FDA approves first drug to treat COVID-19 for children

Accordingly, the drug is used for pediatric patients 28 days old or older, weighing at least 3 kg, hospitalized with COVID-19 or mild to moderate COVID-19 disease, but at high risk of progressing to COVID-19 severe, including hospitalization or death.

As such, veklury becomes the first COVID-19 treatment approved for children under 12 years of age. Previously, veklury was only approved to treat certain adult and pediatric patients (age 12 and older weighing at least 40kg) with COVID-19.

FDA approves COVID-19 drug for young children.

Because COVID-19 can cause severe illness in children, some children currently do not have an option to get vaccinated. Therefore, safe and effective COVID-19 treatment options are urgently needed, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said.

However, experts recommend that veklury is not a substitute for vaccination in people for whom the COVID-19 vaccine and booster doses are recommended. The FDA recommends that the public get vaccinated and get a booster shot when eligible.

Given the similar pattern of COVID-19 disease in adults and children, approval of veklury in children is thought to be effective.

This approval was also supported by a clinical trial in pediatric patients at least 28 days old and weighing at least 3 kg with confirmed SARS-CoV-2 infection with mild, moderate, or severe illness. The safety and pharmacokinetic results in pediatric subjects were similar to those in adults.

The only approved dosage form is veklury for injection.

Possible side effects of using veklury include elevated liver enzymes (which can be a sign of liver damage), allergic reactions, changes in blood pressure and heart rate, low blood oxygen levels, fever , difficulty breathing, wheezing, rash, nausea, sweating or chills…