ABSTRACT
Objective: To analyze the clinical characteristics of fatal cardiac adverse events associated with chloroquine, which was recommended for the antiviral treatment of novel coronavirus pneumonia, and provide reference for clinical safe drug use. Method(s): The fatal cardiac adverse events associated with chloroquine were searched from the World Health Organization global database of individual case safety reports (VigiBase). The clinical characteristics of the individual cases with well-documented reports (VigiGrade completeness score >=0.80 or with detailed original reports) were analyzed. The adverse events were coded using the systematic organ classification (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 22.1 of International Conference on Harmonization (ICH). Result(s): Up to 23 February 2020, a total of 45 reports of fatal heart injuries related to chloroquine were reported in VigiBase, which were from 16 countries. Of them, 30 reports were fully informative. Among the 30 reports,20 cases developed fatal cardiac adverse events after a single large dose of chloroquine. Of them, 17 cases' fatal cardiac adverse events were caused by overdose of chloroquine (15 cases were suicide or suspected suicide, and 2 children took chloroquine by mistake);3 cases' fatal cardiac adverse events were caused in clinical treatment;18 cases showed arrhythmia and cardiac arrest;6 cases showed prolonged QRS wave or QT interval;6 cases were with hypokalemia, including 4 severe ones. Among the 30 reports, 10 cases developed fatal cardiac adverse events after multiple administration of chloroquine, of which 4 cases were treated with chloroquine for 23 days to 2 months and died of heart failure, cardiac arrest or myocardial infarction;6 cases were treated with chloroquine for 20 months to 29 years and all of them had cardiomyopathy, which were confirmed by endomyocardial biopsy to be caused by chloroquine in 3 cases. Conclusion(s): Cardiac toxicity was the primary cause of fatal adverse events caused by chloroquine;the main manifestation of single large dose of chloroquine was arrhythmia and the manifestation of multiple administration was cardiomyopathy.Copyright © 2020 by the Chinese Medical Association.
ABSTRACT
Since late 2019, the pandemic of COVID-19, caused by SARS-CoV-2, has resulted in high morbidity and mortality worldwide. During 2020, safety monitoring of medicinal treatments for this novel disease was performed by Uppsala Monitoring Centre (UMC) in VigiBase, WHO's global database of suspected adverse drug reactions, which is the largest international repository of reported ADRs. Initially, COVID-19 treatments included numerous repurposed medicines previously approved for other indications, such as chloroquine and hydroxychloroquine. Although chloroquine is a widely used drug which has been on the market for a very long time, the efficacy and safety profile have not been thoroughly studied in COVID-19 patients. In early 2020, chloroquine and hydroxychloroquine were authorized by major regulatory agencies for emergency use, or only for use within clinical trials. Given the interest over the use of these drugs in COVID-19, the ADR reports in VigiBase for them were summarized and communicated to reiterate their toxicities, in particular the cardiac reactions which may result in fatal outcomes.1 Remdesivir, the first novel antiviral drug authorized for use in treatment for COVID-19, was the most commonly reported COVID-19 medicine within VigiBase during 2020. Employing indication- focused descriptive statistics (disproportionality analysis), together with the use of a comparator tocilizumab with a known safety profile, it was possible to identify known safety information for both remdesivir and tocilizumab and suggest potential safety concerns for remdesivir. The most reported adverse events were liver dysfunction, kidney injury, death and bradycardia.2 In late 2020, several new vaccines for COVID-19 were developed, received emergency authorization and rolled out on a large scale. The vaccines used novel technology and a rapid and vast deployment was anticipated. For this scale of activity, a well-functioning international postmarketing safety surveillance system is essential. The unprecedented volume of reports of suspected adverse events following immunization has led to the development of new routines and the use of new tools at UMC, for example, a digital reporting form designed for mobile devices was implemented;more frequent updates of VigiBase data allowed timely data analyses;a COVID-19 vaccine-specific standardized drug grouping (SDG) was created enabling the data analysis on a vaccine platform level;and a monthly descriptive report regarding COVID-19 vaccine reporting in VigiBase was made available for member countries of the WHO Programme for International Drug Monitoring (PIDM).3 UMC regularly screened VigiBase for previously unknown or incompletely documented COVID- 19 vaccines adverse reactions. These signals were shared with all WHO PIDM members to complement their signal detection and support local action to protect patients from harm. Some signals were also published outside the WHO PIDM to raise awareness or encourage data collection.4,5 In summary, successful adaptations were made at UMC in a short period to handle the COVID- 19 pandemic situation. However, the pandemic has not ended yet and further challenges are anticipated. The safety monitoring of COVID- 19 therapies and vaccines still needs to continue.
ABSTRACT
Although there has been an increasing number of studies investigating media representations of the COVID-19 outbreak around the world, less international attention has been given to Chinese media outlets' coverage of the COVID-19 outbreak than that of their western counterparts. This study employs corpus-assisted critical discourse analysis to investigate how China is linguistically represented in a state-run English-language news media. The analysis reveals that China is respectively represented as a victim, a fighter, and a cooperative/supportive country with ideological implications for global solidarity and humanitarianism. This study sheds light on the effective use of discursive strategies in promoting international cooperation and building a national image amid a global health crisis. The value of using corpus-assisted critical discourse analysis to examine national image is also highlighted. © The Author(s) 2023.
ABSTRACT
Background/Introduction: Up to 14 June 2021, VigiBase, the World Health Organization (WHO) global database of individual case safety reports (ICSRs) [1], contained over 26 million reports from more than 140 member countries of the WHO Program for International Drug Monitoring (PIDM). VigiBase is managed by Uppsala Monitoring Center (UMC) on behalf of the WHO. Since the end of November 2020, 1.1 million ICSRs for COVID-19 vaccines were entered in VigiBase accounting for 41% of all vaccine reports in the database. The large number of reports received in a short time requires semi-automated data handling and signal prioritization exceeding normal signal detection operations. Objective/Aim: To monitor the safety of the COVID-19 vaccines from a global perspective. Methods: Screenings of VigiBase are performed regularly. Statistically ranked drug-event combination lists that focus on a theme, e.g. low- and middle-income countries, emerging safety signals, or testing new methods are prepared. Multi-disciplinary teams then assess the combinations together. This is typically done during focused multiday workshops. To complement this, general regular screenings are performed and hints from other sources (e.g., scientific literature, media reports, etc.) are followed. Several statistical methods are used in the screening efforts. Disproportionality analysis compares the observed number of reports for a drug-event combination to the expected number based on the overall reporting in the database. vigiRank, [2] an algorithm combining five strength-of-evidence parameters into a score, provides a ranking of drug-event combinations. vigiGroup clustering [3] automatically groups reports with similar adverse event profiles in a data driven way. Its purpose is to uncover clinically coherent pictures that might otherwise evade detection. vigiPoint [4] is a tool to quickly explore differences in one set of reports compared to one or more reference sets. This enables exploration of various covariates. Features that are significantly and robustly different are highlighted for review. Identified preliminary safety signals are subject to weekly prioritization. Points to consider for prioritizing a combination for in-depth assessment include e.g. multinational reporting, the reaction's seriousness, etc. Confirmed safety signals are shared with the WHO PIMD member states. Results: Up to 14 June 2021, ten preliminary safety signals have been identified for in-depth assessment via different signal detection activities. Another 38 preliminary safety signals are being monitored. Conclusion: VigiBase is the world's largest database of ICSRs. Therefore, UMC is in a good position to monitor the COVID-19 vaccines' safety maintaining the global perspective with the potential to find emerging safety signals earlier.
ABSTRACT
Background/Introduction: Disproportionality analysis [1, 2] has been a stalwart of post marketing safety surveillance, however it has some drawbacks. vigiGroup [3, 4] is a novel ICSR clustering method which can complement disproportionality analysis, and we present its first application to prospective monitoring of a drug's safety profile, by incorporating its use into our surveillance activities of the COVID-19 vaccines. Objective/Aim: We aim to explore and develop the utilisation of vigiGroup as a tool for prospective monitoring of COVID-19 vaccine safety reports in VigiBase. Methods: VigiBase receives tens of thousands of adverse event reports per week for all COVID-19 vaccines collectively. Each week, the vigiGroup algorithm has been applied to cluster the accumulated ICSRs of COVID-19 vaccines. The algorithm was applied independently for each vaccine, but also grouping the vaccines by platform. Our multidisciplinary team of pharmacovigilance experts and data scientists have developed powerful data visualisation tools to rapidly explore the evolving safety profile of the vaccines, as well as to strengthen the hypotheses generated with traditional disproportionality analysis. Results: A number of potential safety signals have been identified directly using the tools we have developed in tandem with the vigiGroup clustering algorithm. These include appendicitis and hearing loss/tinnitus for all COVID-19 vaccines and delayed local reactions to the Moderna vaccine, which were identified in a vigiGroup interface with the aid of imbedded data visualisation tools. Several more signals have been strengthened by further incorporating vigiGroup as a complementary tool to traditional disproportionality analysis. We have moreover demonstrated the efficacy of the algorithm and our tools by recovering labelled adverse reactions, such as hypersensitivity and anaphylaxis, and emerging safety signals, e.g. myocarditis, for all of the vaccines. Conclusion: The use of vigiGroup clustering has been explored by pharmacovigilance experts at the Uppsala Monitoring Centre and has been found to be a promising new tool for post-marketing drug safety surveillance. The vigiGroup algorithm and data visualisation tools are being iteratively developed as the prospective monitoring of COVID-19 vaccines continues.
ABSTRACT
The COVID-19 pandemic requires people and political bodies to reflect on the abundant and complicated relationships between human beings, governments, and organizations. We hold that Prof. Sass emphasizes the urgency and necessity of the view that "life is interconnected." With the continuous progress of globalization, mankind has become an interdependent community with a shared future. However, global cooperation and communication face numerous challenges due to the diversity of cultures, national conditions, and competing interests. The COVID-19 pandemic has driven individuals and political bodies to discuss effective measures and control the disaster together, which demands that a basic consensus be reached on how to manage the tension between individual freedom and interests and public health and well-being. Even more importantly, the pursuit of happiness is the common goal of mankind Solidarity and mutual aid are required to create a stable, harmonious, healthy, and orderly community Chinese traditional philosophy can contribute some wisdom and strategies to build similar but not identical bodies and societies.