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

Child receives treatment for COVID-19 infection

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Key Takeaways

  • Children under age 12 can now receive Veklury (remdesivir) if they are hospitalized with COVID-19 or are at risk for severe illness.
  • Previously, the drug was only available to certain adults and children ages 12 and over.
  • The FDA decision has been welcomed by doctors, who now have another option to offer pediatric patients with COVID-19.

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 FDA action means Veklury is now approved to treat pediatric patients who are:

  • 28 days of age and older
  • Weigh at least 3 kilograms (about 7 pounds)
  • Have positive results of direct SARS-CoV-2 viral testing
  • Are either hospitalized or have mild-to-moderate COVID-19
  • Are at high risk for progression to severe COVID-19, including hospitalization or death

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.”

Kelly Fradin, MD, FAAP

I'm very excited to have another option to offer high-risk children, especially those who cannot be vaccinated.

— Kelly Fradin, MD, FAAP

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.

What This Means For You

In the United States, everyone age 6 months and older can get vaccinated against COVID-19. Research shows the vaccine protects kids against serious illness from COVID-19, and the CDC and the American Academy of Pediatrics (AAP) recommend that all eligible kids get vaccinated as soon as they can.

Generally, COVID-19 seems to produce less severe symptoms in kids than adults, but children with compromised immune systems or underlying health conditions have a higher risk of severe symptoms than their peers.

If your child develops severe COVID-19 symptoms, seek medical attention immediately.

2 Sources
Verywell Family uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. U.S. Food & Drug Administration. Coronavirus (COVID-19) update: FDA approves first COVID-19 treatment for young children.

  2. Gottlieb RL, et al. Early remdesivir to prevent progression to severe Covid-19 in outpatients. New Engl J Med. 2022;386:305-315. doi:10.1056/NEJMoa2116846

By Claire Gillespie
Claire Gillespie is a freelance writer specializing in mental health. She’s written for The Washington Post, Vice, Health, Women’s Health, SELF, The Huffington Post, and many more. Claire is passionate about raising awareness for mental health issues and helping people experiencing them not feel so alone.