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Background: Protection provided by seasonal influenza vaccination (SIV) may be measured against numerous outcomes, and their heterogeneity may hamper decision-making. The aim of this study was to explore outcomes used for estimation of SIV efficacy/effectiveness (VE) and obtain expert consensus on their importance., Research Design and Methods: An umbrella review was first conducted to collect and map outcomes considered in systematic reviews of SIV VE. A Delphi study was then performed to reach expert convergence on the importance of single outcomes, measured on a 9-point Likert scale, in principal target groups, namely children, working-age adults, older adults, subjects with co-morbidities and pregnant women., Results: The literature review identified 489 outcomes. Following data reduction, 20 outcomes were selected for the Delphi process. After two Delphi rounds and a final consensus meeting, convergence was reached. All 20 outcomes were judged to be important or critically important. More severe outcomes, such as influenza-related hospital encounters and mortality with or without laboratory confirmation, were generally top-ranked across all target groups (median scores ≥8 out of 9)., Conclusions: Rather than focusing on laboratory-confirmed infection per se, experimental and observational VE studies should include more severe influenza-related outcomes because they are expected to exercise a greater impact on decision-making.

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.

Healthcare workers (HCWs) are among the at-risk groups for whom influenza vaccination is strongly recommended. To assess the proportion of Italian HCWs with positive attitudes toward influenza vaccination, we conducted a systematic review of relevant literature and a meta-analysis. Our focus was on the influenza seasons from 2017/18 to 2021/22. The prevalence of favorable attitudes toward vaccination varied, ranging from 12% during the 2017/18 influenza season to 59% in the 2020/21 season. The significant increase in the 2020/21 season can be attributed to adaptations necessitated by the COVID-19 pandemic. During the 2021/22 influenza season, there was a decline in vaccination coverage (37%), likely due to the absence of a robust preventive culture. Various strategies have been employed to enhance HCWs' attitudes to achieve higher vaccination rates, but none of them have demonstrated satisfactory results. Policymakers should consider implementing a policy of mandatory vaccination to ensure elevated vaccination coverage among HCWs.

Objectives: MF59-adjuvanted standard-dose and nonadjuvanted high-dose seasonal influenza vaccines have been developed to protect the elderly at high risk of severe complications. This study aimed to summarize the available evidence on the comparative efficacy/effectiveness of these two vaccines., Methods: A systematic literature review of experimental and observational studies were conducted according to the preferred reporting items for systematic reviews and meta-analyses guidelines. When possible, the extracted effect sizes were pooled in random-effects meta-analyses., Results: Ten studies were identified. Of these, no head-to-head randomized controlled trials were identified. All available studies had retrospective cohort design and large sample sizes, were conducted in the United States between the 2016-2017 and 2019-2020 seasons, and were at moderate risk of bias. Relative effectiveness estimates were limited to nonlaboratory-confirmed clinical end points, such as medical encounters including hospitalizations. Although most pooled relative effectiveness estimates were close to null, few statistically significant pooled effect sizes were small in magnitude, moved in opposite directions, and depended on the study sponsor and specificity of influenza-related outcomes., Conclusion: At present, MF59-adjuvanted standard-dose and nonadjuvanted high-dose vaccines appear to have similar effectiveness in preventing seasonal influenza in the elderly, and no conclusive recommendations on the preference of one vaccine over another could be drawn., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Vaccination is the most effective intervention to prevent influenza. Adults at risk of complications are among the targets of the vaccination campaigns and can be vaccinated with different types of quadrivalent influenza vaccines (QIVs). In the light of assessing the relative immunogenicity and efficacy of different QIVs, a systematic review was performed. Randomized controlled trials conducted in adults aged 18-64 years until 30 March 2021 were searched through three databases (Medline, Cochrane Library and Scopus). Twenty-four RCTs were eventually included. After data extraction, a network meta-analysis was not applicable due to the lack of common comparators. However, in the presence of at least two studies, single meta-analyses were performed to evaluate immunogenicity and efficacy; on the contrary, data from single studies were considered. Seroconversion rate for H1N1 was higher for standard QIVs, while for the remaining strains it was higher for low-dose adjuvanted QIVs. For seroprotection rate, the recombinant vaccine recorded the highest values for H3N2, while for the other strains, the cell-based QIVs achieved better results. In general, standard and cell-based QIVs showed an overall good immunogenicity profile. Nevertheless, as a relative comparative analysis was not possible, further research would be deserved.

Background: The elderly, commonly defined as subjects aged ≥65 years, are among the at-risk subjects recommended for annual influenza vaccination in European countries. Currently, two new vaccines are available for this population: the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) and the high-dose quadrivalent influenza vaccine (hdQIV). Their multidimensional assessment might maximize the results in terms of achievable health benefits. Therefore, we carried out a Health Technology Assessment (HTA) of the aQIV by adopting a multidisciplinary policy-oriented approach to evaluate clinical, economic, organizational, and ethical implications for the Italian elderly., Methods: A HTA was conducted in 2020 to analyze influenza burden; characteristics, efficacy, and safety of aQIV and other available vaccines for the elderly; cost-effectiveness of aQIV; and related organizational and ethical implications. Comprehensive literature reviews/analyses were performed, and a transmission model was developed in order to address the above issues., Results: In Italy, the influenza burden on the elderly is high and from 77.7% to 96.1% of influenza-related deaths occur in the elderly. All available vaccines are effective and safe; however, aQIV, such as the adjuvanted trivalent influenza vaccine (aTIV), has proved more immunogenic and effective in the elderly. From the third payer's perspective, but also from the societal one, the use of aQIV in comparison with egg-based standard QIV (eQIV) in the elderly population is cost-effective. The appropriateness of the use of available vaccines as well as citizens' knowledge and attitudes remain a challenge for a successful vaccination campaign., Conclusions: The results of this project provide decision-makers with important evidence on the aQIV and support with scientific evidence on the appropriate use of vaccines in the elderly.

Reliable country-specific data on influenza burden play a crucial role in informing prevention and control measures. Our purpose was to provide a comprehensive summary of the available evidence on the burden of seasonal influenza in Italy. We performed a systematic literature review of articles published until July 31, 2020. PubMed, Embase, and Web of Science were searched using terms related to burden, influenza, and Italian population. We included studies investigating seasonal influenza-related complications, hospitalizations, and/or mortality. Sixteen studies were included: eight (50%) analyzed influenza-related complications, eight (50%) hospitalizations, and seven (43.8%) influenza-related deaths. Only three studies (19.7%) concerned pediatric age. The synthesis of results showed that patients with chronic conditions have an increased risk for complications up to almost three times as compared with healthy people. Hospitalizations due to influenza can occur in as much as 5% of infected people depending on the study setting. Excess deaths rates were over sixfold higher in the elderly as compared with the rest of population. Although there are still gaps in existing data, there is evidence of the significant burden that influenza places each year especially on high-risk groups. These data should be used to inform public health decision-making., (© 2021 The Authors. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)

Competing Interests: Tutti gli autori dichiarano assenza di conflitto di interesse.

Background: Influenza vaccination is an important public health intervention for controlling disease burden, but coverage rates are still low also in risk groups. In order to identify non-vaccinating subgroups, deprivation and socio-economic indices, i.e. measures used to synthetically describe people's socio-economic status while taking into account several dimensions, may be used. We aimed to synthetize evidence from studies investigating association between deprivation/socio-economic indices and influenza vaccination coverage in population at risk-persons ≥65 years of age, individuals with comorbidities, pregnant women and health-care workers., Methods: We searched PubMed, ISI WoS, CINAHL and Scopus to identify observational studies published up to October 10th 2017 in English or Italian. Studies reporting quantitative estimates of the association between deprivation/socio-economic indices and influenza vaccination coverage in populations at risk were included., Results: A total of 1474 articles were identified and 12 were eventually included in the final review. Studies were mostly cross-sectional, performed in European countries, from 2004 to 2017. Seven studies focussed on deprivation and five on socio-economic indices. Studies on deprivation indices and vaccination coverage showed that people from the most deprived areas had lower coverage. Regarding socio-economic condition, results were contrasting, even though it may also be concluded that people from lower groups have lower vaccination coverage., Conclusions: Our work supports the possibility to identify people likely to have lower influenza vaccination coverage based on deprivation/socio-economic indices. Efforts should be performed in order to further strengthen robustness, transferability and suitability of these indices in addressing public health problems., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Public Health Association.)

Background: The elderly, defined here as subjects aged ≥ 65 years, are among at-risk subjects for whom annual influenza vaccination is recommended. For the 2018/19 season, three vaccine types are available for the elderly in Italy: trivalent inactivated vaccine (TIV), adjuvanted TIV (aTIV) and quadrivalent inactivated vaccines (QIV). No health technology assessment (HTA) of seasonal influenza vaccination in the elderly has previously been conducted in Italy., Methods: An HTA was conducted in 2017 to analyze the burden of influenza illness, the characteristics, efficacy, safety and cost-effectiveness of available vaccines and the related organizational and ethical implications. This was then contextualized to the 2018/19 influenza season. Comprehensive literature reviews/analyses were performed and a static mathematical model developed in order to address the above issues., Results: In Italy, influenza is usually less common in the elderly than in other age-classes, but the burden of disease is the highest; >10% of infected elderly subjects develop complications, and about 90% of all influenza-related deaths occur in this age-class. All available vaccines are effective, safe and acceptable from an ethical standpoint. However, aTIV has proved more immunogenic and effective in the elderly. Furthermore, from the third payer's perspective, aTIV is highly cost-effective and cost-saving in comparison with TIV and QIV, respectively. Nevertheless, vaccination coverage needs to be improved., Conclusions: According to this HTA, aTIV appeared the vaccine of choice in the elderly. HTA should be reapplied whenever new relevant data become available., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Public Health Association.)

We analysed the impact of several strategies aimed at increasing influenza immunisation rates among Medical Residents (MRs) of an Italian teaching Hospital. During the 2015-16 and 2016-17 influenza seasons we carried out several interventions: ambulatory doubling where vaccination was offered, ambulatory opening hour extension, email invitations, informative materials, forum theatre and vaccination campaign conference. In addition, during the 2016-17 the OSV was carried out: MRs who go to specific wards where they perform influenza immunisation counselling and eventually vaccinate the personnel. 99/1041 (9.5%) and 184/1013 (18.2%) MRs received the vaccine in 2015-16 and in 2016-17 respectively (p < 0.0001). Significant difference was found among three specialisation areas (medicine, surgery, "services"; p < 0.001) and among years of residency (p < 0.001). The highest coverage was found among Infectious Diseases, Paediatrics, Haematology and Hygiene MRs (80%, 67%, 52% and 52% respectively) in 2016-2017 season. The highest coverage increase was found among MRs in Pneumology and Geriatrics (566% and 268%, respectively). The coverage rate has increased even though important differences among specialties persist. The study shows a significant increase in immunisation rate among MRs after the implementation of these strategies.

ABSRACT In the perspective of reaching at least 75% influenza vaccination coverage in the elderly and substantial budget constraints, Italian decision makers are facing important challenges in determining an optimal immunization strategy for this growing and particularly vulnerable population. Four different influenza vaccines are currently available for Italian older adults aged 65 years or above, namely trivalent inactivated vaccines (TIVs), MF59-adjuvanted TIV (MF59-TIV), intradermal TIV (ID-TIV) and quadrivalent inactivated vaccines (QIVs). The present study is the first to compare the cost-effectiveness profiles of virtually all possible public health strategies, including the aforementioned four vaccine formulations as well non-vaccination. For this purpose, a decision tree model was built ex novo; the analysis was conducted from the third-payer perspective in the timeframe of one year. All available vaccines were cost-effective compared with non-vaccination. However, MF59-TIV had the most favorable economic profile in the Italian elderly population. Indeed, compared with non-vaccination, it was deemed highly cost-effective with an incremental cost-effectiveness ratio (ICER) of €10,750 per quality-adjusted life year (QALY). The ICER was much lower (€4,527/QALY) when MF59-TIV was directly compared with TIV. ID-TIV and QIV were dominated by MF59-TIV as the former comparators were associated with greater total costs and lower health benefits. Both deterministic and probabilistic sensitivity analyses confirmed robustness of the base case results. From the economic perspective, MF59-TIV should be considered as a preferential choice for Italian older adults aged 65 years or above.

Introduction: In Italy annual flu vaccination for health care workers is recommended but coverage is usually unsatisfying. The compliance is even worse among medical residents (MRs) both in literature, both in our experience: in the flu season 2014/ 15 only 0.6% of MRs enrolled at the Università Cattolica del Sacro Cuore (UCSC) were vaccinated. For this reason, during the influenza season 2015/16, the Institute of Public Health of the UCSC, in collaboration with the Health Management of the "Agostino Gemelli" Teaching Hospital (FPG) and with the directive board of the Medical Specialization Schools (SSM) present at the University has tested several strategies to improve awareness and adherence to flu vaccination campaign by its staff. This study aims to analyze the impact of the strategies used during the 2015/16 campaign on flu vaccination coverage among MRs of an important Italian Teaching Hospital., Methods: The study was conducted among MRs enrolled at the UCSC - FPG in 2015/16. The data was collected by the Occupational Medicine which, during the influenza seasons, immunize MRs against influenza free of charge. For each variable - vaccination, area of specialization (surgical, medical, clinical services), typology of SSM - was measured the absolute and percentage frequency. In order to compare the flu vaccination coverage between seasons 2014/15 and 2015/16 and between areas of specialization in 2015/16 chi-square test was used (statistical significance level of 0.05). The data were analyzed using STATA Software., Results: Were included in the analysis 42 SSM with a total of 1041 MRs. During the vaccination campaign 2015/16, flu vaccine was administered to 99 MRs (9.5%), 8.9% more than in the previous season (p&lt;0.001). There is also a significant difference in vaccine coverage between surgical, medical and clinical services areas in 2015/16 (p &lt;0.001). The highest vaccination coverage was recorded among MRs of Hematology and Urology (54.5%). However, no one MRs had undergone flu vaccination in about 40% of SSM., Conclusions: Seasonal flu vaccination among HCWs is important to protect patients as well as them self and their family members. Considering that MRs represent the next generation of HCWs, they should be sensitized about the importance of preventing the spread of influenza in hospital population, becoming an active part of the necessary cultural change. This study highlights a first and promising, although insufficient, increase in flu vaccination coverage among MRs enrolled at the UCSC - FPG after introducing simple strategies to promote vaccination itself and, more generally, positive and proactive behaviors. The study summarizes the results in the short term, but it is well known that cultural changes require time and constancy. Therefore, it will be useful to monitor the improvement over time and extend the assessment to all health care professionals.

Although influenza vaccination is recognized to be safe and effective, recent studies have confirmed that immunization coverage among health care workers remain generally low, especially among medical residents (MRs). Aim of the present multicenter study was to investigate attitudes and determinants associated with acceptance of influenza vaccination among Italian MRs. A survey was performed in 2012 on MRs attending post-graduate schools of 18 Italian Universities. Each participant was interviewed via an anonymous, self-administered, web-based questionnaire including questions on attitudes regarding influenza vaccination. A total of 2506 MRs were recruited in the survey and 299 (11.9%) of these stated they had accepted influenza vaccination in 2011-2012 season. Vaccinated MRs were older (P = 0.006), working in clinical settings (P = 0.048), and vaccinated in the 2 previous seasons (P<0.001 in both seasons). Moreover, MRs who had recommended influenza vaccination to their patients were significantly more compliant with influenza vaccination uptake in 2011-2012 season (P<0.001). "To avoid spreading influenza among patients" was recognized as the main reason for accepting vaccination by less than 15% of vaccinated MRs. Italian MRs seem to have a very low compliance with influenza vaccination and they seem to accept influenza vaccination as a habit that is unrelated to professional and ethical responsibility. Otherwise, residents who refuse vaccination in the previous seasons usually maintain their behaviors. Promoting correct attitudes and good practice in order to improve the influenza immunization rates of MRs could represent a decisive goal for increasing immunization coverage among health care workers of the future.

Influenza epidemics are responsible for high mortality and morbidity rates in particular among elderly and high risk groups. This review is aimed at assessing the economic value of vaccination in these groups. A search of full economic evaluations of influenza vaccination in comparison with no interventions was performed on PubMed from January 1990 to May 2011. Only economic evaluations dealing with elderly and high risk groups were considered. The quality of selected articles was assessed through Drummond's checklist. Sixteen cost-effectiveness analyses and four cost-benefit analyses were included: overall, the quality of studies was fairly good. The vaccination was demonstrated to be cost-effective or cost-saving in almost all studies, independently by the perspective and the type of analysis. Influenza vaccination is a worthwhile intervention from the pharmacoeconomic view-point, anyway a standardization of methods should be desirable in order to guarantee the comparability and transferability of results.