FDA Approves First COVID-19 Treatment for Infants, Young Children

The US Food and Drug Administration (FDA) has approved the use of remdesivir (Veklury) to treat COVID-19 infections in infants and children aged 28 days or older who weight at least 3 kilograms and are hospitalized or at risk of progression to severe disease.

Remdesivir was previously granted an emergency use authorization to treat COVID-19 in this patient population and was approved for use in children aged 12 years or older who weigh at least 40 kilograms.

Remdesivir is only approved to be administered through injection. Common adverse events include increased levels of liver enzymes, allergic reactions, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, and sweating or shivering.

“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” concluded the director of the FDA’s Center for Drug Evaluation and Research Patrizia Cavazzoni, MD.

—Leigh Precopio

Reference:

Coronavirus (COVID-19) update: FDA approves first COVID-19 treatment for young children. News release. US Food and Drug Administration; April 25, 2022. Accessed April 26, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-approves-first-covid-19-treatment-young-children