This is the first Covid-19 treatment approved for children younger than 12.
To be eligible for treatment, the FDA said, children must be hospitalized or have mild to moderate Covid-19 and high risk for progressing to severe Covid-19, even if they are not hospitalized.
The drug, made by Gilead Sciences and sold as Veklury, had been approved to treat certain adults and patients 12 and older who weighed at least 88 pounds. It’s given as an injection.
There is no Covid-19 vaccine authorized for children younger than 5 in the United States.
The FDA’s approval of remdesivir for young children is “great,” said Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in the Department of Biochemistry and Molecular Biophysics at Columbia University.
Griffin called remdesivir a “very effective antiviral” at preventing the progression of Covid-19 to a more severe illness, lowering the risk of hospitalization or death, when given early in the course of Covid-19 infection.
“If we can extend this down to children and actually give it to them during the critical time when it can make the biggest difference, finally, we’re really opening up more options, because these kids don’t have a lot of options,” he said. “They don’t have access to some of the other therapies that are restricted to that over-12 age group.”