Published: 28.4.2022 15:34
The U.S. Food and Drug Administration on Monday approved the use of the antiviral therapy, remdesivir, to treat COVID-19 in infants 4 weeks and older, despite having no evidence the treatment is effective or even safe for young children.
According to the press release, the FDA’s decision to approve the therapy, marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds.
The study is underway and will not be completed until February 2023. There are no published results.
However, Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:
A total of 53 hospitalized pediatric patients were enrolled in the clinical study.
72% suffered adverse events.
21% suffered serious adverse events determined to be unrelated to the drug.
Three children died from either underlying conditions or COVID-19.