FDA Approves First COVID-19 Treatment for Children Under 12 Years Old
The U.S. Food and Drug Administration expanded approval on Monday for a COVID-19 antiviral treatment for children under 12 years of age.
The approved drug, remdesivir, is sold under the brand name Veklury and delivered via injection. Developed by Gilead Sciences, the treatment previously received emergency use authorization by the FDA to treat certain adults and pediatric patients who were 12 years of age and older for severe COVID-19 infection.
Children who are 28 days of age and older, weigh at least seven pounds, and who are hospitalized or have mild to moderate COVID-19 and are at high risk of progression to severe illness will now be eligible to receive the remdesivir treatment.
The decision to approve remdesivir for treatment in young children comes after reporting from the U.S. Centers for Disease Control and Prevention from March showed the omicron variant has led to five times as many hospitalizations of children aged 4 and younger than during previous pandemic peaks involving the delta variant.
In December 2021, the FDA approved two other EUAs for different oral antivirals, Paxlovid and Molnupiravir, which both reduce chances of severe hospitalization and treat adults with mild-to moderate COVID-19 if taken within five days of the onset of symptoms.
Paxlovid and Molnupiravir have not yet been authorized for children under 12 years.
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