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, especially given that kids under 5 are still ineligible for a Covid vaccine. However, it doesn’t replace the need for a pediatric vaccine, experts say.
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.
But kids under 5 still aren't able to get vaccinated, leaving them relatively unprotected from severe disease.
“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.
In late March, Moderna asked the FDA to authorize its 2-dose pediatric Covid vaccine for kids ages 6 months to 6 years, but the data is still under review and the agency has not yet granted authorization. Pfizer announced in mid-April that it plans to ask the FDA to authorize a third dose for kids ages 5 to 11, but its current pediatric vaccine for kids under age 5 is still on hold after it asked the FDA to pause its data review in February.