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FDA Rescinds Authorization For Covid Monoclonal Antibody Treatments By Regeneron, Eli Lilly
Forbes ^ | 01/25/2022 | Zachary Snowdon Smith

Posted on 01/25/2022 9:05:02 PM PST by SeekAndFind

The U.S. Food and Drug Administration Monday rescinded its authorization for Covid-19 monoclonal antibody treatments made by Regeneron Pharmaceuticals and Eli Lilly after those treatments proved ineffective against the omicron variant, over a month after some hospitals voluntarily decided to stop offering the drugs.

Monoclonal antibody treatments can prevent serious illness or hospitalization among high-risk Covid-19 patients by reinforcing the body’s natural immune response. Though Regeneron and Eli Lilly’s treatments worked against previous variants of the virus, omicron’s mutation in a spike protein targeted by the treatments all but eliminated their effectiveness. Over a month prior to the FDA’s Monday announcement, hospitals such as NewYork-Presbyterian Hospital had voluntarily stopped offering the treatments.

Sotrovimab, a monoclonal antibody treatment produced by GlaxoSmithKline and Vir Biotechnology, appears to still work against omicron, the Centers for Disease Control and Prevention said.

However, hospitals in New York, Maine, Texas and other states have struggled to maintain supplies of sotrovimab. In December 2021, the White House announced plans to ship about 300,000 sotrovimab doses to state and territorial health departments in January.

On January 11, GlaxoSmithKline announced that the federal government had agreed to purchase an additional 600,000 doses

(Excerpt) Read more at forbes.com ...


TOPICS: Health/Medicine; Science; Society
KEYWORDS: fda; monoclonals; omicron; regeneron; regeneroncombo; vaccines
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1 posted on 01/25/2022 9:05:02 PM PST by SeekAndFind
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To: SeekAndFind

They’re literally killing us


2 posted on 01/25/2022 9:09:27 PM PST by Guenevere (When the foundations are being destroyed what can the righteous do t)
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To: SeekAndFind

Funny: They use ineffectiveness against Omicron as their rationale, yet the data I had last month showed that a majority of hospitalizations were due to Delta.

Hmmmm...


3 posted on 01/25/2022 9:13:38 PM PST by logi_cal869 (-cynicus the "concern troll" a/o 10/03/2018 /!i!! &@$%&*(@ -)
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To: SeekAndFind

Not surprised, after all, it has saved lives. Since the true goal is not to save lives, this makes perfect sense to anyone who exercises critical thinking.


4 posted on 01/25/2022 9:14:45 PM PST by Robert DeLong
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To: SeekAndFind

Must be hurting profits on the so-called vaccines.


5 posted on 01/25/2022 9:17:29 PM PST by Rurudyne (Standup Philosopher)
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To: Rurudyne

Yes, must scare/force everyone to get them..


6 posted on 01/25/2022 9:20:30 PM PST by pnz1 ("These people have gone stone-cold crazy")
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To: Robert DeLong

Bingo.

A young man I know was saved (early on in Covid) was saved by that treatment.


7 posted on 01/25/2022 9:25:29 PM PST by jdsteel ("A Republic, Madam, if you can keep it." Sorry Ben, looks like we blew it.)
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To: Guenevere

The ONLY reason the rescinded this is because the administration hasn’t made sure we have it on hand, this administration has re-routed Covid funds to illegal immigrants housing, food, clothing, travel ect. BANK ON IT!!


8 posted on 01/25/2022 9:27:28 PM PST by Trump Girl Kit Cat (Yosemite Sam raising hell)
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To: logi_cal869; Grampa Dave; mewzilla
They use ineffectiveness against Omicron as their rationale,

I perused the FDA website and cannot find ANY clinical data or efficacy testing to back-up this "ineffectiveness" claim. However, in the EUA memo for REGEN-COV® the Efficacy was about 70%. For the shots, the FDA's minimum threshold was 50% Efficacy. So let's just assume, for now, REGEN-COV® fell below 50%, and that is grounds for removing the EUA.

Let's visit the shots, and see how THEY do in PREVENTING (prevention was the basis of granting the EUA...not lessened symptoms, or keeping you out of the hospital or ground) Omicron: The 2-dose VE against omicron infection was 30.4% (5.0%-49.0%) at 14-90 days and declined quickly to 15.2% (0.0%-30.7%) at 91-180 days and 0.0% after 180 days.

Now, riddle me this, Batman: how is it that the shots haven't had their EUA revoked despite proven and published "ineffectiveness" against Omicron, but REGEN-COV®'s undocumented "ineffectiveness" gets it yanked?

The riddle is answered by Grampa Dave - none of this is about health.

9 posted on 01/25/2022 9:50:26 PM PST by DoodleBob (Gravity's waiting period is about 9.8 m/s^2)
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To: SeekAndFind
If you are “Porcelain” (#6) or lighter, no sotrovimab for you. Don’t even bother asking.


10 posted on 01/25/2022 10:12:44 PM PST by ProtectOurFreedom (81 million votes...and NOT ONE "Build Back Better" hat)
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To: Guenevere

It is all part of forcing vaccinations. Also the Delta variant may very well be out there so using the excuse the treatment does not work for Omicron variant is bullshit.


11 posted on 01/25/2022 10:58:29 PM PST by lastchance (Credo.)
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To: Robert DeLong

I would call this assisted biological warfare by omission but a government-directed omission. Any cover up of other data that differs from their stance would constitute both a civil and criminal deliberate “malfeasance” and “dereliction of duty”.

Lawyers comment welcomed!!


12 posted on 01/25/2022 11:01:46 PM PST by MadMax, the Grinning Reaper (Figures )
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To: SeekAndFind

This is just the beginning.


13 posted on 01/25/2022 11:17:30 PM PST by immadashell (New Planned Parenthood slogan: Black Babies’ Lives Don't Matter!c)
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To: Guenevere

Saves them a lotta money from paying social security?

More to send to ukraine


14 posted on 01/25/2022 11:38:23 PM PST by thinden
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To: MadMax, the Grinning Reaper

If you read the FDA statement they only revoked two of the mAb Regeneron and Eli Lily there are still 2 more that have EUAs thise two have effectiveness against omicron. In addition the FDA statement also allows the use of the two who lost their EUAs when the variant being treated is confirmed to be one they are effective with under compassionate use or better known as right to try law. Those are decided on a case by case basis. Eli Lily and Regeneron both confirm that their mAb have near zero effectiveness against omicron both have done in vitro testing to confirm that. Bulk use of these two without gene sequencing the variant to prove it’s Delta or lambda or gamma is really all that changed. There is no medical sense in giving mAb that the manufacturers themselves say are ineffective to people with omicron better to use the two mAb that do have effectiveness or antivirals and steroids.


15 posted on 01/26/2022 12:52:37 AM PST by JD_UTDallas ("Veni Vidi Vici" )
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To: JD_UTDallas
In addition the FDA statement also allows the use of the two who lost their EUAs when the variant being treated is confirmed to be one they are effective with under compassionate use or better known as right to try law.

What??!! Are you trying to confuse FReepers with actual, pertinent details?

Ok. /s ;-)

I would add that on another thread it was noted that serious Delta can be diagnosed as a LRT (Lower Respiratory Tract) disease*, going after cell receptors in the lungs, while Omicron is primarily a URT (Upper Respiratory Tract) disease. Among other clinical diagnoses. So, it is NOT as if samples have to be sent out to be sequenced to make the diagnosis.

I wish I had the capability to post a GIF of Star Trek's Mr. Worf telling a half-mad Klingon comrade "You fight the wrong battles." And I wouldn't even shoot any of the half-mad 30 seconds later. ;-)

16 posted on 01/26/2022 2:50:40 AM PST by Paul R. (You know your pullets are dumb if they don't recognize a half Whopper as food!)
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To: Paul R.

*I personally consider Delta as a 2-stage disease in SOME people.


17 posted on 01/26/2022 2:52:16 AM PST by Paul R. (You know your pullets are dumb if they don't recognize a half Whopper as food!)
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To: logi_cal869

Not to mention their not pulling the approval for the vaccines because of their continually declining efficacy percentages. They falsely tout ‘boosters’ as being effective against these variants but they are nothing but full strength vax shots. Nothing different about them.

Would that they only be as ‘diligent’ in monitoring efficacy of the vaccines as they are in running rough shod over other non-vax treatments. AFAIC, organizations like the FDA, NIH, NIAID or CDC shouldn’t be the last authorities precisely because they are complicit in actions I believe are patently criminal.


18 posted on 01/26/2022 2:56:37 AM PST by Gaffer
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To: SeekAndFind

Fauci recommended these therapies in August.


19 posted on 01/26/2022 4:10:46 AM PST by Sacajaweau ( )
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To: SeekAndFind

This is a mass genocide event designed by the DS to murder tens of millions of people to then push us in to a NWO run by the Fascists.


20 posted on 01/26/2022 5:06:52 AM PST by stockpirate (Rebellion to tyranny is obedience to God., Where Justice Ends Tyranny Begins.)
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