINFO, ERIC, Health Evidence, Centre for Reviews and Dissemination, Scopus, Web of Science, and Cochrane Library. Nine studies were included in the final synthesis. The role of HL in predicting vaccine hesitancy or acceptance seems to be influenced by a few key factors. These include country, age, and type of vaccine. However, the relationship between HL and vaccination remains unclear. New research studies are needed-particularly longitudinal ones that use multiple measurement tools. This would facilitate a better understanding of the role of HL in predicting vaccine uptake.

Objectives: Periodical assessments of population susceptibility to polioviruses (PV) is essential for evaluating population protection and planning appropriate vaccination strategies. The aim of the current work was to assess serological protective titers against all three polioviruses in the general population of Florence., Methods: A convenience sample of 328 sera, collected in 2009 in Florence (Central Italy) was analyzed. Samples were considered protective if neutralizing antibodies were detected at dilutions ≥1:8, according to the WHO protocols., Results: The immune coverage was 75.3%, 69.2% and 46% for PV1, PV2 and PV3, respectively. The protective titers of neutralizing antibodies were generally higher in children up to 14 years of age, with 74.4% (PV1), 75.6% (PV2) and 56.7% (PV3) of seroprevalence. From the age of 11 years, most of the study subjects were seronegative for PV3., Conclusions: In a polio-free country with strong migration pressures, such as Italy, our results bring clear support to the recent recommendation of Italian health authorities to introduce a fifth dose of IPV vaccine in adolescence all over the country.

Asplenic or hyposplenic (AH) individuals are particularly vulnerable to invasive infections caused by encapsulated bacteria. Such infections have often a sudden onset and a fulminant course. Infectious diseases (IDs) incidence in AH subjects can be reduced by preventive measures such as vaccination. The aim of our work is to provide updated recommendations on prevention of infectious diseases in AH adult patients, and to supply a useful and practical tool to healthcare workers for the management of these subjects, in hospital setting and in outpatients consultation. A systematic literature review on evidence based measures for the prevention of IDs in adult AH patients was performed in 2015. Updated recommendations on available vaccines were consequently provided. Vaccinations against S. pneumoniae, N. meningitidis, H. influenzae type b and influenza virus are strongly recommended and should be administered at least 2 weeks before surgery in elective cases or at least 2 weeks after the surgical intervention in emergency cases. In subjects without evidence of immunity, 2 doses of live attenuated vaccines against measles-mumps-rubella and varicella should be administered 4-8 weeks apart from each other; a booster dose of tetanus, diphtheria and pertussis vaccine should be administered also to subjects fully vaccinated, and a 3-dose primary vaccination series is recommended in AH subjects with unknown or incomplete vaccination series (as in healthy people). Evidence based prevention data support the above recommendations to reduce the risk of infection in AH individuals.

Streptococcus pneumoniae is the main causative organism of acute media otitis in children and meningitis and bacterial pneumonia in the community. Since 2008 in Tuscany, central Italy, the pneumococcal conjugate vaccine (7-valent vaccine, switched to 13-valent vaccine in 2010) was actively offered free of charge to all newborns. Aim of the study is to evaluate the impact of pneumococcal pediatric vaccination in the Tuscan population on hospitalizations potentially caused by S. pneumoniae, during pre-vaccination (PVP, 2002-2007) and vaccination period (VP, 2009-2014). We analyzed hospital discharge records (HDRs) of all hospitals in Tuscany from 2002 to 2014. Hospitalizations potentially due to pneumococcal diseases were 347, 221. The general hospitalization rate was 716/100,000 inhabitants during PVP and 753/100,000 in VP, with a decrease of 29.1% in the age-group 0-9 y ("target" of the vaccination program) and an increase of 75.7% in subjects >64 y of age. During VP, admission days and hospitalization costs increased (6.2% and 24.2%, respectively), especially in patients >64 y (12.9% and 33.8%, respectively); in children <10 y decreased by 21.2% and 12.8%, respectively. The pneumococcal pediatric vaccination resulted in the decrease of hospitalizations in younger but the expected indirect effect in the elderly was not reported, justifying the Tuscan recommendation to extend the vaccination to subjects > 64 y.

Many evaluations have been performed on the economic impact of pneumococcal vaccination in older adults (>64 y of age) in several countries, including Italy. However, these studies did not include the new data on the effectiveness of 13-valent conjugate pneumococcal vaccine (PCV13) in the elderly reported by the CAPiTA Study. The aim of the present study was to update our previous budget impact analysis of multi-cohort PCV13 vaccination in adults in Italy by including new scientific evidence. We also compared single-cohort vaccination strategies per year, in order to identify the cohort with the most favorable economic profile, in the event of the multi-cohort approach not being economically sustainable for the National Health System (NHS). The new impact analysis highlights that the vaccination of one, two or three adult cohorts per year in Italy would lead to a considerable reduction in pneumococcal disease and its related costs over 5 y. The strategies proved cost-effective (ICERs ranging from €14,605 to €15,412/QALY), i.e. well below the threshold of €50,000/QALY. The ICERs were slightly lower than those calculated in the first published analysis and vaccination continued to be economically favorable. In the case of a mono-cohort strategy, the vaccination of 65-year-old subjects, albeit more expensive, proved to be more favorable than the vaccination of 70- or 75-year-old cohorts. Finally, after the inclusion of the recent clinical evidence, the age-based PCV13 vaccination of the elderly in Italy continued to be economically justified from the NHS perspective in the short period. Vaccination of the elderly should therefore be strongly recommended nationwide in Italy.

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.

Herpes zoster (HZ) is a very relevant pathology among elderly people (≥ 60 years of age), with a considerable disease burden and loss of quality of life. In the last years a new vaccine against HZ became available in Italy. Therefore, the Italian decision makers are now confronted with the decision whether that vaccination should be implemented. Pharmaco-economic analyses represent useful tools to value the feasibility of new immunization programs and their sustainability. To this aim, an ad hoc population model was developed in order to value the clinical and economic impact of HZ vaccination program for the elderly in Italy. Particularly, different immunization scenarios were modeled: vaccination of 60 years-old subjects (single cohort strategy), simultaneous vaccination of people aged 60 and 65 years (double cohort strategy) and, lastly, immunization of people aged 60, 65 and 70 years (triple cohort strategy), thus leading to the vaccination of 5, 10 and 15 cohorts during the first 5 years of the program. The mathematical model valued the clinical impact of vaccination on the number of HZ, post-herpetic neuralgia (PHN) and ophthalmic HZ. The results of the analysis show that, in Italy, a cohort-based HZ vaccination program in elderly could have a relevant impact on the reduction of clinical cases and a favorable economic profile for the National Health Service (NHS), as already foreseen in other countries. In addition, further benefits could be obtained when extending the study period beyond the 5-year horizon of our analysis.

Introduction: Pneumococcal infection is a public health concern that disproportionately affects the young, the elderly, and the immunocompromised. There is an open debate on the implementation of polysaccharide and/or conjugate vaccines for pneumococcal diseases in adults and the elderly in many countries. The aim of this paper is to systematically review the economic profile of pneumococcal vaccines in adults in terms of costs and benefits. Areas covered: The search for economic studies on pneumococcal vaccination was carried out in Pubmed, Embase, Scopus, and the HTA and NHS EED databases and through a manual search in journals dealing with economic evaluations. We included original articles and reviews with economic evaluation of polysaccharide 23-valent (PPV23) and/or conjugate pneumococcal vaccine 13-valent (PCV13) use in adults, the elderly, and at-risk groups to provide a systematic review of economical evaluation. Expert commentary: Pneumococcal vaccination is strongly recommended for all adults, especially subjects at risk and the elderly. Pneumococcal vaccination with PCV13 or PPV23 in adults is good value for money and should be a priority for the decision-makers. The main issue is how vaccination could be offered.

Herpes Zoster (HZ) and its main complication, post-herpetic neuralgia (PHN), represent important public health issues because of their relevant burden among older adults. However, data on the epidemiology of HZ and PHN in Italy are very limited. A population-based study was performed by seeking for cases of HZ and PHN, occurred in the period 2013-2015, in the clinical charts of 56 General Practitioners working in 4 Italian Regions (Liguria, Puglia, Toscana and Veneto). The main objective of the study was to estimate the incidence of HZ and the proportion of PHN (at 1 and 3 mo from the onset of HZ; PHN1 and PHN3) among people aged ≥ 50 y. Overall, 598 cases of HZ were identified over 93,146 person-years of observation, thus corresponding to an overall incidence of 6.42 (IC95%: 5.93 - 6.95) HZ cases per 1,000 person-years. The incidence of HZ increased with age and was higher in female than in male. In total, 22.7%, 12.7%, and 2.4% of HZ cases suffered PHN at 1 and 3 mo and 1 y from the onset of acute episode. The proportions of these complications significantly increased with age, with the peak occurring in people aged ≥ 85 y. Four per cent of patients suffered ophthalmic zoster. The study provided an update of the epidemiological burden of HZ and PHN in Italy, confirming the relevant burden of the disease in the elderly population. The study was funded by the Italian Ministry of Health, Center for Disease Prevention and Control (CCM) in 2013.

Given the growing use and great potential of mobile apps, this project aimed to develop and implement a user-friendly app to increase laypeople's knowledge and awareness of invasive pneumococcal disease (IPD). Despite the heavy burden of IPD, the documented low awareness of IPD among both laypeople and healthcare professionals and far from optimal pneumococcal vaccination coverage, no app specifically targeting IPD has been developed so far. The app was designed to be maximally functional and conceived in accordance with user-centered design. Its content, layout and usability were discussed and formally tested during several workshops that involved the principal stakeholders, including experts in IPD and information technology and potential end-users. Following several workshops, it was decided that, in order to make the app more interactive, its core should be a personal "checker" of the risk of contracting IPD and a user-friendly risk-communication strategy. The checker was populated with risk factors identified through both Italian and international official guidelines. Formal evaluation of the app revealed its good readability and usability properties. A sister web site with the same content was created to achieve higher population exposure. Seven months after being launched in a price- and registration-free modality, the app, named "Pneumo Rischio," averaged 20.9 new users/day and 1.3 sessions/user. The first in-field results suggest that "Pneumo Rischio" is a promising tool for increasing the population's awareness of IPD and its prevention through a user-friendly risk checker.

In April 2024, the Adult Immunization Board convened a technical meeting to explore the latest strategies and identify exemplary approaches regarding the implementation of vaccines for adults into Europe's National Immunization Programs (NIPs). The meeting was built around three pillars: decision making for introducing a new vaccine, implementation, monitoring, and evaluation. The increasing number of new vaccines available in a context of competing health priorities warrants transparent and evidence-based decision-making processes for vaccine introduction. In Europe, burden of disease, vaccine efficacy or effectiveness, and safety are universally used decision-making criteria. While economic evaluations and the quality of evidence are being increasingly considered, public acceptance, equity, and operational criteria remain underutilized. Vaccine implementation requires planning and coordination. Implementation activities discussed during the meeting were vaccine program goals, target population identification, communication, training of healthcare professionals, and involvement of pharmacists. Once operational, NIPs are to be monitored in terms of safety, effectiveness, and impact. Implementation science as well as behavioral and cultural insights can be used to identify tangible interventions to improve uptake. Meeting discussions allowed to identify adult vaccine implementation barriers and possible strategies to overcome them. Enhanced cooperation and coordination throughout the Europe region were recognized as critical components of progress.

The 7-valent pneumococcal conjugate vaccine (PCV7) produced a significant herd protection in unvaccinated adult population mostly because of pneumococcus carriage decrease in vaccinated children. It is not known if the 13-valent pneumococcal vaccine can give similar effect on adults. Aims of the work were to evaluate whether the 6 additional serotypes are present in nasopharynx of children and serotype distribution in invasive pneumococcal infections (IPD) in adults. Realtime-PCR was used to evaluate pneumococcal serotypes in adults with confirmed IPD and in nasopharyngeal swabs (NP) from 629 children not vaccinated or vaccinated with PCV7 and resident in the same geographical areas. Two hundred twenty-one patients (116 males, median 67.9 years) with IPD were studied (pneumonia n = 103, meningitis n = 61 sepsis n = 50, other n = 7). Two hundred twelve were serotyped. The most frequent serotypes were 3, (31/212; 14.6%), 19A, (19/212; 9.0%), 12 (17/212; 8.0%), 7F, (14/212; 6.6%). In NP of children, the frequency of those serotypes causing over 50% of IPD in adults was very low, ranging from 0.48% for serotype 7F to 7.9% for serotype 19A. On the other side serotype 5, very frequent in NP (18.7%) caused <1% IPD. In conclusion serotypes causing IPD in adults are very rarely found in children NP. We suggest that herd protection obtainable with the additional 6 serotypes included in PCV13 may be more limited than that demonstrated with PCV7 in the past. In order to reduce the burden of disease in adults, adults should be offered a specific vaccination program with highly immunogenic PCV.

In Italy, between 2003 and 2010, 8/21 Regions recommended varicella routine vaccination (URV). The National Immunization Plan (PNPV) 2012-2014 scheduled the introduction of URV nationwide in 2015, following the results achieved by the eight Regions.   Puglia adopted varicella URV in 2006. This study describes epidemiology and costs of varicella in Puglia between 2003 and 2012. One-dose Vaccine Effectiveness (VE) against varicella of any severity and severe hospitalized cases in children was also evaluated. Vaccination coverage (VC) was estimated from the regional immunization registry. Incidence and hospitalization rates were calculated from computerised surveillance system for communicable diseases and hospital discharge registry (ICD9-CM codes: 052.x), respectively. URV impact was assessed by Incidence Rate Ratios (IIRs) and Hospitalization Risk Ratios (HRRs). Hospitalization costs were also evaluated. VE was estimated using the screening method, where PPV was VC in children aged &lt;72 months and PCV was the proportion of cases vaccinated among notified or hospitalized cases, respectively. One-dose VC in children aged ≤ 24 months increased from 49% in the birth cohort 2006 to 91.1% in the cohort 2010; 2-dose VC was 64.8% and 28.8% in the 2005 and 1997 cohort, respectively. Comparing pre and post-vaccination era, incidence declined from 122.5 ×100 000 in 2003-2005 to 13.7 in 2009-2012 (IRR = 0.11, 95% CI = 0.10-0.12), hospitalization rate from 3.9 ×100 000 to 1.1 (HRR = 0.29, 95% CI = 0.21-0.4), hospitalization costs from 319 000 Euros/year to 106 000. One-dose VE against varicella of any severity and severe hospitalized disease was 98.8% and 99%, respectively. Our findings strongly support varicella URV introduction into the Italian Essential Health Interventions, as scheduled by 2015.

Herpes zoster (HZ) is a disease caused by the reactivation of the latent α-herpes virus varicella zoster virus (VZV), for which, in Italy, a specific surveillance system does not exist, but around 200 000 cases are estimated each year. In older patients, who are at increased risk of developing HZ, symptoms are more severe and the chances to develop postherpetic neuralgia (PHN), the most severe complication, are substantially higher. A vaccine against HZ with demonstrated efficacy and an acceptable safety profile is now available and is recommended in Europe for adults >50 years.   In anticipation of the possible introduction of an immunization programme for the elderly in Tuscany, the burden of disease caused by HZ and its complications was assessed through a retrospective analysis of the hospital discharge records between 2002 and 2012, using the ICD-9-CM 053 code. In the period 2002-2012, 4475 hospital admissions were registered with annual means of 368 hospitalizations and 39 day-hospital admissions. Most of the hospitalizations (68%) involved subjects > 65 years; the mean length of stay was 9.5 days. Slightly more than half (51.2%) of total hospital admissions were complicated cases. The most frequent were neurological complications (24.2% of total admissions), followed by ophthalmic complications (16.5%). Cases with neurological complications were those with the higher average length of stay and higher average costs for case. This study confirmed the epidemiological impact of HZ and its complications and the positive impact on morbidity that the introduction of the HZ vaccination could have in older age groups.

Invasive pneumococcal diseases (IPD) and community acquired pneumonia (CAP) represent two of the major causes of out-patient visits, hospital admissions and deaths in the elderly. In Tuscany (Italy), in the Local Health Unit of Florence, a project aimed at implementing an active surveillance of pneumococcal diseases in the hospitalized elderly population started in 2013. The aim of this study is to show the results of the retrospective analysis (2010-2012) on hospital discharge records (HDRs) related to diseases potentially due to S. pneumoniae, using a selection of ICD9-CM codes. All ordinary hospitalizations (primary and secondary diagnoses) of the elderly population were included (11 245 HDRs). Among a population of about 200 000 inhabitants ≥65 y, the hospitalization rate (HR) increased with increasing age and was higher in males in all age groups. Almost all hospitalizations (95%) were due to CAP, only 5% were invasive diseases. Only few cases of CAP were specified as related to S. pneumoniae, the percentage was higher in case of meningitis (100%) or septicemia (22%). In-hospital deaths over the three-year period were 1703 (case fatality rate: 15%). The risk of dying, being hospitalized for a disease potentially attributable to pneumococcus (as primary diagnosis) increased significantly with age (P < 0.001), the odds ratio (OR) per increasing age year was 1.06 (95% CI 1.05-1.07) and was higher in patients with co-existing medical conditions with respect to patients without comorbidities. Currently, an active surveillance system on S. pneumoniae diseases with the inclusion of bio-molecular tests (RT-PCR), is a key step to assess the effectiveness of the PCV13 vaccine (13-valent pneumococcal conjugate vaccine) in the elderly population after implementation of vaccination policies. The results of this study will provide the comparator baseline data for the evaluation of a possible immunization programme involving one or more cohorts of the elderly in Tuscany.

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.

Background: Health care workers (HCWs) are at risk of infection and transmission of vaccine-preventable infectious diseases. In recent years cases of measles or varicella in health care workers were observed with increasing frequency. The aim of our study was to investigate attitude toward immunization and risk perception of measles, rubella, mumps, varicella, and pertussis in HCWs working in 6 hospitals of Florence (Italy)., Methods: A cross-sectional survey among the physicians, nurses, midwives, and nursing assistants working in selected departments was performed trough a self-administered, anonymous questionnaire. Overall, 600 questionnaires were sent and 436 HCWs' completed forms were included into the study (Participation rate: 72.7%). Data were analyzed with STATA 11.0® and odds ratio (OR) were calculated in a multivariate analysis., Results: Among all respondents 74.9% were females. The average age was nearly 43-years-old (42.9-SD 8.95). The majority of participants (58.6%) were nurses, 21.3% physicians, 12.9% nursing assistants, and 7.2% were midwives. Among those HCWs reporting no history of disease, 52.8% (95% CI: 42.0-63.3%) declared to have been immunized for measles, 46.9% for rubella (95% CI: 39.0-54.9%), 21.6% for mumps (95% CI: 15.1-29.4%), 14.9% for varicella (95% CI: 7.4-25.7%), and 14.5% for pertussis (95% CI: 10.0-20.0%). When considering potentially susceptible HCWs (without history of disease or vaccination and without serological confirmation), less than a half of them feel at risk for the concerned diseases and only less than 30% would undergo immunization. One of the main reasons of the relatively low coverage was indeed lack of active offer of vaccines., Conclusion: Attitudes toward immunization observed in this study are generally positive for preventing some infectious diseases (i.e., measles and rubella), but relatively poor for others (i.e., varicella). More information should be made available to HCWs on the benefits of vaccination and efforts to encourage vaccination uptake should be performed. Educational program on the risk of being infected working in a hospital should be implemented in order to increase the risk perception toward infectious diseases among HCWs.

The aim of this study was to gather data on the safety of the HPV-16/18 AS04-adjuvated vaccine among women aged 25, evaluating the frequency and severity of adverse events reported after vaccination and to compare the results obtained with previously published data regarding a sample of Italian preadolescents. Every woman residing in the province of Florence and in the age group targeted by the cervical cancer screening was invited to participate. Participants registered daily, for 14 d post-vaccination, solicited local and systemic reactions, as well as unsolicited adverse events in a developed ad hoc safety diary card. Data were collected in a database in Access and analyzed using STATA 11 SE statistical software. A total of 271 participants were recruited in the study group. All three diary cards were completed and delivered by 186 subjects (85.7% of participants). In all, a total of 616 diary cards were collected: 216 after the 1st dose, 209 after the 2nd dose and 191 after the 3rd dose. No severe symptoms were registered. The most frequently reported adverse reaction proved to be pain at the site of injection (83.4% of doses), followed by local swelling (20.8%) and pyrexia (14.6%). The safety and tolerability of the HPV-16/18 AS04-adjuvated vaccine in this sample of adult women aged 25 did not differ much from that previously observed in a sample of preadolescents Italian girls. Fever and local pain were however more frequently registered in our sample of adult women.

Italy was one of the first countries in the world to introduce a routine vaccination program against HBV for newborns and 12-y-old children. From a clinical point of view, such strategy was clearly successful. The objective of our study was to verify whether, at 20 y from its implementation, hepatitis B universal vaccination had positive effects also from an economic point of view. An a posteriori analysis evaluated the impact that the hepatitis B immunization program had up to the present day. The implementation of vaccination brought an extensive reduction of the burden of hepatitis B-related diseases in the Italian population. As a consequence, the past and future savings due to clinical costs avoided are particularly high. We obtained a return on investment nearly equal to 1 from the National Health Service perspective, and a benefit-to-cost ratio slightly less than 1 for the Societal perspective, considering only the first 20 y from the start of the program. In the longer-time horizon, ROI and BCR values were positive (2.78 and 2.46, respectively). The break-even point was already achieved few years ago for the NHS and for the Society, and since then more and more money is progressively saved. The implementation of universal hepatitis B vaccination was very favorable during the first 20 y of adoption, and further benefits will be increasingly evident in the future. The hepatitis B vaccination program in Italy is a clear example of the great impact that universal immunization is able to provide in the medium-long-term when health care authorities are so wise as to invest in prevention.

Italy was one of the first industrialized countries to introduce a program of universal vaccination against hepatitis B in 1991. Twenty years later we verified the impact of universal immunisation on the epidemiology of hepatitis B infection by analyzing the prevalence of specific viral markers (anti-HBs, anti-HBc and HBsAg). The ELISA tests were performed on residual blood samples collected by 0.05% of the resident population aged 1-50 years in Tuscany (Italy). About 63% of subjects aged < 30 years were anti-HBs positive compared to about 25% in older subjects, without differences between genders. About 22% of subjects over 40 years were anti-HBc-positive compared to 5% in the younger age groups. The number of HBsAg-positive subjects was almost 10 fold higher in the unvaccinated age groups than in the cohorts involved in the universal vaccination program. The results of our study show the persisting high anti-HBs reactivity in vaccinated cohorts, while HBV markers related to natural exposure or persistent infection remain remarkably higher in older age groups. This sero-epidemiological study supports with prevalence data the downward incidence trend of acute hepatitis B highlighted by epidemiological surveillance systems, and corroborates the forecast for elimination of hepatitis B in Italy in a few decades.

Community-acquired pneumonia (CAP) and invasive pneumococcal disease (IPD) are very relevant pathologies among elderly people (≥ 65 y old), with a consequent high disease burden. Immunization with the 23-valent pneumococcal polysaccharide vaccine (PPV23) has been differently implemented in the Italian regions in the past years, reaching overall low coverage rates even in those with medical indications. In 2010, the 13-valent pneumococcal conjugate vaccine (PCV13) became available and recommended in the universal Italian infant immunization program. Since October 2012, indications for use of PCV13 were extended to subjects ≥ 50 y to prevent invasive pneumococcal diseases. The Italian decision makers should now revise regional indications for the prevention of pneumococcal diseases in the elderly. Pharmaco-economic analyses represent a useful tool to value the feasibility of new immunization programs and their sustainability. Therefore, an ad hoc population model was developed in order to value the clinical and economic impact of an adult pneumococcal vaccination program in Italy.   Particularly, different immunization scenarios were modeled: vaccination of 65 y-olds (1 cohort strategy), simultaneous vaccination of people aged 65 and 70 y (double cohort strategy) and, lastly, immunization of people aged 65, 70 and 75 y (triple cohort strategy), thus leading to the vaccination of 5, 10 and 15 cohorts during the 5 y of the program. In addition, the administration of a PPV23 dose one year after PCV13 was evaluated, in order to verify the economic impact of the supplemental serotype coverage in elderly people. The mathematical model valued the clinical impact of PCV13 vaccination on the number of bacteraemic pneumococcal pneumonia (BPP) and pneumococcal meningitis (PM) cases, and related hospitalizations and deaths. Although PCV13 is not yet formally indicated for the prevention of pneumococcal CAP by the European Medicine Agency (differently from FDA, whose indications include all pneumococcal diseases in subjects ≥ 50 y), the model calculated also the possible impact of vaccination on CAP cases (non-bacteraemic), considering the rate of this disease due to S. pneumoniae. The results of the analysis show that, in Italy, an age-based PCV13 vaccination program in elderly people is cost-effective from the payer perspective, with costs per QALY ranging from 17,000 to 22,000 Euro, according to the adopted vaccination strategy. The subsequent PPV23 offer results in an increment of costs per QALY (from 21,000 to 28,000 Euro, according to the vaccination strategy adopted). Pneumococcal vaccination using the conjugate vaccine turned out to be already favorable in the second year of implementation, with incremental costs per QALY comparable to those of other already adopted prevention activities in Italy (for instance, universal HPV vaccination of 12 y-old girls), with further benefits obtained when extending the study period beyond the 5-y horizon of our analysis.

Despite the launch of a WHO European Region strategic plan 2005-2010 for eliminating measles and rubella and preventing congenital rubella (CR) infection, measles and rubella are still circulating in Europe. Increased transmission and outbreaks of measles in Europe were still observed in 2011. In Italy, the objectives of the National Plan (2003-2007) for measles elimination have not yet been achieved. The goal of measles elimination and incidence reduction of CR cases has been postponed to 2015 by the Italian Ministry of Health through the implementation of the new National Plan 2010-2015 which will require (1) the achievement of more than 95% coverage with 1 dose and two doses of measles containing vaccine (MCV), respectively, within 24 mo and within 12 y of age; (2) supplementary vaccination activities aimed at susceptible populations including adolescents, young adults and those at risk (health care and educational workers, military, groups "hard to reach" like nomads); and in addition, (3) reduction to less than 5% in the proportion of susceptible women of childbearing age (especially immigrant women). Experiences at regional level, like in Tuscany, have shown promising results in order to create an integrated surveillance system between regional and local health authorities, university and laboratory and in the future, to validate elimination. Moreover, the evaluation of all preventive activities performed in Tuscany during the last decade, immunization coverage data, sero-epidemiological population profile and incidence of measles and rubella cases has highlighted critical points which should be improved and good practices already implemented which should be maintained in the future in order to reach the new goals.