A vial of Veklury brand remdesivir anti-viral medication at Salinas Valley Memorial Hospital in Salinas, Calif., on Sept. 2, 2021. Photo: Nic Coury/Bloomberg via Getty Images
The Food and Drug Administration (FDA) on Monday said it expanded the approval of the COVID-19 treatment Veklury, also known as remdesivir, for children 28 days and older.
Why it matters: The Omicron variant hit little kids hard, causing five times as many hospitalizations of children ages 4 and younger than during the previous COVID peak. Monday's move makes Veklury the first approved COVID treatment for children under 12, many of whom remain unable to access vaccines.
Details: Children who weigh at least seven pounds, have tested positive and are hospitalized or at high risk for severe COVID will be able to access the treatment, though the FDA still urged vaccination for those eligible.
- The approval is supported by efficacy results from clinical trials in adults as well as a clinical study of 53 pediatric patients who received Veklury for up to 10 days, per the FDA.
- Both trials showed similar safety and pharmacokinetic results, according to the FDA.
What they're saying: "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," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
- "Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need."
The big picture: Parents of children under 5 are still anxiously waiting for word on when their kids will be able to access COVID shots.
- Young children aren't likely to get severely ill from COVID, but it does happen. There's also an unknown level of risk that little kids who do get infected could fall victim to long COVID, Axios' Tina Reed writes.