28 Apr FDA Fully Approves Remdesivir to Treat COVID-Positive Pediatric Patients

Alexandra Schmitt and her 8-year-old daughter Clara Galush read through the documents after Clara got her first shot of the pediatric vaccine at San Jose’s Emmanuel Baptist Church on Wednesday, Nov. 3, 2021. (Jana Kadah / Bay City News)

By Eli Walsh
Bay City News Foundation

The U.S. Food and Drug Administration approved the use of the COVID-19 treatment remdesivir for children under age 12 this week, the first COVID treatment the agency has approved for pediatric patients.

The medication, which has the brand name Veklury and is developed by Gilead Sciences Inc., will now be available to children at least 28 days old and weighing at least roughly 7 pounds who are hospitalized with COVID or have tested positive and are at high risk of developing severe illness.

Prior to the FDA approving the medication for young children on Thursday, remdesivir had been approved for people ages 12 and older who had tested positive for the virus.

As a result of the FDA’s approval, remdesivir is now fully authorized for all age groups and the agency has rescinded its emergency use authorization for the medication.

“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,” FDA Center for Drug Evaluation and Research Director Dr. Patrizia Cavazzoni said in a statement.

>>>Read: Waiting to Get Kids Vaccinated Comes With Its Own Risks

Federal health officials noted that remdesivir is not a substitute for vaccination, and urged everyone aged 5 and up to complete their initial vaccination series as soon as they can.

Information about the FDA-approved vaccines can be found at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.

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