scholarly journals The Burden of COVID-19 in Children and Its Prevention by Vaccination: A Joint Statement of the Israeli Pediatric Association and the Israeli Society for Pediatric Infectious Diseases

Vaccines ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 81
Author(s):  
Michal Stein ◽  
Liat Ashkenazi-Hoffnung ◽  
David Greenberg ◽  
Ilan Dalal ◽  
Gilat Livni ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Safety Data ◽  
Epidemiological Data ◽  
Vaccine Safety ◽  
Clinical Aspects ◽  
Direct Effects ◽  
Efficacy And Safety ◽  
Benefit Analysis ◽  
Inflammatory Syndrome ◽  
Risk Benefit Analysis

As of October 2021, SARS-CoV-2 infections were reported among 512,613 children and adolescents in Israel (~33% of all COVID-19 cases). The 5–11-year age group accounted for about 43% (223,850) of affected children and adolescents. In light of the availability of the Pfizer-BioNTech BNT162b2 vaccine against COVID-19 for children aged 5–11 years, we aimed to write a position paper for pediatricians, policymakers and families regarding the clinical aspects of COVID-19 and the vaccination of children against COVID-19. The first objective of this review was to describe the diverse facets of the burden of COVID-19 in children, including the direct effects of hospitalization during the acute phase of the disease, multisystem inflammatory syndrome in children, long COVID and the indirect effects of social isolation and interruption in education. In addition, we aimed to provide an update regarding the efficacy and safety of childhood mRNA COVID-19 vaccination and to instill confidence in pediatricians regarding the benefits of vaccinating children against COVID-19. We reviewed up-to-date Israeli and international epidemiological data and literature regarding COVID-19 morbidity and its sequelae in children, vaccine efficacy in reducing COVID-19-related morbidity and SARS-CoV-2 transmission and vaccine safety data. We conducted a risk–benefit analysis regarding the vaccination of children and adolescents. We concluded that vaccines are safe and effective and are recommended for all children aged 5 to 11 years to protect them from COVID-19 and its complications and to reduce community transmissions. Based on these data, after weighing the benefits of vaccination versus the harm, the Israeli Ministry of Health decided to recommend vaccination for children aged 5–11 years.

scholarly journals Evaluation of Current Therapies for COVID-19 Treatment

2020 ◽  
Vol 8 (8) ◽  
pp. 1097 ◽  
Author(s):  
Atin Sethi ◽  
Horacio Bach
Keyword(s):  
Lung Infection ◽  
Multiple Organ ◽  
Efficacy And Safety ◽  
Benefit Analysis ◽  
Efficacious Treatment ◽  
Current Therapies ◽  
Potential Benefits ◽  
Risk Benefit Analysis ◽  
Unproven Therapies

The virus SARS-CoV-2, the etiological agent of COVID-19, is responsible for more than 400,000 deaths worldwide as of 10 June 2020. As a result of its recent appearance (December 2019), an efficacious treatment is not yet available. Although considered a lung infection since its emergence, COVID-19 is now causing multiple organ failure, requiring a continuous adjustment in the procedures. In this review, we summarize the current literature surrounding unproven therapies for COVID-19. Analyses of the clinical trials were grouped as chemotherapy, serotherapy, anticoagulant, and the use of human recombinant soluble ACE2 therapies. We conclude that, while no agent has hit the threshold for quality of evidence to demonstrate efficacy and safety, preliminary data show potential benefits. Moreover, there is a possibility for harm with these unproven therapies, and the decision to treat should be based on a comprehensive risk–benefit analysis.

scholarly journals Applying a Risk-benefit Analysis to Outcomes in Tuberculosis Clinical Trials

2019 ◽  
Vol 70 (4) ◽  
pp. 698-703 ◽  
Author(s):  
Sachiko Miyahara ◽  
Ritesh Ramchandani ◽  
Soyeon Kim ◽  
Scott R Evans ◽  
Amita Gupta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Systematic Approach ◽  
Composite Outcome ◽  
Efficacy And Safety ◽  
Benefit Analysis ◽  
Prevention Study ◽  
Design Considerations ◽  
The Mean ◽  
Risk Benefit Analysis ◽  
Noninferiority Margin

Abstract Although it is common to analyze efficacy and safety separately in clinical trials, this could yield a misleading study conclusion if an increase in efficacy is accompanied by a decrease in safety. A risk-benefit analysis is a systematic approach to examine safety and efficacy jointly. Both the “rank-based” and “partial-credit” methods described in this paper allow researchers to create a single, composite outcome incorporating efficacy, safety, and other factors. The first approach compares the distribution of rankings between arms. In the second approach, a score can be assigned to each outcome category, considering its severity and comparing the mean or median scores of arms. The methods were applied to the A5279/Brief Rifapentine-Isoniazid Efficacy for TB Prevention study, and design considerations for future clinical trials are discussed, including the challenge of arriving at a consensus on rankings/scorings. If well designed, a risk-benefit analysis may allow for a superiority comparison and, therefore, avoid setting a noninferiority margin. Clinical Trials Registration. NCT01404312 (A5279).

scholarly journals Immunotherapy in hepatocellular carcinoma: evaluation and management of adverse events associated with atezolizumab plus bevacizumab

2021 ◽  
Vol 13 ◽  
pp. 175883592110311
Author(s):  
Chiun Hsu ◽  
Lorenza Rimassa ◽  
Hui-Chuan Sun ◽  
Arndt Vogel ◽  
Ahmed O. Kaseb
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Kinase Inhibitor ◽  
Treatment Options ◽  
Healthcare Providers ◽  
Safety Data ◽  
Standard Of Care ◽  
Antiangiogenic Agents ◽  
Efficacy And Safety ◽  
First Line

In light of positive efficacy and safety findings from the IMbrave150 trial of atezolizumab plus bevacizumab, this novel combination has become the preferred first-line standard of care for patients with unresectable hepatocellular carcinoma (HCC). Several additional trials are ongoing that combine an immune checkpoint inhibitor with another agent such as a multiple kinase inhibitor or antiangiogenic agent. Therefore, the range of first-line treatment options for unresectable HCC is likely to increase, and healthcare providers need succinct information about the use of such combinations, including their efficacy and key aspects of their safety profiles. Here, we review efficacy and safety data on combination immunotherapies and offer guidance on monitoring and managing adverse events, especially those associated with atezolizumab plus bevacizumab. Because of their underlying liver disease and high likelihood of portal hypertension, patients with unresectable HCC are at particular risk of gastrointestinal bleeding, and this risk may be exacerbated by treatments that include antiangiogenic agents. Healthcare providers also need to be alert to the risks of proteinuria and hypertension, colitis, hepatitis, and reactivation of hepatitis B or C virus infection. They should also be aware of the possibility of rarer but potentially life-threatening adverse events such as pneumonitis and cardiovascular events. Awareness of the risks associated with these therapies and knowledge of adverse event monitoring and management will become increasingly important as the therapeutic range broadens in unresectable HCC.

Efficacy and safety data for the Ab interno XEN45 gel stent implant at 3 Years: A retrospective analysis

2021 ◽  
pp. 112067212110143
Author(s):  
Itay E Gabbay ◽  
Mordechai Goldberg ◽  
Felicity Allen ◽  
Zhiheng Lin ◽  
Christine Morley ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Failure Rate ◽  
Open Angle Glaucoma ◽  
Safety Data ◽  
Angle Closure ◽  
Efficacy And Safety ◽  
Antihypertensive Medications ◽  
Uk National Health Service ◽  
The Uk ◽  
Comparative Audit

Purpose: To report efficacy and safety measures of the XEN45 gel stent at 36 months in the UK National Health Service setting. Methods: Retrospective non-comparative audit of the records of patients who underwent XEN45 implantation between June 2015 and May 2017 was performed. Main outcome measures were intraocular pressure and number of antihypertensive medications used. Failure was defined as need for further surgery or stent removal. Success was defined as a 20% decrease in intraocular pressure without the need for additional glaucoma medications or a reduction in antihypertensive medications without an increase in baseline intraocular pressure. Needling rates and preoperative factors effect were assessed. Results: The cohort included 205 patients (205 eyes) with primary open angle glaucoma (84.4%), angle closure glaucoma (7.8%), or refractory glaucoma (7.8%), 62.9% had a stand-alone procedure and 37.1%, a combined phaco-XEN45 procedure. Mean intraocular pressure was 22.6 ± 7.0 mmHg at baseline compared to 14.7 ± 3.8 mmHg at 24 months and 14.0 ± 2.9 mmHg at 36 months ( p < 0.001 for both). Mean number of medications used was 2.6 ± 1.1 at baseline compared to 0.5 ± 0.9 and 0.6 ± 1.0, at 24- and 36-months, respectively ( p < 0.001 for both). The failure rate at 36 months was 25%. Needling was required in 36.6%. Evaluation of background factors yielded an increased failure rate in non-Caucasians compared to Caucasians (74% vs 21%, p < 0.001). Conclusion: XEN45 implantation is effective and safe at 36 months’ follow-up. Patients should be advised regarding the risk of failure and possible need for bleb revisions. Careful patient selection may be required.

scholarly journals COVID-19 Vaccine Safety in Cancer Patients: A Single Centre Experience

Cancers ◽  
2021 ◽  
Vol 13 (14) ◽  
pp. 3573
Author(s):  
Alfred Chung Pui So ◽  
Harriet McGrath ◽  
Jonathan Ting ◽  
Krishnie Srikandarajah ◽  
Styliani Germanou ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Safety Data ◽  
Vaccine Safety ◽  
Phase Iii ◽  
Solid Malignancy ◽  
Common Grade ◽  
Phase Iii Trials ◽  
Oncology Care ◽  
Grade 3 ◽  
Oncology Centre

Emergency approval of vaccines against COVID-19 provides an opportunity for us to return to pre-pandemic oncology care. However, safety data in cancer patients is lacking due to their exclusion from most phase III trials. We included all patients aged less than 65 years who received a COVID-19 vaccine from 8 December 2020 to 28 February 2021 at our London tertiary oncology centre. Solicited and unsolicited vaccine-related adverse events (VRAEs) were collected using telephone or face-to-face consultation. Within the study period, 373 patients received their first dose of vaccine: Pfizer/BioNTech (75.1%), Oxford/AstraZeneca (23.6%), Moderna (0.3%), and unknown (1.1%). Median follow-up was 25 days (5–85). Median age was 56 years (19–65). Of the patients, 94.9% had a solid malignancy and 76.7% were stage 3–4. The most common cancers were breast (34.0%), lung (13.4%), colorectal (10.2%), and gynaecological (10.2%). Of the patients, 88.5% were receiving anti-cancer treatment (36.2% parenteral chemotherapy and 15.3% immunotherapy), 76.1% developed any grade VRAE of which 2.1% were grade 3. No grade 4/5 or anaphylaxis were observed. The most common VRAEs within 7 days post-vaccination were sore arm (61.7%), fatigue (18.2%), and headaches (12.1%). Most common grade 3 VRAE was fatigue (1.1%). Our results demonstrate that COVID-19 vaccines in oncology patients have mild reactogenicity.

scholarly journals Cost risk benefit analysis to support chemoprophylaxis policy for travellers to malaria endemic countries

2011 ◽  
Vol 10 (1) ◽  
Author(s):  
Eduardo Massad ◽  
Ben C Behrens ◽  
Francisco AB Coutinho ◽  
Ronald H Behrens
Keyword(s):  
Benefit Analysis ◽  
Risk Benefit Analysis ◽  
Cost Risk

scholarly journals A risk–benefit analysis approach to seafood intake to determine optimal consumption

2011 ◽  
Vol 107 (12) ◽  
pp. 1812-1822 ◽  
Author(s):  
Véronique Sirot ◽  
Jean-Charles Leblanc ◽  
Irène Margaritis
Keyword(s):  
Arsenic Exposure ◽  
Inorganic Arsenic ◽  
Hierarchical Cluster ◽  
Good Health ◽  
Benefit Analysis ◽  
Food Contaminants ◽  
Public Health Perspective ◽  
Contaminant Exposure ◽  
Consumption Level ◽  
Risk Benefit Analysis

Seafood provides n-3 long-chain PUFA (n-3 LC-PUFA), vitamins and minerals, which are essential to maintain good health. Moreover, seafood is a source of contaminants such as methylmercury, arsenic and persistent organic pollutants that may affect health. The aim of the present study was to determine in what quantities seafood consumption would provide nutritional benefits, while minimising the risks linked to food contaminants. Seafood was grouped into clusters using a hierarchical cluster analysis. Those nutrients and contaminants were selected for which it is known that seafood is a major source. The risk–benefit analysis consisted in using an optimisation model with constraints to calculate optimum seafood cluster consumption levels. The goal was to optimise nutrient intakes as well as to limit contaminant exposure with the condition being to attain recommended nutritional intakes without exceeding tolerable upper intakes for contaminants and nutrients, while taking into account background intakes. An optimum consumption level was calculated for adults that minimises inorganic arsenic exposure and increases vitamin D intake in the general population. This consumption level guarantees that the consumer reaches the recommended intake for n-3 LC-PUFA, Se and I, while remaining below the tolerable upper intakes for methylmercury, Cd, dioxins, polychlorobiphenyls, Zn, Ca and Cu. This consumption level, which is approximately 200 g/week of certain fatty fish species and approximately 50 g/week of lean fish, molluscs and crustaceans, has to be considered in order to determine food consumption recommendations in a public health perspective.

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