Action Alert: Join Children’s Health Defense in Demanding that the FDA Withdraw its Approval of Remdesivir for Children

May 26, 2022

The Food and Drug Administration (FDA) announced on April 25 that it expanded approval of the toxic antiviral drug, remdesivir (also known as Veklury), to treat children as young as four weeks old who are either hospitalized with COVID or are considered to be at high risk for progressing to severe COVID. It is unclear whether regulatory authorities, who have expressed repeated concerns about the vulnerability of children under five who cannot yet be vaccinated, might consider those children “high risk.”

While those who stand to profit from remdesivir sales claim that the drug can potentially reduce disease progression and help children recover more quickly, remdesivir is known to be highly toxic. Critical care specialist Dr. Paul Marik calls it a “particularly useless drug” and notes that it actually increases the risk of death by 3% and increases the risk of acute kidney failure by 20%. Presumably, disease progression has already occurred if a child is being hospitalized for COVID so the advisability of adding a dangerous, ineffective drug into the mix is highly questionable. Since children are at virtually zero risk of death or serious complications from COVID, giving them remdesivir defies logic.

TAKE ACTION NOW

The World Health Organization (WHO) initially recommended against the use of remdesivir, even after the FDA approved it in October 2020, due to conflicting results in the drug’s efficacy. While the WHO has since approved the drug’s use in outpatients, there is little if any evidence to show that the drug improves survival outcomes. On the contrary, remdesivir regularly causes elevated liver enzymes and is linked to lethal side effects including multiple organ failure, septic shock and hypotension. In an NIAID-sponsored study of drugs to treat Ebola, 54% of the remdesivir group died, and the drug was dropped from the trial.

The World Council for Health recommends against its use in people suffering from COVID.

The FDA based its approval in part on results from a phase 3 clinical trial for adults, claiming that the course of the disease is similar in adults and children. But research has repeatedly demonstrated that children have a much more robust innate immune response to COVID. Given this, remdesivir likely poses far greater risks than any potential benefits.

From the press release issued by Gilead, we learned the approval was based on an open-label, single-arm trial in 53 hospitalized children, of whom: three died (6%) from either underlying conditions or COVID; 72% suffered adverse events; and 21% had serious adverse events determined to be unrelated to the drug.

All available evidence points to the certainty that some children will die as a result of treatment with remdesivir. These deaths may well be used by vaccine makers and compromised health officials to bolster the push to get the COVID vaccine on the schedule for infants and children under five years of age. The Centers for Disease Control and Prevention estimates that, as of February 2022, 75% of U.S. children have already been infected with SARs-CoV-2 and likely have the most lasting and durable immunity available which should take both remdesivir and COVID vaccines off the table for this age group.

Our children deserve better. Remind the FDA that #ParentsAreWatching and let members know that they need to #FollowTheScience and stop treating our children like guinea pigs for Big Pharma.

Please fill out this quick form to demand the FDA withdraw their approval of remdesivir for children.

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