FDA grants full approval for COVID-19 treatment remdesivir in young kids
The Food and Drug Administration (FDA) on Monday gave its first full approval for a COVID-19 treatment for children under 12.
The agency granted approval to the treatment remdesivir, also known as Veklury, made by Gilead Sciences, which has already been approved as a treatment for adults.
The treatment was earlier under emergency use authorization for children. Full approval from the FDA provides a more formal and higher level of endorsement than emergency authorization.
Still, the FDA stressed that remdesivir is not a replacement for vaccination, and there is still no authorized vaccine for children under 5, a source of stress and disappointment for some parents.
Rep. James Clyburn (D-S.C.), the chair of the House Select Subcommittee on the Coronavirus Crisis, earlier on Monday requested an FDA briefing on the agency’s progress on authorizing a vaccine for children under five.
Authorization for the Pfizer vaccine for young kids could come in June, though previous timelines have been pushed back before.
While the virus is generally less dangerous in children, the FDA noted severe illness can still result.
“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,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
The approval covers children 28 days and older who weigh at least 3 kilograms and are either hospitalized or at high-risk of severe illness.