Herpes zoster (HZ) vaccine coverage and confidence in Italy: a Nationwide cross-sectional study, the OBVIOUS project.

BACKGROUND: Herpes Zoster is an age dependent disease and as such it represents a problem in the Italian social context, where the demographic curve is characterized by an overrepresentation of the elderly population. Vaccines against Herpes Zoster are available, safe and effective, however coverage remains sub-optimal. This study was therefore conducted to examine the variations in Herpes Zoster vaccine uptake and confidence across different regions in Italy. METHODS: This study utilized a cross-sectional computer-assisted web interview (CAWI) methodology. The survey was conducted by Dynata, an online panel provider, and involved 10,000 respondents recruited in Italy between April 11 and May 29, 2022. The sample was stratified based on geographic region, gender, and age group. Data management adhered to European Union data protection regulations, and the survey covered demographics, living conditions, and vaccination against herpes zoster (HZ), following the BeSD framework. RESULTS: The findings indicate regional disparities in herpes zoster vaccine uptake across Italy. Notably, the Islands region exhibits a particularly low vaccination rate (2.9%), highlighting the need for targeted interventions. The multivariate regression analysis showed that sociodemographic factors, limited access to healthcare services, and inadequate awareness of vaccine eligibility contribute to the lower uptake observed in this region. CONCLUSION: In conclusion, this research emphasizes regional disparities in herpes zoster (HZ) vaccination uptake in Italy. Demographic, socioeconomic, and geographic factors impact individuals' willingness to receive the vaccine. The study highlights the importance of awareness of vaccine eligibility and accessible vaccination facilities in increasing uptake rates.

Influenza Vaccine Uptake in Italy-The 2022-2023 Seasonal Influenza Vaccination Campaign in Italy: An Update from the OBVIOUS Project.

Influenza is a significant public health concern, with Italy being profoundly impacted annually. Despite extensive vaccination campaigns and cooperative initiatives between the Public Health Departments of Local Healthcare Authorities and family physicians, low vaccine uptake rates persist. This study builds upon the OBVIOUS project, providing an updated picture of influenza vaccine uptake in Italy through a representative sample. A cross-sectional computer-assisted web interviewing (CAWI) survey of 10,001 Italian citizens was conducted between 31 March and 5 June 2023. Our findings underscore the negative impact of a lack of awareness that a person is in a priority group for influenza vaccination (-26.1 percentage points in vaccine uptake) and the profound influence of social circles on vaccination decisions (-5 percentage points when unfavorable). Medical professionals played a pivotal role, with recommendations from family doctors significantly promoting vaccine uptake (+20.2 percentage points). Age, chronic conditions, and socio-demographic factors also influenced vaccination behaviors. For children, parental negative perceptions regarding the flu (-10.4 percentage points) and vaccine safety (-23.4 percentage points) were crucial determinants. The present study emphasizes the need for a comprehensive approach addressing awareness, societal beliefs, and tailored medical advice to enhance vaccination rates and protect public health in Italy.

Rates and determinants of Rotavirus vaccine uptake among children in Italy: a cross-sectional study within the 2022 OBVIOUS* project.

INTRODUCTION: The World Health Organization defines rotavirus as among the most severe causes of viral gastroenteritis affecting children under 5 year old. Italy and other European countries do not release disaggregated data on rotavirus vaccination coverage. This study aimed to assess the uptake and drivers of rotavirus vaccination in Italy. METHODS: We administered a survey to 10,000 Italian citizens recruited via an online panel and proportionate to key demographic strata. We examined rotavirus vaccine uptake among parents whose youngest child was aged 6 weeks to 4 years, their sociodemographic characteristics, their beliefs about vaccine administration, and who recommended the rotavirus vaccination. RESULTS: A total of 711 respondents met the inclusion criteria for the rotavirus vaccine questionnaire. The uptake was estimated at 60.3% nationwide (66.4% among mothers and 50.2% among fathers). Being a mother and living in cities/suburbs was significantly associated with a higher likelihood of vaccine uptake, while fathers were more likely to be uncertain of their children's vaccine status. Living in Central Italy and having friends/relatives opposed to vaccination were found to be significantly associated with a lower likelihood of vaccine uptake, while parents' education level and children's demographics were not found to correlate with any outcomes. In 90.3% of cases, the rotavirus vaccination was recalled as being recommended by a paediatrician. CONCLUSIONS: Consistent collection of behavioural preferences and socioeconomic characteristics of recipients of rotavirus vaccine campaigns, their epidemiological information, cost-benefit, and national policy data are crucial for designing effective vaccination strategies in Italy and other European countries with similar social profiles to reach the target uptake.

Pneumococcal vaccine uptake among high-risk adults and children in Italy: results from the OBVIOUS project survey.

BACKGROUND: Streptococcus pneumoniae infections, including Invasive Pneumococcal Diseases (IPDs), pose a substantial public health challenge, causing significant morbidity and mortality, especially among children and older adults. Vaccination campaigns have played a vital role in reducing pneumococcal-related deaths. However, obstacles related to accessibility and awareness might impede optimal vaccine adoption. This study aims to provide comprehensive data on pneumococcal vaccine coverage and attitudes within at-risk groups in Italy, with the goal of informing public health strategies and addressing vaccination barriers. METHODS: Between April 11 and May 29, 2022, a questionnaire investigating vaccine uptake and attitudes toward several vaccinations was administered to 10,000 Italian adults, chosen through population-based sampling. Respondents who were targets of the campaign according to the 2017-2019 National Vaccination Plan, accessed questions regarding pneumococcal vaccination. Data on uptake, awareness of having the right to free vaccination, opinion on vaccine safety, concern with pneumococcal disease, and ease of access to vaccination services were summarized and presented based on statistical regions. Multinomial logistic regression analysis was used to explore factors influencing vaccine uptake. RESULTS: Out of 2357 eligible adult respondents (42.6% women; mean age: 58.1 ± 15.7), 39.5% received pneumococcal vaccination. Uptake differed among at-risk groups: respondents aged ≥65 (33.7%), with lung disease (48.4%), cardiovascular disease (46.6%), and diabetes (53.7%). Predictors of not being vaccinated and unwilling to included female gender, residing in rural areas, lower education, low concern about pneumococcal disease, vaccine safety concerns, and associations with vaccine-opposed acquaintances. Health access issues predicted willingness to be vaccinated despite non-vaccination. Pneumopathy, heart disease, diabetes, and living in Northeastern or Central Italy were linked to higher uptake. Among the 1064 parents of eligible children, uptake was 79.1%. Parental unawareness of children's free vaccination eligibility was a predictor of non-vaccination. Vaccine safety concerns correlated with reluctance to vaccinate children, while perceived healthcare access challenges were associated with wanting but not having received vaccination. CONCLUSIONS: Pneumococcal vaccination uptake within prioritized groups and children in Italy remains inadequate. Scarce awareness of vaccine availability and obstacles in accessing vaccinations emerge as principal barriers influencing this scenario.

Human Papillomavirus (HPV) Vaccine Coverage and Confidence in Italy: A Nationwide Cross-Sectional Study, the OBVIOUS Project.

BACKGROUND: Human Papillomavirus (HPV) vaccination rates are still below the target due to vaccine refusal or delay, lack of knowledge, and logistical challenges. Understanding these barriers is crucial for developing strategies to improve HPV vaccination rates. METHODS: This cross-sectional study used a questionnaire to investigate social and behavioral factors influencing decision making about the HPV vaccine. The survey was conducted from 11 April to 29 May 2022 and involved 10,000 Italian citizens aged ≥ 18 years. The sample was stratified based on region of residence, gender, and age group. RESULTS: 3160 participants were surveyed about themselves, while 1266 respondents were surveyed about their children's vaccine uptake. Among females aged ≥ 26 years, the national average HPV vaccine uptake was 21.7%, with variations across different regions. In the 18-25 age group, females had a vaccine uptake (80.8%) twice as much as males (38.1%), while vaccine uptake among male and female children aged 9-11 was similar. CONCLUSIONS: The OBVIOUS study in Italy reveals factors influencing low HPV vaccine uptake, suggesting targeted approaches, tailored information campaigns, heightened awareness of eligibility, promoting early vaccination, addressing low-risk perception among males, addressing safety concerns, and enhancing perceived accessibility to improve vaccine uptake and mitigate health risks.

Influenza vaccination landscape in Italy: A comprehensive study through the OBVIOUS project lens.

Influenza annually claims an estimated 8,000 lives in Italy. Despite no-cost vaccinations for high-risk groups, hesitancy persists. This study aims to pinpoint social and behavioral vaccination determinants, forming strategies to bolster vaccine uptake. From April 11 to May 29, 2022, we surveyed a demographic-stratified sample of 10,000 Italian adults, employing the WHO's Behavioral and Social Drivers of Vaccination (BesD) framework. Of those, 4,613 (46.1%) were eligible for the influenza vaccine and included in the analysis. Roughly a third remained unvaccinated and unwilling. Central Italy showed the highest resistance, with significant percentages of seniors and professionals like teachers, law enforcement, and healthcare workers expressing noncompliance. A lack of awareness of being in a target group correlated significantly with vaccine refusal or delayed acceptance. Other refusal factors included female gender, being aged 45-54, rural residency, absence of higher education, perceived vaccine unsafety, and having vaccine-opposed acquaintances. Thus, addressing these perceptions and enhancing awareness can potentially increase vaccination rates and lessen disease impact.

COVID-19 Vaccine Refusal and Delay among Adults in Italy: Evidence from the OBVIOUS Project, a National Survey in Italy.

BACKGROUND: Vaccine hesitancy was defined by the World Health Organization (WHO) in 2019 as a major threat to global health. In Italy, reluctance to receive vaccines is a widespread phenomenon that was amplified during the COVID-19 pandemic by fear and mistrust in government. This study aims to depict different profiles and characteristics of people reluctant to vaccinate, focusing on the drivers of those who are in favor of and those who are opposed to receiving the COVID-19 vaccine. METHODS: A sample of 10,000 Italian residents was collected. A survey on COVID-19 vaccination behavior and possible determinants of vaccine uptake, delay, and refusal was administered to participants through a computer-assisted web interviewing method. RESULTS: In our sample, 83.2% stated that they were vaccinated as soon as possible ("vaccinators"), 8.0% delayed vaccination ("delayers"), and 6.7% refused to be vaccinated ("no-vaccinators"). In general, the results show that being female, aged between 25 and 64, with an education level less than a high school diploma or above a master's degree, and coming from a rural area were characteristics significantly associated with delaying or refusing COVID-19 vaccination. In addition, it was found that having minimal trust in science and/or government (i.e., 1 or 2 points on a scale from 1 to 10), using alternative medicine as the main source of treatment, and intention to vote for certain parties were characteristics associated with profiles of "delayers" or "no-vaccinators". Finally, the main reported motivation for delaying or not accepting vaccination was fear of vaccine side effects (55.0% among delayers, 55.6% among no-vaccinators). CONCLUSION: In this study, three main profiles of those who chose to be vaccinated are described. Since those who are in favor of vaccines and those who are not usually cluster in similar sociodemographic categories, we argue that findings from this study might be useful to policy makers when shaping vaccine strategies and choosing policy instruments.

Vial Sharing of High-Cost Drugs to Decrease Leftovers and Costs: A Retrospective Observational Study on Patisiran Administration in Bologna, Italy.

Waste of high-cost medicines, such as orphan drugs, is a major problem in healthcare, which leads to excessive costs for treatments. The main objective of this study was to evaluate the impact of a vial-sharing strategy for patisiran, an orphan drug used for the treatment of hereditary transthyretin-mediated amyloidosis, in terms of a reduction in the discarded drug amount and cost savings. The retrospective observational study was conducted in a tertiary referral center (Emilia-Romagna, Italy), between February 2021 and November 2022. Data on drug waste were calculated as "(mg used-mg prescribed)/mg prescribed" for each session. We found a statistically significant (-9.14%, p < 0.001, 95% CI 5.87-12.41) absolute difference in mean discarded drug rates per session based on the study phase (before and after vial-sharing introduction) at the two-sample t-test. The absolute difference corresponded to a percentage decrease in the average reduction in the discarded drug rate with vial sharing of 82.96% per session. On an annual scale, the estimated cost savings was EUR 26,203.80/year for a patient with a standard body weight of 70 kg. In conclusion, we demonstrated that a patisiran vial-sharing program undoubtedly offsets some of the high costs associated with this treatment. We suggest that this easy-to-introduce and cost-effective approach can be applied to the administration of other high-cost drugs.

Obesity and COVID-19 in Children and Adolescents: Reciprocal Detrimental Influence-Systematic Literature Review and Meta-Analysis.

The dramatic lifestyle changes forced by COVID-19-related lockdown promoted weight gain, with a stronger impact on obese subjects, at higher risk of severe infection. The PubMed database was searched to identify original studies assessing: (1) the extent and risk factors of lockdown-induced weight increase; and (2) the impact of obesity on the risk of hospital admission in children and adolescents. A systematic literature review and meta-analyses were performed. Twenty out of 13,986 identified records were included. A significant weight increase was reported in the majority of subjects, with no apparent gender or age differences. It was induced by a higher consumption of hypercaloric/hyperglycemic/junk food and/or the reduction of physical activity, often associated with an altered sleep-wake cycle. On the other hand, obesity increased the risk of hospitalization (OR = 4.38; 95% C.I. 1.46-13.19; p = 0.009; I2 = 96%) as compared to the normal weight population. COVID-19 and obesity represent epidemic conditions with reciprocal detrimental impact. Urgent public health interventions, targeting the various age and social strata, and involving governmental authorities, health care personnel, teachers and families are warranted to increase awareness and actively promote healthy lifestyles to contrast pediatric obesity and its detrimental consequences at a global level.

ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance.

Background: Gam-COVID-Vac is the world's first registered vector vaccine against COVID-19 based on a combination of two heterologous adenoviruses. It was chosen by the Republic of San Marino as the main tool in its vaccination campaign, which started on 25 February 2021. Our aim was to build up on the ROCCA study, focused on the older population, by describing adverse effects following immunisation (AEFIs) rates and characteristics in all age groups for the first time in a real-world context. Methods: An active surveillance study on recipients of at least one dose of the Gam-COVID-Vac vaccine was conducted. Participants were administered online questionnaires through live/phone interviews with physicians, by e-mail or by scanning a QR code at different points in time after the first dose: one week (Q1) one month (Q2), and three months (Q3) between March and August 2021. Findings: Overall, 6190 vaccine recipients were recruited. Mean age was 52·4 ± 18·2 years. After the first dose, systemic reactions were reported by 57·5% of the participants, while injection site reactions were reported by 46·7%. The most common AEFIs were pain at the injection site, fatigue and headache. Grade 3 or 4 AEFIs were reported by 0·8% and 0·3% of the participants, respectively. After the second dose, systemic reactions were reported by 63·1% of the participants, while injection site reactions by 54·7%. The most common AEFIs were malaise, pain at injection site and myalgia. Grade 3 or 4 AEFIs were reported by 2·7% and 1·1% of the participants, respectively. Multivariate analysis showed younger age, being a woman and food allergies are risk factors for more severe AEFIs. Interpretation: Our results confirm a good tolerability profile for the population aged 18 and over providing useful data for vaccination campaigns ongoing in countries planning to use Gam-COVID-Vac. Funding: None.

Gam-COVID-Vac (Sputnik V) and Pfizer-BioNTech Vaccines Adverse Events following Immunization in Patients Affected by Parkinson's Disease and Multiple Sclerosis: A Longitudinal Study.

The Republic of San Marino COVID-19 vaccination campaign used Gam-COVID-Vac and Pfizer-BioNTech vaccines. To assess adverse events following immunization (AEFIs), approximately 6000 vaccine recipients were monitored by the ROCCA study, including subgroups with Parkinson's Disease (PD) and Multiple Sclerosis (MS). The purpose of this study is to evaluate short-term AEFIs through a 1-month follow-up. We conducted a longitudinal study, using active surveillance to evaluate the safety profiles of COVID-19 vaccines in PD and MS patients. Participants were actively administered a standardized online questionnaire to collect information on AEFIs. Among all PD and MS assisted by the San Marino hospital, a total of 82 patients completed the questionnaires. One week after administration of the first dose, vaccine recipients reported AEFIs in 26% of cases in the PD group, 67% in the MS group, and 68% in the control group. Participants reported slightly higher rates of AEFIs after dose 2 compared with dose 1, being 29%, 75%, and 78% for PD, MS, control group, respectively. Most of the reported symptoms were mild. Patients with PD and MS reported few AEFIs after administration of the COVID-19 vaccines. The frequency of AEFIs in the PD population was significantly lower than in the control group.

Vaccinations and Healthy Ageing: How to Rise to the Challenge Following a Life-Course Vaccination Approach.

In the context of an ageing population, one of the major Public Health goals is to promote healthy ageing. To rise to this challenge, rethinking conventional prevention paradigms and implementing them with vaccination at all stages of life is necessary. Indeed, vaccinations are able to both prevent pathogen specific diseases and all their downstream effects and to increase overall immune system plasticity and resilience. Our aim is to discuss the obstacles and opportunities in pursuing a "life-course vaccination approach" and to highlight the role of vaccines in healthy ageing. In doing so, we address the close connections between immunology and vaccinology advances and introduce the novel concept of immune fitness. Finally, we conclude that even though vaccinology is making giant steps towards tailored vaccination strategies, more studies are needed to investigate this topic.

ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance.

BACKGROUND: In August 2020, Sputnik V was registered as Gam-COVID-Vac by the Russian Ministry of Health, and since December 2020 it has been distributed in 61 countries worldwide. On 25 February 2021, the Republic of San Marino started its vaccination campaign, which includes Sputnik V. Our aim was to describe the adverse events following immunization (AEFIs) with this vaccine through participant-based active surveillance in the country. METHODS: Beginning from 4 March to 8 April 2021, a nationwide study was conducted on San Marino's population aged 18-89 years who received one or two doses of Sputnik V. E-questionnaire dissemination occurred through e-mails, QR-codes or live/phone interviews ~7 days after the first and second vaccine dose. A descriptive analysis was conducted to quantify AEFI incidence on both occasions, stratifying results by type and severity of symptoms. FINDINGS: Mean age of the 2558 vaccine recipients was 66±14 years. First-dose AEFI incidence was 53.3% (systemic reactions at 42.2%), while second-dose AEFI incidence was 66.8% (systemic reactions at 50.4%) (n = 1288). In general, 76.0% of two-dose recipients reported some AEFIs after either vaccine dose, and 2.1% suffered severe reactions; in 60- to 89-year-olds (n = 1021), AEFI incidence was 70.0%, with 53.0% of subjects describing systemic reactions and 0.8% reporting severe symptoms. The most frequent symptoms were local pain, asthenia, headache and joint pain. INTERPRETATION: Our results, albeit preliminary, suggest that Sputnik V has a high tolerability profile in the population aged ≥60 years in terms of short-term AEFIs. FUNDING: None.

The Arousal Disorders Questionnaire: a new and effective screening tool for confusional arousals, Sleepwalking and Sleep Terrors in epilepsy and sleep disorders units.

BACKGROUND: Arousal Disorders (DoA) include Confusional Arousals, Sleepwalking and Sleep Terrors. DoA diagnosis is mainly clinical but no validated questionnaires exist for DoA screening according to the criteria of the International Classification of Sleep Disorders, Third Edition. Recently our group proposed the Arousal Disorders Questionnaire (ADQ) as a new diagnostic tool for DoA diagnosis. The objective of this study was to evaluate the diagnostic accuracy of the ADQ in a sleep and epilepsy center. METHODS: One interviewer blinded to clinical and video-polysomnographic (VPSG) data administered the ADQ to 150 patients consecutively admitted to our Sleep and Epilepsy Centers for a follow-up visit. The final diagnosis, according to VPSG recordings of at least one major episode, classified patients either with DoA (DoA group) or with other sleep-related motor behaviors confounding for DoA (nDoA group). RESULTS: 47 patients (31%) composed the DoA group; 56 patients with REM sleep behavior disorder, 39 with sleep-hypermotor epilepsy, six with night eating syndrome, and two with drug-induced DoA composed the nDoA group. The ADQ had a sensitivity of 72% (95% CI: 60-82) and a specificity of 96% (95% CI: 89-98) for DoA diagnosis; excluding the items regarding consciousness and episode recall, sensitivity was 83% (95% CI: 71-90) and specificity 93% (95% CI: 86-97). CONCLUSIONS: The ADQ showed good accuracy in screening patients with DoA in a sleep and epilepsy center setting. Diagnostic criteria related to cognition and episode recall reduced ADQ sensitivity, therefore a better definition of these criteria is required, especially in adults.