The Food and Drug Administration on Monday fully approved the Covid-19 antiviral remdesivir for children 28 days of age and older and weighing 6.6 pounds or more, in a bid to protect children too young for vaccination from the omicron variant, which has caused a spike in pediatric hospitalizations.
Remdesivir, marketed under the brand name Veklury by Gilead Sciences, is the first FDA-approved Covid-19 treatment for children under 12.
Though other Covid-19 treatments, such as Eli Lilly’s monoclonal antibody therapy, have received an FDA emergency use authorization for children under 12—based on a risk-benefit analysis and lasting only as long as the current public health emergency—remdesivir is the only treatment to receive full-fledged FDA approval.
Clinical trials on Covid-19 patients as young as 28 days of age showed remdesivir had similar effects on young children as on adults, the FDA said.
Though remdesivir has been shown to reduce the risk of death among hospitalized Covid-19 patients, it does not serve as a vaccine substitute for patients who can’t safely receive vaccines, the FDA said.
While increased levels of liver enzymes—a symptom of liver injury—is a common remdesivir side effect for patients without Covid-19, patients with the disease are more likely to experience relatively mild side effects like nausea.
Before Monday, remdesivir was only approved for people ages 12 and over.
In October 2020, remdesivir became one of the first treatments approved for use on hospitalized Covid-19 patients. However, subsequent studies produced conflicting results on remdesivir’s usefulness, and the World Health Organization quickly issued a conditional recommendation against using the drug, noting “there is currently no evidence remdesivir improves survival and other outcomes” for hospitalized Covid-19 patients.Subsequent research supported remdesivir’s efficacy, with one study published by the New England Journal of Medicine finding patients who took remdesivir recovered about 33% faster than patients taking a placebo. In 2021, researchers detected a remdesivir-resistant strain of the coronavirus in a patient who had previously received the drug, indicating the virus might grow immune to such treatments over time. Expanding access to Covid-19 treatments for people under 5, who are still too young to be vaccinated in the United States, has taken on new urgency since the emergence of the omicron variant. Though omicron is generally less severe than other variants, it has caused a fourfold increase in Covid-19 hospitalizations among children.
Remdesivir is given intravenously in a once-per-day session lasting between 30 minutes and two hours.
“The Challenges of Treating Covid-19: Lessons from Gilead’s Remdesivir” (Forbes)