Anti-Sars-CoV-2 vaccination campaign in children aged 5-11 years: the experience of a mass vaccination center in the city of Milan.

BACKGROUND AND AIM: After the approval of the anti-Sars-CoV-2 vaccines for the pediatric population, it is necessary to encourage the immunization of children aged 5-11 years, as this can reduce intergenerational transmission. Therefore, this goal has become a priority for the COVID 19 vaccination campaign in Italy. In the city of Milan, the mass vaccination center (MVC) Fiera Milano City, previously settled for general population, became the main site to host pediatric vaccinations. The center was consequently remodeled to ensure a suitable space for children. This paper provides an overview on the organization strategy implemented by Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. The modular structure and the wide surface available in the center allowed the administration of hundreds of vaccines per day, especially in the first opening phase. METHODS: All the data for the entire period of activity of Fiera MCV, from December 16th 2021 to February 20th 2022, were analyzed using descriptive statistics. RESULTS: During the entire period of activity, from 16 December 2021 to 20 February 2022, 23% of the population in the province of Milan aged 5-11 years has been reached and vaccinated with at least one shot of vaccine in this center. CONCLUSIONS: Despite an enthusiastic response in the first weeks of the campaign, a progressive reduction in vaccination adherence was observed, maybe due to the absence of restrictive measures for unvaccinated children in Italy.

Surveillance of Severe Acute Respiratory Infection and Influenza Vaccine Effectiveness among Hospitalized Italian Adults, 2021/22 Season.

Following an extremely low incidence of influenza during the first waves of the ongoing COVID-19 pandemic, the 2021/22 Northern Hemisphere winter season saw a resurgence of influenza virus circulation. The aim of this study was to describe epidemiology of severe acute respiratory infections (SARIs) among Italian adults and estimate the 2021/22 season influenza vaccine effectiveness. For this purpose, a test-negative case-control study was conducted in a geographically representative sample of Italian hospitals. Of 753 SARI patients analyzed, 2.5% (N = 19) tested positive for influenza, most of which belonged to the A(H3N2) subtype. Phylogenetic analysis showed that these belonged to the subclade 3C.2a1b.2a.2, which was antigenically different from the 2021/22 A(H3N2) vaccine component. Most (89.5%) cases were registered among non-vaccinated individuals, suggesting a protective effect of influenza vaccination. Due to a limited number of cases, vaccine effectiveness estimated through the Firth's penalized logistic regression was highly imprecise, being 83.4% (95% CI: 25.8-97.4%) and 83.1% (95% CI: 22.2-97.3%) against any influenza type A and A(H3N2), respectively. Exclusion of SARS-CoV-2-positive controls from the model did not significantly change the base-case estimates. Within the study limitations, influenza vaccination appeared to be effective against laboratory-confirmed SARI.

Knowledge, Attitudes, Behavior, Acceptance, and Hesitancy in Relation to the COVID-19 Vaccine among Pregnant and Breastfeeding Women: A Systematic Review Protocol

A new coronavirus, SARS-CoV-2, was identified at the end of 2019. It swiftly spread all over the world, affecting more than 600 million people and causing over 6 million deaths worldwide. Different COVID-19 vaccines became available by the end of 2020. Healthcare workers and more vulnerable people (such as the elderly and those with comorbidities) were initially prioritized, followed by the entire population, including pregnant and breastfeeding women. Despite the safety and efficacy of COVID-19 vaccines, a certain level of skepticism was expressed, including among pregnant and breastfeeding women. There were several reasons for this reluctancy, among them, fear of side-effects for both women and fetuses. Nevertheless, acceptance, as well as hesitancy, were time, country and vaccine specific. This review will collect available evidence assessing knowledge, attitudes, behaviour, practice and acceptance/hesitancy of pregnant/breastfeeding women in relation to the COVID-19 vaccination. The PubMed/MEDLINE, Scopus and EMBASE databases will be consulted. A predefined search strategy that combines both free text and MESH terms will be used. The systematic review will adhere to the PRISMA guidelines and the results will be reported in both narrative and summary tables. A meta-analysis will be conducted if data are available.

Hospital acquired infections in COVID-19 patients in sub intensive care unit: analysis of two waves of admissions.

BACKGROUND AND AIM: The pandemic caused by SARS-COV-2 has increased Semi-Intensive Care Unit (SICU) admission, causing an increase in healthcare-associated infection (HAI). Mostly HAI reveals the same risk factors, but fewer studies have analyzed the possibility of multiple coinfections in these patients. The study aimed was to identify patterns of co-presence of different species describing at the same time the association between such patterns and patient demographics and, finally, comparing the patterns between the two cohorts of COVID-19 patients admitted at Policlinico during the first wave and the second one). METHODS: All the patients admitted to SICUs during two COVID-19 waves, from March to June 2020 months and from October to December 2020, were screened following the local infection control surveillance program; whoever manifested fever has undergone on microbiological culture to detect bacterial species. Statistical analysis was performed to observe the existence of microbiological patterns through DBSCAN method. RESULTS: 246 patients were investigated and 83 patients were considered in our study because they presented infection symptoms with a mean age of 67 years and 33.7% of female patients. During the first and second waves were found respectively 10 and 8 bacterial clusters with no difference regarding the most frequent species. CONCLUSIONS: The results show the importance of an analysis which considers the risk factors for the possibility of co- and superinfection (such as age and gender) to structure a good prognostic tool to predict which patients will encounter severe coinfections during hospitalization.

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).

Modulating Role of Breastfeeding Toward Long COVID Occurrence in Children: A Preliminary Study.

The SARS-CoV-2 (Severe acute respiratory syndrome Coronavirus-2) pandemic has forced the global health system to face new challenges both in the acute management of COVID-19 (Coronavirus Disease 2019) patients and in its consequences. In particular, the long-term effects of this new virus, especially in children, are still poorly understood. Scientific research is currently trying to understand the mechanisms underlying the so called "long COVID syndrome". Since the beginning of the pandemic, breastmilk has been studied for its antiviral and immunomodulatory properties. Based on these assumptions, we conducted a preliminary study in order to investigate the prevalence of long COVID in a cohort of Italian children with previously detected SARS-CoV-2 infection and evaluate if breastfeeding might play a role in modulating long COVID occurrence.

Caregivers' Intention to Vaccinate Their Children Under 12 Years of Age Against COVID-19: A Cross-Sectional Multi-Center Study in Milan, Italy.

The impact of Coronavirus disease 2019 (COVID-19) on the pediatric population is increasingly recognized. A widespread vaccination in childhood would provide benefits for children and might help ending the pandemic by enhancing community protection. Following recent approval by the European Medicines Agency (EMA) of Comirnaty (Pfizer-BioNTech) for children aged 5-11 years, we aimed to investigate caregivers' intention to vaccinate their children <12 years of age against COVID-19. A structured questionnaire was administered to caregivers of children aged <12 years visiting the Emergency Department or the outpatient clinics in three major hospitals of Milan, Italy, from 20 September to 17 October 2021. A total of 612 caregivers were invited to participate and 604 accepted (response rate >98%). Three questionnaires were excluded due to compiling errors and 601 were included in the analysis. A total of 311 (51.7%) caregivers stated they would have their child vaccinated, 138 (23%) would refuse to vaccinate their child and 152 (25.3%) were unsure. The intention to vaccinate the child was higher in caregivers vaccinated against COVID-19, in those with a bachelor's degree or higher level of education, and in those with friends/acquaintances who became ill or died due to COVID-19. This study shows that increasing efforts are necessary to provide evidence-based tailored information to caregivers and to promote vaccination in this pediatric age group.

COVID-19 and Influenza Vaccination Campaign in a Research and University Hospital in Milan, Italy.

BACKGROUND: Healthcare workers (HCWs) are a historical key target of influenza vaccination programs. For the 2021-2022 season, WHO considered the coadministration of a flu and a COVID-19 vaccine as acceptable and recommended it to allow for higher uptake of both vaccines. The aim of this study was to investigate demographic and occupational features of vaccinated HCWs, reasons behind flu vaccine acceptance and a possible effect of the coadministration of a COVID-19 vaccine, in order to potentially draw general conclusions on HCWs' attitude towards flu vaccination and inform further strategies for consistent improvement of vaccine acceptance. METHODS: a promotional and educational campaign, a gaming strategy, and vaccination delivery through both a large central hub and on-site ambulatories, were the implemented strategies. In the central hub, the flu/COVID-19 vaccine coadministration was offered. Statistical descriptive analysis, multiple correspondence analysis (MCA) and logistic regression models were performed. RESULTS: 2381 HCWs received the flu vaccine, prompting a vaccination coverage rate (VCR) of 52.0% versus 43.1% in the 2020-2021 campaign. Furthermore, 50.6% vaccinated HCWs belonged to the 18-39 years-old age group. The most expressed reasons for vaccine uptake were "Vaccination is the most effective strategy of prevention" (n = 1928, 81.0%), "As HCW it's my duty to get vaccinated to protect my patients" (n = 766, 32.2%), and the group of COVID-19-related reasons (n = 586, 24.6%). In addition, 23.3% HCWs received the flu vaccine in the current campaign but not in the previous one (newly vaccinated) and the flu/COVID-19 vaccine coadministration was more frequent in this group. A total of 51.0% HCWs were hesitant towards the coadministration, while residents and nurses showed the highest propensity to receive it. CONCLUSIONS: in the second year of the COVID-19 pandemic, the Fondazione's influenza VCR continued to increase, with the greatest participation among HCWs aged 18-39 years. A potential propelling role of the COVID-19 vaccine coadministration was highlighted.

Caregivers' Attitudes Toward COVID-19 Vaccination in Children and Adolescents With a History of SARS-CoV-2 Infection.

Background: Limited data are available on the attitudes of caregivers toward COVID-19 vaccination in children and adolescents with a history of SARS-CoV-2 infection or Long Covid symptoms. The aim of this study was to investigate the vaccine hesitancy among caregivers of children and adolescents with a documented history of SARS-CoV-2 infection and to explore the possible associations between COVID-19 manifestations and the acceptance of the vaccine. Methods: Caregivers of children or adolescents with a microbiologically confirmed diagnosis of SARS-CoV-2 infection evaluated in two University Hospitals were interviewed. Results: We were able to contact 132 caregivers and 9 declined to participate. 68 caregivers (56%) were in favor of COVID-19 vaccination for their child. In the multiple logistic regression, child's age (OR 1.17, 95%CI 1.06-1.28) and hospitalization due to COVID-19 (OR 3.25, 95%CI 1.06-9.95) were positively associated with being in favor of COVID-19 vaccination. On the contrary, the occurrence of child's Long Covid was associated with a higher likelihood of being against the vaccination (OR 0.28, 95%CI 0.10-0.80). Conclusions: This preliminary study shows that only about half of the interviewed parents of children and adolescents with a previous SARS-CoV-2 infection are willing to vaccinate them to prevent a repeated COVID-19 infection. These findings might help healthcare workers to provide tailored information to caregivers of children with a previous SARS-CoV-2 infection.

Tdap Booster Vaccination for Adults: Real-World Adherence to Current Recommendations in Italy and Evaluation of Two Alternative Strategies.

BACKGROUND: While the effectiveness of tetanus-diphtheria-pertussis childhood immunization programs is unquestionable, the actual need for a periodic boosting vaccination in adults is controversial. In Italy, the Ministry of Health recommends a Tdap booster vaccination every 10 years. The aim of this study is to assess the real-world adherence of Italian regional healthcare services to national recommendations and to evaluate two alternative strategies. METHODS: Annual Tdap vaccine requirements by the 21 Italian regions were retrieved from related tender announcements, and regional and national vaccination coverage rates (VCRs) were estimated for three scenarios, namely the currently recommended 10-year booster vaccination, a single booster shot at age 50 and at age 65. RESULTS: In Scenario 1, no region reached a VCR > 30%, and the national VCR was 10.6%; in Scenario 2, five regions achieved the optimal vaccination coverage of ≥95%, but the vast majority continued to have inadequate VCRs, with a national VCR of 54.4%; in Scenario 3, five regions reached VCRs exceeding 100%, with VCRs from other regions significantly improving and a national VCR of 74.8%. CONCLUSIONS: A substantial lack of adherence by Italian regional healthcare services to current national recommendations on tetanus-diphtheria-pertussis adult vaccination was shown. Scenario 3 is the most feasible, i.e., a single booster shot at age 65, possibly administrable along with other already-recommended, age-specific vaccines.

Trends in outcomes following COVID-19 symptom onset in Milan: a cohort study.

BACKGROUND: For people with symptomatic COVID-19, the relative risks of hospital admission, death without hospital admission and recovery without admission, and the times to those events, are not well understood. We describe how these quantities varied with individual characteristics, and through the first wave of the pandemic, in Milan, Italy. METHODS: A cohort study of 27 598 people with known COVID-19 symptom onset date in Milan, Italy, testing positive between February and June 2020 and followed up until 17 July 2020. The probabilities of different events, and the times to events, were estimated using a mixture multistate model. RESULTS: The risk of death without hospital admission was higher in March and April (for non-care home residents, 6%-8% compared with 2%-3% in other months) and substantially higher for care home residents (22%-29% in March). For all groups, the probabilities of hospitalisation decreased from February to June. The probabilities of hospitalisation also increased with age, and were higher for men, substantially lower for healthcare workers and care home residents, and higher for people with comorbidities. Times to hospitalisation and confirmed recovery also decreased throughout the first wave. Combining these results with our previously developed model for events following hospitalisation, the overall symptomatic case fatality risk was 15.8% (15.4%-16.2%). CONCLUSIONS: The highest risks of death before hospital admission coincided with periods of severe burden on the healthcare system in Lombardy. Outcomes for care home residents were particularly poor. Outcomes improved as the first wave waned, community healthcare resources were reinforced and testing became more widely available.

The first major vaccination campaign against smallpox in Lombardy: the mass vaccination campaign against coronavirus nothing new only terminology.

Terminology, technology, communication and organizational strategies are different but we tried to compare the mass vaccination campaign against smallpox with the one we are doing against coronavirus.

Health Technology Assessment to assess value of biomarkers in the decision-making process.

Clinical practice guidelines (CPGs) on screening, surveillance, and treatment of several diseases recommend the selective use of biomarkers with central role in clinical decision-making and move towards including patients in this process. To this aim we will clarify the multidisciplinary interactions required to properly measure the cost-effectiveness of biomarkers with regard to the risk-benefit of the patients and how Health Technology Assessment (HTA) approach may assess value of biomarkers integrated within the decision-making process. HTA through the interaction of different skills provides high-quality research information on the effectiveness, costs, and impact of health technologies, including biomarkers. The biostatistical methodology is relevant to HTA but only meta-analysis is covered in depth, whereas proper approaches are needed to estimate the benefit-risk balance ratio. Several biomarkers underwent HTA evaluation and the final reports have pragmatically addressed: 1) a redesign of the screening based on biomarker; 2) a de-implementation/replacement of the test in clinical practice; 3) a selection of biomarkers with potential predictive ability and prognostic value; and 4) a stronger monitoring of the appropriateness of test request. The COVID-19 pandemic has disclosed the need to create a robust and sustainable system to urgently deal with global health concerns and the HTA methodology enables rapid cost-effective implementation of diagnostic tests allowing healthcare providers to make critical patient-management decisions.

Italy's rollout of COVID-19 vaccinations: The crucial contribution of the first experimental mass vaccination site in Lombardy.

BACKGROUND: In occurrence of the coronavirusdisease 19 (COVID-19) pandemic, carrying out an efficient large-scale vaccination campaign is vital in order to control the virus. Especially in high prevalence areas of COVID - 19, it is crucial to implement an effective vaccination strategy. In Italy, programming an efficient COVID-19 mass vaccination campaign has been the main target of the Ministry of Health. AIMS: This paper gives a comprehensive overview of how the mass vaccination campaign is performed in Milan, one of the cities that has been mostly affected by the COVID-19 pandemic in Italy. We analyze the vaccination strategy implemented by Fondazione Ca' Granda - Ospedale Maggiore Policlinico located in Milan. Furthermore, we compare the organization of this campaign in regards of those carried out across EU and UK. MATERIALS AND METHODS: The data derive from an analysis of the different vaccination plans implemented across EU and UK from the 27/12/2020 to the 15/06/2020. In addition, we discuss the data collected from the internal data server of IRCCS Fondazione Ca' Granda - Ospedale Maggiore Policlinico from the 15/02/2021 to the 15/06/2021.The collected data are examined by means of descriptive statistics. RESULTS: From the analysis of the internal data server, we observe that the modular organization of Fiera Milano City guarantees up to 5000 vaccinations/day. Moreover, the precise flow organization of users and a series of strategies adopted to avoid identification errors or vaccine type administration errors are crucial to reach the aforementioned target. CONCLUSIONS: The institution of mass vaccination centers thanks to the optimization of all the involved processes and the meticulous organization of these structures, allows to avoid crowds and guarantees the administration of elevated amounts of vaccines. All these elements assure a rapid vaccination coverage of the population in Lombardy, with a meaningful increase in daily administration doses.

Side effects among healthcare workers from a large Milan university hospital after second dose of BNT162b2 mRNA COVID-19 vaccine.

BACKGROUND: In Italy, healthcare workers (HCWs) were among the first to receive COVID-19 vaccination. Aim of the present study is to evaluate frequency and severity of adverse events (AEs) following the second dose of BNT162b2 vaccine among HCWs of a large university hospital in Milan, Italy. METHODS: One month after having received the second dose of vaccine, HCWs filled-in a form about type, severity, and duration of post-vaccination local and systemic symptoms. We calculated the overall frequency of AEs and used multivariable Poisson regression models (adjusted for sex, age, BMI, smoking, allergy history, previous SARS-CoV-2 infection, anti-hypertensive therapy, and occupation) to calculate risk ratios (RR) and 95% confidence intervals (CI) of AEs according to selected variables. RESULTS: We included 3659 HCWs. Overall, 2801 (76.6%) experienced at least one local event, with pain at injection site being the most frequent (2788, 76.2%). Systemic events were reported by 2080 (56.8%) HCWs, with fatigue (52.3%), muscle pain (42.2%), headache (37.7%), joint pain (31.9%), and fever (26.2%) being the most frequent. Risks of systemic events were associated with female gender (RR=1.14, CI: 1.06-1.23), age (strong decrease with increasing age, p-trend<0.001), allergy history (RR=1.13, CI: 1.05-1.20), and current smoking (RR=0.90, CI: 0.84-0.97). HCWs with previous SARS-CoV-2 infection (even if symptomatic) were not at increased risk. CONCLUSIONS: Both local and systemic acute effects after second dose of BNT162b2 vaccine were frequently reported. However, symptoms were mostly light/mild and of short duration. Thus, our findings support the safety of COVID-19 vaccination in adults in relatively good health.

The management of the Sars-CoV-2 pandemic in Italy, lessons earnt and reflections for the future.

BACKGROUND: Italy and especially Lombardy region was the first European Country hit by the covid 19 pandemic, without a proper preparedness plan. Italy's health-care service is a regionally based National Health Service (NHS) that provides universal coverage, largely free of charge at the point of service. Aim of this paper is to analyse the national and especially the regional strategies put in place to face the pandemic, focusing on the impact of the overlap of the political and health competences among national and regional authority. METHODS: Italian hygiene and preventive medicine society (SITI) realized a questionnaire submitted to National Institute for Health and regional stakeholder to investigate the response to the epidemic analysing the strategies and actions put in place both by the national and regional governments and the regional health authorities. RESULTS: The national survey highlighted several critical points in the management of the covid 19 pandemic in the different regional contexts such as lack of personnel in preventive departments and preparadness. CONCLUSIONS: Lessons learnt during the pandemic should shape the future of the Italian health service. (www.actabiomedica.it).

2020-21 Influenza vaccination campaign strategy as a model for the third COVID-19 vaccine dose?

BACKGROUND AND AIM: Seasonal influenza exerts a deep and multi-level impact on population and public health systems. Among at risk groups, healthcare workers (HCWs) represent a crucial one due to the threat of absenteeism and consequent disruption of healthcare services (and economic losses). Also in this group vaccine hesitancy is a well known issue, therefore innovative and 360-degree strategies are urgently needed to overcome the problem. METHODS: in the 2020-21 influenza vaccination campaign in a research and teaching hospital in Milan, Italy, the working group implemented three different strategies: the offer of vaccination through both an ad hoc ambulatory and several itinerant (on site) vaccinating teams, a promotional and educational communication campaign, a gaming strategy Results: vaccinated employees nearly doubled (2103 vs 1153 in 2019-20 flu vaccination campaign), reaching a comprehensive vaccination coverage rate (VCR) of 43,1%. A highly significant increase in the 40-59 age group was registered. While physicians and nursing staff confirmed to be the most represented categories among vaccinated subjects, administrative and auxiliary staffs performed the greatest increase compared to the previous campaign. The on site vaccination was clearly preferred than the ad hoc one (1693 HCWs, 80,5% vs 410, 19,5%). Vaccinated for the first time registered a significant increase (40,2% vs 36,2% in 2019-20 campaign). CONCLUSIONS: such meaningful results confirm the effectiveness of the strategies implemented in the present campaign, suggesting their possible application in the debated COVID19-third-dose vaccination campaign.