Mon May 2, 2022 – 5:15 pm EDT
WASHINGTON, D.C. (Children’s Health Defense) – The U.S. Food and Drug Administration (FDA) announced on April 25 its approval of remdesivir (Veklury), an antiviral treatment for COVID in infants 28 days and older who weigh at least 7 pounds and are either hospitalized with a positive COVID test or have mild to moderate COVID and are at “high risk” for progression to severe disease or death. The approval came despite a lack of short- and long-term data to support that remdesivir is effective or safe for young children.
Remdesivir, developed by Gilead Sciences, is known to be highly toxic in adults. A study published in the New England Journal of Medicine found “serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%).”
According to an FDA press release, its decision to approve the therapy is supported by a clinical study conducted on infants four weeks and older weighing a minimum of 6.6 pounds. However, the study won’t be completed until February 2023. Gilead Sciences issued its own press release the same day regarding the study and provided the following details on what the study has found so far:
A total of 53 hospitalized pediatric patients were
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