FDA Approved the First COVID-19 Treatment For Children Under 12

In April 2022, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 treatment for children ages 11 and under. Veklury (remdesivir) was previously approved only to treat certain adults and children ages 12 and over who weigh at least 40 kilograms (around 88 pounds) and have COVID-19. 

The drug had so far only been available to pediatric patients in this age group under a special FDA emergency use authorization (EUA) order. At the same time as granting approval, the agency revoked this EUA. 

“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, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”

About the Treatment

Remdesivir is considered to be very effective at preventing the progression of COVID-19 to a more severe illness and lowering the risk of hospitalization or death when it is administered early in the course of COVID-19 infection.

A landmark paper published in the New England Journal of Medicine showed that if a COVID-19 patient gets Remdesivir in the first five days—the acute viral phase—it’s possible to stop the progression of the illness by 87%. In other words, remdesivir can be a very effective antiviral if the right patient receives it at the right time. 

The only approved dosage form for Veklury is an injection, and possible side effects parents should be aware of include increased levels of liver enzymes (a possible sign of liver injury) and allergic reactions, such as changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling of the lips, around eyes, or under the skin, etc., rash, nausea, sweating, or shivering.

Welcome News for Doctors and Parents

While the new treatment option will only be appropriate for a small subgroup of children (those who are hospitalized with COVID-19 or at very high risk of severe illness), doctors are welcoming the change. 

“I'm very excited to have another option to offer high-risk children, especially those who cannot be vaccinated,” says Kelly Fradin, MD, FAAP, pediatrician and author of "Parenting in a Pandemic: How to Help Your Family Through COVID-19." “I know those parents will sleep easier knowing they have more options, particularly as precautions like masking on airplanes roll back.”

Although the list of conditions elevating the risk of severe illness from COVID-19 is long, Dr. Fradin believes many children won’t qualify for the new treatment. “If you are unsure if your child qualifies, speak to your doctor because it's best to know before illness or exposure occurs so that logistics around accessing the necessary treatment are arranged,” she advises. 

The FDA noted that Veklury is not a substitute for getting a vaccination if your child is eligible. Two COVID-19 vaccines, Pfizer and Moderna, have been fully approved and three are available for emergency use, depending on age. The vaccines are meant to prevent serious clinical outcomes, including hospitalization and death, the FDA said. People should also receive a booster, if eligible, the agency added.

The approval was based on results from a phase 3 clinical trial for adults, the FDA said, noting that the course of the disease is similar in both adult and pediatric patients.