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The FDA has now fully approved the use of the antiviral drug Veklury (remdesivir) for use in kids older than 1 month who fall into two specific categories: They’re either hospitalized with severe Covid infection, or have mild or moderate illness but are at risk for severe Covid. 

The antiviral Covid treatment is given via injection and prevents the SARS-CoV-2 virus, the virus causing Covid infection, from replicating. It's the first fully FDA-approved Covid treatment for kids under 12.

This approval provides a much needed safety net for our youngest population. However, it doesn’t replace the need for a pediatric vaccine, experts say, which are now available for kids as young as 6 months.

Not a substitute for vaccination

A recent Morbidity and Mortality Weekly Report (MMWR) report from the Centers for Disease Control and Prevention (CDC) found that of nearly 400 kids between the ages of 5 and 11, 9 out of 10 kids who were hospitalized with Covid during the Omicron wave were unvaccinated. These findings highlight the fact that vaccines are still the best method to protect kids from serious illness.

Related: Got questions about the Covid vaccine for kids under 5? We've got answers

“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,” Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, states in an agency press release on Monday. "Today's approval of the first COVID-19 therapeutic for this population demonstrates the agency's commitment to that need."

The drug was previously authorized for kids 12 and up but was available under emergency use authorization for kids under age 12. Prior to its full approval, Veklury was recently studied in a clinical trial of 50 kids and teens who used the drug for up to 10 days. It is generally given as a three-day course within seven days of symptom onset. Because it is administered via injection, it is usually given in a hospital or other clinical setting.

Potential side effects of using remdesivir include increased liver enzyme levels and allergic reactions, The American Academy of Pediatrics (AAP) reports

The FDA, AAP and CDC still strongly urge vaccination for all who are eligible. “Veklury is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended,” the FDA states. 

Covid treatments for kids are still limited

Other treatments for kids are still hard to come by. Another antiviral drug, Pfizer's Paxlovid, is currently authorized for kids ages 12 and up, and is now undergoing further studies in kids between the ages of 6 and 17. Paxlovid is an oral antiviral that may be taken twice a day for five days to help reduce the risk of hospitalization or death from Covid.

But in June, the CDC approved the use of both Moderna's vaccine for kids ages 6 months to 6 years and Pfizer's vaccine for kids ages 6 months to 5 years. Both vaccines were shown to produce a strong antibody response in younger children that was at least equal to that seen in older kids and adolescents. The vaccines are highly protective against severe disease, hospitalization or death from Covid infection. For more information where to find a vaccine for your child, contact your pediatrician's office.

A version of this story was originally published on April 26, 2022. It has been updated.