Search

Author(s): Marco Massari 1, Stefania Spila Alegiani 1, Cristina Morciano 1,*, Matteo Spuri 2, Pasquale Marchione 3, Patrizia Felicetti 3, Valeria Belleudi 4, Francesca Romana Poggi 4, Marco Lazzeretti 5, [...], Background Myocarditis and pericarditis following the Coronavirus Disease 2019 (COVID-19) mRNA vaccines administration have been reported, but their frequency is still uncertain in the younger population. This study investigated the association between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA vaccines, BNT162b2, and mRNA-1273 and myocarditis/pericarditis in the population of vaccinated persons aged 12 to 39 years in Italy. Methods and findings We conducted a self-controlled case series study (SCCS) using national data on COVID-19 vaccination linked to emergency care/hospital discharge databases. The outcome was the first diagnosis of myocarditis/pericarditis between 27 December 2020 and 30 September 2021. Exposure risk period (0 to 21 days from the vaccination day, subdivided in 3 equal intervals) for first and second dose was compared with baseline period. The SCCS model, adapted to event-dependent exposures, was fitted using unbiased estimating equations to estimate relative incidences (RIs) and excess of cases (EC) per 100,000 vaccinated by dose, age, sex, and vaccine product. Calendar period was included as time-varying confounder in the model. During the study period 2,861,809 persons aged 12 to 39 years received mRNA vaccines (2,405,759 BNT162b2; 456,050 mRNA-1273); 441 participants developed myocarditis/pericarditis (346 BNT162b2; 95 mRNA-1273). Within the 21-day risk interval, 114 myocarditis/pericarditis events occurred, the RI was 1.99 (1.30 to 3.05) after second dose of BNT162b2 and 2.22 (1.00 to 4.91) and 2.63 (1.21 to 5.71) after first and second dose of mRNA-1273. During the [0 to 7) days risk period, an increased risk of myocarditis/pericarditis was observed after first dose of mRNA-1273, with RI of 6.55 (2.73 to 15.72), and after second dose of BNT162b2 and mRNA-1273, with RIs of 3.39 (2.02 to 5.68) and 7.59 (3.26 to 17.65). The number of EC for second dose of mRNA-1273 was 5.5 per 100,000 vaccinated (3.0 to 7.9). The highest risk was observed in males, at [0 to 7) days after first and second dose of mRNA-1273 with RI of 12.28 (4.09 to 36.83) and RI of 11.91 (3.88 to 36.53); the number of EC after the second dose of mRNA-1273 was 8.8 (4.9 to 12.9). Among those aged 12 to 17 years, the RI was of 5.74 (1.52 to 21.72) after second dose of BNT162b2; for this age group, the number of events was insufficient for estimating RIs after mRNA-1273. Among those aged 18 to 29 years, the RIs were 7.58 (2.62 to 21.94) after first dose of mRNA-1273 and 4.02 (1.81 to 8.91) and 9.58 (3.32 to 27.58) after second dose of BNT162b2 and mRNA-1273; the numbers of EC were 3.4 (1.1 to 6.0) and 8.6 (4.4 to 12.6) after first and second dose of mRNA-1273. The main study limitations were that the outcome was not validated through review of clinical records, and there was an absence of information on the length of hospitalization and, thus, the severity of the outcome. Conclusions This population-based study of about 3 millions of residents in Italy suggested that mRNA vaccines were associated with myocarditis/pericarditis in the population younger than 40 years. According to our results, increased risk of myocarditis/pericarditis was associated with the second dose of BNT162b2 and both doses of mRNA-1273. The highest risks were observed in males of 12 to 39 years and in males and females 18 to 29 years vaccinated with mRNA-1273. The public health implication of these findings should be considered in the light of the proven mRNA vaccine effectiveness in preventing serious COVID-19 disease and death.

Fatal Adverse Events (FADEs) are a major public health problem, and some FADEs could be preventable. The aim of the present study is to describe the frequency, the drugs involved and the preventability in the FADEs collected through the MEREAFaPS Study between 2012 and 2018. All cases including the outcome "death" have been examined. We excluded cases with vaccine-related ADEs, overdose or suicide, and ADEs occurred during the hospitalisation. Two trained assessors evaluated all cases fulfilling the inclusion criteria. ADEs' preventability was evaluated applying the Schumock and Thornton algorithm. During the study period, we observed 429 cases of death, 92 of which were excluded. The remaining 337 cases involved 187 women and 150 men, with a mean age of 79 and of 77 years, respectively. For each report, the suspected drugs and concomitant ones were 1.26 and 4.20, respectively. Anticoagulants and antiplatelet agents account for more than 40% of FADE cases and the most frequent reactions are haemorrhages (37.5%). The 25% of the FADEs were preventable. This study confirms that FADEs are still a relevant clinical occurrence, and are often caused by widely used old drugs associated with adverse events. The death of one in four patients was preventable. Further efforts should be done to improve the appropriateness of the therapy, especially in older patients who are treated with anticoagulants. [ABSTRACT FROM AUTHOR]

The Mediterranean Sea is a unique meteorological environment and a weather forecasting challenge, where severe weather events of different nature often originate and develop to hit coastal regions, causing major damages and casualties. Conventional ground-based instruments (e.g., raingauges and weather radars) are often inadequate to monitor events during their offshore development. On the other hand, in spite of their irregular time sampling, Low Earth Orbit satellites, carrying passive and active microwave (MW) sensors, can be fully exploited for the characterization and monitoring of heavy precipitation systems over this area. In this respect, the NASA/JAXA Global Precipitation Measurement (GPM) Core Observatory (CO), equipped with the most advanced MW radiometer (GPM Microwave Imager, GMI) and the first spaceborne Dual-frequency Precipitation Radar (DPR), allows for the 3-D analysis of precipitation structures. Moreover the GPM constellation of MW radiometers ensures 1-3 hourly global coverage of precipitation. In this presentation, we show the GPM mission role in the characterization and monitoring of precipitation associated to extreme events, that hit Italy in the last years. Moreover, we test the capabilities and limitations of advanced satellite precipitation products in the GPM era for quantification and monitoring of precipitation associated with very intense and localized convective cells. To this aim, we analyze the flash flood occurred in Livorno, on the coast of Tuscany, Italy, in the night between 9 and 10 Sept. 2017. In this case, the precipitation products based on the GPM constellation of MW radiometers offer a wide spectrum of results, showing that better performances come from algorithms tailored for the specific region, while algorithms designed for global application are less sensitive to such small-scale thunderstorms. An analogous study is carried out for Numa, a Mediterranean tropical-like cyclone occurred on 16-18 November 2017 over southern Italy. GPM-CO measurements are used, in conjunction with LINET (LIghtning NETwork) data, to show how the rain-band structure evolves as the storm develops into its mature phase. High-resolution simulations were carried out with the Regional Atmospheric Modeling System (RAMS) to analyze the key mechanisms leading to the formation and evolution of Numa. We also show the impact of the assimilation of DPR reflectivity on the precipitation forecast. Long data records of reliable satellite precipitation-related measurements and products are becoming available in the GPM era. Here we make a first attempt to exploit them for a preliminary analysis of occurrence and intensity of extreme events in the Mediterranean, where they can be recognized as climate change signatures. This study evidences the need to fully exploit satellite data and products for studying and monitoring severe weather in the Mediterranean area, and to improve forecasting (and nowcasting) capabilities in this complex region. Thus efforts should be undertaken to develop satellite products tailored for these areas (working on algorithm calibration), and to provide the error structure of the products (working on validation). This would enable users to apply the most suitable product for a specific need, including hydrological applications, and for data assimilation of precipitation-related fields over the sea, where these systems often initiate. [ABSTRACT FROM AUTHOR]

Introduction: The therapeutic approach to the patient with acute bacterial skin and skin structure infection (ABSSSI) and complicated infections often involves the early transition from intravenous to oral therapy (early switch) or early discharge. Our study aimed to evaluate sustainable and innovative care models that can be transferred to community healthcare and the economic impact of dalbavancin therapy vs Standard of Care (SoC) therapy for the treatment of ABSSSI and other Gram-positive infections including those by multidrug-resistant organisms. We also described the organization of an infectious disease network that allows optimizing the treatment of ABSSSI and other complex infections with dalbavancin., Materials and Methods: We retrospectively studied all patients treated with dalbavancin in the University Hospital "S. Anna" of Ferrara, Italy, between November 2016 and December 2022. The clinical information of each patient was collected from the hospital's SAP database and used to evaluate the impact of dalbavancin in early discharge with reduction of length of stay promoting dehospitalization and in improving adherence to antibiotic therapy., Results: A total of 287 patients (165 males and 122 females) were included in the study of which 62 were treated with dalbavancin. In 13/62 patients dalbavancin was administered in a single dose at the completion of therapy to facilitate early discharge. Assuming a 12-day hospitalization required for the treatment of ABSSSI or to complete the treatment of osteomyelitis or spondilodiscitis, the treatment with dalbavancin results in a cost reduction of more than €3,200 per single patient compared to SoC (dancomycin, linezolid or vancomycin)., Conclusions: Dalbavancin has proven to be a valid therapeutic aid in the organization of a territorial infectious disease network given its prolonged action, which allows the dehospitalization with management of even patients with complex infections in outpatient parenteral antimicrobial therapy., (© 2024 The Authors.)

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., Competing Interests: Conflicts of interest statement The other authors declare no conflict of interest related to this manuscript. GG declares that he does not have a specific conflict of interest related to this paper; however, he reports grants from Sanofi Pasteur MSD, GSK Biologicals SA, Pfizer, Sanofi Pasteur Italy, MSD Italy, Emergent BioSolutions and Seqirus for taking part to advisory boards, expert meetings, for acting as speaker and/or organizer of meetings/congresses and as principal investigator and chief of O.U. in RCTs., (©2022 Pacini Editore SRL, Pisa, Italy.)