Costs and healthcare utilisation due to respiratory syncytial virus disease in paediatric patients in Italy: a systematic review.

OBJECTIVES: Respiratory syncytial virus (RSV) is a frequent cause of acute lower respiratory infection in children, imposing a substantial economic burden on healthcare systems. This systematic review aimed to assess the economic burden and healthcare utilisation of RSV in children aged 0-59 months in Italy. STUDY DESIGN: Systematic review. METHODS: A systematic search of PubMed, Embase, Scopus, and the International HTA Database, including studies published in English or Italian, was conducted between January 2000 and July 2022. Inclusion criteria required studies to be conducted in Italy and provide data on the economic costs and healthcare resource utilisation related to RSV infections. RESULTS: Out of 20,845 records screened, 18 articles met the inclusion criteria. Only one study provided comprehensive data on RSV disease costs, including hospitalisation, diagnostic tests, and medical procedures for infants with RSV-bronchiolitis. The mean cost per inpatient was higher for RSV-positive children (€5753.43 ± €2041.62) than that for RSV-negative children. Additionally, five studies reported a median length of hospital stay of 5 days for RSV-infected children, and four studies indicated a higher frequency of intensive care unit admissions for RSV-infected children than for those with other viral infections. CONCLUSIONS: This is the first systematic review to examine the economic burden and healthcare utilisation of RSV in children aged 0-59 months in Italy. While limited data were available, the findings underscore the urgency to conduct further research and gather additional evidence on the costs and healthcare resource utilisation associated with RSV infections. Such efforts are essential for informing the development of effective prevention strategies for paediatric RSV infections in Italy.

Anti-rubella seroprevalence assessment in an adult sample population in Italy.

Introduction: Despite global immunization efforts, rubella remains a public health concern, particularly in high- and middle-income countries. This study focused on rubella seroprevalence in the province of Florence, Italy, aiming to identify susceptibility clusters, especially among women in their childbearing age. Methods: A cross-sectional study was conducted between April 2018 and December 2019, enrolling 430 adult subjects (age over 18 years). Serum samples were collected, and anti-rubella antibodies were quantified using the ELISA test. Data were analyzed descriptively and compared by sex, nationality, and age groups using statistical tests. Results: The overall rubella seroprevalence was high (92.3%), with no significant differences between genders or nationalities. Among childbearing-age females (18-49 years), the highest seroprevalence was observed in the 30-39 age group (94.1%). However, susceptibility clusters exceeding the 5% threshold set by WHO were identified, especially in females aged 40-49 years (7.0%). Conclusions: Despite high overall seroprevalence, the study identified pockets of susceptibility, even in childbearing age women. Continuous monitoring, targeted immunization strategies, and public health interventions are recommended to maintain rubella elimination, emphasizing the importance of sustained vaccination efforts to protect vulnerable populations.

Efficacy of HPV Vaccination Regarding Vulvar and Vaginal Recurrences in Previously Treated Women: The Need for Further Evidence.

Vulvar and vaginal cancers are relatively rare cancers, but their incidence is increasing worldwide. Overall, 78% of vaginal cancers and 25% of vulvar cancers are associated with Human papillomavirus (HPV) infection. Immunization could be an option for the management of these cases. We researched and assessed the evidence on the efficacy of HPV vaccination administered to women previously treated with surgery, radiotherapy, or chemotherapy with respect to the recurrence of vulvovaginal disease. From 2006 to November 2022, only one study evaluated the efficacy of HPV vaccination with respect to preventing vulvovaginal recurrences in treated women and showed that a quadrivalent HPV vaccine administered after the surgical treatment of vulvar high-grade squamous intraepithelial lesion (HSIL) can reduce vulvar recurrence of the disease. Therefore, the efficacy of HPV vaccination with respect to vulvovaginal recurrence is still an unexplored field. Further studies are needed to produce stronger evidence in order to appropriately support interventions to protect women's health.

Effectiveness of pneumococcal vaccination on hospitalization and death in the adult and older adult diabetic population: a systematic review.

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

Human Respiratory Syncytial Virus Epidemiological Burden in Pediatric Outpatients in Italy: A Systematic Review.

BACKGROUND: Human respiratory syncytial virus (hRSV) is a key contributor to lower respiratory tract infections (LRTIs), affecting children aged 0-5 years and often leading to outpatient visits, emergency department utilization, and hospitalization. With the development of hRSV vaccines for mitigation, understanding the epidemiological impact of hRSV infections among 0-5-year-old pediatric outpatients in Italy is crucial. METHODS: This systematic review conducted searches on PubMed, Embase, Scopus, and the International HTA Database, yielding 20,845 English and Italian records from January 2000 to July 2022. RESULTS: Six eligible articles were identified following inclusion and exclusion criteria. These studies demonstrated hRSV-positivity proportions ranging from 18% to 41% in pediatric outpatients with respiratory infections. However, data comparability was hindered by diverse diagnostic approaches, data sources, sample populations, and study designs. Notably, hRSV-positivity showed temporal variability, rising from 23.8% (2001-2002) to 40.6% (2019-2020). This trend could stem from evolving epidemiological factors, heightened clinician awareness in hRSV diagnosis, or more sensitive molecular techniques. CONCLUSION: As the first review of its kind, this study underscores the need for more comprehensive data to inform effective preventive strategies against hRSV-related burdens in pediatric outpatients.

Review of scientific evidence to support recommendations of the full-dose DTaP-IPV vaccination in pre-school age children in Italy.

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

The First 30 Years of the Universal Hepatitis-B Vaccination-Program in Italy: A Health Strategy with a Relevant and Favorable Economic-Profile.

In 1991, Italy was one of the first countries worldwide to introduce a universal hepatitis-B vaccination for children. Since then, epidemiological data have clearly demonstrated the huge clinical benefits of the vaccination. The aim of this study was to update the favorable economic impact of the hepatitis B virus (HBV) vaccination, 30 years after its implementation. A mathematical model was developed to simulate the clinical/economic impact of the universal HBV-vaccination program versus a hypothetical no-vaccination scenario as a posteriori analysis. We assessed the vaccination benefits over a 30-year-immunization-period (1991−2020), and the following period, 2021−2070. Our data showed a big drop in HBV-related diseases (−82% in infections, chronic disease, and hepatocellular-carcinoma cases), and related costs (−67% in the immunization period and −85% in 2021−2070), attributable to vaccination. The return on investment (ROI) and the benefit-to-cost (BCR) ratios are >1 for the first thirty-year-immunization-period, and are predicted to almost triplicate the economic savings in the period 2021−2070, both for the National Health Service (NHS) and from societal perspectives. Our model confirmed that the implementation of universal HBV-vaccination in Italy during the first 30 years continues to be a cost-saving strategy, and more advantageous effects will be further achieved in the future. The HBV-vaccination strategy greatly expresses a huge impact in both the short- and long-term, and from the clinical and economic point-of-views.

Descriptive Observational Study of Tdap Vaccination Adhesion in Pregnant Women in the Florentine Area (Tuscany, Italy) in 2019 and 2020.

Background: Tdap (Tetanus-Diphtheria-acellular Pertussis) vaccination is nowadays a worldwide-recommended practice to immunize pregnant women. The vaccine administration at the third trimester of pregnancy (as recommended by the WHO) would ensure antibody protection to both the mother and the newborn and has contributed to the significant drop of pertussis cases in infants. The aim of this observational study was to describe for the first time the socio-demographic characteristics and determinants of Tdap vaccination adhesion of pregnant women in the Florentine area. Methods: Information about parents' vaccination status, their citizenship, employment type and mothers' previous pregnancies and/or abortions were collected at the time of birth through the assistance birth certificates (CedAP) both for the years 2019 and 2020. This archive and the regional SISPC (Collective Prevention Healthcare Information System) linked using an anonymous unique personal identifier to retrieve the mother's vaccination status. Results: We found an overall Tdap vaccination adhesion of 43% in 2019 and 47.3% in 2020. Several socio-demographic parameters would determine an increased vaccination adhesion, including parents' geographical origin, mothers' age and educational background, as well as the number of previous deliveries, abortions or voluntary termination of pregnancy. Conclusions: Since not much data are available on this topic in Italy, this study may constitute the baseline information for Tdap vaccination adhesion in pregnant women in the Florentine area (Italy). Thus, future successful vaccination strategies may be designed accordingly.

Vaccine Production Process: How Much Does the General Population Know about This Topic? A Web-Based Survey.

BACKGROUND: Vaccine hesitancy has been recognized as a major global health threat by the World Health Organization. Many studies have investigated vaccine safety as a determinant for vaccine hesitancy; however, not much attention has been paid to vaccine production and quality control during the vaccine production process or whether knowledge about this topic may influence vaccine confidence. The aim of this study was to characterize the common knowledge about the vaccine production process. METHODS: A freely accessible online questionnaire was developed on Google Modules and disseminated through social networks. A descriptive analysis of the collected answers was performed, and the chi-square test was used to assess significant differences for the sociodemographic characteristics of the study population (age, gender, work or education and training in the healthcare setting, minor offspring). A binary logistic regression model was performed considering these socio-demographic categories as independent variables. RESULTS: The number of collected questionnaire was 135. Most of the participants (127/135, 94.1%) were aware that quality control measures are carried out during manufacturing, although some knowledge gaps emerged in specific aspects of the vaccine production process, without statistically significant differences between age groups. Working in the healthcare setting or being educated in healthcare may be considered predictors for a better understanding that more than 50% of the production time is spent on quality control (AOR = 3.43; 95% CI: 1.84-8.14, p = 0.01) and that considering quality control performed during the vaccine production process is adequate for avoiding contamination (AOR = 7.90; 95% CI: 0.97-64.34; p = 0.05). CONCLUSIONS: This study allowed for a characterization of common knowledge about the vaccine production process. It highlighted the need to implement specific strategies to spread correct information about the vaccine production process. This study may contribute to increased confidence and trust in vaccines and vaccination among the general population.

Quality and Safety of Vaccines Manufacturing: An Online Survey on Attitudes and Perceptions of Italian Internet Users.

Background: Vaccination is a worldwide public health practice that requires high uptake levels in order to effectively reduce the incidence of vaccine-preventable diseases. The manufacturing of vaccines is a complex process, and little is known about people's feelings and opinions on that. Our study aimed at investigating perceptions and attitudes of the general population towards the vaccine production process before the availability of COVID-19 vaccines. Methods: We designed a 15-question online survey in the Italian language which was spread via Facebook and an Italian website "Vaccinarsintoscana" between January and May 2020. We performed a descriptive analysis and applied statistical tests to assess differences in the given answers according to participants' sociodemographic characteristics. Results: The collected responses (135 participants) about the perceptions on vaccine production process were largely positive: not being concerned about the vaccine production (70.3%); believing the vials did not contain harmful substances (75.6%) and considering the precautionary withdrawal of some batches as highly effective (83.7%). In contrast, a less positive perception was found for the question about the conflict of interest between manufacturing companies and the control systems (48.9%). Moreover, people's perceptions towards the vaccine components (i.e., microorganism, adjuvants and opinion on batches withdrawal) also showed a good level of confidence and trust. Conclusions: Our study highlighted a generally positive attitude towards the vaccine production process and showed people's confidence in the control systems, safety and high standards of quality of the vaccine production process.

A Study of Varicella Seroprevalence in a Pediatric and Adolescent Population in Florence (Italy). Natural Infection and Vaccination-Acquired Immunization.

Background: Varicella is a well-known infectious disease that can have severe complications, also in young children. The Universal Varicella Vaccination (UVV) program was introduced in Tuscany (Italy) in 2003, with a two-dose vaccine schedule given to children between their 13th and 15th month, and at 5-6 years old, as a monovalent for varicella (V) or tetravalent (measles, mumps, rubella and varicella (MMRV)) formulation. Although varicella notifications have dramatically fallen in the last two decades, varicella disease underreporting remains a challenge. Methods: A qualitative immunoenzymatic test (ELISA) was used to measure the presence of anti-varicella antibodies in 165 sera of subjects aged 1-18 years residing in the province of Florence (Italy). Information regarding the anamnestic and vaccination status (including disease notification) was also collected. Results: Our study showed an overall varicella seropositivity of 75.8% (reaching the maximum at 96.3% in the 15-18 years age group). We found that varicella disease notification had been recorded for only 7/165 subjects; however, since 42/165 recalled having had the disease, we can hypothesize that some of them must have been underreported. Furthermore, our study showed that the presence of antibodies after the varicella vaccination remained over time, lasting up to 12 years. Conclusions: Although varicella seroprevalence is <95% in almost all our age groups (except for the 15-18 years age group), our data are encouraging and reflect the success of the introduction of the UVV program and the vaccination campaigns promoted in the Tuscany region.

A Study of Hepatitis A Seroprevalence in a Paediatric and Adolescent Population of the Province of Florence (Italy) in the Period 2017-2018 Confirms Tuscany a Low Endemic Area.

Background: Italy is considered an area with very low HAV (hepatitis A virus) endemicity. Currently in Italy the anti-HAV vaccine is recommended only for specific risk groups and there is no universal vaccination program. The aim of this study was to assess the level of immunity against hepatitis A in a sample of children and adolescents from the province of Florence. Methods: A total of 165 sera were collected from subjects aged 1 to 18 years, proportionally selected according to the general population size and stratified by age and sex. A qualitative evaluation of anti-HAV antibodies was performed using the enzyme-linked immunosorbent assay (ELISA). Anamnestic and vaccination status data were also collected. Results: Our study showed a hepatitis A seroprevalence of 9.1% in the enrolled population. A statistically significant difference in the prevalence of anti-HAV was found between Italian and non-Italian subjects. About half of the population having anti-HAV antibodies was reported to be vaccinated, and no cases of hepatitis A were found. Conclusions: The data from our study confirmed Tuscany as an area with low HAV endemicity and showed that hepatitis A seroprevalence is significantly higher in foreign children and adolescents. The presence of more seropositive subjects than those vaccinated was probably due to a natural immunization achieved through a subclinical infection and/or to underreporting of the surveillance systems.

Increasing Measles Seroprevalence in a Sample of Pediatric and Adolescent Population of Tuscany (Italy): A Vaccination Campaign Success.

Background: Despite the National Plan for the Elimination of Measles and congenital Rubella (NPEMcR), in 2017, a measles outbreak occurred in Italy, due to sub-optimal vaccination coverage (<95%) for many years. Since that year, the anti-measles vaccination became compulsory in minors (0-16 years) for school attendance. The aim of our study was to assess the immunity/susceptibility against measles in a representative sample of pediatric and adolescent (1-18 years) residents of the province of Florence (Tuscany, Italy), and to compare these results with two previous surveys (2003 and 2005-2006). Methods: The enzyme-linked immunosorbent assay (ELISA) was applied for a qualitative measurement of anti-measles antibodies on 165 sera. The anamnestic and vaccination status was also collected. Results: No measles notification was reported. The overall seropositivity was 88.5%; mostly in the 5-9 years old subjects (97.9%). Among the 152 vaccinated, 92.1% were positive. The seropositivity persisted after many years since the last dose of vaccine and tended to be more long-lasting in those who had received two or three doses. The susceptibility towards measles decreased over time, reaching a lower value in the current survey (8.5%) than in 2003 (30.8%) and in 2005-2006 (25.5%). Conclusions: This study confirmed the anti-measles vaccination campaign success, which allowed for the increase in vaccination coverage and immunity levels against measles in the Florentine pediatric and adolescent population following the NPEMcR implementation.

Rubella Seroprevalence Boost in the Pediatric and Adolescent Population of Florence (Italy) as a Preventive Strategy for Congenital Rubella Syndrome (CRS).

BACKGROUND: Despite the availability of an effective vaccine since the 1970s, rubella disease and, importantly, congenital rubella syndrome (CRS) remain a public health concern. The aim of this study was to analyze the rubella seroprevalence in the children population of the province of Florence and compare the obtained results to a previous survey conducted in 2005-2006. METHODS: A qualitative measurement of anti-rubella antibodies was performed on 165 sera using the enzyme-linked immunosorbent Assay (ELISA). The anamnestic and vaccination status was also collected. RESULTS: Our study highlighted a very high rubella seroprevalence (85-100%) in our enrolled population. In the vaccinated group (153/165), 98.7% of them were positive to rubella antibodies. CONCLUSIONS: Our study showed the highest seroprevalence rate reached in the province of Florence for rubella in the last 15 years, thanks to the several successful vaccination campaigns promoted in the Tuscany region. Our findings in pediatric and adolescent subjects are a key factor in preventing CRS in adult life, specifically in childbearing women. Thus, the set goal will be to keep the awareness about the vaccination for this preventable disease high.