FDA Gives 1st Full Approval to COVID-19 Treatment for Children
By Jack Phillips
April 25, 2022 Updated: April 25, 2022
https://www.theepochtimes.com/fda-gives-...aign=digitalsub


The U.S. Food and Drug Administration (FDA) on April 25 expanded approval of the first COVID-19 treatment for very young children.

The agency “took two actions” to expand the use of Veklury, or remdesivir, to include pediatric patients who are 28 days and older, weigh at least 7 pounds, and have tested positive for COVID-19. The FDA approval is applicable to children who are hospitalized or have mild-to-moderate COVID-19 symptoms and are also at high risk of severe COVID-19.

It means Veklury is the first fully approved COVID-19 treatment for pediatric patients who are under the age of 12.

Before the decision, Veklury, made by Gilead Sciences, was only fully approved to treat certain adults and patients aged 12 and older who weigh at least 88 pounds with COVID-19, the agency said. The move also comes months after the FDA expanded the drug’s emergency use authorization to include children below 12 years of age weighing at least 7 pounds.

“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,” said Patrizia Cavazzoni, who heads the FDA’s Center for Drug Evaluation and Research. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”

The agency wrote that expanding Veklury’s usage for certain pediatric patients was backed by several “phase 3 clinical trials in adults.” It also cited a clinical study of 53 pediatric patients who are at least 28 days old and weigh at least 7 pounds, or 3 kilograms, “with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19,” according to the FDA.

“Patients in this pediatric phase 2/3 trial received Veklury for up to 10 days. The safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults,” it said.

Potential remdesivir side effects include increased liver enzyme levels, which may be a sign of hepatotoxicity—or liver injury, as well as various allergic reactions such as blood pressure changes, low blood oxygen levels, shortness of breath, fever, swelling, sweating, shivering, or nausea.-- excerpt, rest at link above --

Twitter vs Remdesivir
How (the news of) Elon Musk's Twitter acquisition quashed the chilling news of the FDA's approval of remdesivir for young children

Karen Hunt aka KH Mezek | 4/27/2022

https://khmezek.substack.com/p/twitter-vs-remdesivir-12b?s=r


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That deal that the FDA signed with Europe was worth a cool $1 billion. Two weeks after the deal was inked, on October 22, 2020, the FDA approved remdesivir, the first drug to receive that status.

The decision to go with remdesivir baffled scientists since studies had shown no worth for the drug in combatting COVID.

Nine members of the FDA Panel tasked with determining acceptable COVID-19 treatments disclosed financial ties to Gilead. At least 7 other members failed to disclose their financial ties to Gilead while a number of other panel members appeared to have links to Gilead that required no disclosure.

Together, Gilead-linked individuals made up a majority of the panel that decided to approve remdesivir.

It also should be noted that the price tag for remdesivir is $5000, or $3,120 with private insurance, versus approximately $37 for say, Hydroxychloroquine, or even less for Ivermectin. It should therefore be no surprise which drug the corrupt FDA chose to approve while discrediting the others.

Remdesivir isn’t a pill. It isn’t easy to take. It has to be injected and monitored in a clinical setting.

As for side effects, the NIH website says that Remdesivir can cause gastrointestinal symptoms (e.g., nausea), elevated transaminase levels (causing inflammation of the liver), an increase in prothrombin time without a change in the international normalized ratio, and hypersensitivity reactions.

In plain English, over and over we see this warning: liver failure. Study after study sounded alarms as noted in Forbes article The Strange Story of Remdesivir, the Drug that doesn't work.

A September 2021 Lifesite article said, “the high mortality rate and frequency of adverse effects associated with Remdesivir 'begs the question … Why is this the protocol in American hospitals?'“

A lot happened in October of 2020 leading up to remdesivir’s approval by the FDA. For those of you who don’t remember, the best sales pitch for remdesivir came at the beginning of that month when President Donald Trump announced he had contracted COVID-19 and was admitted to Walter Reed National Military Medical Center in Bethesda, Maryland.

On October 3rd, 2020, it was announced that Trump was receiving an experimental antiviral for Covid-19 called remdesivir as “part of a double-barreled treatment plan that includes an antibody cocktail meant to give the president's immune system a boost to fight off the coronavirus.”

We all held our breath as Trump fought off the virus and made a miraculous recovery. I, for one, will never forget that inspiring moment when he returned from hospital, stood on the balcony of the White House and defiantly tore off his mask.


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Quote: Isailedaway wrote in post #3

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My question is whether this is still an emergency approval or actually full approval of a vaccine

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