The Defender ~> FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy

The U.S. Food and Drug Administration on Monday approved the use of the antiviral therapy, remdesivir, to treat COVID-19 in infants 4 weeks and older, despite having no evidence the treatment is effective or even safe for young children.

By Madhava Setty, M.D.

FDA Remdesivir infants feature

Miss a day, miss a lot. Subscribe to The Defender’s Top News of the DayIt’s free.

The U.S. Food and Drug Administration (FDA) on Monday approved the use of the antiviral therapy, remdesivir, to treat COVID-19 in infants four weeks and older.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release:

“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.”

According to the press release, the FDA’s decision to approve the therapy, marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds.

The study is underway and will not be completed until February 2023. There are no published results.

However, Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:

  • A total of 53 hospitalized pediatric patients were enrolled in the clinical study.
  • 72% suffered adverse events.
  • 21% suffered serious adverse events determined to be unrelated to the drug.
  • Three children died from either underlying conditions or COVID-19.

1 Million Copies Sold — ‘The Real Anthony Fauci’ — The book that launched a movement. BUY TODAY!

Nevertheless, Gilead Science assured that “no new safety signals were apparent for patients treated with Veklury.”

The study was of single-arm, open-label design.

single-arm study has no control group, making it impossible to compare its effectiveness against standard of care.

CONTINUE

About michael burgwin

A child of the peace and antiWar movements, a Truther with self-diagnosed Opposition Defiance Disorder, formerly politically liberal tho now politically marooned, and Post-Doomer, on any issue, I trend to the conspiracy side, sort through the absurd, fantastical and insane, until I find firm ground usually located just the other side of the censorship firewall of propaganda and orthodoxy, dogma, and other either / or thinking.
This entry was posted in Uncategorized. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s