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      Self-reported side effects of the Oxford AstraZeneca COVID-19 vaccine among healthcare workers in Ethiopia, Africa: A cross-sectional study

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          Abstract

          Introduction

          Ethiopia is the second most populous country in Africa. Ethiopia received most of its COVID-19 vaccines through donations. The Oxford AstraZeneca vaccine is the first to be donated to Ethiopia by the COVAX facility. Healthcare workers were the priority population that received the Oxford AstraZeneca COVID-19 vaccine. However, there was no nationwide study on the safety of the vaccine in Ethiopia. This study aimed to measure the prevalence and predictors of self-reported side effects of the Oxford AstraZeneca vaccine.

          Materials and methods

          The study employed a cross-sectional design. A sample of healthcare workers who took Oxford AstraZeneca COVID-19 vaccine was drawn from four regions of Ethiopia; namely, Amhara, Oromia, Somali, and Southwest. Data were collected on sociodemographic characteristics, medical anamnesis, COVID-19 related anamnesis, and COVID-19 vaccine anamnesis via telephone interview. Descriptive and inferential analyses were done. The software, IBM SPSS Statistics v21.0, was used for analyses of data.

          Results

          Out of 384 people, 346 responded (response rate: 90.1%). Female accounted for 34.1% of the respondents. The mean age of the respondents was 31.0 years (Standard Deviation (SD) = 7.4). Nurses accounted for 43.7% of the respondents. The prevalence of at least one local- and systemic-side effect was 50.6 and 44.5%, respectively. The most frequent local- and systemic- side effect were injection site pain and headache, respectively. Both types of side effects mostly subsided in the first 3 days. A third of healthcare workers with side effects took at least one medication. Paracetamol followed by diclofenac sodium were taken by healthcare workers to overcome side effects. There was no independent predictor of local side effect. After controlling for age and chronic diseases, the odds of healthcare workers with COVID-19 like symptoms to experience systemic side effects was 1.38 (Confidence Interval (CI): 1.04–1.82) times more than that of healthcare workers without COVID-19 like symptoms.

          Conclusions

          The prevalence of local- and systemic-side effects of the Oxford AstraZeneca COVID-19 vaccine was modest. As the symptoms were mostly common in the first 3 days, it is preferable to monitor healthcare workers at least in the first 3 days following the administration of the vaccine.

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          Most cited references23

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          The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

          Much of biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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            Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

            Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; p interaction =0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. Funding UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.
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              A living WHO guideline on drugs for covid-19

              What is the role of drug interventions in the treatment and prevention of covid-19? The first version on this living guidance focuses on corticosteroids. It contains a strong recommendation for systemic corticosteroids in patients with severe and critical covid-19, and a weak or conditional recommendation against systemic corticosteroids in patients with non-severe covid-19. Corticosteroids are inexpensive and are on the World Health Organisation list of essential medicines. this guideline was created This guideline reflects an innovative collaboration between the WHO and the MAGIC Evidence Ecosystem Foundation, driven by an urgent need for global collaboration to provide trustworthy and living covid-19 guidance. A standing international panel of content experts, patients, clinicians, and methodologists, free from relevant conflicts of interest, produce recommendations for clinical practice. The panel follows standards, methods, processes, and platforms for trustworthy guideline development using the GRADE approach. We apply an individual patient perspective while considering contextual factors (that is, resources, feasibility, acceptability, equity) for countries and healthcare systems. A living systematic review and network meta-analysis, supported by a prospective meta-analysis, with data from eight randomised trials (7184 participants) found that systemic corticosteroids probably reduce 28 day mortality in patients with critical covid-19 (moderate certainty evidence; 87 fewer deaths per 1000 patients (95% confidence interval 124 fewer to 41 fewer)), and also in those with severe disease (moderate certainty evidence; 67 fewer deaths per 1000 patients (100 fewer to 27 fewer)). In contrast, systemic corticosteroids may increase the risk of death in patients without severe covid-19 (low certainty evidence; absolute effect estimate 39 more per 1000 patients, (12 fewer to 107 more)). Systemic corticosteroids probably reduce the need for invasive mechanical ventilation, and harms are likely to be minor (indirect evidence). The panel made a strong recommendation for use of corticosteroids in severe and critical covid-19 because there is a lower risk of death among people treated with systemic corticosteroids (moderate certainty evidence), and they believe that all or almost all fully informed patients with severe and critical covid-19 would choose this treatment. In contrast, the panel concluded that patients with non-severe covid-19 would decline this treatment because they would be unlikely to benefit and may be harmed. Moreover, taking both a public health and a patient perspective, the panel warned that indiscriminate use of any therapy for covid-19 would potentially rapidly deplete global resources and deprive patients who may benefit from it most as potentially lifesaving therapy. This is a living guideline. Work is under way to evaluate other interventions. New recommendations will be published as updates to this guideline. This is version 1 of the living guideline, published on 4 September ( BMJ 2020;370:m3379) version 1. Updates will be labelled as version 2, 3 etc. When citing this article, please cite the version number. August 28 August 31
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                Author and article information

                Contributors
                Journal
                Front Public Health
                Front Public Health
                Front. Public Health
                Frontiers in Public Health
                Frontiers Media S.A.
                2296-2565
                19 July 2022
                2022
                19 July 2022
                : 10
                : 937794
                Affiliations
                [1] 1Department of Health Policy and Management, Jimma University , Jimma, Ethiopia
                [2] 2Department of Public Health, Masaryk University , Brno, Czechia
                [3] 3Czech National Center for Evidence-Based Healthcare and Knowledge Translation (Cochrane Czech Republic, Czech EBHC: JBI Center of Excellence, Masaryk University GRADE Center), Institute of Biostatistics and Analyses, Masaryk University , Brno, Czechia
                [4] 4Cochrane Iran Associate Center, National Institute for Medical Research Development , Tehran, Iran
                [5] 5Seqiz Health Network, Kurdistan University of Medical Sciences , Seqiz, Iran
                [6] 6Department of Health, Behavior and Society, Jimma University , Jimma, Ethiopia
                [7] 7Jimma University Medical Center, Jimma University , Jimma, Ethiopia
                [8] 8Department of Pediatrics and Child Health, Jimma University , Jimma, Ethiopia
                [9] 9Department of Public Health, Woldia University , Woldia, Ethiopia
                [10] 10Gebretsadik Shawo Hospital, Southwest Health Bureau , Bonga, Ethiopia
                [11] 11Jigjiga University Specialized Hospital, Jigjiga University , Jigjiga, Ethiopia
                [12] 12Department of Gynecology and Obstetrics, Jigjiga University , Jigjiga, Ethiopia
                [13] 13Department of Economics, Jimma University , Jimma, Ethiopia
                [14] 14Institute of Health Information and Statistics of the Czech Republic , Prague, Czechia
                Author notes

                Edited by: Bijaya Kumar Padhi, Post Graduate Institute of Medical Education and Research (PGIMER), India

                Reviewed by: Ramzi Mukred Saeed, University of Marburg, Germany; Meely Panda, AIIMS Bibinagar, India

                This article was submitted to Infectious Diseases - Surveillance, Prevention and Treatment, a section of the journal Frontiers in Public Health

                Article
                10.3389/fpubh.2022.937794
                9343757
                35928493
                5a5355ed-c65d-47a7-b347-17b5bc00ff36
                Copyright © 2022 Yesuf, Riad, Sofi-Mahmudi, Sudhakar, Mekonnen, Endalkachew, Mama, Muhidin, Ayele, Yahya, Usman, Abafita and Klugar.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 06 May 2022
                : 27 June 2022
                Page count
                Figures: 1, Tables: 14, Equations: 0, References: 27, Pages: 0, Words: 6067
                Categories
                Public Health
                Original Research

                healthcare workers,covid-19 vaccine,side effects,oxford astrazeneca,ethiopia,africa

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