May 4, 2022

In The News: FDA Approves Remdesivir to Treat Young Children with COVID-19

CNN reports on the FDA announcement concerning the COVID-19 drug remdesivir and its expanded approval to children younger than 12. Sold under the name Veklury, the drug had been approved for adults and adolescents who weigh at least 88 pounds. Last week’s decision expands the pool of patients eligible for the injection to children as young as 28 days and weighing seven pounds.

It will be the first COVID-19 treatment approved for children in this age group, which is the only group (under five) that remains without an authorized vaccine option. To be eligible, children must be hospitalized or have moderate COVID-19 with a high risk for progressing to severe, even if not hospitalized.

COVID-19 can cause severe illness in children, though it has been less prevalent than in adults. The number of cases in children has seen a sharp increase during the Omicron variant wave. And while Moderna and Pfizer-BioNTech seek emergency authorization for their vaccines in the youngest age group, that decision likely will not occur until next month. That only intensifies the need for safe and effective COVID therapeutics for children.

Remdesivir has been demonstrated to be successful in preventing the progression of COVID-19 to severe illness and lowering the risk of hospitalization when administered early in the infection. The drug could prove to be a difference maker for child health during the battle with COVID. With vaccines and many treatment options accessible to adults and older children, the FDA’s approval has been welcomed by pediatric doctors and the agency.

Commenting on the decision, PIDS member Mari Nakamura said, “Approval of remdesivir for patients under 12 years of age is a welcome development, one that is hopefully just the first of more to come for pediatric patients. It removes barriers to use for children who have severe COVID-19 or are at high risk of disease progression. FDA approval also provides reassurance to families and clinicians about the safety of this medication. This decision underscores the importance of studies to confirm safety and efficacy and optimize dosing of therapies in the pediatric population.”

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