The U.S. Food and Drug Administration approved the use of the COVID-19 treatment remdesivir for children under age 12 this week, the first COVID treatment the agency has approved for pediatric patients.
The medication, which has the brand name Veklury and is developed by Gilead Sciences Inc., will now be available to children at least 28 days old and weighing at least roughly 7 pounds who are hospitalized with COVID or have tested positive and are at high risk of developing severe illness.
Prior to the FDA approving the medication for young children on Thursday, remdesivir had been approved for people ages 12 and older who had tested positive for the virus.
As a result of the FDA’s approval, remdesivir is now fully authorized for all age groups and the agency has rescinded its emergency use authorization for the medication.
“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,” FDA Center for Drug Evaluation and Research Director Dr. Patrizia Cavazzoni said in a statement.
Federal health officials noted that remdesivir is not a substitute for vaccination, and urged everyone aged 5 and up to complete their initial vaccination series as soon as they can.
They said it wasn’t approved or available when Trump said it works…
You’re talking about Ivermectin and Hydroxychloroquine.
Remdesivir is what the are killing people in hospitals with.
That’s it. The FDA is permanently on my Quack list. Along with Fauci and the CDC.
Remdesivir is straight up poison. No benefits, all downside. Look it up.
The only reason to prescribe Remdesivir is if you’re a doctor who needs a kitchen remodel and you really, REALLY hate your patients.
Time for kidney disease.
So, when do they approve Pfizermectin? 😉
Poison for the kiddos. Lovely.
Glad to see the FDA recognizing the need and fact.
You know what they say…
“With remdesivir, death is near”
So libbbbbbberal
The FDA has approved this (name changed to Veklury) with only 53 pediatric participants; data was from phase 3 trials on adults–see FDA news release:
‘Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. Information on the trials in adults can be found in the FDA-approved drug labeling for Veklury. This approval is also supported by a phase 2/3, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kilograms (about 7 pounds) with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19. 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.
The only approved dosage form is Veklury for injection.”
RemDEATHsavir. Good luck with that. The information is out there on what works.
Only 20 percent that take this failed fauci Ebola drug survive , it’s banned in many countries because it kills you! Our fda is a joke!!!! And bought and paid for by big pharma,
I now do the opposite of what the FDA recommends.
Wow. How many of these comments are from people who told/directed others to “follow the science” until now? That is, until politics and bias gets in the way?