Children under the age of 12 now have a Covid-19 drug after the US Food and Drug Administration (FDA) approved remdesivir for use.
It will be the first treatment option for children to be reviewed authorization for emergency use is revoked and full authorization has been granted.
This is despite the World Health Organization discouraging its use in 2020, when Covid-19 was at its peak.
< p>The drug has now received FDA approval and is being marketed as Veklury. It is given as an injection.
The FDA said the youngest recipients of the drug to test positive for Covid-19 should be 28-day-old infants weighing at least three kilograms.In an FDA press release, Patrizia Cavazzoni, executive director of the FDA’s Center for Drug Evaluation and Research, said the approval was a commitment to include children, as they too have been severely affected by Covid-19.
“Because Covid-19 can cause serious illness in children, some of whom currently have no vaccination option, there remains a need for safe and effective treatment options for Covid-19 for this population.” she said.
Children on pediatric wards have been given the drug to show its effectiveness, but the FDA also announced that the efficacy of the results was backed up by phase three clinical trials conducted in adults. was supported.
Researchers at Gilead Sciences also conducted clinical trials in children and the approval is only based on this in the second phase of the trials.
“Patients in of this pediatric phase 2/3 study received Veklury for up to 10 days. The safety and pharmacokinetics (activity of drugs in the body over a period of time) results from the Phase 2/3 study in pediatric subjects were similar to those in adults,” the FDA said in a statement.
However, the agency notes that the drug is not an alternative to a vaccine for the recommended populations.
The drug also has possible side effects.
They are; increased levels of liver enzymes which may be a sign of liver damage; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen levels, fever, shortness of breath, wheezing, swelling (lips, around eyes, under the skin), skin rash, nausea, sweating and tremors.
The World Health Organization “strongly” recommended baricitinib for patients with severe Covid-19 earlier this year. The drug is administered orally and is currently used to treat rheumatoid arthritis.
Other drugs highly recommended by the WHO include: nirmatrelvir and ritonavir.