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An efficient and punctual monitoring of air pollutants is very useful to evaluate and prevent possible threats to human beings' health. Especially in areas where such pollutants are highly concentrated, an accurate collection of data could suggest mitigation actions to be implemented. Moreover, a well-performed data collection could also permit the forecast of future scenarios, in relation to the seasonality of the phenomenon. With a particular focus on COVID pandemic period, several literature works demonstrated a decreasing of pollutant concentrations in air of urban areas, mainly for NOx, while CO and PM10, on the opposite, has been observed to remain still, mainly because of the intensive usage of heating systems by the people forced to stay home (on specific regions). With the present contribution the authors here present an application of Time Series analysis (TSA) approach to pollutants concentration data of two Italian cities during first lockdown (9 march – 18 may 2020), demonstrating the possibility to predict pollutants concentration over time. © 2023, World Scientific and Engineering Academy and Society. All rights reserved.
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Introduction: Concerns have emerged during Covid-19 pandemic about management of Disease Modifying Therapies (DMTs) in patients with Multiple Sclerosis (pwMS). In particular, Ocrelizumab (OCR)-treated pwMS faced possible delays of scheduled infusions due to disruption of MS Centers activities as well as safety worries during lockdown periods. Objective(s): To assess changes of OCR infusion schedule in Italian pwMS during the first wave of COVID-19 pandemic (observation period: February-June 2020) and to investigate predictive factors determining delaying of OCR infusions. Material(s) and Method(s): Data were extracted from the Italian MS Register database. pwMS with an OCR infusion scheduled during the observation period and at least two previous OCR infusions were selected. Demographics (age, gender), disease characteristics (MS phenotype, disease duration, Expanded Disability Status Scale score, number of previous OCR infusions) and location of MS Centers among three Italian macro-regions (North, Center, South) were tested as potential predictors for treatment delay using univariable and multivariable linear model analyses. Result(s): Five-hundred ninety-nine pwMS (343 F/256 M;411 Relapsing MS/188 Progressive MS) from 65 MS centers were included in the analysis. Mean interval between two OCR infusions was 28.1 weeks (SD 2.72) before the observation period compared to 30.8 weeks (SD 5.45) during the observation period, with a mean delay of 2.7 weeks (p <0.001). No clinico-demographic factors emerged as predictors of infusion postponement, except for location of MS centers in the North of Italy (4.7 weeks vs 1.5 in the Center and 1.6 in the South). Such a difference was confirmed in multivariate analysis (p < 0.001) adjusting for prelockdown mean OCR infusion schedule. Conclusion(s): This large registry-based study shows that OCR infusions were significantly delayed during the first wave of COVID-19 pandemic in Italy. The location of the MS Centers in Northern Italy was the only predictor of OCR infusion postponement. This geographical area corresponds to the region in Italy that was hit first and more strongly by Covid-19 pandemic. The observed delay in OCR infusions disruptions of MS centers activities due to a drastic reduction of healthcare workers availability (because of infection/quarantine and/or reallocation in Covid Units) and concerns about using an immunosuppressive DMT like OCR during a new virus pandemic with many uncertainties.
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Introduction: MS centers (MSc) activities related to OCR management were strongly and diffusely hit during the first wave of COVID-19 pandemic. Concerns were mainly related to its immunosuppressive effects and the need for in-hospital administration. Objective(s): To investigate changes in OCR schedule among Italian MS centers participating to the Italian MS Register during the first wave of COVID-19 pandemic and to identify factors determining such changes. Material(s) and Method(s): A quick online survey was sent to 65 Italian MSc in order to collect from them the following data: macro-region (North, Center, South) location, number of OCRtreated patients, modifications of OCR schedule and a list of factors potentially influencing the postponement of OCR infusions (i.e. age, co-morbidity, MS phenotype, number of previous OCR cycles, disease severity/activity, CD-20 lymphocytes count, distance to MS center, fear of infection, inclusion in a research trial, infections trend, shortage of medical/paramedical staff for reallocation/ infection). Result(s): Among 55 MSc who answered the survey, 50 (91%) declared to have suspended or extended OCR interval dosing for at least one patient. The MSc that didn't modify OCR schedule were all from the South of Italy (33% of all South MSc). Main factors influencing OCR schedule delay were advanced age/comorbidity (70%) and pandemic trend in the area (72%), while recent MS-disease activity hindered OCR schedule modifications (65%). Conclusion(s): This study shows that most Italian MSc decided either to delay or suspend OCR treatment during the first wave of COVID-19 pandemic. Advanced age and co-morbidity and no evidence of recent MS-disease activity were the most relevant patient-dependent predictors of OCR postponement. Among patient-independent factors the most relevant factor was the local trend of infections. Contrary to what expected, the shortage of medical and/or paramedical staff in MSc did not come out as relevant. The disruption of OCR schedule during the first COVID-19 pandemic wave in Italy mostly reflected the geographical distribution and the impact on the National Health System of COVID- 19 pandemic.
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Introduction: Recently mRNA-based COVID-19 vaccines have been approved also for use in pediatric population. Vaccines safety require particular attention in this population. Analysis of pharmacovigilance database allows to extrapolate important information to identify possible safety signals. Objective(s): Our pharmacovigilance study aims to describe and evaluate the onset of adverse events following immunization (AEFIs) with COVID-19 mRNA vaccines in the pediatric population. Method(s): We retrieved all pediatric Individual Case Safety Reports (ICSRs) collected in the European pharmacovigilance database, Eudravigilance from the 01/01/2021 to 4/03/2022 related to Spikevax and Comirnaty. We carried out a disproportionality analysis (Reporting Odds Ratio-95% CI) to compare the reporting probability of some AEFIs of interest (seizure, pericarditis, myocarditis, multisystem inflammatory syndrome (MIS), menstrual disorders, failure and anaphylactic shock) between Comirnaty and Spikevax. Result(s): We retrieved in Eudravigilance 25.019 ICSR related to Comirnaty describing a total of 75.040 AEFIs and 1.862 ICSRs referred to Spikevax reporting overall 5.361 AEFIs occurred in pediatric population. Majority of ICSRs reported well-known general disorders (headache, pyrexia, fatigue and nausea) for both mRNA vaccines. ICSRs were more frequently referred the adolescent patients (Comirnaty, 86.2%;Spikevax, 86.4%). We found a slight prevalence of female gender for both mRNA vaccine (Spikevax, 52.6 %;Comirnaty 53.9%). Reproductive system disorders were more frequently referred to females. In particular, these events included menstrual disorders (N = 609, Comirnaty;N = 23, Spikevax), amenorrhoea (N = 408, Comirnaty;N = 16, Spikevax) or intermenstrual bleeding (N = 169, Comirnaty;N = 10, Spikevax), polymenorrhoea (N = 172, Comirnaty;N = 10, Spikevax). Few cases described reproductive system disorders in males, mainly related to Comirnaty. These AEFIs included testicular pain (N = 14, Comirnaty;N = 1, Spikevax), erectile dysfunction (N = 5, Comirnaty), testicular torsion (N = 4, Comirnaty) or swelling (N = 4, Comirnaty), scrotal pain (N = 3, Comirnaty) or oedema (N = 1, Comirnaty). Outcome of AEFIs was unknown in 14.8% and 21.1% cases for Spikevax and Comirnaty, respectively. AEFIs had a favorable outcome in more than 50% of cases for both mRNA vaccines, including a complete resolution (30%) or an ongoing resolution (20%). From disproportionality analysis emerged a statistically significant ROR for menstrual disorders (ROR 1.72, 95% CI 1.43-2.10;p<0.05), failure (ROR 8.11, 95% CI 5.05-13.97;p<0.05) and seizure (ROR 1.54, 95% CI 1.03-2.41;p = 0.037) when compared Comirnaty versus Spikevax. Conclusion(s): Majority of pediatric AEFIs are mild and with a positive outcome, supporting the role of ongoing COVID-19 vaccination campaign in this population as a critical public health tool for disease prevention and control of pandemic. Further investigations are needed in this population.
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Introduction: Recently, capillary leak syndrome (CLS) emerged as new suspected adverse event after immunization (AEFI) associated to COVID-19 vaccination. This condition is rare, but serious and potentially fatal [1]. Objective(s): Our pharmacovigilance study aims to evaluate the onset of CLS as AEFI with COVID-19 mRNA vaccines (Spikevax and Comirnaty) compared to viral vector vaccines (Janssen and Vaxzevria). Method(s): We carried out descriptive and disproportionality analyses of all Individual Case Safety Reports (ICSRs) reporting a vaccine COVID-19 as suspected drug and the CLS as AEFI, which were collected in the pharmacovigilance database EudraVigilance from January 1st, 2021, to January 14th, 2022. For the disproportionality analysis we applied the Reporting Odds Ratio (ROR) 95% CI. Result(s): During study period, CLS was described as AEFI in 84 out of 1,357,962 ICRs reporting a vaccine COVID-19 as suspected drug and collected in the EV database. Overall, the ICSR reported by CLS were mainly related to the viral vector COVID-19, Vaxzevria-, (N = 36) and Janssen-, (N = 9), while the ICSR reported to vaccines COVID-19 mRNA were 39 (Comirnaty-, N = 33;Spikevax-, N = 6). Majority of ICSRs were reported by healthcare professionals (N = 60;71.4%). The nonhealthcare professional represented the primary source in the 41.7% of Vaxzevria related ICSRs. Majority of the patients were adult (N = 49;58.3%). The female gender accounted in more than 65% of ICSRs referred both to mRNA and viral vector vaccines. The CLS outcome was more frequently favorable in mRNA ICSRs (N = 13;33,3%). On the other hand, among the ICSRs reporting CLS with unfavorable outcome (N = 25;29.8%) we found 9 ICSRs describing fatal CLS (Comirnaty N = 1;Vaxzevria N = 4;Janssen N = 4). From disproportionality analysis emerged a lower CLS reporting probability after COVID-19 vaccination with mRNA vaccines compared to viral vector-based ones. Conclusion(s): According to our results, few ICSRs describing CLS have been collected in EV in front of billion administered doses. This could underline the rarity of this AEFI or the limit of underreporting of spontaneous reporting and therefore also our study. Since the significant clinical relevance of CLS, this AEFI requires a careful monitoring. Healthcare professionals as well as patients should be aware of the signs and symptoms of CLS. Patients with a history of CLS require particular attention because of a possible risk of flare-up of disease. Since a precise mechanism is still not identified, further studies are necessary to confirm the causal relationship between CLS and COVID-19 vaccination.
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Introduction: COVID-19 is a complex disease with several clinical phases of progression, affecting many organs apart from the respiratory tract that has shown a worst prognosis in both patients with type 1 and type 2 diabetes mellitus [1]. Based on these considerations, the vaccination for COVID-19 is a priority for this subpopulation [2]. However, few data have been published on the effects of impaired glucose metabolism induced by COVID-19 vaccines. Objective(s): We decided to perform a study to describe Individual Case Safety Reports (ICSRs) of impaired glucose metabolism events reported in the European database (Eudravigilance, EV). Method(s): ICSRs were retrieved for the period from January 1st, 2021 to December 11th, 2021. An ICSR related to events of impaired glucose metabolism was identified by using selected preferred terms (PTs) from Standardized MedDRA Queries ''Hyperglycaemia/new onset diabetes mellitus'' and ''Hypoglycaemia''. Impaired glucose metabolism events were described and analyzed based on the Diabetologists' classification into nine groups: ''diabetes in pregnancy'', ''acute complications of diabetes'', ''pre-diabetes'', ''type 1 diabetes mellitus'', ''type 2 diabetes mellitus'', ''high glucose levels'', ''diabetes mellitus inadequate control'', ''diabetes melli-tus not specified'', and ''hypoglycaemia''. The reporting odds ratios were computed to assess the reporting frequency for COVID-19 mRNA vaccines compared to COVID-19 viral vector-based vaccines. Result(s): During the study period, 3,917 ICSRs with a COVID-19 vaccine as suspected and at least an event of impaired glucose metabolism were retrieved from the EV, of which 2,027 (51.75%) referred to Pfizer-BioNTech vaccine, 586 (14.96%) to Moderna vaccine, 1,163 (29.70%) to Oxford-AstraZeneca vaccine, and 141 (3.59%) to Janssen vaccine. From 3,917 ICSRs, we observed 4,275 impaired glucose metabolism events (1.09 adverse events per ICSR). Most adverse events were classified as serious (2,694;63.02%), and the most reported events were related to ''high glucose levels'' (2,012;47.06%). The mRNA vaccines were associated with an increased reporting frequency of ''type 1 diabetes mellitus'' (ROR 1.86;95% CI 1.33-2.60), ''type 2 diabetes mellitus'' (ROR 1.58;95% CI 1.03-2.42), ''high glucose levels'' (ROR 1.16;95% CI 1.06-1.27), ''diabetes mellitus inadequate control'' (ROR 1.63;95% CI 1.25-2.11), and ''hypoglycemia'' (ROR 1.62;95% CI 1.41-1.86) compared to viral vector-based vaccines. The highest reporting rate per 100,000 was observed for Oxford-AstraZeneca vaccine (1.87;95% CI 1.77-1.97). Conclusion(s): In conclusion, mRNA COVID-19 vaccines were associated with an increased reporting frequency of alterations of glucose homeostasis compared to viral-vector COVID-19 vaccines. Clinicians should be aware of these events to better manage glycaemic perturbations. Larger nationwide studies are warranted to verify these findings.
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Introduction: Recently mRNA-based COVID-19 vaccines have been approved also for use in pediatric population. Vaccines safety require particular attention in this population. Analysis of pharmacovigilance database allows to extrapolate important information to identify possible safety signals. Objective: Our pharmacovigilance study aims to describe and evaluate the onset of adverse events following immunization (AEFIs) with COVID-19 mRNA vaccines in the pediatric population. Methods: We retrieved all pediatric Individual Case Safety Reports (ICSRs) collected in the European pharmacovigilance database, Eudravigilance from the 01/01/2021 to 4/03/2022 related to Spikevax and Comirnaty. We carried out a disproportionality analysis (Reporting Odds Ratio-95% CI) to compare the reporting probability of some AEFIs of interest (seizure, pericarditis, myocarditis, multisystem inflammatory syndrome (MIS), menstrual disorders, failure and anaphylactic shock) between Comirnaty and Spikevax. Results: We retrieved in Eudravigilance 25.019 ICSR related to Comirnaty describing a total of 75.040 AEFIs and 1.862 ICSRs referred to Spikevax reporting overall 5.361 AEFIs occurred in pediatric population. Majority of ICSRs reported well-known general disorders (headache, pyrexia, fatigue and nausea) for both mRNA vaccines. ICSRs were more frequently referred the adolescent patients (Comirnaty, 86.2%;Spikevax, 86.4%). We found a slight prevalence of female gender for both mRNA vaccine (Spikevax, 52.6 %;Comirnaty 53.9%). Reproductive system disorders were more frequently referred to females. In particular, these events included menstrual disorders (N = 609, Comirnaty;N = 23, Spikevax), amenorrhoea (N = 408, Comirnaty;N = 16, Spikevax) or intermenstrual bleeding (N = 169, Comirnaty;N = 10, Spikevax), polymenorrhoea (N = 172, Comirnaty;N = 10, Spikevax). Few cases described reproductive system disorders in males, mainly related to Comirnaty. These AEFIs included testicular pain (N = 14, Comirnaty;N = 1, Spikevax), erectile dysfunction (N = 5, Comirnaty), testicular torsion (N = 4, Comirnaty) or swelling (N = 4, Comirnaty), scrotal pain (N = 3, Comirnaty) or oedema (N = 1, Comirnaty). Outcome of AEFIs was unknown in 14.8% and 21.1% cases for Spikevax and Comirnaty, respectively. AEFIs had a favorable outcome in more than 50% of cases for both mRNA vaccines, including a complete resolution (30%) or an ongoing resolution (20%). From disproportionality analysis emerged a statistically significant ROR for menstrual disorders (ROR 1.72, 95% CI 1.43-2.10;p < 0.05), failure (ROR 8.11, 95% CI 5.05-13.97;p < 0.05) and seizure (ROR 1.54, 95% CI 1.03-2.41;p = 0.037) when compared Comirnaty versus Spikevax. Conclusion: Majority of pediatric AEFIs are mild and with a positive outcome, supporting the role of ongoing COVID-19 vaccination campaign in this population as a critical public health tool for disease prevention and control of pandemic. Further investigations are needed in this population.
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Introduction: Recently, capillary leak syndrome (CLS) emerged as new suspected adverse event after immunization (AEFI) associated to COVID-19 vaccination. This condition is rare, but serious and potentially fatal [1]. Objective: Our pharmacovigilance study aims to evaluate the onset of CLS as AEFI with COVID-19 mRNA vaccines (Spikevax and Comirnaty) compared to viral vector vaccines (Janssen and Vaxzevria). Methods: We carried out descriptive and disproportionality analyses of all Individual Case Safety Reports (ICSRs) reporting a vaccine COVID-19 as suspected drug and the CLS as AEFI, which were collected in the pharmacovigilance database EudraVigilance from January 1st, 2021, to January 14th, 2022. For the disproportionality analysis we applied the Reporting Odds Ratio (ROR) 95% CI. Results: During study period, CLS was described as AEFI in 84 out of 1,357,962 ICRs reporting a vaccine COVID-19 as suspected drug and collected in the EV database. Overall, the ICSR reported by CLS were mainly related to the viral vector COVID-19, Vaxzevria®, (N = 36) and Janssen®, (N = 9), while the ICSR reported to vaccines COVID-19 mRNA were 39 (Comirnaty®, N = 33;Spikevax®, N = 6). Majority of ICSRs were reported by healthcare professionals (N = 60;71.4%). The non-healthcare professional represented the primary source in the 41.7% of Vaxzevria® related ICSRs. Majority of the patients were adult (N = 49;58.3%). The female gender accounted in more than 65% of ICSRs referred both to mRNA and viral vector vaccines. The CLS outcome was more frequently favorable in mRNA ICSRs (N = 13;33,3%). On the other hand, among the ICSRs reporting CLS with unfavorable outcome (N = 25;29.8%) we found 9 ICSRs describing fatal CLS (Comirnaty® N = 1;Vaxzevria® N = 4;Janssen® N = 4). From disproportionality analysis emerged a lower CLS reporting probability after COVID-19 vaccination with mRNA vaccines compared to viral vector-based ones. Conclusion: According to our results, few ICSRs describing CLS have been collected in EV in front of billion administered doses. This could underline the rarity of this AEFI or the limit of underreporting of spontaneous reporting and therefore also our study. Since the significant clinical relevance of CLS, this AEFI requires a careful monitoring. Healthcare professionals as well as patients should be aware of the signs and symptoms of CLS. Patients with a history of CLS require particular attention because of a possible risk of flare-up of disease. Since a precise mechanism is still not identified, further studies are necessary to confirm the causal relationship between CLS and COVID-19 vaccination.
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Introduction: COVID-19 is a complex disease with several clinical phases of progression, affecting many organs apart from the respiratory tract that has shown a worst prognosis in both patients with type 1 and type 2 diabetes mellitus [1]. Based on these considerations, the vaccination for COVID-19 is a priority for this subpopulation [2]. However, few data have been published on the effects of impaired glucose metabolism induced by COVID-19 vaccines. Objective: We decided to perform a study to describe Individual Case Safety Reports (ICSRs) of impaired glucose metabolism events reported in the European database (Eudravigilance, EV). Methods: ICSRs were retrieved for the period from January 1st, 2021 to December 11th, 2021. An ICSR related to events of impaired glucose metabolism was identified by using selected preferred terms (PTs) from Standardized MedDRA Queries "Hyperglycaemia/new onset diabetes mellitus" and "Hypoglycaemia". Impaired glucose metabolism events were described and analyzed based on the Diabetologists' classification into nine groups: "diabetes in pregnancy", "acute complications of diabetes", "pre-diabetes", "type 1 diabetes mellitus", "type 2 diabetes mellitus", "high glucose levels", "diabetes mellitus inadequate control", "diabetes melli-tus not specified", and "hypoglycaemia". The reporting odds ratios were computed to assess the reporting frequency for COVID-19 mRNA vaccines compared to COVID-19 viral vector-based vaccines. Results: During the study period, 3,917 ICSRs with a COVID-19 vaccine as suspected and at least an event of impaired glucose metabolism were retrieved from the EV, of which 2,027 (51.75%) referred to Pfizer-BioNTech vaccine, 586 (14.96%) to Moderna vaccine, 1,163 (29.70%) to Oxford-AstraZeneca vaccine, and 141 (3.59%) to Janssen vaccine. From 3,917 ICSRs, we observed 4,275 impaired glucose metabolism events (1.09 adverse events per ICSR). Most adverse events were classified as serious (2,694;63.02%), and the most reported events were related to "high glucose levels" (2,012;47.06%). The mRNA vaccines were associated with an increased reporting frequency of "type 1 diabetes mellitus" (ROR 1.86;95% CI 1.33-2.60), "type 2 diabetes mellitus" (ROR 1.58;95% CI 1.03-2.42), "high glucose levels" (ROR 1.16;95% CI 1.06-1.27), "diabetes mellitus inadequate control" (ROR 1.63;95% CI 1.25-2.11), and "hypoglycemia" (ROR 1.62;95% CI 1.41-1.86) compared to viral vector-based vaccines. The highest reporting rate per 100,000 was observed for Oxford-AstraZeneca vaccine (1.87;95% CI 1.77-1.97). Conclusion: In conclusion, mRNA COVID-19 vaccines were associated with an increased reporting frequency of alterations of glucose homeostasis compared to viral-vector COVID-19 vaccines. Clinicians should be aware of these events to better manage glycaemic perturbations. Larger nationwide studies are warranted to verify these findings.
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Introduction: HemoDialysis eXpanded (HDx) represents an innovative strategy to remove uremic toxins of Large-Medium Molecular weight (LMMs, up to 45 Kda) thanks to the medium cutoff membranes (MCO) and internal convection. Transcription of pro-inflammatory cytokines in peripheral leukocytes is markedly reduced and removal of soluble mediators of inflammation is enhanced after HDx. Also in vitro studies confirmed that HDx is associated with a limitation of neutrophil activation: decrease of ROS, TNF-alpha and IL6 production, and increase of apoptosis. The aim of this study is to evaluate the clinical response to treatment with HDx during AKI related to sepsis. Methods: An 88 year old woman with a history of ischemic heart disease,heart failure and chronic kidney disease stage III-B KDOQI (eGFR 31 ml/m') had been in his usual state of health until 10 days before admission, when fever developed associated with diarrhea and urinary tract infection (UTI). Treated at home with Ceftriaxone 1 g/day without improvement, for the onset of oligoanuria and the detection of sepsis associated with bronchopneumonia and AKI, she was hospitalized. Microangiopathic hemolitic anemia (MAHA) is excluded. He then comes to daily renal replacement theraphy (RRT) through sustained low efficiency dialysis (SLED) and start antibiotic therapy with Imipenem and Teicoplanina. After 72 hours, for the worsening of leukocytosis, the persistence of high values of inflammation indexes and anuria the patient was undergo to daily HDx using Theranova® 400 (1.7m2, Baxter). Antibiotic therapy was still unchanged. After 9 days of this treatment there was a normalization of the inflammation indexes, diuresis recovery and HDx stop. At T0-T3-T12 were evaluated: complete blood count, Procalcitonin (PCT), C-Reactive Protein (CRP) and albumin. Serum creatinine, urea and the daily urine output have been monitored to follow progression of renal dysfunction. Results: HDx (Qb = 255 ± 45ml/min, TT 235 ± 27 m) shows a significant reduction at 12 days for Leukocyte (WBC), Nutrophils, Lymphocytes, Platelets (PLT), PCT and CRP, whereas the albumin is unchanged (Tab.1). HDx also induces relevant RR of Urea (73.5%) and serum creatinine (75.2%). Conclusions: HDx theraphy, through the use of a MCO membrane, effectively is involved on resolution of sepsis and AKI of our patient compared to SLED, despite unchanged antibiotic therapy. Probably this is due to interesting results of HDx on inflammation and increased clearance of cytokines. His possible support in the treatment of positive COVID-19, in fact, has recently been postulated in some Italian dialysis centers, even in the absence of trials to confirm these evidences. [Formula presented] No conflict of interest