The US Food and Medication Administration stated on Monday that the Covid-19 drug remdesivir has been approved to treat patients as young as 28 days old and weighing around 7 pounds.
This is the first time that Covid-19 has been approved for children under the age of 12.
The FDA stated that children must be hospitalised or have mild to moderate Covid-19 with a high risk of advancing to severe Covid-19, even if they are not hospitalised, to be eligible for treatment.
The medicine, marketed as Veklury by Gilead Sciences, was approved to treat certain adults and patients aged 12 and up who weighed at least 88 pounds. It is administered as an injection.
In a news release, Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said, “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.” “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
In the United States, the Covid-19 vaccination is not approved for children under the age of five.
Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in Columbia University’s Department of Biochemistry and Molecular Biophysics, called the FDA’s clearance of remdesivir for young children “great.”
When taken early in the course of Covid-19 infection, Griffin described remdesivir as a “very effective antiviral” for reducing the advancement of Covid-19 to a more severe illness, minimising the chance of hospitalisation or death.
“More recently, the results have come out — it was a really landmark paper published in the New England Journal of Medicine — showing that if you give remdesivir in the first five days, during the acute viral phase, before you wait for the door to close, you could prevent progression by almost 90%. It was 87% in that study. So remdesivir actually can be a very effective antiviral if you give it at the right time in the right patient ” Griffin stated this on Monday.
“If we can extend this down to children and actually give it to them during the critical time when it can make the biggest difference, finally, we’re really opening up more options, because these kids don’t have a lot of options,” he added. “They don’t have access to some of the other therapies that are restricted to that over-12 age group,” she says.