The FDA Just Approved Remdesivir for Infants and Young Children

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  • Source: UncoverDC
  • 09/19/2023

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."

Dr. Paul Marik: Remdesivir increases the risk of death!

Remdesivir Approval in Infants Follows WHO Recommendation of Drug

The approval of Veklury in babies and young children follows the Apr. 22, 2022 Gilead announcement of updates to the World Health Organization's (WHO) Therapeutics and COVID-19: living guideline, which now recommends Veklury for use in treating "patients with non-severe COVID-19 at the highest risk of hospitalization."

According to a statement by Gilead, the revised WHO recommendation (denounced by peer-reviewed studies and the World Council for Health) is based on evidence from a Gilead-funded Phase 3 double-blind, placebo-controlled clinical trial (PINETREE) demonstrating that a three-day course of Veklury "significantly reduced the risk of hospitalization for non-hospitalized patients at risk of progression." 

Interestingly, portions of the Study Protocol's declared Jan. 4, 2021 objectives, design, criteria, source data, blinding, assessments, discontinuation criteria, analysis objectives, secondary endpoints, final analysis, and appendix for the clinical trial on Remdesivir had been redacted. Likewise, the Aug. 12, 2021, Statistical Analysis Plan for the clinical trial—which was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants—also had significant redactions throughout its 61 pages. 

In announcing the termination of the clinical trial, revenue-driven Gilead remarked that Veklury remains a standard of care for the treatment of hospitalized adult patients with COVID-19. According to the pharmaceutical company, over half of all hospitalized patients with COVID-19 in the U.S. are treated with Veklury. Still, since Dr. Anthony Fauci initially pushed the drug, many have railed at the drug's $3,120 price tag per treatment course.

FDA's Decision to Approve Remdesivir for Pediatric Care

The FDA maintains its decision to approve Veklury in America's infants and young children is backed by efficacy results in ongoing National Institute of Allergy and Infectious Diseases (NIAID)-sponsored Phase 3 trials on adults. Additionally, the agency references a Gilead-sponsored Phase 2/3 single-arm, open-label clinical study of 53 pediatric patients who received the drug for up to ten days. Although no study results are posted for the clinical trial used to approve Veklury for infants and young kids—the estimated primary completion date is February 2023—the FDA notes that "the safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults." 

The FDA notes that side effects of using Veklury may include "increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering."

Ongoing Concerns About Remdesivir

First and foremost, as reported by TrialSiteNews, the regulatory processes promoting the authorization of remdesivir for treating COVID-19 have been questioned by numerous experts for two years. During the initial NIAID-led studies (ACTT-1) at the beginning of the pandemic, the primary endpoint (reduce deaths) was changed toward the end of the study when they did not meet their endpoint. Instead, the drug decreased the period of hospitalization to a few days. That endpoint was used as the justification for the initial EUA and then formal approval by the FDA without an advisory meeting.

Eric Topol, a prominent cardiologist at the Scripps Research Translational Institute and outspoken supporter of COVID-19 "vaccines", objected to the approval of Remdesivir by the FDA. Referring to the European Union's authorization of the drug just one week before negative findings by the WHO Solidarity findings, Topol commented, "This is a very, very bad look for the FDA, and the dealings between Gilead and EU make it another layer of badness." 

Equally revealing, on July 15, 2021, in an "Original Investigation" titled "Association of Remdesivir Treatment with Survival and Length of Hospital Stay Among U.S. Veterans Hospitalized with COVID-19," a JAMA study found that "routine use of remdesivir may be associated with increased use of hospital beds but not with improvements in survival."

Gilead is Making Billions Off Questionable COVID Treatments

Reaping huge COVID-19 profits similar to big pharma giants Pfizer and Moderna, Gilead Sciences reported an astounding $27.3 billion in year-end revenue for 2021, anchored by sales of its drug Veklury (Remdesivir). On Feb. 1, the drugmaker released its fourth quarter and 2021 financial results, reporting $1.4 billion in sales for Veklury in the fourth quarter of 2021, a decrease of about 30 percent from the same quarter in 2020. However, full-year revenue for Veklury hit $5.6 billion in 2021, a 98 percent jump from 2020 revenue. 

According to Gilead, Veklury "sales closely align with COVID-19 hospitalization trends in the U.S." The drugmaker, which is working on a Veklury inhaler, said it expects hospitalization rates to fall in 2022 but is still projecting $2 billion in Veklury sales this year.

Remdesivir: Toxic Drug That Kills People, Dr. Paul Marik

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