Ostracizing Children from Research in COVID-19: Is it Ethical?
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SCIENTIFIC LETTER
Ostracizing Children from Research in COVID-19: Is it Ethical? Jitendra Meena 1 & Arushi Yadav 2 & Jogender Kumar 1 Received: 23 July 2020 / Accepted: 5 October 2020 # Dr. K C Chaudhuri Foundation 2020
To the Editor: COVID-19 pandemic has affected all age groups including children, who comprise 2–5% of total cases, leading to significant mortality and morbidity [1]. Around 3% of the total COVID-19 deaths reported from India are in children [2]. Recently, many drugs (antivirals, steroids, and immunomodulators) are being explored in trials [3, 4]. Traditionally, the drug-trials are first conducted in adults, and if proven efficacious, children are included after a significant time gap. The potential reasoning for the exclusion of children in the initial phase is the risk of unknown adverse effects of the drug under trial and lack of an adequate number of patients for that disease. Children are particularly vulnerable due to their limited freedom and capability to make informed choices, protect themselves from the intended risk, and inability to report adverse effects like a bitter taste, smell, anxiety, palpitation, abdominal pain, etc. However, in pandemic like COVID-19 affecting children, the exclusion from drug trials that are already being widely used in them for other indications is inappropriate and is against medical ethics [3–5]. Recently, Dexamethasone (FDA approved in children) showed a reduction in mortality in hospitalized patients with severe COVID-19 [3]. Researchers stated that the cheap and universally available dexamethasone can reduce one-third of the deaths and shall ensure universal access and equity in the care. Unfortunately, this benefit is not extended to children due to their initial exclusion, which was followed by an abrupt inclusion, detailed information of which is not yet available [3].
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12098-020-03525-3) contains supplementary material, which is available to authorized users. * Jogender Kumar [email protected] 1
Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh 160012, India
2
Department of Radiodiagnosis, Government Medical College and Hospital, Chandigarh, India
Despite the evidence, its use in children is limited by a lack of proven efficacy data in them. Hydroxychloroquine, which has been used off-label in children for many years in the treatment of autoimmune disorders and is studied in the non-COVID-19 clinical trial too, has shown the same exclusion in COVID-19 trial [6]. Many COVID-19 trials evaluating drugs that are widely used in pediatrics for other clinical indications also excluded children (Supplementary Table 1). The zeal for developing vaccines against SARS-CoV-2 appears paradoxical by leaving behind the vulnerable population and violates the action rule of equitable access to an intervention for a new disease. Including children in clinical trials for newer intervention might result in better understan
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