Health Advocates Demand FDA Rescind Approval of Remdesivir in Infants

Children’s health advocates are calling on the U.S. Food and Drug Administration to rescind its approval for a high-risk and dangerous drug for young children in the name of combatting COVID-19.

The FDA announced last month that it is approving remdesivir, distributed as Veklury, as an antiviral COVID treatment for infant children at least 28 days old and weighing at least 7 pounds. An infant must be hospitalized with a positive test for COVID or have “mild to moderate” symptoms from COVID while being “high-risk” of illness or death.

The FDA approval came without short- or long-term data the drug is safe or effective for treating young children.

Gilead Sciences developed remdesivir, which has been the subject of studies in adults. A published study found 25 percent of adults in the study had “serious adverse events” as a result of the toxicity of the drug.

The FDA said in a press release that a clinical study supports the approval of the drug for use in infants. That study will not be completed until February 2023. A press release from Gilead Sciences issued the same day as the FDA statement said that the study so far has revealed 72 percent of pediatric patients suffered adverse events from the drug. Additionally, 21 percent suffered adverse effects not related to the drug. Three children in the study died from either COVID or other underlying conditions.

The U.S. Centers for Disease Control and Prevention (CDC) issued a report last month showing that an estimated 75 percent of American children have previous COVID infection.

Children’s Health Defense (CHD) science director Dr. Brian Hooker said that it is shocking that the FDA is “completely ignoring” the fact of natural immunity among so many children to COVID. He added that children with COVID have “virtually zero risk” for serious illness or death. His group urged the FDA to rescind its approval of remdesivir for that age group.

Dr. Madhava Setty wrote in The Defender that the drug has no data to support its use in young children although it does show “no more than a meager benefit” in the adults who have survived its use.