FDA Approves First COVID-19 Treatment for Children Younger Than 12 Years of Age

The FDA expanded the approval of the COVID-19 treatment remdesivir (Veklury) to include pediatric patients 28 days of age and older, weighing at least 3 kg (approximately 7 pounds) with positive results of direct SARS-CoV-2 viral testing who are:
Hospitalized, or
Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

Remdesivir is the first approved COVID-19 treatment for children younger than 12. Before this expanded approval was granted, remdesivir was approved only to treat certain adults and pediatric patients (12 years and older who weigh at least 40 kg, or about 88 pounds) with COVID-19.

The only approved dosage form of remdesivir is injection. Possible adverse effects of using remdesivir include increased levels of liver enzymes, allergic reactions, rash, nausea, sweating, or shivering. Consult product labeling for detailed prescribing information.

Remdesivir is a product of Gilead Sciences.