FDA Expands Emergency Use Authorization of Remdesivir to Pediatric Patients Under 12 Years of Age

The U.S. Food and Drug Administration expanded the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease.

The previous guidelines limited the use of remdesivir to hospitalized adults and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds).

Today we took two actions to expand the use of remdesivir to certain non-hospitalized adults & pediatric patients for the treatment of mild-to-moderate #COVID19 in places such as skilled nursing facilities, home healthcare settings & outpatient facilities. https://t.co/wXUHVxWRVl pic.twitter.com/yF2AKO6Hon

— U.S. FDA (@US_FDA) January 21, 2022

The FDA has approved remdesivir for the treatment of patients with COVID-19 who are not hospitalized but who have high risk for disease progression, and has expanded the EUA for pediatric patients.

Learn more: https://t.co/QagPh4k84k pic.twitter.com/VEzDTjfrYp

— Pharmacy Times (@Pharmacy_Times) January 25, 2022

Per the FDA Press Release on January 21, 2022:

“On the heels of the FDA’s recent authorization of two oral antiviral drugs, today’s actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s actions provide adults and pediatric patients, with mild-to-moderate COVID-19 who are at high risk of severe COVID-19, with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers.” 

cont.

The FDA has expanded the approved indication for Veklury to include its use in adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

The agency also revised the Emergency Use Authorization (EUA) for Veklury to additionally authorize the drug for treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization of death.

Based on today’s actions, these high-risk non-hospitalized patients may receive Veklury via intravenous infusion for a total of three days for the treatment of mild-to-moderate COVID-19 disease.

Remdesivir is a toxic drug responsible for catastrophic side effects like multi-organ dysfunction syndrome and kidney failure.

The antiviral drug manufactured by Gilead Sciences has remained the standard treatment for COVID-19 hospitalized patients. 

Dr. Bryan Ardis explained several months ago how hospital protocols that utilize remdesivir killed COVID-19 patients. 

https://twitter.com/2Genervter/status/1486091831154819078

Remdesivir- acute renal failure, acute liver failure, doesn't shorten Covid infection.
mAb's save lives. https://t.co/6Rugx65mzd pic.twitter.com/1D7xA4pX6p

— DrKathrynPhD- typer of typos (@KathMLee1) January 25, 2022

The WHO does NOT recommend remdesivir for the treatment of COVID-19.

Per the WHO’s statement released on November 20, 2020:

WHO has issued a conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity, as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.

Yet, the FDA has expanded the use of remdesivir to little children.

Here's the FDA EUA- Remdesivir for children 🚫🚫🚫https://t.co/bcaDiMNkRe https://t.co/JomLZ2bIih pic.twitter.com/ceTwAOq7VD

— DrKathrynPhD- typer of typos (@KathMLee1) January 25, 2022

Dr. Paul Marik explained the detrimental impact of remdesivir for COVID-19 patients in this clip from Senator Ron Johnson’s COVID-19 ‘Second Opinion’ Panel.

Dr. Paul Marik on the use of Remdesivir in our hospitals

“The federal government is incentivizing hospitals to prescribe a medication which is toxic” 🚨 @PaulMarik pic.twitter.com/i6Pg9tHCIu

— Chief Nerd (@TheChiefNerd) January 24, 2022

That’s the drug the FDA wants to give young kids for an illness that’s statistically zero risk to them.

Read the full fact sheet for the Emergency Use Authorization (EUA) of remdesivir on this FDA document.