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This study shows how satellite-based passive and active microwave (MW) sensors can be used in conjunction with high-resolution Numerical Weather Prediction (NWP) simulations to provide insights of the precipitation structure of the tropical-like cyclone (TLC) Numa, which occurred on 15–19 November 2017. The goal of the paper is to characterize and monitor the precipitation at the different stages of its evolution from development to TLC phase, throughout the storm transition over the Mediterranean Sea. Observations by the NASA/JAXA Global Precipitation Measurement Core Observatory (GPM-CO) and by the GPM constellation of MW radiometers are used, in conjunction with the Regional Atmospheric Modeling System (RAMS) simulations. The GPM-CO measurements are used to analyze the passive MW radiometric response to the microphysical structure of the storm, while the comparison between successive MW radiometer overpasses shows the evolution of Numa precipitation structure from its early development stage on the Ionian Sea into its TLC phase, as it persists over southern coast of Italy (Apulia region) for several hours. Measurements evidence stronger convective activity at the development phase compared to the TLC phase, when strengthening or weakening phases in the eye development, and the occurrence of warm rain processes in the areas surrounding the eye, are identified. The weak scattering and polarization signal at and above 89 GHz, the lack of scattering signal at 37 GHz, and the absence of electrical activity in correspondence of the rainbands during the TLC phase, indicate weak convection and the presence of supercooled cloud droplets at high levels. RAMS high-resolution simulations support what inferred from the observations, evidencing Numa TLC characteristics (closed circulation around a warm core, low vertical wind shear, intense surface winds, heavy precipitation), persisting for more than 24 h. Moreover, the implementation of DPR 3D reflectivity field in the RAMS data assimilation system shows a small (but non negligible) impact on the precipitation forecast over the sea up to a few hours after the DPR overpass. [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]

This paper describes a new rainfall rate retrieval algorithm, developed within the EUMETSAT H SAF program, based on the Passive microwave Neural network Precipitation Retrieval approach (PNPR v3), designed to work with the conically scanning Global Precipitation Measurement (GPM) Microwave Imager (GMI). A new rain/no-rain classification scheme, also based on the NN approach, which provides different rainfall masks for different minimum thresholds and degree of reliability, is also described. The algorithm is trained on an extremely large observational database, built from GPM global observations between 2014 and 2016, where the NASA 2B-CMB (V04) rainfall rate product is used as reference. In order to assess the performance of PNPR v3 over the globe, an independent part of the observational database is used in a verification study. The good results found over all surface types (CC > 0.90, ME < −0.22 mm h−1, RMSE < 2.75 mm h−1 and FSE% < 100% for rainfall rates lower than 1 mm h−1 and around 30–50% for moderate to high rainfall rates), demonstrate the good outcome of the input selection procedure, as well as of the training and design phase of the neural network. For further verification, two case studies over Italy are also analysed and a good consistency of PNPR v3 retrievals with simultaneous ground radar observations and with the GMI GPROF V05 estimates is found. PNPR v3 is a global rainfall retrieval algorithm, able to optimally exploit the GMI multi-channel response to different surface types and precipitation structures, that provide global rainfall retrieval in a computationally very efficient way, making the product suitable for near-real time operational applications. [ABSTRACT FROM AUTHOR]

Aims: To assess the extent of off-label drug use and the occurrence of suspected adverse drug reactions (ADRs) among paediatric patients in Italian hospitals., Methods: We conducted a 2-year prospective cohort study across 22 Italian hospital wards from September 2020 to September 2022. As part of the surveillance project, we performed a 6-month retrieval of all reported ADRs and evaluated all drug prescriptions for their possible off-label use. Following an educational project on pharmacovigilance addressed to healthcare professionals in participating wards, the same data collection was performed., Results: Among the 892 patients included in the study, 64% were admitted to paediatric wards and 36% to neonatal wards. Fifty per cent of all drugs prescribed were used off-label and mainly concerned the administration of a different dose from the one authorized. In neonatal wards, off-label prescriptions occurred slightly more often, with antibacterials being the most frequently used off-label drugs. A total of 35 reports of suspected ADRs were collected, five before the educational project and 30 afterwards. Based on product licence, 10 of the total 35 reports concerned at least one off-label drug use., Conclusions: The off-label use of drugs in treating paediatric patients was extensive in Italian hospitals. Regulatory interventions are needed to promote the use of drugs based on the latest available literature and improve ADR reporting on children. Paediatric indications and dosages of the drugs most commonly used in children should be supported by appropriate ad hoc studies., (© 2024 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

Introduction: The purpose of TheShinISS-Vax|Flu study is to examine the association between influenza vaccines and adverse events requiring hospital admission or emergency care during the influenza vaccination campaigns 2021/2022 and 2022/2023 in Italy., Methods and Analysis: This is a Self-Controlled Case Series multiregional study using linked routinely collected data from regional healthcare databases of the participating regions. Study participants will be persons aged ≥6 months, unvaccinated or who have received influenza vaccine during the influenza vaccination campaigns in the seasons 2021/2022 and 2022/2023 in Italy and who have experienced the outcome of interest for the first time during the study period (1 September 2021-30 June 2022 and 1 September 2022-30 June 2023 for the first and second vaccination campaigns, respectively). Risk periods will be specifically defined for each outcome and further subdivided into periods of 7 days. The exposures will be the first or second dose of the influenza vaccines administered during the two vaccination campaigns. Statistical analysis will be conducted separately for the data of the two campaigns. Exposure risk period will be compared with baseline risk period defined as any time of observation out of the risk periods. The modified SCCS method will be applied to handle event-dependent exposure and mortality and fitted using unbiased estimating equations to estimate relative incidences and excess of cases per 100 000 vaccinated by dose, age, sex and type of vaccine. Calendar period will be included as time-varying confounder in the model, where appropriate., Ethics and Dissemination: The study received the approval from the National ethics committee for clinical trials of public research bodies and other national public institutions (PRE BIO CE n.0036723, 23/09/2022). Results will be published in peer-reviewed journals and reports in accordance with the publication policies of the Italian National Institute of Health and of the Italian Medicines Agency., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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.)

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., Competing Interests: I have read the journal’s policy and the author of this manuscript have the following competing interests: in the last 36 months, GT coordinated a pharmacoepi team at the University of Messina till Oct 2020 and currently at the academic spin-off INSPIRE that received research grants from PTC Therapeutics, Kiowa Kirin, Chiesi, Daiichi Sankyo for the conduct of observational studies on topics not related to the paper; GT participated to Advisory Board/interview sponsored by Eli Lilly, Amgen, Sanofi, SOBI, Gilead, ABBvie, Verpora and Daiichi Sankyo on topics not related to the paper.

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.