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Influenza is associated with a substantial health burden, especially in high-risk subjects such as older adults, frail individuals and those with underlying chronic diseases. In this review, we summarized clinical findings regarding the impact of influenza in vulnerable populations, highlighted the benefits of influenza vaccination in preventing severe illness and complications and reviewed the main evidence on the efficacy, effectiveness and safety of the vaccines that are best suited to older adults among those available in Italy. The adverse outcomes associated with influenza infection in elderly and frail subjects and those with underlying chronic diseases are well documented in the literature, as are the benefits of vaccination (mostly in older adults and in patients with cardiovascular diseases, diabetes and chronic lung disease). High-dose and adjuvanted inactivated influenza vaccines were specifically developed to provide enhanced immune responses in older adults, who generally have low responses mainly due to immunosenescence, comorbidities and frailty. These vaccines have been evaluated in clinical studies and systematic reviews by international immunization advisory boards, including the European Centre for Disease Prevention and Control. The high-dose vaccine is the only licensed influenza vaccine to have demonstrated greater efficacy versus a standard-dose vaccine in preventing laboratory-confirmed influenza in a randomized controlled trial. Despite global recommendations, the vaccination coverage in high-risk populations is still suboptimal. All healthcare professionals (including specialists) have an important role in increasing vaccination rates.
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As the COVID19 pandemic progresses, there is an increasing need to evaluate the performance of vaccine strategies. This study investigated the vaccine schedule performance of heterologous vaccination compared to homologous vaccination in preventing Omicron SARS-CoV2 infection in the adult population. This retrospective cohort study utilized data from the Infections Regional Information System and the Apulia Regional Vaccine Registry to identify individuals who received a booster dose of one of 14 different COVID19 vaccination schedules between September 2021 and August 2022 in the province of Lecce, Southern Italy. The standardized cumulative incidence of SARS-CoV2 infection after the booster dose was assessed and the risk of infection between subgroups of heterologous and homologous vaccination schedules was compared using the Cochran-Mantel-Haenszel test. A total of 469,069 subjects were included in the study. The standardized incidence of SARS-CoV2 infection varied greatly among different vaccine schedules, with the highest and lowest being AZ-AZ-BNT (34.7 %) and MOD-MOD-BNT (18.9 %), respectively, and some heterologous schedules performing better than homologous ones. The risk of SARS-CoV2 infection was significantly lower in individuals who received specific heterologous vaccination schedules compared to homologous vaccination schedules, the best performing being MOD-MOD-BNT with a common odd ratio of 0.661 (IC. 95 % [0.620-0.704]). This study provides evidence that heterologous vaccination schedules may be more effective in preventing Omicron SARS-CoV2 infection compared to homologous vaccination schedules, highlighting how the vaccine product, rather than the platform, is involved in the different protection provided by heterologous vaccination.
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Vacinas contra COVID-19 , COVID-19 , Adulto , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , RNA Viral , Estudos Retrospectivos , SARS-CoV-2 , Itália/epidemiologia , Vacinação , Anticorpos AntiviraisRESUMO
BackgroundEuropean Union/European Economic Area (EU/EEA) countries annually report hepatitis A (HepA) notifications to The European Surveillance System (TESSy).AimTo describe EU/EEA HepA notifications from 2010 to 2019 and identify infection drivers and surveillance improvements.MethodsWe analysed demographic, clinical and transmission information of HepA confirmed cases from TESSy. We stratified countries by population susceptibility profile and performed time-series analysis to describe trends in notification rates, sex distribution and travel history.ResultsTwenty-nine EU/EEA countries reported 139,793 HepA cases. Six eastern EU countries reported > 60% of these cases. EU/EEA notification rate during the study period was 3.2 cases per 100,000 population (range 2.7-5.6). Notifications peaked in 2014 and 2017, with marked differences in case demographic characteristics. Notification trends varied across different country susceptibility groups. In 2017, the proportion of males (74%) and case median age (31 years) increased steeply, while no changes occurred in 2014. Travel history showed seasonal case peaks following the summer. More than 47,000 hospitalisations were reported. Annual case fatality was < 0.2% for all years. Information on travel history, hospitalisation, death and mode of transmission was suboptimal.DiscussionApart from some countries in its east, the EU/EEA is characterised by low HepA incidence baseline and susceptible to recurrent large cross-border outbreaks. Analysis of European surveillance data highlighted the need for stronger prevention policies for eastern EU countries, men who have sex with men and travellers. Improving surveillance data-quality will enhance knowledge on food-borne, and travel-related exposures to inform more effective and tailored regional prevention policies.
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Hepatite A , Minorias Sexuais e de Gênero , Masculino , Humanos , Adulto , Hepatite A/epidemiologia , União Europeia , Viagem , Homossexualidade Masculina , Doença Relacionada a Viagens , Europa (Continente)/epidemiologiaRESUMO
Background: Vaccine hesitancy (VH) remains worldwide a reason of concern. Most of the vaccination education strategies followed a "fact-based" approach, based on the assumption that decision making is a rational process, without considering the influence of cognitive biases and heuristics. Our study aimed at identifying factors involved in the parents' vaccination choice to inform and shape communication interventions. Methods: We conducted an online national survey among parents between November 2020 and April 2021. The questionnaire consisted of 42 items organised in 4 parts: (1) personal information, (2) cognitive biases and risk propension, (3) Analytic Thinking (Cognitive Reflection Test), (4) conspiracy mentality, health literacy, and VH. Exploratory factor analysis was conducted to identify latent variables underlying the 19 items related to the 6 cognitive biases. Factors were categorised in quintiles and the corresponding pseudo-continuous variables used as predictors of the VH. Logistic regression model was applied to assess the association of the VH with factors, conspiracy mentality and risk propension. We adjusted for age, gender, economic status, and education levels. Results: The study included 939 parents, 764 women (81.4%), 69.8% had a degree or higher level of education. Considering cognitive biases, four factors explaining 54% of the total variance were identified and characterised as: fear of the side effects of vaccines (scepticism factor); carelessness of the risk and consequences of infections (denial factor); optimistic attitude (optimistic bias factor); preference for natural products (naturalness bias factor). All factors were positively associated to VH (p < 0.001) as were conspiracy mentality (p = 0.007) and risk propension (p = 0.002). Conclusions: This study confirmed the need to amplify the model used to analyse the VH considering cognitive biases as important factor affecting the parents' decision making. These results may be useful to design personalised communication interventions regarding vaccines and vaccination.
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OBJECTIVES: We analysed hepatitis A (HepA) notifications and hospitalisations in Italy, the Netherlands, Norway, Spain, and Sweden for available periods between 1995 and 2014. We aimed to investigate whether decreasing HepA incidence is associated with increasing age at infection and worsening HepA presentation and to identify groups at risk of severe disease. METHODS: We performed a retrospective cohort study including 36 734 notified and 36 849 hospitalised patients. We used negative binomial regressions to identify over time: i) trends in hospitalisation and notification rates; ii) proportion of hospitalised and notified patients aged ≥40 years; iii) proportion of "severe hospitalisations"; and iv) risk factors for severe hospitalisation. RESULTS: During the study period both HepA notifications and hospitalisations decreased, with notification rates decreasing faster, patients aged ≥40 years increased, however, the proportion of severe HepA hospitalisations remained stable. Older patients and patients with comorbidities, particularly liver diseases, were more likely to experience severe disease. CONCLUSIONS: We used digitalised health information to confirm decreasing trends in HepA hospitalisations and notifications, and the increasing age of patients with HepA in Europe. We did not identify an increase in the severity of the clinical presentation of patients with HepA. Older patients with liver diseases are at increased risk of severe disease and should be prioritised for vaccination.
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Hepatite A , Europa (Continente)/epidemiologia , Hepatite A/epidemiologia , Hospitalização , Humanos , Incidência , Estudos Retrospectivos , VacinaçãoRESUMO
BACKGROUND: Transmission of antimicrobial-resistant Gram-negative bacteria (AMR-GNB) amongst hospitalised patients can lead to new cases of carriage, infection and outbreaks, hence the need for early carrier identification. We aim to explore two key elements that may guide control policies for colonisation/infection in hospital settings: screening practices on admission to hospital wards and risk of developing infection from colonisation. METHODS: We searched on PubMed, Scopus and Cochrane databases for studies published from 2010 up to 2021 reporting on adult patients hospitalised in high-income countries. RESULTS: The search retrieved 11,853 articles. After screening, 100 studies were included. Combining target patient groups and setting type, we identified six screening approaches. The most reported approach was all admitted patients to high-risk (HR) wards (49.4%). The overall prevalence of AMR-GNB was 13.8% (95%CI 9.3-19.0) with significant differences across regions and time. Risk of progression to infection amongst colonised patients was 11.0% (95%CI 8.0-14.3) and varied according to setting and pathogens' group (p value<0.0001), with higher values reported for Klebsiella species (18.1%; 95%CI 8.9-29.3). CONCLUSIONS: While providing a comprehensive overview of the screening approaches, our study underlines the considerable burden of AMR-GNB colonisation and risk of progression to infection in hospitals by pathogen, setting and time.
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Infecção Hospitalar , Infecções por Bactérias Gram-Negativas , Adulto , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Bactérias , Infecção Hospitalar/microbiologia , Bactérias Gram-Negativas , Infecções por Bactérias Gram-Negativas/microbiologia , HumanosRESUMO
The development and use of messenger RNA-based (mRNA) vaccines against the SARS-CoV-2 spike protein have proven to be highly effective against symptomatic COVID-19, especially for severe forms. Since the declaration of a public health emergency in early 2020, however, the SARS-CoV-2 virus has continuously evolved, giving rise to several variants that have caused and continue to cause concern in the scientific community. Currently, viruses circulating worldwide belong to the Omicron lineage, with several identified sub-variants. In response to virus mutation, mRNA vaccines have been adapted into bivalent vaccines containing two mRNAs: one encoding the original Wuhan SARS-CoV-2 spike protein and one encoding the BA.1 or BA.4-5 spike protein of the Omicron sub-variant. This strategy is based on the hypothesis that the immune system's response improves when variants are included in the vaccine, leading to an increase in the magnitude and diversity of both the humoral and cellular immune response. The evidence gathered to date confirms the use of bivalent vaccines as the optimal strategy. In the light of current knowledge, and in the awareness of the impossibility of making precise predictions on the evolution of the COVID-19 pandemic, as a group of experts we propose some considerations for the progressive evolution of vaccination against SARS-CoV-2 from pandemic to endemic vaccination.
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This article explores why governments do not respond to public compliance problems in a timely manner with appropriate instruments, and the consequences of their failure to do so. Utilising a case study of Italian vaccination policy, the article considers counterfactuals and the challenges of governing health policy in an age of disinformation. It counterposes two methods of governing vaccination compliance: discipline, which uses public institutions to inculcate the population with favourable attitudes and practices, and modulation, which uses access to public institutions as a form of control. The Italian government ineffectively employed discipline for a number of years. Epistemological and organisational constraints stymied its efforts to tackle a significant childhood vaccination compliance problem. With a loss of control over the information environment, vaccinations were not served well by exogenous crises, the sensationalism of the news cycle and online misinformation. Hampered by austerity, lack of capacity and epistemic shortcomings, the Italian government did not protect the public legitimacy of the vaccination programme. Instead of employing communications to reassure a hesitant population, they focused on systemic and delivery issues, until it was too late to do anything except make vaccinations mandatory (using modulation). The apparent short-term success of this measure in generating population compliance does not foreclose the need for ongoing governance of vaccine confidence through effective discipline. This is evident for the COVID-19 vaccination campaign, with many Italians still indicating that they would not accept a vaccine despite the devastation that the disease has wrought throughout their country.
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INTRODUCTION: The national and international guidelines recommend evaluating all healthcare workers (HCWs) for their measles immune status and possibly vaccinating those who are seronegative. AREAS COVERED: We conducted a systematic review and meta-analysis in order to estimate the rate of measles susceptibility among HCWs in Italy and to explore possible options for the management of those found to be susceptible. Twenty-three studies were included in the meta-analysis. The prevalence of HCWs susceptible to measles was 11.5% (95%CI = 8.1-15.4%) and was higher in studies in which prevalence was evaluated by survey (16.7%; 95%CI = 8.9-26.3) than by the direct evaluation of blood specimens (9.1%; 95%CI = 6.2-12.5%). Occupational medicine examinations for measles screening with possible subsequent vaccination of seronegatives and the exclusion of susceptible HCWs from high-risk settings were common management strategies. EXPERT OPINION: HCWs susceptible to measles are an important epidemiological concern in Italy, and efforts to identify and actively offer the vaccine to this population should be increased.
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Pessoal de Saúde/estatística & dados numéricos , Vacina contra Sarampo/administração & dosagem , Sarampo/prevenção & controle , Suscetibilidade a Doenças , Humanos , Itália , Sarampo/imunologia , Vacina contra Sarampo/imunologia , Medicina do Trabalho , Guias de Prática Clínica como Assunto , Prevalência , VacinaçãoAssuntos
Betacoronavirus , Infecções por Coronavirus , Pandemias , Pneumonia Viral , COVID-19 , Humanos , SARS-CoV-2Assuntos
Infecções por Coronavirus , Epidemiologistas , Pneumonia Viral , Formulação de Políticas , Betacoronavirus , COVID-19 , Coronavirus , Infecções por Coronavirus/epidemiologia , Tomada de Decisões , Surtos de Doenças/prevenção & controle , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Saúde Pública , SARS-CoV-2RESUMO
The aim was to investigate the effectiveness of glucocorticoid therapy in patients with COVID-19. A systematic search of the literature across nine databases was conducted from inception until 15th March 2020, following the PRISMA guidelines. Patients with a validated diagnosis of COVID-19 and using corticosteroids were included, considering all health outcomes. Four studies with 542 Chinese participants were included. Two studies reported negative findings regarding the use of corticosteroids in patients with COVID-19, i.e., corticosteroids had a detrimental impact on clinical outcomes. One study reported no significant association between the use of corticosteroids and clinical outcomes. However, one study, on 201 participants with different stages of pneumonia due to COVID-19, found that in more severe forms, the administration of methylprednisolone significantly reduced the risk of death by 62%. The literature to date does not fully support the routine use of corticosteroids in COVID-19, but some findings suggest that methylprednisolone could lower mortality rate in more severe forms of the condition.
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In Tuscany, Italy, New Delhi metallo-beta-lactamase-producing carbapenem-resistant Enterobacterales (NDM-CRE) have increased since November 2018. Between November 2018 and October 2019, 1,645 samples were NDM-CRE-positive: 1,270 (77.2%) cases of intestinal carriage, 129 (7.8%) bloodstream infections and 246 (14.9%) infections/colonisations at other sites. Klebsiella pneumoniae were prevalent (1,495; 90.9%), with ST147/NDM-1 the dominant clone. Delayed outbreak identification and response resulted in sustained NDM-CRE transmission in the North-West area of Tuscany, but successfully contained spread within the region.
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Antibacterianos/farmacologia , Carbapenêmicos/farmacologia , Surtos de Doenças , Infecções por Klebsiella/epidemiologia , Infecções por Klebsiella/microbiologia , Klebsiella pneumoniae/efeitos dos fármacos , beta-Lactamases/metabolismo , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Farmacorresistência Bacteriana Múltipla/efeitos dos fármacos , Feminino , Humanos , Lactente , Recém-Nascido , Itália/epidemiologia , Infecções por Klebsiella/tratamento farmacológico , Klebsiella pneumoniae/enzimologia , Klebsiella pneumoniae/metabolismo , Masculino , Testes de Sensibilidade Microbiana , Pessoa de Meia-Idade , Adulto Jovem , beta-Lactamases/efeitos dos fármacos , beta-Lactamases/genéticaRESUMO
Aim of this paper is to describe the management of an outbreak of COVID-19 in a slaughtering and meat processing plant in Bari Province (Southern Italy). At the end of the outbreak investigation, 18.4% of the employees were positive to the molecular test for SARS-CoV-2. Higher prevalence has been reported in the bovine slaughtering house and swine meat processing plant.In addition to lack of physical distancing and correct use of personal protective equipment, the spread of the virus has been eased by low level of literacy, indoor microclimate, intensive working time, and aerosol-generating procedures in specific areas of the processing plant where more positive cases have been detected. The analysis of this cluster may suggest specific actions to prevent similar outbreaks in the future.
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Matadouros/organização & administração , COVID-19/epidemiologia , Surtos de Doenças , Manipulação de Alimentos , Indústria Alimentícia/organização & administração , Controle de Infecções/organização & administração , Carne , Doenças Profissionais/epidemiologia , Pandemias , SARS-CoV-2/isolamento & purificação , Matadouros/estatística & dados numéricos , Adulto , Aerossóis , Poluição do Ar em Ambientes Fechados , Animais , Infecções Assintomáticas/epidemiologia , COVID-19/transmissão , Bovinos , Busca de Comunicante , Bases de Dados Factuais , Escolaridade , Contaminação de Equipamentos , Feminino , Manipulação de Alimentos/instrumentação , Manipulação de Alimentos/métodos , Manipulação de Alimentos/estatística & dados numéricos , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Equipamento de Proteção Individual , Ovinos , SuínosRESUMO
BACKGROUND: Information on the incubation period and period of infectiousness or shedding of infectious pathogens is critical for management and control of communicable diseases in schools and other childcare settings. METHODS: We performed a systematic literature review (Pubmed and Embase) to identify and critically appraise all relevant published articles using incubation, infectiousness or shedding, and exclusion period as parameters for the search. No language, time, geographical or study design restrictions were applied. RESULTS: A total of 112 articles met the eligibility criteria. A relatively large number were retrieved for gastrointestinal diseases and influenza or respiratory syncytial virus, but there were few or no studies for other diseases. Although a considerable number of publications reported the incubation and shedding periods, there was less evidence concerning the period of infectiousness. On average, five days of exclusion is considered for measles, mumps, rubella, varicella and pertussis. For other diseases, such as most cases of meningococcal disease, hepatitis A and influenza exclusion is considered as long as severe symptoms persist. However, these results are based on a diverse range of study characteristics, including age, treatment, vaccination, underlying diseases, diagnostic tools, viral load, study design and definitions, making statistical analysis difficult. CONCLUSIONS: Despite inconsistent definitions for key variables and the diversity of studies reviewed, published data provide sufficient quantitative estimates to inform decision making in schools and other childcare settings. The results can be used as a reference when deciding about the exclusion of a child with a communicable disease that both prevents exposure and avoids unnecessary absenteeism.
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Controle de Doenças Transmissíveis/métodos , Doenças Transmissíveis/transmissão , Período de Incubação de Doenças Infecciosas , Adolescente , Varicela/prevenção & controle , Varicela/transmissão , Criança , Cuidado da Criança , Pré-Escolar , Hepatite A/prevenção & controle , Hepatite A/transmissão , Humanos , Lactente , Influenza Humana/prevenção & controle , Influenza Humana/transmissão , Sarampo/prevenção & controle , Sarampo/transmissão , Caxumba/prevenção & controle , Caxumba/transmissão , Rubéola (Sarampo Alemão)/prevenção & controle , Rubéola (Sarampo Alemão)/transmissão , Instituições Acadêmicas , Vacinação , Coqueluche/prevenção & controle , Coqueluche/transmissãoRESUMO
The spread of antibiotic resistance is one of the leading public health problems in Italy. A European Centre for Disease Prevention and Control country visit recently confirmed the major challenges and made important suggestions. In response, the Ministry of Health published the National Plan for Antimicrobial Resistance Containment, and a group of experts belonging to the Italian Group of Antimicrobial Stewardship (GISA) convened to develop a summary of practical recommendations. The GISA document is intended for use by practising physicians; it aims to increase the rational use of antimicrobials in the treatment of infections, and to change the culture of infection control of antibiotic-resistant bacteria, through the translation of theoretical knowledge into priority actions. This document has been endorsed by several national scientific societies, and reflects the particular challenges that are faced in Italy. Nevertheless, it is considered that the general principles and approaches discussed are relevant, particularly to other developed economies.
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Antibacterianos/uso terapêutico , Gestão de Antimicrobianos/organização & administração , Infecções Bacterianas/tratamento farmacológico , Infecções Bacterianas/prevenção & controle , Saúde Pública/normas , Acinetobacter/efeitos dos fármacos , Acinetobacter/crescimento & desenvolvimento , Infecções Bacterianas/microbiologia , Vacinas Bacterianas/administração & dosagem , Farmacorresistência Bacteriana/efeitos dos fármacos , Escherichia coli/efeitos dos fármacos , Escherichia coli/crescimento & desenvolvimento , Humanos , Itália , Klebsiella pneumoniae/efeitos dos fármacos , Klebsiella pneumoniae/crescimento & desenvolvimento , Staphylococcus aureus Resistente à Meticilina/efeitos dos fármacos , Staphylococcus aureus Resistente à Meticilina/crescimento & desenvolvimento , Pseudomonas aeruginosa/efeitos dos fármacos , Pseudomonas aeruginosa/crescimento & desenvolvimento , Enterococos Resistentes à Vancomicina/efeitos dos fármacos , Enterococos Resistentes à Vancomicina/crescimento & desenvolvimentoRESUMO
In Italy, the phenomenon of vaccine hesitancy has increased with time and represents a complex problem that requires a continuous monitoring. Misinformation on media and social media seems to be one of the determinants of the vaccine hesitancy since, for instance, 42.8 percent of Italian citizens used the internet to obtain vaccine information in 2016. This article reports a quantitative analysis of 560 YouTube videos related to the link between vaccines and autism or other serious side effects on children. The analysis revealed that most of the videos were negative in tone and that the annual number of uploaded videos has increased during the considered period, that goes from 27 December 2007 to 31 July 2017, with a peak of 224 videos in the first seven months of 2017. These findings suggest that the public institutions should be more engaged in establishing a web presence in order to provide reliable information, answers, stories, and videos so to respond to questions of the public about vaccination. These actions could be useful to allow citizens to make informed decisions about vaccines so to comply with vaccination regulations.
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Comunicação , Internet , Mídias Sociais , Vacinação/psicologia , Transtorno Autístico/etiologia , Criança , Humanos , Disseminação de Informação , Vacinação/efeitos adversos , Recusa de Vacinação/psicologia , VacinasRESUMO
Most of the European Union (EU) and European Economic Area (EEA) is considered a region of very low hepatitis A virus (HAV) endemicity; however, geographical differences exist. We did a systematic review with the aim of describing seroprevalence and susceptibility in the general population or special groups in the EU and EEA. We searched databases and public health national institutes websites for HAV seroprevalence records published between Jan 1, 1975, and June 30, 2014, with no language restrictions. An updated search was done on Aug 10, 2016. We defined seroprevalence profiles (very low, low, and intermediate) as the proportion of the population with age-specific anti-HAV antibodies at age 15 and 30 years, and susceptibility profiles (low, moderate, high, and very high) as the proportion of susceptible individuals at age 30 and 50 years. We included 228 studies from 28 of 31 EU and EEA countries. For the period 2000-14, 24 countries had a very low seroprevalence profile, compared with five in 1975-89. The susceptibility among adults ranged between low and very high and had a geographical gradient, with three countries in the low susceptibility category. Since 1975, EU and EEA countries have shown decreasing seropositivity; however, considerable regional variability exists. The main limitations of this study are that the studies retrieved for analysis might not be representative of all EU and EEA publications about HAV and might have poor national representativeness. A large proportion of EU and EEA residents are now susceptible to HAV infection. Our Review supports the need to reconsider specific prevention and control measures, to further decrease HAV circulation while providing protection against the infection in the EU and EEA, and could be used to inform susceptible travellers visiting EU and EEA countries with different HAV endemicity levels.
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Hepatite A/sangue , Hepatite A/epidemiologia , Estudos Soroepidemiológicos , Envelhecimento , Europa (Continente)/epidemiologia , União Europeia , Humanos , Fatores de TempoRESUMO
In order to successfully control and eliminate vaccine-preventable infectious diseases, an appropriate vaccine coverage has to be achieved and maintained. This task requires a high level of effort as it may be compromised by a number of barriers. Public health agencies have issued specific recommendations to address these barriers and therefore improve immunization programs. In the present review, we characterize issues and challenges of immunization programs for which digital tools are a potential solution. In particular, we explore previously published research on the use of digital tools in the following vaccine-related areas: immunization registries, dose tracking, and decision support systems; vaccine-preventable diseases surveillance; surveillance of adverse events following immunizations; vaccine confidence monitoring; and delivery of information on vaccines to the public. Subsequently, we analyze the limits of the use of digital tools in such contexts and envision future possibilities and challenges.