The FDA announced Monday that they have expanded approval of Remdesivir to treat COVID-19 positive patients to include pediatric patients 28 days old and older and weighing at least around 7 pounds.
This made Remdesivir the first approved treatment for children less than 12 years of age. It had already been used to treat some younger patients under an emergency use authorization.
“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, M.D., director of the FDA’s Center for Drug Evaluation and Research in a news release. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
Remdesivir is used to treat COVID-19 positive patients who are:
- Hospitalized
- Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Dr. James Wood, Infectious Disease Specialist at Riley Children’s Health, says the hospital has been using Remdesivir for awhile now and have monitored its safety.
"Especially for the younger kids who aren't able to be vaccinated, this does give us an option for treatment and it's really kind of preventing them from getting severe illness. That's where we really know that it works the best," Dr. Wood said.
As of Tuesday, IU Health says it has 35 COVID-19 patients across the state with three of those being at Riley. Dr. Wood says the best protection against COVID-19 for kids is to get the vaccine if they are eligible.
"I do want to stress that for those who are vaccine eligible, this is not a substitute. Just because this has been approved now, I still very much promote and will say that the vaccine is much more effective than any medicine in terms of building up that immunity and preventing you from either getting infection or preventing you from going on to severe illness," Dr. Wood said.
The COVID-19 vaccine has not yet been approved for kids under the age of 5. Pfizer is seeking an emergency use authorization for its COVID-19 booster shot for children ages 5 to 11.
WXYZ in Detroit, Michigan contributed to this report.
