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Objectives: Delaying of policies for immunization of aging adults, low vaccine uptake, and the lack of supportive evidence at the national level could diminish the value in health and economics of such programs. This study aims to develop a "country score tool" to assess readiness and to facilitate evidence generation for aging adult immunization programs in Europe, and examine the comprehensiveness, relevance, acceptability, and feasibility of the tool., Methods: The tool was developed in two phases. First, a modified Delphi process was used to construct the tool. The process included a literature review, stakeholder consultations, and a three-round Delphi study. The Delphi panel included researchers, supra-national and national decision-makers of immunization programs recruited from five countries, using snowball sampling method. The consensus was predefined at the agreement rate of 70%. Pilot testing of the tool was conducted in the Netherlands, Germany, Serbia, and Hungary involving researchers in the field of health technology assessment. After assessing the countries' readiness, researchers evaluated four features, namely comprehensiveness, relevance, acceptability, and feasibility of the tool via an online survey that included 5-scale Likert questions. The percentages of affirmative answers including "agree" and "totally agree" choices were presented., Results: The review identified 16 tools and frameworks that formed the first version of our tool with 14 items. Eight experts were involved in the Delphi panel. Through three Delphi rounds, four items were added, one was dropped, and all others were amended. The consensus was achieved on the tool with 17 items divided into decision-making and implementation parts. Each item has a guiding question, corresponding to explanations and rationales to inform assessment with readiness scores. Eight researchers completed the pilot testing. The tool was rated as comprehensive (75%), relevant (100%), acceptable (75%), and feasible (88%) by participants., Conclusion: Through a thorough and transparent process, a country score tool was developed helping to identify strengths, weaknesses, and evidential requirements for decision-making and implementation of immunization programs of aging adults. The tool is relevant for different European contexts and shows good comprehensiveness, acceptability, and feasibility., Competing Interests: MP reports grants and personal fees from various pharmaceutical industries, all outside the submitted work. EB is an employee of and holds shares in the GSK group of companies. TP was employed by Asc Academics. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Pham, Beck, Postma, Németh, Ágh, de Waure, Salisbury, Nutma and van der Schans.)

Objectives: To provide a new value-based immunization approach collating the available scientific evidence on the topic., Methods: Four value pillars (personal, allocative, technical, and societal) applied to vaccination field were investigated. A systematic literature review was performed querying three database from December 24th, 2010 to May 27th, 2020. It included studies on vaccine-preventable diseases (VPDs) that mentioned the term value in any part and which were conducted in advanced economies. An in-depth analysis was performed on studies addressing value as key element., Results: Overall, 107 studies were considered. Approximately half of the studies addressed value as a key element but in most of cases (83.3%) only a single pillar was assessed. Furthermore, the majority of papers addressed the technical value by looking only at classical methods for economic assessment of vaccinations whereas very few dealt with societal and allocative pillars., Conclusions: Estimating the vaccinations value is very complex, even though their usefulness is certain. The assessment of the whole value of vaccines and vaccinations is still limited to some domains and should encompass the wider impact on economic growth and societies., Competing Interests: GEC, EC, AT, IG, EB, MM, and CdW received a fee by VIHTALI (Value in Health Technology and Academy for Leadership & Innovation, Spin-Off of Università Cattolica del Sacro Cuore, Rome, Italy) for the scientific activities of the project entitled “The value (s) of vaccination: building the scientific evidence according to a Value-Based Healthcare approach.” WR was not paid for his time by him. The project was funded by MSD. The funders had no role in the design of the study, the collection, analysis and interpretation of data, or the writing of the manuscript., (Copyright © 2022 Calabro', Carini, Tognetto, Giacchetta, Bonanno, Mariani, Ricciardi and de Waure.)

Introduction: Health systems worldwide need to pay attention to both sustainability and quality. The explosion of health technologies represents a challenge for health systems' sustainability, and evidence-based tools should support resources allocation to guarantee a continuous quality improvement. The value-based approach could disentangle the full benefit of a health technology, and this is of utmost importance in the vaccination field because of several obstacles still existing in reaching optimal vaccination uptake., Areas Covered: The paper conveys the evidence on the full value of vaccine(s)/vaccination based on the framework suggested by the Expert Panel on Effective Ways of Investing in Health of the European Commission. Indeed, evidence on the personal, technical, allocative, and societal value of vaccine(s)/vaccination published in the last decade was described as foundation of a following consultation with international experts of the field. The result was the issuing of recommendations for research, decision-making, and public engagement that aimed to drive a value-based decision-making on vaccination., Expert Opinion: The development of vaccination programs based on the recognition of the full value of vaccine(s)/vaccination is essential. To achieve this goal, it is necessary to launch intersectoral and multidisciplinary research and implementation initiatives involving all relevant stakeholders.

Background: Vaccination coverages need to be constantly maintained and improved with the implementation of vaccination strategies. This paper describes the development of an evidence-based tool to guide their planning and evaluation. Methods: A scoping review was performed in MEDLINE and institutional websites to search for similar available tools. A first version of the tool was developed considering review results and a four-step method used for the control and continuous improvement of processes and products, namely the Deming cycle. A panel of eight experts was then involved in a Delphi study for the finalization of the tool that was eventually discussed in a face-to-face meeting. Results: The scoping review found only one document and the first version of the tool was composed of 30 items. After the Delphi first round, 11 additional items were suggested and 5 original items amended. After the Delphi second round 41 items were eventually included. During the face-to-face meeting, 7 items were recognized as requisites for setting vaccination strategies, whereas 17 as relevant ones. Conclusions: Current public health challenges impose the need for evidence-based tools to organize effective vaccination strategies. Our tool is a first proposal which aims to reflect this focus., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Calabrò, Carini, Tognetto, Mancinelli, Sarnari, Colamesta, Ricciardi, de Waure and The BRAVE Project Expert panel.)

Introduction Coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), has quickly spread around the world. Areas covered This review will discuss the available immunologic and clinical evidence to support the benefit of the influenza, pneumococcal, and tuberculosis vaccines in the context of COVID-19 as well as to provide an overview on the COVID-19-specific vaccines that are in the development pipeline. In addition, implications for vaccination strategies from a public health perspective will be discussed. Expert opinion Some vaccines are being considered for their potentially beneficial role in preventing or improving the prognosis of COVID-19: influenza, pneumococcal and tuberculosis vaccines. These vaccines may have either direct effect on COVID-19 via different types of immune responses or indirect effects by reducing the burden of viral and bacterial respiratory diseases on individual patients and national healthcare system and by facilitating differential diagnoses with other viral/bacterial respiratory disease. On the other hand, a large number of candidate vaccines against SARS-CoV-2 are currently in the pipeline and undergoing phase I, II, and III clinical studies. As SARS-CoV-2 vaccines are expected to be marketed through accelerated regulatory pathways, vaccinovigilance as well as planning of a successful vaccination campaign will play a major role in protecting public health.

Rotavirus (RV) infections are a leading cause of severe gastroenteritis in children, and vaccination is currently recommended in Italy, according to the National Immunization Plan 2017-2019. The objective of this study was to describe the epidemiological and molecular RV surveillance in the pediatric population of Perugia province, Umbria. Between September 2007 and August 2018, 663 RV-positive stool specimens were collected from children <15 years of age presenting with gastroenteritis to the emergency room of the Perugia province hospitals who were then hospitalized. Yearly hospitalization rates were expressed per 100,000 persons, and denominators were extrapolated from the National Institute of Statistics. During the 10-year surveillance, the epidemiological trend was fluctuating but slightly decreasing (Max: 89.7 per 100,000 in 2010/2011; Min: 34.8 per 100,000 in 2017/2018). The hospitalization rate was higher in males and in children under five years of age. Among common genotypes, G1P[8] was prevalent most of the years. The uncommon G12P [8] genotype emerged and was the most common in 2012/2013 (58.2%). Afterwards, its circulation remained high. As the Umbria Region started vaccinating from the 2018 birth cohort, our study reviewed pre-vaccination data and will help to assess the protection induced by vaccination and its effect on circulating strains., Competing Interests: The authors declare no conflicts of interest.

Italy is witnessing relevant challenges in the field of prevention and control of vaccine-preventable diseases. The worrying and growing phenomenon of "vaccine-hesitancy" has contributed to the reduction of vaccination coverage, undermining goals reached thanks to vaccines introduction. The new Italian National Immunization Plan (NIP) 2017-2019 and the update of the list of Essential Care Levels (LEA), approved in the current year, extend the vaccination offer based on the latest scientific evidence with the introduction of new vaccines and the enlargement of target population. The decree-law containing urgent measures in immunization field issued in June 2017 represents a tool to achieve the goals reported in global and national immunization plans. Among others it has increased mandatory vaccinations from 4 to 10 and has made them compulsory for pre-school admission. Following the global and European vaccination goals, the priorities identified by the Italian NIP are to: maintain the polio-free status; pursue the elimination of measles and congenital rubella; ensure an active and free of charge vaccination offer, the access to services and the availability of vaccines; target hard to reach populations with low vaccination coverage; develop an institutional communication plan on vaccinations. Regarding the vaccination offer, the main novelties introduced by the NIP 2017-2019 include the introduction of: vaccines against N. meningitidis B, rotavirus and varicella in newborns; tetravalent meningococcal vaccine (ACWY135) and a booster dose of anti-polio in adolescents; pneumococcal vaccines (PCV13 + PPV23) and anti-Zoster in subjects aged sixty-five. Furthermore, the NIP 2017-2019 establishes to extend HPV vaccination to male adolescents. The cost of new vaccinations, funded by the National Health System, is about 100 million euros in 2017 but, thanks to the new vaccination schedule, it is estimated that approximately 200 million euros will be saved because of the annual reduction of direct costs of vaccine-preventable diseases. Furthermore, the NIP tries to act against the growing public skepticism in vaccines, proposing solutions to counteract the fall in vaccination coverage by promoting a culture of vaccination and the empowerment of both health workers and general population. In this perspective, the NIP proposes to promote institutional communication campaigns, based on transparency, conveying information about vaccines risks and benefits and the ethical and social value of vaccinations. It is further proposed to strengthen the training of healthcare professionals, jointly with disciplinary actions against physicians who do not recommend vaccinations. Particular attention is also placed on the implementation of vaccines registries for the homogenization of data recording that allows to evaluate and to monitor vaccine policies. The update of LEA, which include a list of services provided by SSN, has adopted the innovations of the NIP and overcomes the criticism of regional inequalities in vaccination offer guaranteeing the same offer all over the Italian country. In conclusion, the NIP 2017-2019 and the new LEA are fully integrated into the current epidemiological and cultural scenario. They envisage a supply of evidence-based vaccinations, ensuring a free, equal and uniform vaccination offer on a national scale and striving for the promotion of a culture of vaccination.

Introduction: Decision-making in healthcare should rely on evidence-based approaches able to make possible a transparent and robust assessment of all the aspects related to health technologies. One of the assessment elements is represented by the efficiency that is the specific objective of economic evaluations and also of Health Technology Assessment (HTA). The collection and synthesis of evidence is the first indispensable step in order to foster a proper convey of scientific knowledge to the decision-makers. This work, carried out within a broader project on the transfer of evidence from the scientific to the decision making world, is aimed to release an overview of economic evaluations and HTA on vaccines conducted in Italy. The project was carried out within the activities of the ISPOR Italy-Rome Chapter., Methods: A systematic review of Italian economic evaluations and HTA performed on vaccines and published up to May 2015 was carried out. PubMed, Scopus and the NIHR HTA databases were queried and a hand-search was performed on key journals in the field (Global & Regional Health Technology Assessment; PharmacoEconomics Italian Research Articles; Giornale italiano di HTA; Politiche Sanitarie; HTA Focus - Pills of Clinical Governance; Pillole di Farmacoeconomia; Giornale Italiano di Farmacoeconomia e Farmacoutilizzazione; IJPH; Quaderni dell'IJPH). Studies were considered eligible if showing the results of a full economic evaluations and if performed in Italy., Results: The literature search yielded 10 HTA reports and 33 economic evaluations. Among the latter, 20 (60,6%) were cost-effectiveness analyses. Ten studies (23,3%) assessed the vaccination against S. pneumoniae figuring out that it is cost-effectiveness and even costsaving in cases of newborns and subjects at risk. Nine studies (20,9%) addressed influenza vaccination and demonstrated its dominance on non-vaccination in the elderly. Eight studies (18,6%) evaluated the HPV vaccines concluding that they are cost-effective. Five studies (11,6%) devoted to anti-rotavirus vaccination showing its dominance on non-vaccination, in particular from the society perspective. Vaccination against pertussis, hepatitis B, chicken pox, measles, rubella, mumps were eventually shown cost-saving. The vaccine against Neisseria meningitidis was considered potentially cost-effective., Conclusion: The Italian scientific evidence on efficiency of vaccination is broad and allows concluding that vaccinations are value for money interventions.

Objectives: This study addressed knowledge of Streptococcus pneumoniae, Neisseria meningitidis and human papillomavirus (HPV), and attitudes and behaviours towards vaccines against them., Study Design: This is a cross-sectional, multicentre study., Methods: Data were collected through a questionnaire administered to 530 adults who accessed four Departments of Prevention of the Italian National Health Service in 2013., Results: Less than 50% of people gave the right answer to all the questions concerning the three diseases, but 96.2%, 94% and 92.7% agreed with the importance of vaccination against N. meningitidis, S. pneumoniae and HPV, respectively, and 58.4% expressed own willingness to have their children vaccinated with N. meningitidis B vaccine. The attitude towards vaccination was more positive in women for N. meningitidis and in people having children for HPV. Furthermore, individuals giving correct answers to all knowledge items were more in favour of both HPV and S. pneumoniae vaccination. A total of 68.8%, 82.6% and 84.5% of respondents vaccinated their own children against N. meningitidis C, S. pneumoniae and HPV, respectively. About 50% of the respondents reported paediatricians' or other health professionals' recommendations as the main reason for vaccination., Conclusions: Vaccinations may be promoted through actions aimed at increasing citizens' knowledge. Health professionals should be educated to actively provide information on vaccinations in a clear, comprehensive and effective way., (Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.)

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.

The HTA is a multidisciplinary approach which is increasingly applied worldwide in order to support decision-makers in the introduction of health technologies. The application of HTA to vaccines is quite recent and linked to the increasing number of vaccines available or in development, especially to those intended to non pediatric immunization. In this article a description of the HTA approach used in the evaluation of the bivalent HPV vaccine in Italy is provided; moreover the reasons for keeping HTA process "alive" and identifying new or pending Public Health issues are discussed. In fact, the project raised questions and challenges about the standardization and sharing of HTA methods in Italy. Recently the need of updating the results is starting to be seen as urgent due to the evolution of scientific knowledge, the availability of the first results after technology introduction and the observed differences in vaccination strategies among Italian regions. Moreover in these last two years after the completion of the HTA project a number of new issues have risen in the Italian context as immunization rates, regional vaccination strategies, processes for vaccine selection and health economic issues.

Abstract: Introduction: We performed a pooled analysis of randomised clinical trials (RCT) on HPV vaccine efficacy in preventing cervical persistent infection. Methods: We carried out a bibliographic search on electronic databases and we selected RCT to perform the meta-analyses. Results: We selected five studies. The first meta-analysis, including all studies, showed an important reduction of the risk of infection from HPV 16 in vaccinated cohort [RR 0.10 (95% CI: 0.07–0.15)]. The second and third meta-analyses, including only studies on bivalent and tetravalent vaccines, showed a RR of 0.13 (95% CI: 0.09–0.20) for HPV 16 infections and a RR of 0.22 (95% CI: 0.13–0.38) for HPV 18 ones. Discussion: HPV vaccine efficacy in preventing persistent infection is high but there is the need for further studies on the duration of immunization and long-term vaccine efficacy. [Copyright &y& Elsevier]

The WHO defines vaccine hesitancy (VH) as 'a delay in acceptance or refusal of vaccines despite the availability of vaccine services'. In spite of the models explaining VH and the tools used to address it, VH still represents a current problem and has been declared one of the top ten global health threats by WHO in 2019. This is mainly true for the adolescents who represents 25% of the global population. This systematic review aims to address the determinants of VH in this target population. Methods: PubMed, Web of Science and Scopus were searched to retrieve articles, published in English, assessing adolescents' attitudes and confidence towards vaccinations with any study design (qualitative or quantitative) from the inception until Dec 2020. A methodological quality assessment of the articles was performed based on the study designs. Results: Out of 14,704 articles, 20 studies were included in the qualitative analysis. Ten out of 20 studies were evaluated as of "good quality", while nine had "moderate quality" and only one had "poor quality". Factors associated to a positive attitude towards vaccination included knowledge of vaccine preventable diseases, the awareness of vaccines, their efficacy, safety and free of charge, higher education level and active involvement in decision-making. An association between VH and socio-economic conditions was also highlighted. [ABSTRACT FROM AUTHOR]