FDA Grants Full Approval of COVID-19 Treatment Remdesivir for Young Children

The U.S. Food and Drug Administration granted full approval of remdesivir to treat COVID pediatric patients, many of whom are not yet eligible for a vaccine

This picture shows a vial of Remdesivir at Movianto premises, as parcels of drugs are being sent to India, in Aalst, on April 30, 2021. - Belgium will help India, where the situation in the ongoing pandemic is very severe, with 9000 doses of the antiviral drug Remdesivir. The pharmaceuticals have to be packed in special cases before they leave on a flight tonight
Photo: DIRK WAEM/Belga/AFP via Getty

The U.S. Food and Drug Administration announced Monday that full approval will be granted to a COVID-19 drug to treat children aged 28 days and older.

Though there are other COVID-19 treatments that have received emergency use authorization for children younger than 12, Veklury by Gilead Sciences, commonly known as remdesivir, is the first to receive full FDA approval.

The FDA said treatment can be used for children who have been hospitalized for COVID or those experiencing mild-to-moderate symptoms who are at high risk for progression to a severe case.

"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," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a news release. "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 FDA warns that remdesivir is not a substitute for a COVID vaccine, which is highly recommended.

In November 2021, Pfizer's COVID-19 vaccine was approved for use in 5 to 11 year olds. Adolescents 12 and up receive the same dose of the Pfizer vaccine as adults, and are booster eligible if it has been five months from their last shot.

Children under five years old remain the only age group not yet approved for the COVID-19 vaccine. Though there was speculation that a two-dose series might be approved in early 2022, Pfizer recently postponed its rolling application to the Food and Drug Administration to expand the use of its two-dose vaccine for children ages six months to four years.

In a press release, company cited the need to wait for data on a three-dose series of the vaccine, stating that their researchers believed that a third dose "may provide a higher level of protection in this age group." Data on the third dose is expected in early April, Pfizer said.

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