The Food and Drug Administration (FDA) has extended the authorisation of remdesivir (Veklury) to children’s patients under the age of 12 years who test positive for SARS-CoV-2 and are hospitalised or at high risk of developing severe COVID-19.
The patient must be at least 28 days old and 3 kilogrammes in weight (about 7 pounds).
Given the comparable course of disease in adult and paediatric patients, the FDA stated the clearance is based on a clinical study of 53 juvenile patients as well as studies in adults.
Through a press release, Patrizia Cavazzoni, the managing director of the FDA’s Centre for Drug Evaluation and Research said that the approval is a commitment to include children since they, too, are hard hit by Covid-19.
“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,” Cavazzoni said.
The medicine was administered to children in paediatric wards to see how effective it was.
Phase three clinical trials in adults were used to support the efficacy of the medicine, according to the FDA.
Clinical trials in children were also undertaken by Gilead Sciences experts, and the approval is based solely on the second phase of the trials.
“Patients in this paediatric phase 2/3 trial received Veklury for up to 10 days.
The safety and Pharmacokinetic (activity of drugs in the body over a certain period) results from the phase 2/3 study in pediatric subjects were similar to those in adults,” said the FDA in the statement.
The authorities did add a disclaimer, stating that the medicine is not a substitute for vaccination in the indicated populations.
There is also the possibility of negative effects with this medication.
Increased levels of liver enzymes, which could indicate liver injury, and allergic reactions, which could include changes in blood pressure and heart rate, low blood oxygen levels, fever, shortness of breath, wheezing, swelling of the lips, around the eyes, and under the skin, rash, nausea, sweating and shivering.