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The U.S. Food and Drug Administration Monday rescinded its authorization for Covid-19 monoclonal antibody treatments made by Regeneron Pharmaceuticals and Eli Lilly after those treatments proved ineffective against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 ...
They’re literally killing us
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...
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.
Must be hurting profits on the so-called vaccines.
Yes, must scare/force everyone to get them..
Bingo.
A young man I know was saved (early on in Covid) was saved by that treatment.
The ONLY reason the rescinded this is because the administration hasn’t made sure we have it on hand, this administration has re-routed Covid funds to illegal immigrants housing, food,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!!
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.
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.
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!!
This is just the beginning.
Saves them a lotta money from paying social security?
More to send to ukraine
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.
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. ;-)
*I personally consider Delta as a 2-stage disease in SOME people.
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.
Fauci recommended these therapies in August.
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.
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