Children aged below 12 years now have a Covid-19 drug after the Food and Drug Administration (FDA) of the USA approved Remdesivir for use.
It becomes the first treatment option for children to be checked off the emergency use authorisation and given full authorisation.
This is despite the World Health Organisation recommending against its use in 2020 when Covid-19 was at its peak.
The drug has now received approval by the FDA and it will be marketed as Veklury. It will be administered as an injection.
The FDA announced that the youngest recipients of the drug who have tested positive for Covid-19 should be 28-day old infants who weigh at least three kilogrammes.
In a press release by the FDA, Patrizia Cavazzoni, the managing director of the FDA’s Center 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,” she said.
Children in paediatric wards were given the drug to show its potency, but also, the FDA announced that the efficacy of the results was supported by phase three clinical trials that were conducted in adults.
The researchers from Gilead Sciences also conducted clinical trials in children and the approval is based only on the second phase of the trials.
“Patients in this pediatric 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 a statement.
The authority, however, put a caveat 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 injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling of the (lips, around eyes, under the skin), rash, nausea, sweating and shivering.
The World Health Organisation earlier this year ‘strongly’ recommended baricitinib for patients who have severe Covid-19. The drug is given orally and is currently being used in the treatment of rheumatoid arthritis.
Other drugs that the WHO has strongly recommended include; Nirmatrelvir and ritonavir.
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