Search

Pier Luigi Lopalco Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy Abstract: Starting in 2006, vaccination against human papillomavirus (HPV) has been progressively implemented in most developed countries. Two vaccines have been successfully used, a bivalent vaccine targeting HPV-related cancers (bHPV) and a quadrivalent vaccine (qHPV) targeting both HPV-related cancers and genital warts. Between December 2014 and June 2015, a new nonavalent HPV vaccine (9vHPV) was granted marketing authorization in the USA and Europe. The 9vHPV was developed from the qHPV and includes five additional HPV types that should increase the level of protection toward HPV-related cancers. Efficacy and/or immunogenicity of 9vHPV has been assessed in eight clinical studies. The 9vHPV vaccine induced a very robust immune response against all vaccine types, with seroconversion rates close to 100%. The safety profile of 9vHPV is comparable to that of qHPV. Local reactions, especially swelling, have been more frequently reported after 9vHPV than qHPV, and this slightly increases when the 9vHPV is coadministered with other vaccines. The additional coverage offered by the 9vHPV may prevent a significant proportion of HPV-related cancers (variable between 8% and 18%) depending on the local distribution of high-risk HPV types in the population. It is impossible, at present, to anticipate the actual impact of the wide use of the 9vHPV in comparison with the bHPV or the qHPV, since it depends on many variables including duration of protection, potential cross-protection toward nonvaccine types, and herd immunity effect. Keywords: human papillomavirus vaccine, immunogenicity, vaccine safety, cervical cancer, head and neck cancer, genital warts

The aim of the study is to assess the determining factors and the level of vaccination coverage for those vaccinations recommended to health care workers. The employees of the Apulian Vaccination Services were given an interview-based standardized anonymous questionnaire. Of the 302 replies from the employees, 54.5% of the respondents had received the hepatitis B vaccine and 32.7% the influenza vaccine in the 2007-2008 season. There were 4.6% susceptible to varicella, and 2.6% had been vaccinated. Of the replies received, 9.3% were susceptible to measles or mumps or rubella, and 5.9% had been vaccinated. There is the need for on-going education for vaccine requirements to improve immunoprophylaxis among health care workers. [ABSTRACT FROM AUTHOR]

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.)