https://uncoverdc.com/2022/04/27/the-fd ... -children/
The U.S. Food and Drug Administration (FDA) announced on Monday the approval of Veklury (remdesivir) to treat infants 28 days and older weighing at least 7 pounds with positive results of SARS-CoV-2 viral testing and are either hospitalized or have mild to moderate COVID-19 and are at high risk for progression to severe COVID-19.
Prior to the approval of Veklury for infants and children, the drug was only approved to treat “certain adults” and pediatric patients 12 years of age and older who weigh at least 88 pounds. Yesterday’s action, which revoked the emergency use authorization (EUA) that previously covered this pediatric population, makes the drug the first approved COVID-19 treatment for children younger than twelve.
In a news release, the FDA explained that part of the rationale behind the approval of Veklury for infants and young children is that there is no alternative “safe and effective treatment,” including the COVID-19 experimental “vaccine,” which is currently not approved for children under five. Patricia Cavazzoni, M.D., director of the agency’s Center for Drug Evaluation and Research, remarked:
“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. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
The FDA quickly pointed out that Veklury, manufactured by Gilead Sciences, Inc., is not a substitute “for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended.” Indeed, the FDA “urges the public to get vaccinated and receive a booster when eligible.”