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Despite well-established vaccination programs, seasonal influenza is still causing substantial clinical, economic and societal burdens. As part of strategies to continually improve influenza vaccine clinical performance, several new approaches are being examined, including high-dose vaccines, adjuvanted vaccines, egg-free vaccines, nasal spray vaccines and mRNA vaccines. Given this range of influenza vaccines, coupled with various vaccine hesitancy concerns, healthcare professionals' understanding and confidence in the clinical performance of influenza vaccines remain key. In this podcast, we discuss the challenges for healthcare professionals in understanding the clinical performance of influenza vaccines and the importance of education in this area, particularly to address perceptions of influenza vaccine failure. We also explore several elements that should be considered in the assessment of influenza vaccine clinical performance: (1) assessing relevant clinical outcomes, such as hospitalization data, (2) utilizing robust methodology in influenza vaccine trials to ensure high quality evidence and (3) approaches used when considering the full body of evidence., Competing Interests: Declarations Conflict of Interest Dr Nihar Desai declares receipt of consulting fees within the past 36 months (of podcast article submission) from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Merck, Novartis, CSL Behring, CSL Vifor, SC Pharmaceuticals and Verve Therapeutics. Prof Pier Luigi Lopalco declares receipt of consulting fees, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, support for attending meetings and/or travel within the past 36 months (of podcast article submission) from, GSK, Moderna, MSD, Novavax, Pfizer, Sanofi and CLS Seqirus. Ethical Approval This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors., (© 2024. The Author(s).)

Introduction: This study investigates the association between parental attitudes towards mandatory and recommended vaccines in the National Immunization Plan (NIP) of Italy and their acceptance of the COVID-19 vaccine in children aged 5-11 years., Methods: Using data from approximately 42,000 children in Southern Italy, parental attitudes towards previous vaccinations were examined. Mandatory and recommended vaccinations were considered for the analysis, with the first shot of each schedule being considered relevant, regardless of when it was administered or whether the recommended number of doses was administered. A multivariate logistic regression was performed to analyze associations between the covariates of age, sex, adherence to mandatory vaccinations, number of recommended vaccinations, and COVID-19 vaccination., Results: The COVID-19 vaccine acceptance rate was 50.7% in our sample. We revealed a strong association between parental attitudes towards previous vaccinations and the acceptance of the COVID-19 vaccine. Mandatory vaccinations under the NIP showed the highest acceptance rates, and among non-mandatory vaccines, the pneumococcal conjugate vaccine had the highest acceptance rate, potentially due to its co-administration with the hexavalent vaccine. The study identified a trend of lower COVID-19 vaccine coverage in younger children., Conclusions: The study underscores the importance of co-administration approaches and well-planned vaccination schedules in enhancing vaccine coverage. It suggests that integrating newer vaccines, like the COVID-19 vaccine, into established vaccination schedules could potentially increase acceptance and coverage. The findings highlight the urgency of addressing vaccine hesitancy, particularly in the pediatric population, to ensure high vaccination coverage and effective disease control. Further research is needed to explore the potential strategies to increase vaccine acceptance., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Luigi De Angelis reports a relationship with Moderna Inc that includes: travel reimbursement. Alberto Fedele reports a relationship with Seqirus Vaccines Ltd that includes: board membership. Francesco Baglivo reports a relationship with Moderna Inc that includes: travel reimbursement. Francesco Baglivo reports a relationship with AstraZeneca that includes: educational grant. Caterina Rizzo reports a relationship with Seqirus Vaccines Ltd that includes: board membership. Caterina Rizzo reports a relationship with MSD that includes: board membership. Caterina Rizzo reports a relationship with GlaxoSmithKline (GSK) that includes: board membership. Caterina Rizzo reports a relationship with Sanofi that includes: board membership. Caterina Rizzo reports a relationship with AstraZeneca that includes: board membership., (Copyright © 2024 Elsevier India Pvt Ltd. Published by Elsevier Ltd.. All rights reserved.)

Abstract: Japanese encephalitis, caused by the JE virus transmitted by mosquitoes, is the most common type of epidemic encephalitis in Asia. It is endemic in most of South and Southeast Asia, but the number of cases can vary greatly between areas. While many infections do not lead to disease, the symptomatic cases can be very severe and life-threatening. It mainly affects children, whereas adults are generally immune to the disease due to either being infected in childhood or receiving vaccination. However, individuals who are not immune, such as travelers from non-endemic countries, are susceptible to the disease when exposed to the virus for the first time, regardless of age. Without antiviral treatment options, vaccination is the only strategy to establish effective protection against Japanese encephalitis.

Background: It has been shown that COVID-19 affects people at socioeconomic disadvantage more strongly. Previous studies investigating the association between geographical deprivation and COVID-19 outcomes in Italy reported no differences in case-hospitalisation and case-fatality. The objective of this research was to compare the usefulness of the geographic and individual deprivation index (DI) in assessing the associations between individuals' deprivation and risk of Sars-CoV-2 infection and disease severity in the Apulia region from February to December 2020., Methods: This was a retrospective cohort study. Participants included individuals tested for SARS-CoV-2 infection during the study period. The individual DI was calculated employing polychoric principal component analysis on four census variables. Multilevel logistic models were used to test associations between COVID-19 outcomes and individual DI, geographical DI, and their interaction., Results: In the study period, 139,807 individuals were tested for COVID-19 and 56,475 (43.5%) tested positive. Among those positive, 7902 (14.0%) have been hospitalised and 2215 (4.2%) died. During the first epidemic wave, according the analysis done with the individual DI, there was a significant inversely proportional trend between the DI and the risk of testing positive. No associations were found between COVID-19 outcomes and geographic DI. During the second wave, associations were found between COVID-19 outcomes and individual DI. No associations were found between the geographic DI and the risk of hospitalisation and death. During both waves, there were no association between COVID-19 outcomes and the interaction between individual and geographical DI., Conclusions: Evidence from this study shows that COVID-19 pandemic has been experienced unequally with a greater burden among the most disadvantaged communities. The results of this study remind us to be cautious about using geographical DI as a proxy of individual social disadvantage because may lead to inaccurate assessments. The geographical DI is often used due to a lack of individual data. However, on the determinants of health and health inequalities, monitoring has to have a central focus. Health inequalities monitoring provides evidence on who is being left behind and informs equity-oriented policies, programmes and practices. Future research and data collection should focus on improving surveillance systems by integrating individual measures of inequalities into national health information systems., (© 2024. The Author(s).)

Background: Respiratory syncytial virus (RSV), a single-stranded RNA virus, is a leading cause of hospitalization in infants, especially ≤ 2 months of life. In the light new immunization strategies adoption, we described epidemiological and clinical characteristics of RSV-associated hospitalizations in pediatric and neonatal intensive care units of the Policlinico Foggia Hospital, Apulia Region, Italy., Methods: Hospitalized children with a laboratory-confirmed RSV infection from 2011 to 2023 were retrospectively evaluated. Clinical information was collected from Hospital Discharge Registry in the period 2011-2020. The proportion of the hospitalization for acute respiratory infections (ARIs) associated to RSV was calculated and the hospitalization cost was analyzed by using the diagnosis-related group reimbursement rate. The anticipated impact of immunization either with monoclonal antibodies or maternal immunization on the number of hospitalizations was estimated. All analyses and quality assessment were performed using STATA/SE15.0., Results: A total of 1,005 RSV-cases were included in the study, of which 86.3% occurred between December-March. In the period 2011-2020, 832 RSV-cases were matched with the corresponding hospital admissions; 75.2% were aged < 1 year (49.6% 0-2 months). Bronchiolitis was the most frequent admission diagnosis occurring in 63.3% of patients; 25% of children were affected by a very severe RSV-disease. Younger age ≤ 2 months (OR:14.8, 95%CI:8.30-26.31, p = 0.000), higher length-of-hospital-stay (OR:1.01, 95%CI:1.0-1.02, p = 0.030) and history of prematurity (OR:4.4, 95%CI:1.57-12.11, p = 0.005) were associated with a higher disease severity. RSV caused 48.9% of ARIs among children < 1 year. The mean cost of an RSV-associated hospitalization was 3,036 euros/year, with the higher cost in the 0-2 months age group (4,225 euros/year). Immunization programs with nirsevimab could prevent 51.4 RSV hospitalizations/year and 18.1 very severe RSV disease/year in infants < 1 year of age. RSV vaccine could prevent 46.1 of hospitalizations/year caused by RSV within 180 days after birth., Conclusions: Our study contributes to outlining the baseline profile of RSV-associated hospitalizations among Italian children by providing epidemiological/clinical/economic estimates. While awaiting new recommendations on immunization, healthcare-workers should persist in implementing public health measures and appropriate case management to control RSV seasonal epidemics. Strengthened laboratory RSV surveillance is needed to inform the implementation of the new immunization strategies., (© 2024. The Author(s).)

Introduction: The language of medicine is constantly evolving, typically to better describe a new understanding of disease, adjust to changing social sensibilities, or simply to reflect a new drug class or category. We address the need for an updated language around monoclonal antibodies, or "mAbs" - a widely used medical term, but one which is now too general to accurately reflect the range of mAb pharmaceuticals, their effects, and the intended patients., Methods: The question of "what should we call a monoclonal antibody immunisation against respiratory syncytial virus (RSV) to ensure accurate understanding of the product?" was the basis for a virtual advisory panel in May 2022. The panel was convened by Sanofi with the intention of reviewing appropriate language in terminology in the context of mAb-based prophylaxis for RSV. The panel comprised several global experts on RSV and vaccination, a trained linguist specialising in doctor-patient interactions and medical language, and several experts in marketing and communications., Results: We suggest the term "Direct Long-acting Antibody" (DLA) for a specific sub-class of mAbs for use in prevention of RSV disease in infants. This terminology should differentiate from other mAbs, which are generally not used as therapies in infants., Discussion and Conclusions: This change will more accurately convey the specific mode of action of a mAb in infants, and how it could impact the prevention of communicable diseases: this class of mAbs is not an active treatment, but rather will offer direct and rapid protection lasting at least 5 months., Competing Interests: Pier Luigi Lopalco: Advisory Board Participation & Honoraria for Lectures and other Training activities from GSK, Moderna, MSD, Pfizer, Sanofi, Seqirus. Susanna Esposito: Advisory Board Participation & Honoraria for Lectures. GSK, Janssen, Pfizer, Moderna, MSD, Qiagen, Sanofi, Genzyme, Janssen. Federico Martinón-Torres Received honoraria from GSK group of companies, Pfizer Inc, Sanofi Pasteur, MSD, Seqirus, Biofabri and Janssen for taking part in advisory boards and expert meetings and for acting as a speaker in congresses outside the scope of the submitted work. FM-T has also acted as principal investigator in randomised controlled trials of the above-mentioned companies as well as Ablynx, Gilead, Regeneron, Roche, Abbott, Novavax, and MedImmune, with honoraria paid to his institution. Jacqui Thornton Communications Ltd. Received honoraria from Sanofi, Ipsen, Angelini Pharma, PTC Therapeutics, AbbVie and Indivior for moderating events and training work. Todd Wolynn Received honoraria from Merck, Sanofi Pasteur, Mordera, Novavax, Seqirus, Pfizer for speaker events and in a consultant capacity. Giovanni Checcucci Lisi and Kocfa Chung-Delgado are employed by Sanofi and may hold shares and/or stock options in the company, a company that may be affected by the research reported in the enclosed paper. Stephanie Evans, Amit Patel, Claire Fellingham, Ben Pounds, Charlotte Harris and Tapas Mukherjee are employees of Havas Lynx Group, which was paid by Sanofi to facilitate the working group session described herein, and contribute to this manuscript. Brad Davidson is an employee of Havas Health & You, and was a paid consultant to Sanofi in connection with developing new language of mAbs and with the development of this manuscript., (©2024 Pacini Editore SRL, Pisa, Italy.)

Introduction: Influenza causes significant morbidity and mortality, but influenza vaccine uptake remains below most countries' targets. Vaccine policy recommendations vary, as do procedures for reviewing and appraising the evidence., Areas Covered: During a series of roundtable discussions, we reviewed procedures and methodologies used by health ministries in four European countries to inform vaccine recommendations. We review the type of evidence currently recommended by each health ministry and the range of approaches toward considering randomized controlled trials (RCTs) and real-world evidence (RWE) studies when setting influenza vaccine recommendations., Expert Opinion: Influenza vaccine recommendations should be based on data from both RCTs and RWE studies of efficacy, effectiveness, and safety. Such data should be considered alongside health-economic, cost-effectiveness, and budgetary factors. Although RCT data are more robust and less prone to bias, well-designed RWE studies permit timely evaluation of vaccine benefits, effectiveness comparisons over multiple seasons in large populations, and detection of rare adverse events, under real-world conditions. Given the variability of vaccine effectiveness due to influenza virus mutations and increasing diversification of influenza vaccines, we argue that consideration of both RWE and RCT evidence is the best approach to more nuanced and timely updates of influenza vaccine recommendations.

During COVID-19 vaccination campaign, possible ChAdOx1-S-associated risks of thrombosis with thrombocytopenia syndrome led to implement ChAdOx1-S/BNT162b2 heterologous vaccination, despite the limited information on its reactogenicity and safety. We conducted a prospective observational post-marketing surveillance study to assess the safety of this heterologous schedule. A casually selected sample of recipients (n: 85; age: 18-60 years) of ChAdOx1-S/BNT162b2 at the vaccination hub of the Foggia Hospital, Italy, was matched with an equal sample of recipients of homologous BNT162b2. Safety was evaluated 7 days, 1 month and 14 weeks after the primary vaccination series using an adapted version of the "V-safe active surveillance for COVID-19 vaccine safety" CDC standardized questionnaire. After 7 days, local reactions were highly frequent (>80%) in both groups, and systemic reactions were less common (<70%). Moderate or severe pain at the injection site (OR = 3.62; 95%CI, 1.45-9.33), moderate/severe fatigue (OR = 3.40; 95%CI, 1.22-9.49), moderate/severe headache (OR = 4.72; 95%CI, 1.37-16.23), intake of antipyretics (OR = 3.05; 95 CI%, 1.35-6.88), inability to perform daily activities and work (OR = 2.64; 95%CI, 1.24-5.62) were significantly more common with heterologous than homologous vaccination. No significant difference in self-reported health status was recorded 1 month or 14 weeks after the second dose with BNT162b2 or ChAdOx1-S/BNT162b2. Our study confirms the safety of both heterologous and homologous vaccination, with a slight increase in some short-term adverse events for the heterologous regimen. Therefore, administering a second dose of a mRNA vaccine to the recipients of a previous dose of viral vector vaccine may have represented an advantageous strategy to improve flexibility and to accelerate the vaccination campaign.

The decline in children's vaccination coverage and the resurgence of preventable infectious diseases draw attention to parents' vaccine hesitancy. Our study introduces two validated tools to independently assess vaccine hesitancy and health literacy among parents with school-age children. We developed a Vaccine Confidence Index (VCI) from 10 Likert items, exploring their relationships through exploratory and confirmatory factor analyses. We modified the IMETER (Italian medical term recognition test) to measure health literacy. We assessed the internal consistency of the modified IMETER and the 10 Likert items using Cronbach's alpha test (α) and McDonald's omega total coefficient (ω) with good results (ω = 0.92, α = 0.90; ω = 0.87, α = 0.82 respectively). We used these tools within a questionnaire conducted on 743 parents recruited from pediatric clinic waiting rooms in Italy, collecting demographic data, information sources on vaccines and vaccine-preventable diseases knowledge. The VCI resulting from factor analyses consisted of six items on a ten-point Likert scale, reflecting the ratio of positive to negative items. The survey revealed significant variations in the VCI according to individual features such as education, use of social networks, or Health institutions as sources of information. Multivariate logistic regression identified an association between vaccine intention and the VCI. Health literacy was functional for 91.2% of participants, but knowledge about vaccine-preventable diseases was generally low. The VCI showed no significant association with health literacy and vaccine-preventable diseases knowledge. The VCI and the modified IMETER effectively assess vaccination attitude and health literacy, offering valuable public health tools for tailoring vaccination campaigns to hesitant population subgroups.

In Europe, National Immunisation Technical Advisory Groups (NITAGs) were established in most countries to promote evidence-informed decision-making in introducing new or improved vaccines or changing recommendations for existing ones. Still, the role, activities and outcomes of NITAGs have not been optimally implemented across Europe. Within the European Joint Action on Vaccination (EU-JAV), we conducted a survey to collect information on decision-making process including the main criteria for the introduction of new vaccines or changes to recommendations on their use. Between December 2021 and January 2022, 13 of the 28 European countries invited participated in an online survey. The criteria ranked as most relevant were disease burden and availability of financial resources. Only one country specified that the NITAG recommendations were binding for the government or the health authority. Vaccinations more often reported for introduction or recommendation changes were those against herpes zoster, influenza, human papillomavirus infection, pneumococcal and meningococcal disease. The planned changes will mainly address children and adolescents (2-18 years) and adults (≥ 45-65 years). Our findings show potential overlaps in the activities of NITAGs between countries; and therefore, collaboration between NITAGs may lead to optimisation of the workload and better use of resources.

Objective: To evaluate the impact of the health educational program "Igiene Insieme 2021/2022" on Italian primary school children's knowledge, attitudes and practice of hygiene and sanitation and to compare incidence of SARS-CoV-2 in schools participating the project with regional data of Lombardy and Apulia., Methods: Participating schools were provided with a hygiene kit containing educational material for teachers and sanitizing products for students. We conducted a pre-post evaluation administering a questionnaire before and after the intervention. In addition, we compared SARS-CoV-2 incidence of the participating primary schools (225 in Lombardy and 120 in Apulia) to regional-level data. We tested the differences between groups by using the Chi-squared test., Results: Of 1,991 schools, 472 responded to both questionnaires for a total of 16,988 students. 17.3% of the students learned the importance of handwashing in preventing infections, 22.6% when to wash hands, 18.5% the existence of alternative solutions in absence of soap and water, 23.2% how to correctly wash hands. A lower incidence of SARS-CoV-2 infections was recorded in primary schools participating in the project as compared to the average regional incidence in Lombardy (9.6% vs.14.8%) and Apulia (10.7% vs.12.0%) for the same age group., Conclusions: We report an overall positive effect of health education interventions in primary schools. Although the limitations in the study design, our findings are important to inform planning, implementation and monitoring of health promotion campaigns in young generations so as to contribute to limit the risk of infection spread at the community level.

Rare Disease patients manifested high concern regarding the possible increased risk of severe outcomes and worsening of disease-specific clinical manifestation due to the impact of COVID-19. Our aim was to assess the prevalence, outcomes, and impact of COVID-19 in patients with a rare disease such as Hereditary Hemorrhagic Telangiectasia (HHT) in Italian population. A nationwide, multicentric, cross-sectional observational study was conducted on patients with HHT from five Italian HHT centers by online survey. The association between COVID-19-related signs and symptoms and nosebleeds worsening, the impact of personal protective equipment on nosebleeds pattern, and the relationship between the presence of visceral AVMs and severe outcomes were analyzed. Out of 605 total survey responses and eligible for analysis, 107 cases of COVID-19 were reported. A mild-course COVID-19 disease, not requiring hospitalization, was observed in 90.7% of patients, while the remaining eight cases needed hospitalization, two of them requiring intensive-care access. No fatal outcome was recorded and 79.3% of patients reported a complete recovery. No difference in infection risk and outcome between HHT patients and general population was evidenced. No significative interference of COVID-19 on HHT-related bleeding was found. The majority of patients received COVID-19 vaccination, with relevant impact on symptoms and need for hospitalization in case of infection. COVID-19 in HHT patients had an infection profile similar to the general population. COVID-19 course and outcome were independent from any specific HHT-related clinical features. Moreover, COVID-19 and anti-SARS-CoV-2 measures did not seem to affect significantly HHT-related bleeding profile., (© 2023. The Author(s).)

Aim: Long-term-care facility residents are a vulnerable population who experienced reduced healthcare access during the pandemic. This study aimed to assess the indirect impact of the COVID-19 pandemic, in terms of hospitalisation and mortality rates, among this population in two Italian Regions, Tuscany and Apulia, during 2020 in comparison with the pre-pandemic period., Subject and Methods: We conducted a retrospective cohort study on people residing in long-term-care facilities from 1 January 2018 to 31 December 2020 (baseline period: 1 January 2018-8 March 2020; pandemic period: and 9 March-31 December 2020). Hospitalisation rates were stratified by sex and major disease groups. Standardised weekly rates were estimated with a Poisson regression model. Only for Tuscany, mortality risk at 30 days after hospitalisation was calculated with the Kaplan-Meier estimator. Mortality risk ratios were calculated using Cox proportional regression models., Results: Nineteen thousand two hundred and fifty individuals spent at least 7 days in a long-term-care facility during the study period. The overall mean non-Covid hospital admission rate per 100 000 residents/week was 144.1 and 116.2 during the baseline and pandemic periods, with a decrease to 99.7 and 77.3 during the first (March-May) and second lockdown (November-December). Hospitalisation rates decreased for all major disease groups. Thirty-day mortality risk ratios for non-Covid conditions increased during the pandemic period (1.2, 1.1 to 1.4) compared with baseline., Conclusion: The pandemic resulted in worse non-COVID-related health outcomes for long-term-care facilities' residents. There is a need to prioritise these facilities in national pandemic preparedness plans and to ensure their full integration in national surveillance systems., Supplementary Information: The online version contains supplementary material available at 10.1007/s10389-023-01925-1., Competing Interests: Conflicts of interestThe authors have no competing interests to declare that are relevant to the content of this article., (© The Author(s) 2023.)

Background: COVID-19 has been characterised by its global and rapid spread, with high infection, hospitalisation, and mortality rates worldwide. However, the course of the pandemic showed differences in chronology and intensity in different geographical areas and countries, probably due to a multitude of factors. Among these, socio-economic deprivation has been supposed to play a substantial role, although available evidence is not fully in agreement. Our study aimed to assess incidence and fatality rates of COVID-19 across the levels of socio-economic deprivation during the first epidemic wave (March-May 2020) in the Italian Province of Foggia, Apulia Region., Methods: Based on the data of the regional active surveillance platform, we performed a retrospective epidemiological study among all COVID-19 confirmed cases that occurred in the Apulian District of Foggia, Italy, from March 1st to May 5th, 2020. Geocoded addresses were linked to the individual Census Tract (CT) of residence. Effects of socio-economic condition were calculated by means of the Socio-Economic and Health-related Deprivation Index (SEHDI) on COVID-19 incidence and fatality., Results: Of the 1054 confirmed COVID-19 cases, 537 (50.9%) were men, 682 (64.7%) were 0-64 years old, and 338 (32.1%) had pre-existing comorbidities. COVID-19 incidence was higher in the less deprived areas (p < 0.05), independently on age. The level of socio-economic deprivation did not show a significant impact on the vital status, while a higher fatality was observed in male cases (p < 0.001), cases > 65 years (p < 0.001), cases having a connection with a nursing home (p < 0.05) or having at least 1 comorbidity (p < 0.001). On the other hand, a significant protection for healthcare workers was apparent (p < 0.001)., Conclusions: Our findings show that deprivation alone does not affect COVID-19 incidence and fatality burden, suggesting that the burden of disease is driven by a complexity of factors not yet fully understood. Better knowledge is needed to identify subgroups at higher risk and implement effective preventive strategies., (© 2023. The Author(s).)

Background: Contradictory results were reported on the role of school closure/reopening on the overall SARS-CoV-2 transmission rate, as well as on which kind and level of mitigation measures implemented in schools may be effective in limiting its diffusion. Some recent studies were reassuring, showing that opening did not increase the community spread, although teachers and families are worried about the high class density. On the other hand, distance learning was associated with a negative impact on learning, sociability and psychological health, especially in vulnerable children. As it becomes clear that the SARS-CoV-2 pandemic will last for a long time, there is a high need for studies and solutions to support safe schools opening based on scientific evidence of harms and benefits. The Lolli-Methode (LM) is a strategy for epidemiological surveillance and early intervention aiming at SARS-CoV-2 outbreaks' reduction in schools, relying on polymerase chain reaction analysis of saliva samples., Methods: In this cluster randomised trial protocol, we aim to determine whether the LM is useful to support schools opening and to reduce clusters and attack rates in schools, compared with the standard of care (SoC) surveillance by public health departments. This multicenter study will enrol 440 classes (around 8800 students, teachers and other personnel) from two countries, cluster randomised to LM or SoC. The samples from the pools will be collected and tested using PCR-based techniques. Test results will be combined with questionnaires filled in by children, parents, schoolteachers, and principals, concerning ongoing mitigation measures, their perceived psychological impact and other health and socio-economic information. An ancillary observational study will be carried out to study the prevalence of SARS-CoV-2 in schools, frequencies and size of clusters and attack rates, to compare the effectiveness of the different preventive measures adopted and to evaluate psychological issues in students and teachers in relation to the pandemic's containment measures., Discussion: By the end of this study, we will have defined and characterised the applicability of the LM for SARS-CoV-2 surveillance, as well as the impact of pandemic preventive measures on children and teachers. Trial registration International Standard Randomised Controlled Trial Number: NCT05396040, 27.05.2022., (© 2022. The Author(s).)

Studies reporting vaccine effectiveness against COVID-19 outcomes concentrate mainly on estimates of one single type of vaccine and variant, seldom considering waning effects. We aimed to estimate the effectiveness of the overall COVID-19 vaccination programme implemented in the Apulia region of Italy at preventing SARS-CoV-2 infections, COVID-19-related hospital admissions and deaths during alpha and delta variant dominant periods. We conducted a retrospective cohort study using electronic health records of persons 16 years and older resident in the Apulia region, assessing the effectiveness of the combined use of BNT162b2, mRNA-1273, ChAdOx1-S and Ad26.COV2.S vaccines against confirmed COVID-19 infections, hospitalisations and deaths, for fully and partially vaccinated persons as well as by time since vaccination and variants. Cox regression models yielding hazard ratios were used to calculate the overall vaccination programme effectiveness. From 1 January to 1 December 2021, we included 3,530,967 eligible persons in the cohort, of whom 2,770,299 were fully vaccinated and 158,313 were COVID-19 positive at the end of the study period. The effectiveness of the programme over the entire study period for fully vaccinated persons against COVID-19 infection, hospitalisation and death were 87.69% (CI95% 87.73-88.18), 94.08% (93.58-94.54) and 95.95% (CI95% 95.26-96.54), respectively. The effectiveness against COVID-19 infection of fully vaccinated subjects during the alpha and delta period was respectively 88.20% (CI95% 87.60-99.78) and 59.31% (CI95% 57.91-60.67), against hospitalisation 93.89% (CI95% 92.67-94.90) and 88.32% (CI95% 86.50-89.90) and against death 93.83% (CI95% 91.65-95.45) and 85.91 (CI95% 79.98-90.09). The waning effects of the programme regarding COVID-19 infection during the delta period were stronger than for alpha, with 75.85% (CI95% 74.38-77.24) effectiveness after 1-2 months and 8.35% (CI95% 3.45-13.01) after 5-6 months after full vaccination. The effectiveness against hospitalisation and death during the delta period waned rapidly and at 7-8-months after the full vaccination respectively decreased to 27.67% (CI95% 7.48-43.45) and 48.47 (CI95% 53.97-34.82). Our study suggests that the COVID-19 vaccination program in Apulia was strongly protective against COVID-19 infection, hospitalisation, and death due to alpha as well as delta variants, although its effectiveness is reduced over time., (© 2022. The Author(s).)

Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests.

Introduction: The DTaP5-IPV-Hib-HepB vaccine is the most recently approved combination hexavalent vaccine. In Europe, it is licensed since 2016 for primary and booster vaccination in infants and toddlers above the age of 6 weeks to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis, invasive diseases caused by Haemophilus influenzae type b and hepatitis B. In the US, DTaP5-IPV-Hib-HepB is approved since 2018 in children 6 weeks through 4 years of age. Its safety profile has been extensively documented in infants and children born at term, and also data in preterm infants are made available., Areas Covered: In this article, we conducted a safety evaluation of the DTaP5-IPV-Hib-HepB vaccine in infants and toddlers considering evidence from clinical trials and post-marketing use, also with regard to data on special populations e.g. preterm infants., Expert Opinion: Based on the available data, the DTaP5-IPV-Hib-HepB vaccine has demonstrated a good safety profile, similar to that of other approved penta- and hexavalent vaccines. Rather, post-marketing data are limited and are frequently reported in combination with other hexavalent vaccines or are not adjusted for shares of vaccines use. Neither relevant interferences with other co-administered pediatric vaccines nor safety issues in premature infants have been shown.

Introduction: Data have suggested that SARS-CoV-2 infection causes an antibody response at least as strong as one BNT162b2 vaccine dose. Nevertheless, some aspects require further investigation to better understand the immunogenicity of one vaccine dose among infected individuals. Thus, we evaluated how previous SARS-CoV-2 infection may influence the humoral immunity after a single Pfizer BNT162b mRNA vaccine dose in a sample of healthcare workers (HCWs)., Methods: As part of the routine surveillance activity conducted among HCWs of the Policlinico Riuniti Foggia Hospital (Apulia region, Italy), we conducted a retrospective serosurvey in the period January-March 2021. We compared specific antibody titres (anti-spike IgGs measured by enzyme-linked immunoassay, ELISA) after SARS-CoV-2 infection and after the first dose of the BNT162b2 vaccine, analysing the impact of sex, age, time since infection, and presence of symptoms on the humoral response., Results: We included in the study 58 HCWs (mean age 44.1 years, 48.2% male) with anti-spike IgG titres available before and after the first BNT162b2 vaccine dose. Among these, we observed higher titres in previously infected cases (N = 21) than in COVID-19-naïve subjects (N = 37) (medians 1510 vs. 0.68; p < 0.001). A statistically significant difference in anti-spike IgG titres was also observed among previously infected HCWs before vaccine dose in comparison with post-dose infection-naïve HCWs (medians 18.37 vs. 0.68, p < 0.001). Among infected individuals, no differences by sex, age, or time since infection were reported (p > 0.05). Post-dose titres of symptomatic and asymptomatic infected HCWs slightly differed (medians = 1900 vs. 1090; p = 0.048)., Conclusion: Our data support the viable hypothesis of a single-dose vaccine regimen in individuals with a history of COVID-19, but no conclusion on duration of protection in this group can be drawn from our study., (© 2021. The Author(s).)

Background: From the initial stages of the pandemic in early 2020, COVID-19-related olfactory and gustatory dysfunctions have been widely reported and are emerging as one of the most frequent long-term sequelae of SARS-CoV-2 infection. However, data regarding the long-term recovery of the sense of smell and taste are lacking. This study aimed to characterize the evolution up to one year after the diagnosis of self-reported olfactory and gustatory dysfunctions in COVID-19 cases., Methods: Based on the data of the active surveillance platform of the Apulia region, Italy, we selected the residents of Foggia district who were confirmed positive for SARS-CoV-2 from March 1st to June 16th, 2020, and home-quarantined with paucisymptomatic-to-mild clinical presentation. Self-reported olfactory and gustatory dysfunctions were recorded at baseline through a survey of dichotomous questions. The evolution of these symptoms at approximately one year was prospectively assessed via telephone by the validated sino-nasal outcome test 22 (SNOT-22, Italian version)., Results: Among the 1,175 COVID-19 cases notified in the Foggia district during the first epidemic wave, 488 had paucisymptomatic-to-mild clinical presentation. Of these, 41.2% (n = 201, 95% confidence interval [CI] 36.8-45.7%) reported at least one sensory dysfunction. A total of 178 to 201 (88.5%) patients agreed to participate in the follow-up survey. According to the SNOT-22 results, the persistence of a sensory dysfunction was observed in the 29.8% (n = 53, 95% CI 23.2-37.1%) of them. Particularly, loss of smell persisted in 25.8% (n = 46, 95% CI 19.6-32.9%), loss of taste in 21.3% (n = 38, 95% CI 15.6-28.1%), loss of both in 17.4% (n = 31, 95% CI 12.2-23.8%) of participants in the follow-up. The rates of full recovery increased over time: from 59% at 30 days to 71.9% at 90 days for the sense of smell; from 61.3% at 30 days to 74.7% at 90 days for the sense of taste., Conclusions: The persistence of COVID-19-related olfactory and gustatory dysfunctions up to 12 months after the disease onset in a noteworthy proportion (approximately 3 out of 10) of patients with paucisymptomatic-to-mild clinical presentation deserves further investigations due to its possible pathophysiological implications and impact on the quality of life., (© 2022. The Author(s).)

Early in the COVID-19 pandemic, asymptomatic transmission represented an important challenge for controlling the spread of SARS-CoV-2 through the traditional public health strategies. Further understanding of the contribution of asymptomatic infections to SARS-CoV-2 transmission has been of crucial importance for pandemic control. We conducted a retrospective epidemiological study to characterize asymptomatic COVID-19 cases occurred in the Apulia region, Italy, during the first epidemic wave of COVID-19 outbreak (February 29-July 7, 2020). We analyzed data collected in a regional platform developed to manage surveillance activities, namely, investigation and follow-up of cases and contacts, contact tracing, and laboratory and clinical data collection. We included all asymptomatic cases that were laboratory-confirmed during the appropriate follow-up, defined as persons infected with SARS-CoV-2 who did not develop symptoms/clinical signs of the disease. Between February 29 and July 7, 2020, a total of 4,536 cases were diagnosed with COVID-19 among 193,757 tests performed. The group of persons with asymptomatic SARS-CoV-2 infection consisted of 903 cases; the asymptomatic proportion was 19.9% (95% CI: 18.8-21.1%); this decreased with increasing age (OR: 0.89, 95% CI: 0.83-0.96; p = 0.001), in individuals with underlying comorbidities (OR: 0.55, 95% CI: 0.41-0.73; p < 0.001), and in males (OR: 0.69, 95% CI: 0.54-0.87; p = 0.002). The median asymptomatic SARS-CoV-2 RNA positive period was 19 days (IQR: 14-31) and the cumulative proportion of persons with resolution of infection 14 days after the first positive PCR test was 74%. As the public health community is debating the question of whether asymptomatic and late spreaders could sustain virus transmission in the communities, such cases present unique opportunities to gain insight into SARS-CoV-2 adaptation to human host. This has important implications for future COVID-19 surveillance and prevention., Competing Interests: The authors declare that there is no conflict of interest regarding the publication of this paper., (Copyright © 2022 Domenico Martinelli et al.)

(1) Background: Children with chronic medical conditions may be at increased risk for severe complications related to vaccine-preventable infections. Therefore, additional booster doses or supplementary vaccines are recommended, over and above the routine immunization schedule for healthy children. The aim of this study was to investigate attitude, knowledge, and practices toward additional vaccinations for children affected by chronic conditions among pediatricians and parents. (2) Methods: This study is based on two surveys: (i) a national cross-sectional survey, targeting pediatrician working in hospitals or in the primary health sector; (ii) a local cross-sectional survey, targeting parents of children with a previous diagnosis of chronic disease. (3) Results: Despite the fact that most of the health professionals and parents interviewed had an overall positive vaccine attitude, most pediatricians did not show an adequate knowledge of additional vaccinations for children affected by chronic diseases. Moreover, the coverage of additional recommended vaccinations in chronic pediatric patients was low. (4) Conclusions: This research highlighted important existing challenges hampering optimal vaccination coverage among pediatric chronic patients, including knowledge gaps on tailored vaccination schedules among pediatricians and organizational issues. The ongoing review of the Italian national immunization plan is a not-to-be-missed-opportunity to include evidence-based, detailed, and comprehensive recommendations on vaccinations for children affected by chronic conditions.

Objectives: The present study aimed to explore differences in COVID-19 outcomes between male and female cases in the Apulian District of Foggia, Italy., Design and Setting: We performed a retrospective epidemiological study among all COVID-19 confirmed cases that occurred in the Apulian District of Foggia from 29 February to 30 June 2020. The surveillance data from a regional registry (GIAVA-COVID) were used., Main Outcomes: The main outcome measures were the proportion of hospitalisations, virus clearance and the case fatality rate., Results: A total of 1175 cases (50.7% female; median age: 55 years) were identified among 55 131 tests performed. The proportion of hospitalisation with COVID-19 diagnosis was 45.4% in men versus 37.9% in women (p<0.01), while the average length of stay in hospitals was 31.3±14.6 days in women versus 26.8±14.4 days in men (p<0.01). The proportion of cases who achieved virus clearance was higher in women (84.2%; days to clearance: 28.0±12.1) than in men (79.3%; days to clearance: 29.4±12.9; p<0.05). Men were associated with a significantly higher risk of dying from COVID-19 than women (case fatality rate 16.1% vs 10.4%; p<0.01). The mean time, from diagnosis to death, was 14.5±14.4 days in women compared with 10.6±10.7 days in men (p<0.01). The male sex, age ≥55 years and presence of at least one underlying comorbidity significantly raised the risk of hospitalisation, persistent infection and death (p<0.05)., Conclusions: This study suggests that more attention should be paid to sex as a variable for the interpretation of COVID-19 data. Sex-disaggregated data will help clinicians to make appropriate patient-tailored medical decisions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Infants are at risk of developing serious diseases as a consequence of pertussis infection. Thus, to protect newborns, many countries, including Italy, have introduced pertussis maternal immunization. However, despite the compelling evidence supporting Tdap vaccinations, the rates of coverage among Italian pregnant women have remained consistently very low. Numerous studies have shown that healthcare providers' recommendations are critical for achieving high maternal vaccination coverages. This study explores Italian gynecologists' knowledge, attitude and practices concerning pertussis maternal immunization. Between July 2018 and September 2018, we performed a national cross-sectional survey administered by e-mail using the mailing list of the Association of Italian Hospital Obstetricians and Gynecologists (AOGOI): the mailing list included more than 3500 members. A total of 451 respondents distributed throughout Italy completed the online survey. Overall, 275 (60.97%) respondents did not routinely recommend pertussis vaccination to pregnant women, mainly for suboptimal knowledge of the maternal pertussis vaccine, protocols, and guidelines: furthermore, 15.44% (69/447) of gynecologists were not aware of the pertussis vaccination program for pregnant women. Gynecologists working in the South or in the Islands of Italy were less aware about the need of administering Tdap in expectant mothers, suggesting that there is a potential risk of health inequalities based on differing levels of vaccine knowledge and recommendations across Italy. In order to enable healthcare professionals to provide accurate and timely information on pertussis immunization to pregnant women, targeted educational programs to improve gynecologists' knowledge on pertussis vaccination are needed.

COVID-19 is an infectious disease caused by the novel coronavirus SARS-CoV-2. Several measures aimed at containing the spread of this virus have been recommended by international and nation public health institutions, but whether the influenza vaccine, while not protective against COVID-19, nonetheless reduces disease severity is unclear. This study evaluated the potential role of influenza vaccine in reducing the rate of hospitalization and death in COVID-19 patients. COVID-19 cases recorded in the province of Brindisi (Apulia, Southern Italy) during the first pandemic wave (February-May 2020) and occurring in patients vaccinated with the influenza vaccine during the 2019-2020 influenza season were considered. From February 2020 to May 2020, 3872 inhabitants of the province of Brindisi underwent SARS-CoV-2 PCR testing and 664 (8.7%) tested positive. A multivariate analysis showed that among COVID-19 patients neither hospitalization nor death was significantly associated with influenza vaccination ( p > 0.05), whereas within this group male sex, older age, and chronic diseases were identified as risk factors for morbidity and mortality. Our study did not show an association between the influenza vaccine and complications of COVID-19. Nonetheless, influenza vaccination must be promoted as a central public health measure, because by reducing the burden on hospitals it can greatly benefit the management of COVID-19 patients.

Background: Healthcare workers (HCWs) are highly exposed to SARS-CoV-2 infection given their specific tasks. The IgG-IgM serological assay has demonstrated good accuracy in early detection in symptomatic patients, but its role in the diagnosis of asymptomatic patients is uncertain. The aim of our study was to assess IgM and IgG prevalence in sera in a large cohort of HCWs previously subjected to Nasopharyngeal swab test (NST) after accurate risk assessment due to positive COVID-19 patient exposure during an observation period of 90 days., Methods: 2407 asymptomatic HCWs that had close contact with COVID-19 patients in the period between April 8th and June 7th were screened with NST based on the RT-PCR method. In parallel, they underwent large-scale chemiluminescence immunoassays involving IgM-IgG serological screening to determine actual viral spread in the same cohort., Results: During the 90-day observation period, 18 workers (0.75%) resulted positive for SARS-CoV-2 infection at the NST, whereas the positivity rates for IgM and IgG were 11.51% and 2.37%, respectively (277 workers). Despite high specificity, serological tests were inadequate for detecting SARS-CoV-2 infection in patients with previous positive NST results (IgM and IgG sensitivities of 27.78% and 50.00%, respectively)., Conclusions: These findings indicate a widespread low viral load of SARS-CoV-2 among hospital workers. However, serological screening showed very low sensitivity with respect to NST in identifying infected workers, and negative IgG and IgM results should not exclude the diagnosis of COVID-19. IgG-IgM chemiluminescence immunoassays could increase the diagnosis of COVID-19 only in association with NST, and this association is considered helpful for decision-making regarding returning to work., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background : There is a need to better understand HPV vaccination (HPVv) implementation in WHO Europe Region (WHO/ER), including recommendations, funding, and vaccination coverage rates (VCR). Methods : A targeted literature review (up to 31 January 2020) was conducted using national health ministry websites, WHO database, and published studies from WHO/ER countries (n = 53). HPVv recommendations and funding data (target age, gender, schedule, setting, target and monitored VCR) for primary and catch-up cohorts were collected. Results : National recommendations for HPVv exist in 46/53 (87%) countries, of which 38 (83%), 2 (4%), and 6 (13%) countries provided full, partial, or no funding, respectively, for the primary cohort. Fully or partially funded HPVv was provided for girls only in 25/53 (47%) countries and for both boys and girls in 15/53 (28%) countries. HPVv catch-up was fully or partially funded in 14/53 (26%) countries. Among 40 countries with a national immunization program (NIP), monitored VCRs ranged from 4.3% to 99% (n = 30). Of the 10 countries reporting VCR targets, only Portugal exceeded its target. Conclusion : Of the 53 WHO/ER countries, 40 have funded HPVv NIPs, among which 30 report VCRs. Additional efforts are required to ensure HPVv NIPs are fully funded and high VCRs maintained.

Background: Toscana virus (TOSV) is an arbovirus transmitted to humans by Phlebotomus spp sandflies. It causes aseptic meningitis and meningoencephalitis with marked seasonality. Here we describe the clinical, microbiological and epidemiological features of two clusters of cases occurred in Tuscany in 2018., Methods: A confirmed case was defined as the detection of anti-TOSV IgM and IgG in serum sample, in presence of typical clinical manifestations. We consulted hospital records of hospitalized patients to collect clinical information and obtained epidemiological information from the local health authority investigation report. We telephonically interviewed patients using a standard questionnaire for a 6 months follow-up., Results: A total of 12 cases of TOSV meningo-encephalitis with onset between 4th of July and 12th of September accessed health care services in the province of Livorno. Eight cases were males with median age 41,5 and four were not resident in the area. Serological investigations confirmed a recent TOSV infection. Eight cases reported visiting Elba Island and four had a possible occupational-related exposure., Conclusions: This surge of infection emphasizes the need of information campaigns coupled with adequate surveillance and control interventions against TOSV that, among other arboviruses, is a growing issue of concern in Italy.

Invasive pneumococcal disease (IPD) is a vaccine-preventable disease characterized by the presence of Streptococcus pneumoniae in normally sterile sites. Since 2007, Italy has implemented an IPD national surveillance system (IPD-NSS). This system suffers from high rates of underreporting. To estimate the level of underreporting of IPD in 2016-2017 in Tuscany (Italy), we integrated data from IPD-NSS and two other regional data sources, i.e., Tuscany regional microbiological surveillance (Microbiological Surveillance and Antibiotic Resistance in Tuscany, SMART) and hospitalization discharge records (HDRs). We collected (1) notifications to IPD-NSS, (2) SMART records positive for S. pneumoniae from normally sterile sites, and (3) hospitalization records with IPD-related International Classification of Diseases, Ninth Revision, Clinical Modification (ICD9) codes in discharge diagnoses. We performed data linkage of the three sources to obtain a combined surveillance system (CSS). Using the CSS, we calculated the completeness of the three sources and performed a three-source log-linear capture-recapture analysis to estimate total IPD underreporting. In total, 127 IPD cases were identified from IPD-NSS, 320 were identified from SMART, and 658 were identified from HDRs. After data linkage, a total of 904 unique cases were detected. The average yearly CSS notification rate was 12.1/100,000 inhabitants. Completeness was 14.0% for IPD-NSS, 35.4% for SMART, and 72.8% for HDRs. The capture-recapture analysis suggested a total estimate of 3419 cases of IPD (95% confidence interval (CI): 1364-5474), corresponding to an underreporting rate of 73.7% (95% CI: 34.0-83.6) for CSS. This study shows substantial underreporting in the Tuscany IPD surveillance system. Integration of available data sources may be a useful approach to complement notification-based surveillance and provide decision-makers with better information to plan effective control strategies against IPD.

Vaccination is the main public health intervention to prevent influenza. We aimed to evaluate the efficacy and safety of influenza vaccination including systematic reviews and meta-analyses of observational studies and randomized controlled trials (RCTs). Peer-reviewed systematic reviews with meta-analyses of prospective studies that investigated the association of influenza vaccination with any health-related outcome, as well as RCTs that investigated the efficacy and safety of influenza vaccination, were included. Among 1240 references, 6 meta-analyses were included. In cohort studies of community-dwelling older people influenza vaccination was associated with a lower risk of hospitalization for heart disease and for influenza/pneumonia (strength of evidence: convincing). Evidence in lowering the risk of mortality in community-dwelling older people, of all deaths/severe respiratory diseases in high risk community-dwelling older people and of hospitalization for influenza/pneumonia in case-control studies, was highly suggestive. In RCTs, influenza vaccination, compared to placebo/no intervention, was associated to higher risk of local tenderness/sore arm and to a reduced risk of influenza like-illness. Both these associations showed moderate evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation). In conclusion, influenza vaccination in older people seems safe and effective. Further, the evidence on safety and efficacy of vaccines in this population might benefit by an extension of the follow-up period both in RCTs and in longitudinal studies, beyond the usual 6-month period, in order to be able to evaluate the impact of vaccination on long term outcomes., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Although Personal Electronic Health Records (PEHR) have been identified as innovative tools enabling the provision of patient-centered care and prevention, evidence on the impact of their use is scant. With PEHRs being more and more marketed as easily implementable and cost-effective instruments to provide people with direct control on their health, the question on whether their use might be associated with the priority to improve vaccine coverage arises., Methods: We conducted a systematic review following the PRISMA guidelines to retrieve, quantitatively pool and critically appraise the effectiveness of PEHR access on vaccine uptake. Analysis on PEHR effectiveness were carried out for the following comparison strata: i) PEHR access vs no intervention (standard care, no access to PEHR), ii) PEHR access only vs access to PEHR with additional features (e.g. health education materials, active reminders)., Results: Of 3114 identified citations, 8 studies were included, the majority published in the US and before 2015; 62% were randomized trials, the rest having an observational study design. Evidence suggests a moderate positive impact of PEHR access in increasing vaccine uptake, with data available for influenza and pneumococcal vaccines, diabetic patients and childhood immunization. Pooled data report the addition of digital communication features, i.e. the delivery of educational messages, reminders and availability of scheduling features might increase vaccine uptake, as compared to PEHR access alone. However, evidence is not conclusive., Conclusion: While immunization programs are struggling to achieve optimal coverage targets, it seems the potential of PEHRSs supporting informed adherence to vaccines recommendations is neither fully exploited nor explored. Which factors mediate the association between PEHRs access and vaccine uptake? Which PEHRs' design and functional components can maximize their impact? On which target populations? Which PEHR models works better for high-risk populations? Our findings can only partially answer those questions and further experimental research is needed., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Adolescents engagement is fundamental to develop dedicated educational interventions. We piloted non-standard sociological methodology to assess risk perception, information sources and perceived educational needs of a group of Italian adolescents focusing on three infectious diseases. Three high-school classes students participated in a World Café event. A thematic analysis was performed. Participants showed lack of knowledge on diseases prevention. Family and school were key health information sources and social media considered unreliable. Future interventions preferences included interactive and informal sessions. We showed the utility of non-standard sociological methods to assess health knowledge among adolescents and enhance the design of dedicated interventions., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Public Health Association.)

Starting from 2013, the number of unvaccinated people alarmingly increased in Italy; therefore, in 2017 a new Vaccine National Plan was approved. Healthcare workers (HCWs), especially public health professionals (PHPs, i.e., workers in in the sector of hygiene and preventive medicine), have an important role in informing and promoting vaccinations. In this context, the Italian Study Group of Hospital Hygiene of the Italian Society of Hygiene, Preventive Medicine and Public Health (GISIO-SItI) conducted a national survey to assess knowledge, attitude, and practices towards recommended vaccinations among PHPs. The survey was conducted during October 2019 with an anonymous questionnaire distributed to PHPs attending the 52° SItI National Congress. Overall, 57.1% of operators answered correctly to all seven recommended vaccinations, 12.8% reported to be vaccinated for all seven recommended vaccinations, while 30% were naturally immunized. A higher immunization coverage was reported for anti-hepatitis B (88.9%) and measles (86.1%), and 81.3% of the participants reported being offered the influenza vaccination during the 2018/2019 season. The majority of our sample indicated that hepatitis B (95%) and influenza (93.7%) were the recommended vaccines for HCWs, while less was known regarding varicella, pertussis, diphtheria, and tetanus boosters every 10 years. PHPs who were vaccinated (or who intended to be vaccinated) were more likely to recommend vaccinations to their patients and provided a reassuring example to those hesitant patients. Finally, this is the first study that identified good algorithms (using the techniques of machine learning as Random Forest and Deep Learning) to predict the knowledge of PHPs regarding recommended vaccinations with possible applications in other national and international contexts.

Introduction: Invasive meningococcal disease (IMD) is one of the most severe vaccine-preventable disease not yet under control. In Italy, although different anti-meningococcal vaccines are available, their offer among regions is heterogeneous. The aim of this study is to describe the epidemiology of IMD in Italy based on analysis of national surveillance data for 2011-2017 to optimize the vaccination strategy., Methods: IMD surveillance data from the Italian National Health Institute were analysed. Microsoft Excel was used to present trend analysis, stratifying by age and serogroups., Results: In Italy, during the period 2011-2017, the incidence of IMD increased from 0.25 cases/100,000 inhabitants in 2011 to 0.33 cases/100,000 in 2017. Most cases after 2012 were caused by non-B serogroups. The number of cases in subjects aged 25-64 years increased steadily after 2012 (36 cases in 2011, 79 in 2017), mostly due to non-B serogroups, representing more than 65% of cases in those aged 25+ years., Conclusions: In the period from 2011 to 2017, the incidence of IMDs increased in Italy. The increase, probably due also to a better surveillance, highlights the importance of the disease in the adult population and the high level of circulation of non-B serogroups in particular after 2012. Our analysis supports an anti-meningococcal vaccination plan in Italy that should include the highest number of preventable serogroups and be aimed at vaccinating a wider population through a multicohort strategy., Competing Interests: Conflicts of interest statement SI, LB, SP and GCL work for Sanofi Pasteur Italia. The other authors declare no conflict of interest., (©2020 Pacini Editore SRL, Pisa, Italy.)

Surveillance of new cases of invasive pneumococcal disease (IPD) in Italy was started in 2007 by the Ministry of Health (MoH). In 2012, pneumococcal childhood vaccination was introduced at the national level and, in 2017, for citizens aged 65 years and over. We describe here IPD epidemiology in Italy over the past 10 years investigating the impact of the vaccine programme on disease burden. Reports of IPD cases, data on serotype and vaccination coverage (VC) data were obtained from MoH annual reports, for the period 2007-2017. IPD notification rate and proportion by year, region, age and serotype were calculated. In 2007, 525 cases were reported (rate 0.88/100 000), rising to 1703 cases (rate 2.82/100 000) in 2017. The distribution of IPD cases by age group over time registered the largest share among individuals aged 65 years and over. A decreasing trend in notification rate was observed among those aged 0-4 years. During the same period, the 24-month VC increased, ranging from 80.9% to 96.7% in 2017. Molecular data indicated re-emergence of PPSV23-specific serotypes and non-vaccine serotypes. We observed an increase in IPD notifications during 2007-2017, likely due to an improved surveillance system, at least in some regions, with the relative quota of IPD notifications decreasing among vaccinated children cohorts. Further strengthening of IPD surveillance system, including molecular and vaccine coverage data, would be needed to assess and inform pneumococcal vaccination strategies in Italy.

Social media have become a common way for people to express their personal viewpoints, including sentiments about health topics. We present the results of an opinion mining analysis on vaccination performed on Twitter from September 2016 to August 2017 in Italy. Vaccine-related tweets were automatically classified as against, in favor or neutral in respect of the vaccination topic by means of supervised machine-learning techniques. During this period, we found an increasing trend in the number of tweets on this topic. According to the overall analysis by category, 60% of tweets were classified as neutral, 23% against vaccination, and 17% in favor of vaccination. Vaccine-related events appeared able to influence the number and the opinion polarity of tweets. In particular, the approval of the decree introducing mandatory immunization for selected childhood diseases produced a prominent effect in the social discussion in terms of number of tweets. Opinion mining analysis based on Twitter showed to be a potentially useful and timely sentinel system to assess the orientation of public opinion toward vaccination and, in future, it may effectively contribute to the development of appropriate communication and information strategies.

Whooping cough (pertussis) represents one of the most prevalent vaccine-preventable diseases in Western countries, capable of causing disease in infants, with a high risk of severe complications. To protect new-borns from pertussis, many countries have introduced the acellular pertussis adult vaccine in combination with tetanus and diphtheria toxoids for women in the third trimester of pregnancy. Thanks to the approval of the new National Immunization Prevention Plan 2017-2019: Italy is among those countries. The Italian health-care system is a regionally based National Health Service, therefore, regions organize and implement new vaccination strategy on their own. This study focuses on Tuscany's experience in implementing the maternal pertussis vaccination. The present study had a qualitative design: we obtained information about the implementation process through interviews with relevant stakeholders involved in the planning or implementation of vaccination programme at different levels. We noticed heterogeneous implementation's status between Tuscan Health Care Departments. The most frequently reported barriers influencing the success of the implementation process of this prevention strategy included: lack of accountability, lack of enabling instruments, financial constraints, logistics barriers, training deficiencies, attitudes of health care workers, and lack of communication experts. The implementation of new vaccination programs is complex and challenging. Often the importance of education and information activities targeting health professionals are underestimated and underfunded. These elements would need to be carefully considered and adequate provisions should be made to address them when designing and implementing effective vaccine interventions., (Copyright © 2020 Mazzilli, Tavoschi and Lopalco.)

Background: In times of vaccine hesitancy and decreasing immunization coverage, it is crucial to exploit the potential of digital solutions to support immunization programmes and ultimately increase vaccine uptake. Scant evidence exists on the impact of email-based immunization reminders. In particular, while email communication is exponentially increasing at the global level, its use for health communication is still sporadic and limited data exists on its application to immunization programmes. The objective of this study is to systematically retrieve and critically appraise the available literature on the effectiveness of email-based reminders to increase vaccine uptake, with the ultimate aim to inform and encourage its integration in the implementation of immunization programmes., Methods: We conducted a systematic review of literature following the PRISMA. We included studies providing quantitative comparative data on any measure of vaccine uptake. We extracted data on study design, study population, vaccine type and details of email-based interventions; data were pooled by type of comparison (no reminders, traditional reminders, other digital reminders)., Results: Eleven studies were included, 90% with experimental study designs. While email communication succeeds in increasing vaccine uptake when compared with no intervention, weak and heterogeneous data exist supporting the superiority of email reminders, as compared to traditional methods or other digital reminders. Encouraging evidence report the effectiveness of reminder methods combining different strategies and tailored to target populations' preferences., Conclusions: Theoretically, email communication offers many advantages: it is cheaper and faster, it can be automated and linked to electronic immunization registries, and reach people on the move. As we urge the need for further research to prove email communication impact on vaccine uptake in different settings, we underline the importance of identifying how to best integrate email communication in vaccine delivery equipping immunization programmes with technical infrastructures and normative frameworks suitable to embrace innovation., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Introduction: In 2016, more than 600,000 persons were being held in EU/EEA correctional facilities on a given day. People in prison may be at risk of vaccine-preventable diseases. While vaccination recommendations for people in prison exist, little is known on coverage and implementation options., Methods: We performed a systematic review on existing evidence on vaccination in prison settings in the EU/EEA. We searched peer-reviewed and grey literature following international methodology and reporting standards, to gather records published between 1980 and 2016 in all languages. We analysed quantitative (acceptance, uptake, cost-effectiveness) and qualitative (barriers) outcomes., Results: Out of 7041 identified records, 19 full-text articles were included from peer-reviewed literature and two from grey literature. Of these, 18 reported on hepatitis A and/or B virus (HAV/HBV), two on influenza and one on MMR vaccination. Two studies on HAV vaccine reported varying acceptance (5-91%) and uptake rates (62.9-70.5%). Seven studies reported on HBV vaccination. A comparative study showed a significantly higher uptake of the third HBV vaccine dose with the very rapid (63%) compared to the standard schedule (20%). HBV vaccination was generally well accepted (54-100%), whereas uptake was variable (dose 1:23-100%, dose 2:48-92%, dose 3:19-80%). One study on the combined HAV/HBV vaccine reported an acceptance rate of 34%, and declining uptake following dose 1. One study on influenza vaccine showed an uptake of 42-46%, while another reported a MMR vaccine acceptance of 80% and an uptake of 74%. Overall, main reasons for non-vaccination included release from/or transfer between prisons, and refusal., Conclusions: This systematic review highlighted important knowledge gaps and operational challenges for vaccination in prison settings. Vaccination is an effective measure that warrants comprehensive and tailored implementation to reduce the preventable disease burden, avoid risks of large outbreaks of vaccine-preventable diseases, and contribute to health equity for people in prison., (Crown Copyright © 2019. Published by Elsevier Ltd. All rights reserved.)

The transmission of infectious agents within healthcare settings is a priority public health problem. Although the main burden of healthcare-associated infections is commonly caused by Gram-negative bacteria and fungi, vaccine-preventable diseases represent an additional infectious risk for patients attending healthcare facilities. Hepatitis B, rotavirus gastroenteritis, influenza, measles, pertussis and pneumococcal and meningococcal invasive bacterial infections still represent a threat, notwithstanding the presence of universal vaccination programs. For this reason, healthcare worker immunization is an important strategy to limit the risk of vaccine-preventable diseases in such a fragile population.

Protection of healthcare workers (HCWs) from biological hazards in the workplace has the added benefit of contributing to the quality of patient care and patient safety. Vaccinated HCWs act as a barrier against the spread of infections and maintain essential healthcare delivery during outbreaks. In Italy, specific recommendations for vaccination of HCWs are issued by the Ministry of Health within the framework of the National Immunization Prevention Plan. These recommendations provide advice regarding HCW vaccination for hepatitis B, influenza, pertussis, measles, mumps, rubella, varicella and tuberculosis. This paper summarizes the current literature on vaccine-preventable diseases and vaccination among Italian HCWs.

Background: Invasive meningococcal disease (IMD) in high-income countries usually occurs sporadically with low incidence and occasionally as small clusters or outbreaks. The WHO guidelines (GLs) for IMD outbreak applies only to African countries with high endemic incidence. Several high-income countries developed their own GLs on IMD outbreak, and we compare their terminology, classification, definitions, and public health interventions., Methods: National IMD outbreak GLs of the European Union and the Organisation for Economic Co-operation and Development member states were compared. Due to linguistic barriers, 17 out of forty-one countries were selected, and the GLs on the websites of the national health authorities were independently screened by two researchers., Results: National GLs on IMD outbreak were available for 12 countries. All GLs classify IMD outbreak into organization and community based using different terminology (cluster, epidemic, etc.). Two GLs introduce also a third condition of hyperendemic. Definitions, thresholds, and countermeasures vary among countries., Conclusions: Different definitions of organization and community-based outbreaks and countermeasures are expected because of uncertainties about their effectiveness, and differences between countries in health-care systems and public health policy approaches. Nevertheless, variations in terminology, definitions and countermeasures are confusing and reflect the need for an international standardization.

The Italian National Vaccine Prevention Plan (PNPV) of 2017-19 and subsequent mandatory vaccination law (Law 119/2017) both occurred in the context of a progressive decrease in vaccine coverage levels in Italy and led to important policy changes, including the introduction of new vaccine recommendations and increasing the number of mandatory vaccinations in childhood from four to ten. A survey on a sample of 446 Italian health care workers (HCW) was carried out in order to assess their opinions on policy changes introduced by the PNPV and by the mandatory vaccination law. The convenience sample was selected among participants in a training course on vaccination counselling. The large majority of participants expressed overall satisfaction about the policy changes introduced by the PNPV but some highlighted pitfalls related to its implementation. Moreover, the majority of HCW believe that vaccination coverage for both recommended and mandatory vaccinations has increased thanks to Law 119/2017, therefore expressing a positive attitude towards the enforcement of vaccine mandates.