The U.S. Food and Drug Administration announced on Monday that it has approved the COVID-19 drug remdesivir, sold under the brand Veklury, to treat patients as young as 28 days and weighing about 7 pounds.

Why it matters: This is the first coronavirus treatment approved for young children, revoking emergency authorization of the treatment for those younger than 12 and less than 88 pounds with COVID-19.

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Clinical trials still assess whether children younger than 5 years of age should get vaccinated.

Details: The treatment, given as an injection, isn’t a substitute for getting the vaccine.

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  • The approval of the treatment drug is supported by results from phase 3 clinical trials in adults, as well as “a phase 2/3, single-arm, open-label clinical study” with 53 pediatric patients (at least 28 days of age and weighing more than 7 pounds) who received Veklury for up to 10 days. The results were similar to those seen in adults.

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,” said Patrizia Cavazzoni, M.D., 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.”
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The bigger picture: Last week, 37,000 child COVID-19 cases were reported, the first increase since January, according to ABC News.

  • Numbers still remain lower than during other surges and only a small percentage of cases have resulted in hospitalization and death.
  • Even so, the rise in cases among children is concerning, especially when some are not eligible to receive the vaccine yet.
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