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Remdesivir has received FDA sanction for coronavirus disease management in pediatrics.
On 25 April 2022, the United States Food and Drug Administration (US-FDA) expanded the authorization of SARS-CoV-2 therapy remdesivir to encompass pediatrics twenty-eight days of age and older weighing at least three kilograms (about seven pounds) with positive results of direct viral testing, who are:
(a) Hospitalized
(b) Not hospitalized and have mild-to-moderate coronavirus disease and are at elevated risk for advancement to severe coronavirus disease, including hospitalization or mortality
This action makes remdesivir the first approved SARS-COV-2 therapy for children less than twelve years of age. Based on this approval, the FDA also cancelled remdesivir's emergency use authorization that formerly covered this pediatric population. Prior to this, remdesivir was only authorized to manage few adults and pediatrics (twelve years of age and older who weigh at least forty kilograms/eighty-eight pounds) infected with SARS-CoV-2 infection.
The coronavirus disease can elicit serious illness in children. For children that do not currently have a vaccination choice, there continues to be a requirement for safe and efficacious therapeutic choices for SARS-CoV-2 management. Remdesivir is not a substitute for vaccination in people for whom SARS-CoV-2 vaccination and booster doses are suggested. The US-FDA has authorized 2 vaccines, and 3 vaccines are available for emergency use for the prevention of coronavirus diseases and the serious clinical outcomes linked with SARS-CoV-2 infection, including hospitalization and mortality.
Given the similar course of coronavirus disease in adults and pediatrics, remdesivir's approval in certain pediatrics is assisted by effectiveness outcomes from phase 3 trials in adults. Remdesivir's authorization is also favored by an open-label, phase 2/3, single-arm trial of 53 pediatrics (weight at least three kilograms/about 7 pounds and age at least twenty-eight days) with confirmed coronavirus infection and mild, moderate or serious coronavirus disease.
The volunteers in this pediatric phase II/III study were given remdesivir therapy for up to ten days. The pharmacokinetic and safety findings from phase II/III study in pediatrics were comparable to those in adult volunteers. The only authorised dosage form is remdesivir for injection.
The possible adverse effects of using remdesivir include raised levels of liver enzymes, that might be a sign of hepatic injury; and allergic reactions, that might incorporate alterations in blood pressure and heart rate, wheezing, reduced blood oxygen level, fever, breath shortness, swelling (like under the skin, lips, around eyes), shivering, rash, nausea, or sweating.
US-FDA
Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children
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