Active surveillance of adverse events after immunization (AEFI) from the Local Health Unitof Ferrara, Italy.

Introduction: Vaccine vigilance implies the collection, evaluation, analysis and communication of adverse events following immunization (AEFI) and is a useful tool for vaccine monitoring allowing, even after approval and marketing, to check its safety/tolerability. The multiregional project "Active surveillance of adverse vaccine reactions", joined by the AUSL of Ferrara, is aimed at making parents of children, who have undergone at least one vaccination provided by the regional vaccination calendar in the first 24 months of life, aware of the reporting of any AEFI via mobile phone-SMS. Methods: An analysis of the project data, collected in the period March 2018 - May 2019, was carried out, to evaluate the effectiveness of the reporting tool and the type and frequency of AEFI. Anonymized data were analyzed by number, gender, distribution by age, type of vaccine, adverse event, severity and outcome. Results: A total of 1,494 consents and 983 SMS messages were obtained from parents. The vaccine doses carried out were 1,984 (28.3% hexavalent, 28% PCV13, 17% anti-rotavirus, 14.3% Men-B). Almost all (99.5%) AEFI were classified as "not serious". Based on the Organ System Class (SOC), most reports are related to "General Disorders and Administration Site Conditions" (52.3%), followed by "Psychiatric Disorders" (26.5%) and "Metabolic and nutrition disorders" (12.5%). Conclusions: The reported AEFI are in line with the ones reported in the literature. Reporting via SMS is a valid vaccine surveillance tool contributing to the qualitative and quantitative improvement of the information transmitted.

COVID-19: opinions and behavior of Italian general population during the first epidemic phase.

BACKGROUND AND AIM: On January 9, 2020, the World Health Organization (WHO) declared that Chinese health authorities had identified a new coronavirus strain never before isolated in humans, the 2019-nCoV later redefined SARS-CoV-2, that still today represent a public health problem. The present survey started on 10 February 2020 with the aim of a) assessing the risk perception in healthcare workers and young students, following the evolution of attitudes, perception and knowledge over time, b) provide useful information to the general population during survey. RESULTS: A study sample consisting of 4116 Italian individuals of both sexes was enrolled. High levels of risk perception, low perception of self-efficacy and low levels of knowledge scores (24.55 ± 5.76 SD) were obtained indicating the need for continuous population monitoring as well as further communication strategies carried out at institution levels. CONCLUSION: The results of the present study could help public health authorities in carrying out informative campaigns for general population and could be an important tool in evaluating public knowledge and misperceptions during the management of the COVID-19. (www.actabiomedica.it).

Trends in influenza coverage rates in five consecutive immunisation seasons in the Local Health Unit of Ferrara (North Italy).

Seasonal influenza epidemics yearly affects 5-15% of the world's population, resulting in 3-5 million serious cases and up to 650,000 deaths. Elderly, pregnant women and individuals with underlying conditions are at increased risk of complications. According to the Italian National Immunisation Prevention Plan 2017-2019, these categories benefit from free vaccination but coverage rate in Italy are below desirable levels. The study considered the coverage rate in five consecutive influenza seasons (2010/2011-2014/2015) in Local Health Unit (LHU) of Ferrara (Italy). The amount of delivered vaccinations was not constant, with a decreasing trend. Coverage rose with increasing age, but the 75% target of over-65 years old individuals immunised was never achieved. In addition to age, coverage rates varied also according to District (the area of residence within the LHU). The District with the lowest vaccination coverage was the Western District. Higher levels of immunisation were observed in South-Eastern District in the pediatric age and in North-Central District in adult age group with a statistically significant difference. In the considered timespan, the percentage of immunisations delivered by the General Practitioners (GPs) increased. The trend in the LHU of Ferrara was similar to regional and national data, conditioned in the 2014/2015 season by the spreading of worrying news, although unfounded, on the safety of the vaccine. The GPs were essential in ensuring vaccine uptake, growing the percentage of delivered doses and achieving as much as possible effective elderly immunisation.

Human Papilloma Virus Vaccination: Focus on the Italian Situation.

Human papilloma virus (HPV) is a viral agent whose transmission occurs mainly by sexual means. It causes different pathological conditions in both males and females, ranging from benign pathologies up to cancers. The introduction of vaccination has certainly had a major impact in terms of reducing the incidence of both HPV infections and diseases but in the European Union and the European Economic Area (EU/EEA) there are still about more than 13,000 deaths due to cervical cancer each year. To date in Europe and in Italy there are three vaccines available (bi-, tetra-, and nonvalent vaccines). The vaccination campaign started irregularly in Europe and Italy in 2007, with pre-adolescent girls as the primary target. Later, other cohorts were introduced such as 12-year-old boys, additional cohorts of >25-year-old women, women who already underwent cervical surgery and other subjects entitled to free vaccination. The COVID-19 pandemic has strongly impacted on public health services, particularly on vaccinations that, especially during the first pandemic phase, have been often delayed and/or canceled. The most affected vaccinations by the pandemic have been the non-mandatory ones, particularly those addressing the adolescent and adult population, such as immunization against papillomavirus. To date the achievement of the coverage target set by the Italian National Immunization Plan (NIP) has not yet been achieved. The aim of this work is to summarize the current situation in Italy and to discuss the strategies that have been implemented to increase overall vaccination coverage rates.

The Epidemiological Characteristics of the COVID-19 Pandemic in Europe: Focus on Italy.

Starting from December 2019, SARS-CoV-2 has forcefully entered our lives and profoundly changed all the habits of the world population. The COVID-19 pandemic has violently impacted the European continent, first involving only some European countries, Italy in particular, and then spreading to all member states, albeit in different ways and times. The ways SARS-CoV-2 spreads are still partly unknown; to quantify and adequately respond to the pandemic, various parameters and reporting systems have been introduced at national and European levels to promptly recognize the most alarming epidemiological situations and therefore limit the impact of the virus on the health of the population. The relevant key points to implement adequate measures to face the epidemic include identifying the population groups most involved in terms of morbidity and mortality, identifying the events mostly related to the spreading of the virus and recognizing the various viral mutations. The main objective of this work is to summarize the epidemiological situation of the COVID-19 pandemic in Europe and Italy almost a year after the first reported case in our continent. The secondary objectives include the definition of the epidemiological parameters used to monitor the epidemic, the explanation of superspreading events and the description of how the epidemic has impacted on health and social structures, with a particular focus on Italy.

Value of Immunizations during the COVID-19 Emergency.

Recent estimates by World Health Organization (WHO, Geneva, Switzerland) and United Nations International Children's Emergency Fund (UNICEF) show a significant decline in vaccinal coverage rates in both pediatric and adult populations. The interruption of vaccination services is reported in at least 68 countries, with the involvement of about 80 million children worldwide. The situation is alarming if we consider that already in the period preceding the pandemic, immunization programs slowed down in various areas of the world. For these reasons, there is the risk of overloading health systems, already under pressure from the pandemic emergency, by employing human and economic resources for the management of epidemic outbreaks from vaccine-preventable diseases. The restoration and integration of vaccination services, the immunization of susceptible individuals as well as the adoption of adequate monitoring and surveillance measures are the main activities adopted by different countries to address the current global health emergency.

Cholera, the Current Status of Cholera Vaccines and Recommendations for Travellers.

Cholera is endemic in approximately 50 countries, primarily in Africa and South and Southeast Asia, and in these areas, it remains a disease associated with poverty. In developed nations, cholera is rare, and cases are typically imported from endemic areas by returning travellers. Cholera is readily preventable with the tools available to modern medicine. In developing nations, cholera transmission can be prevented through improved water, sanitation, and hygiene services and the use of oral cholera vaccines (OCVs). For travellers, risk can be mitigated by practicing regular hand hygiene and consuming food and water from safe sources. OCVs should be considered for high-risk travellers likely to be exposed to cholera patients or contaminated water and food. There are currently three World Health Organization pre-qualified OCVs, which are based on killed whole-cell strains of Vibrio cholerae. These established vaccines offer significant protection in adults and children for up to 2 years. A novel live attenuated vaccine that provides rapid-onset protection in adults and children is licensed in the USA and Europe only. Live attenuated OCVs may mimic the natural infection of V. cholerae more closely, generating rapid immune responses without the need for repeat dosing. These potential benefits have prompted the ongoing development of several additional live attenuated vaccines. The objective of this article is to provide a general review of the current landscape of OCVs, including a discussion of their appropriate use in international travellers.

Influenza coverage rates in subjects with chronic heart diseases: results obtained in four consecutive immunisation seasons in the Local Health Unit of Ferrara (North Italy)".

BACKGROUND: Seasonal influenza epidemics yearly affects 5-15% of the world's population, resulting in 3-5 million serious cases and up to 650,000 deaths. According to the 2017-2019 Italian National Immunisation Plan, free immunisation is offered to the categories at increased risk of experience the complications of the infection (over 65 years old subjects, pregnant women and individuals with underlying conditions, including chronic heart diseases). Rising evidence suggests that influenza can trigger adverse cardiovascular events therefore the vaccination is recommended for secondary prevention of cardiovascular diseases. Despite this, the influenza coverage rate in subjects with chronic heart disease is underestimated. METHODS: The study investigated the coverage rate in four consecutive influenza seasons (from 2011/2012 to 2014/2015) in subjects that benefit from exemption from paying healthcare costs for chronic heart disease living in Local Health Unit (LHU) of Ferrara (Italy), comparing the databases of exemptions and immunisations. RESULTS: The levels of influenza vaccine uptake were unstable, reaching the 50.3% in 2011/2012 immunisation season and falling to 42.2% in the following year. Coverage rates increased with increasing age, without achieving the 75% target, neither in over 65 years old subjects. The logistic regression analysis showed that influenza coverage rates were statistically significant different (p < 0.0001, 0.003 only for category of disease in 2011/2012 immunisation season) according to age, district of residence, category of chronic heart disease and length of exemption, but not influenced by gender. CONCLUSIONS: The recommendation of influenza immunisation was weakly followed in individuals with chronic heart diseases. A collaboration between cardiologists, GPs, scientific societies and patient associations could successfully support influenza vaccine uptake.

Ceftolozane/Tazobactam and Ceftazidime/Avibactam for Multidrug-Resistant Gram-Negative Infections in Immunocompetent Patients: A Single-Center Retrospective Study.

Complicated infections from multidrug-resistant Gram-negative bacteria (MDR-GNB) represent a serious problem presenting many challenges. Resistance to many classes of antibiotics reduces the probability of an adequate empirical treatment, with unfavorable consequences, increasing morbidity and mortality. Readily available patient medical history and updated information about the local microbiological epidemiology remain critical for defining the baseline risk of MDR-GNB infections and guiding empirical treatment choices, with the aim of avoiding both undertreatment and overtreatment. There are few literature data that report real-life experiences in the use of ceftolozane/tazobactam and ceftazidime/avibactam, with particular reference to microbiological cure. Some studies reported experiences for the treatment of MDR-GNB infections in patients with hematological malignancies or specifically in Pseudomonas aeruginosa infections. We report our clinical single-center experience regarding the real-life use of ceftolozane/tazobactam and ceftazidime/avibactam to treat serious and complicated infections due to MDR-GNB and carbapenem-resistant Enterobacterales (CRE), with particular regard given to intra-abdominal and urinary tract infections and sepsis.

Viral Respiratory Infections in Hematological Patients.

Viral infections of the respiratory system represent one of the most important complications in hematological patients in terms of both the severity of the clinical picture and its related impact on the duration of hospitalization, and of mortality. The most implicated viruses are those that commonly cause community-based respiratory diseases: respiratory syncytial virus, Influenza virus and rhinovirus. However, in some cases the clinical picture may be triggered by first infection with or reactivation of pathogens normally not responsible for clinically relevant diseases in immunocompetent subjects. This issue is currently being taken into greater consideration within the scientific community. However, the strong heterogeneity in the epidemiology and clinical expression of these infections and the lack of adequate therapeutic options imply that there is currently no uniform consensus on the best management of these patients. The main purpose of this review is to highlight which viruses are currently most implicated in the onset of these infections, what is their incidence in so heterogeneous and fragile patients and the factors that lead to disease's onset and evolution. Possible or available clinical management options, diagnostic and therapeutic tools, and preventive and prophylaxis measures are also discussed.

Diagnostic anticipation to reduce emergency department length of stay: a retrospective cohort study in Ferrara University hospital, Italy.

BACKGROUND: Emergency Department (ED) crowding reduces staff satisfaction and healthcare quality and safety, which in turn increase costs. Despite a number of proposed solutions, ED length of stay (LOS) - a main cause of overcrowding - remains a major issue worldwide. This retrospective cohort study was aimed at evaluating the effectiveness on ED LOS of a procedure called "Diagnostic Anticipation" (DA), which consisted in anticipating the ordering of blood tests by nurses, at triage, following a diagnostic algorithm approved by physicians. METHODS: In the second half of 2019, the ED of the University Hospital of Ferrara, Italy, adopted the DA protocol on alternate weeks for all patients with chest pain, abdominal pain, and non-traumatic bleeding. A retrospective cohort study on DA impact was conducted. Using ED electronic data, LOS independent predictors (age, sex, NEDOCS and Priority Color Code, imaging tests, specialistic consultations, hospital admission) were evaluated through multiple regression. RESULTS: During the weeks when DA was adopted, as compared to control weeks, the mean LOS was shorter by 18.2 min for chest pain, but longer by 15.7 min for abdominal pain, and 33.3 for non-traumatic bleeding. At multivariate analysis, adjusting for age, gender, triage priority, specialist consultations, imaging test, hospitalization and ED crowding, the difference in visit time was significant for chest pain only (p < 0.001). CONCLUSIONS: The impact of DA varied by patients' condition, being significant for chest pain only. Further research is needed before the implementation, estimating the potential proportion of inappropriate blood tests and ED crowding status.

Coronavirus: Update Related to the Current Outbreak of COVID-19.

In December 2019, some cases of viral pneumonia were epidemiologically related to a new coronavirus in the province of Hubei, China. Subsequently, there has been an increase in infections attributable to this virus throughout China and worldwide. The World Health Organization (WHO) has officially named the infection coronavirus disease 2019 (COVID-19), and the virus has been classified as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This appears to be a virus from Rhinolophus bats, but the intermediate host has not yet been identified. The mechanism of infection of SARS-CoV-2 is not yet known; it appears to have affinity for cells located in the lower airways, where it replicates. The interhuman transmission of coronaviruses mainly occurs through saliva droplets and direct and indirect contact via surfaces. As of March 10, 2020, the number of cases worldwide was 113,702. Along with severe acute respiratory syndrome (SARS) and Middle Eastern respiratory syndrome (MERS), COVID-19 appears to cause a severe clinical picture in humans, ranging from mild malaise to death by sepsis/acute respiratory distress syndrome. The prognosis is worse in elderly patients with comorbidities. To date, there is no specific therapy for COVID-19. Prevention of SARS-CoV-2 infection implies strategies that limit the spread of the virus. WHO and other international and national bodies have developed continuously updated strategic objectives and provisions to contain the spread of the virus and infection.

A 2-year point-prevalence surveillance of healthcare-associated infections and antimicrobial use in Ferrara University Hospital, Italy.

BACKGROUND: Healthcare-Associated Infections (HAIs) represent one of the leading issues to patient safety as well as a significant economic burden. Similarly, Antimicrobial Use (AMU) and Resistance (AMR) represent a growing threat to global public health and the sustainability of healthcare services. METHODS: A Point Prevalence Survey (PPS) following the 2016 ECDC protocol for HAI prevalence and AMU was conducted at Ferrara University Hospital (FUH). Data were collected by a team of trained independent surveyors in 2016 and 2018. Risk factors independently associated with HAI were assessed by a multivariate logistic regression model. RESULTS: Of the 1102 patients surveyed, 115 (10.4%) had an active HAI and 487 (44.2%) were on at least 1 systemic antimicrobial agent. Factors independently associated with increased HAI risk were a "Rapidly Fatal" McCabe score (expected fatal outcome within 1 year), presence of medical devices (PVC, CVC, indwelling urinary catheter or mechanically assisted ventilation) and a length of hospital stay of at least 1 week. The most frequent types of HAI were pneumonia, bloodstream infections, and urinary tract infections. Antimicrobial resistance to third-generation cephalosporins was observed in about 60% of Enterobacteriaceae. CONCLUSIONS: The survey reports a high prevalence of HAI and AMU in FUH. Repeated PPSs are useful to control HAIs and AMU in large acute-care hospitals, highlighting the main problematic factors and allowing planning for improvement actions.

Identifying people at risk for influenza with low vaccine uptake based on deprivation status: a systematic review.

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.

Impact of Pertussis on the Italian population: Analysis of hospital discharge records in the period 2001-2014.

OBJECTIVES: The study aimed to analyze and update the impact of pertussis on the Italian population by evaluating pertussis-related hospital admissions in the period 2001-2014. DESIGN OR METHODS: Hospital Discharge Records (HDR) were provided by the National Archive of HDR data of the Ministry of Health. Only hospitalizations included in the primary diagnosis were evaluated. Significant trends over the considered years were assessed as average annual percent changes (AAPC) applying the Joinpoint model. RESULTS: A total of 7,102 hospital admissions for pertussis (main diagnosis) were registered; the trend of hospitalizations progressively decreased from >1/100,000 inhabitants in the years 2001-2004 to 0.64/100,000 inhabitants in 2014. A great part of hospitalizations (63.6%) involved subjects <1 year of life; almost 20% of cases were registered in the age class 5-14 years. The Joinpoint analysis showed a statistically significant variation in some age classes. CONCLUSIONS: Even if this study shows a decreasing trend in the number of pertussis-related hospitalizations, the impact of the disease in Italy in terms of hospital admissions continues to be relevant, especially in the <1 year age class. Pertussis therefore continues to be, in Italy as well as in other European countries, an important public health issue.

Varicella zoster virus vaccines: an update.

Varicella zoster virus (VZV) is the etiological agent of varicella, a highly infectious, self-limiting disease with serious complications. The decline in cell-mediated immunity (CMI) that occurs with aging or immunodepression causes a reactivation of the latent VZV as herpes zoster (HZ). Prevention of VZV through varicella vaccination strategies allows to avoid the primary infection in newborns and susceptible subjects. Available monovalent and combined VZV vaccines are effective, safe and generally well tolerated. Universal varicella vaccination has significantly impacted on incidence, complications and deaths related to this disease. Prevention of HZ through vaccination is a priority to avoid the significant burden of its incidence and complications. Currently two HZ vaccines are available. The recombinant zoster vaccine (RZV), approved by the FDA in 2017 and Zoster Vaccine Live (ZVL) licensed in the United States by the FDA in 2006. The advisory committee on immunization practices (ACIP) preferentially recommends RZV. ZVL remains an option for prevention of HZ in immunocompetent adults aged ≥60 years, although the CMI tends to wane a few years after vaccination.

Assessment of seroprevalence against poliovirus among Italian adolescents and adults.

In 2002, the WHO European Region was declared polio-free. Nonetheless global eradication has not yet been completed and the reintroduction from at risk areas is still possible. This seroprevalence study evaluated samples collected from each Italian region in the 12-50 years old age range to assess protection against Poliovirus (PV) 1, 2 and 3 among subjects immunised with different vaccination schedules. 1073 samples (50.5% females) were examined. WHO standardized microneutralization assay was used. Seroprotection rates were 92.9%, 96.2% and 83.4%, for PV1, PV2 and PV3, respectively. Geometric Mean Titres (GMTs) were higher for PV2 (52.8) and PV1 (41.1) than for PV3 (21.0). Increasing the age, a decreasing trend in seropositivity was observed, in particular for PV3. The 2017-2019 Italian National Immunisation Plan emphasises, as primary objective, the maintenance of the polio-free status and strongly validates the 2 + 1 schedule in the first year of life with IPV vaccine associated with the administration of booster doses at 6 years and during the adolescence. Surveillance system and high population immunity are crucial to ensure the maintenance of polio-free status.

Use of Information Sources on Vaccine-Preventable Diseases in Pregnant Women: An Experience in Ferrara, Italy.

The "vaccine hesitancy" and the consequent lowering of vaccination coverage have, on one hand, pushed the Italian government to reintroduce some new compulsory vaccinations for access to schools and, on the other, have imposed a greater effort on health operators to understand the causes and, consequently, to intervene with tools for promotion and health education. In Ferrara, we administered 201 non-self-filling questionnaires to 201 pregnant women within a cross-sectional multicenter study, consisting of 63 items divided into 7 sections. In particular, we wanted to investigate the correlation between the socio-demographic characteristics of the interviewees and the sources used to obtain information and, on the other side, the intention to vaccinate in relation to the perception of the diffusion and of the risk of vaccine-preventable diseases. The institutional information sources are less used by foreigners, primiparous, and women with a low education level. The perception of the severity of vaccine-preventable diseases was greater in those inquiring from institutional sources. In a public health perspective, knowing the profile of future mothers in terms of socio-demographic characteristics and of the quality of the used information channels may help to guide the choices of communication in the vaccination field.

A novel nonlive, adjuvanted herpes zoster subunit vaccine: a report on the emerging clinical data and safety profile.

Herpes zoster (HZ) is an acute vesicular dermatitis with a typical dermatomal distribution, caused by the varicella zoster virus (VZV), often preceded and accompanied by prodromal pain or pruritus. HZ may be related to several complications such as postherpetic neuralgia (PHN). The incidence and severity of the disease increase with aging, due to immunosenescence and in particular to the decline of the specific cell-mediated immunity (CMI). The impact of HZ in terms of morbidity and short- and long-term complications, the availability of suboptimal treatment options to date, and the high costs for the diagnostic and clinical-therapeutic management of patients have motivated the search for a new preventive approach through the development of a vaccine. The vaccine currently in use with live-attenuated virus (ZVL) has been shown to be effective in reducing the incidence of HZ, its impact, and the onset of PHN, although the efficacy is lower in older subjects and tends to decrease some years after immunization. A new adjuvanted recombinant subunit vaccine (HZ/su), containing the VZV glycoprotein E (gE) and the AS01B adjuvant system, is now a very promising alternative to ZVL; in several clinical studies, it showed a good safety profile and was able to elicit high immune humoral and cell-mediated responses, both maintained up to 9 years. Furthermore, HZ/su vaccine was effective both in preventing HZ and in reducing the onset of PHN and other complications. HZ/su has been recommended and preferred over ZVL by the Advisory Committee on Immunization Practices (ACIP) for the prevention of HZ and its complications in immunocompetent adults aged ≥50 years, even if already vaccinated with ZVL, through a two-dose schedule. HZ/su has been approved in Canada, USA, Europe, and Japan and is currently being approved in Australia. The aim of this review was to describe the epidemiological data, HZ and PHN risks and their impact on the social life and common life of infected people, and ZVL and HZ/su vaccine development including various clinical trials and efficacy, safety, and tolerability profiles.