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 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
In an April 26 report, the Centers for Disease Control and Prevention (CDC) estimated that three out of every four children in the U.S. have already had COVID. “It’s shocking that our federal health agencies are completely ignoring the fact that so many children have developed natural immunity to COVID,” said Children’s Health Defense (CHD) chief science director Dr. Brian Hooker. “When they do have COVID, young children are at virtually zero risk for serious complications or death. The FDA should rescind its approval of such a dangerous drug for this age group.”
According to Madhava Setty, MD, writing for The Defender, “Beyond the absence of any publicly available data on the efficacy and safety of this drug in humans of this age, available studies on older subjects indicate remdesivir offers no more than a meager benefit to those who survive its use.” Dr. Setty goes on to explain, “In fact, this is why the World Health Organization (WHO) in November 2020 recommended against the use of remdesivir to treat COVID-19. The WHO only recently (April 22, 2022) updated its recommendation to support the drug’s use in patients who are at high risk for hospitalization.”
“These and other studies demonstrate remdesivir’s dubious safety profile and call into question ever using the drug for infants and children especially when they are not at serious risk of hospitalization or death from COVID,” said Dr. Hooker.
Reprinted with permission from Children’s Health Defense.