Remdesivir: the first FDA-approved anti-COVID-19 Treatment for Young Children

Abstract

Following the emergence of the SARS-CoV-2 pandemic, finding efficient forms of treatment is seen as a priority for both adults and children. On April 25, 2022, remdesivir has become the first United States Food and Drug Administration (FDA) approved COVID-19 treatment for young children, specifically ≥28-days-old children, weighing ≥3 kilograms, who are either hospitalized or non-hospitalized, showing a high risk for progression to severe COVID-19 (prone to hospitalization or death). This new approval, which expands its already FDA-approved use in adults to young children, is supported by the CARAVAN study (a phase 2/3 single-arm, open-label study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of remdesivir (GS-5734™) in participants, from birth to < 18 years of age, with COVID-19). This study is in progress, with an estimated primary completion in February 2023. While positive effects of remdesivir have been ascertained through various studies, controversy has surrounded remdesivir since its initial FDA approval in 2020 due to the contradictory results obtained by various studies. However, many case reports state its positive effects on the outcome of the patients, encouraging an optimistic vision for the future.

Keywords: COVID-19; benefits and limitations.; pediatric; remdesivir; young children.

Figure 1. SARS-CoV-2 pathogenesis

S protein binds to ACE2 and they enter the cell through endocytosis, followed by a process of cathepsin L (CTSL)-dependent viral escape from the endosome. PAMPs are intercepted by TLR3 and TLR7, which trigger intracellular signaling cascades by activating IRF3 and IRF7. This results in nuclear synthesis of cytokines such as type I IFN or IL-1β.Partially reproduced and adapted from reference⁹ (this is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited⁹).