Coronavirus: FDA approves first COVID-19 treatment for children younger than 12

WASHINGTON — The U.S. Food and Drug Administration has expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include children who have tested positive and who are either hospitalized or at high risk from the disease.

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On Monday, the FDA said that pediatric patients 28 days and older weighing at least 7 pounds and having COVID-19 can receive the treatment under certain circumstances.

Veklury, administered via injection, is the first approved COVID-19 treatment for children under 12 years of age.

California-based Gilead Sciences Inc. makes the drug which works by inhibiting a substance the virus uses to make copies of itself, according to the Associated Press.

Previously, Veklury was only approved for children 12 under an emergency use authorization.

“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.”

Veklury was first fully approved by the FDA for people over 11 years old in 2020, according to The Associated Press. President Donald Trump notably received the treatment after he tested positive for COVID-19.

The FDA said that Veklury is not a substitute for vaccination. The label also warns against using it with the malaria drug hydroxychloroquine because that can curb its effectiveness.

The Associated Press contributed to this story.

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