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Bye bye monoclonal antibodies. . .

R

Ralph Sir Edward

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Now, according to the article, that the Omicron variant comprises of 99% of the cases it makes sense to stop this treatment. If you want to understand why, watch this video:


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Why can't patients on the advice of their doctors choose the treatment methods they see as the best fit? Are we all the same? Fat, fit, old, young?

Not all of the monoclonal treatments are verboten. But here is part the CDC wants you to know: "While it’s critical that we have ways to treat those who contract COVID-19, the authorized treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended."

What a joke.
 
I've been watching medcram since March 2020. Not all COVIDs are Omicron nor is there any guarantee that any future variant will be resistant to monoclonal antibodies. How will we know if that becomes the case, without any initial treatments to suggest a trial? (And no initial treatments can be done without a drug to test with.)

Something to think about.
 
In the FDA paper:

"This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant.

I was looking for a footnote that would list all of the documented "which can be potentially serious" reactions. But the FDA provided none.
 
Here's my little bitty experience and skepticism about them.

* 88 year old mother, asymptomatic, vaxed and boosted, doctor requested immediately she have the monoclonal antibodies. She got them on day 7. And it was the GSK one that is supposed to work against omicron. Mother (continued) to recover splendidly. Is that a monoclonal antibody success story?
* 50 something year old sister-in-law, copd, on oxygen, terrible health, not vaccinated. Wasn't able to get monoclonal antibodies (likely because she didn't jump through the necessary hoops, I did provide info on best chances/steps for getting them). Recovered splendidly. Would have been a great success story for monoclonal antibodies, had she gotten them.

How do we know? I have no clue what these costs. With my Mom, I wasn't a fan (but not her health care proxy). I got to a point I researched to make sure I felt comfortable they wouldn't hurt her (it doesn't take much to put her off balance). And then let it go (if my sister wanted to spend her day that way, so be it).
 
Ralph Sir Edward said:
The FDA revoked the EUA for monoclonal antibodies last night. . .

Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

The FDA revised the authorizations for two monoclonal antibody treatments to limit their use due to the omicron variant.
www.fda.gov

(Unless this was some sort of hack. . .)
Click to expand...

To be clear - they revoked only those MAB treatments that have not shown any efficacy against omicron given 99% of the COVID infections are omicron now. The MAB treatment from GSK is still approved under EUA because it has shown efficacy against omicron.
 
Old Hickory said:
Why can't patients on the advice of their doctors choose the treatment methods they see as the best fit? Are we all the same? Fat, fit, old, young?

Not all of the monoclonal treatments are verboten. But here is part the CDC wants you to know: "While it’s critical that we have ways to treat those who contract COVID-19, the authorized treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended."

What a joke.
Click to expand...

You can - provided those treatments are FDA approved. The same rules do not apply for EUA treatments that have not completed RCTs, and for good reason. This is no different than treatment protocols in clinical trial stages that have explicit requirements for qualification to be included in the trial.
 
Old Hickory said:
In the FDA paper:

"This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant.

I was looking for a footnote that would list all of the documented "which can be potentially serious" reactions. But the FDA provided none.
Click to expand...

A list of side effects: https://www.drugs.com/mtm/sotrovimab.html#side-effects

It should be noted that any EUA treatment does not yet have a full list of potential side effects given the long term RCTs that are required for FDA approval have not yet been completed.
 
Does anyone else find it particularly ironic that many of those that were anti-covid-vaxxers due to the vaccines being "experimental drugs" and only had EUA from the FDA were also strong supporters of monoclonal antibody treatments (that are "experimental drugs" and only have EUA from the FDA)?

Things than make you go hmmm...

Kurt
 
PigsDad said:
Does anyone else find it particularly ironic that many of those that were anti-covid-vaxxers due to the vaccines being "experimental drugs" and only had EUA from the FDA were also strong supporters of monoclonal antibody treatments (that are "experimental drugs" and only have EUA from the FDA)?

Things than make you go hmmm...

Kurt
Click to expand...

Well, this treatment has had a few obvious supporters who promoted it...along with other drugs we shouldn't take...oh, and lysol...
 
PigsDad said:
Does anyone else find it particularly ironic that many of those that were anti-covid-vaxxers due to the vaccines being "experimental drugs" and only had EUA from the FDA were also strong supporters of monoclonal antibody treatments (that are "experimental drugs" and only have EUA from the FDA)?

Things than make you go hmmm...

Kurt
Click to expand...

It's called "informed consent". I have nothing against people taking mRNA vaccines. Nor do I have anything against people taking various treatments. I DO have a problem with people being forced to take any vaccine/treatment.

Example - I won't take the Merck COVID treatment pill. It has already proven to mutagenic in tissue cultures, and has a low efficacy rate in addition. Substances with a mutagenic effect have consistently proven to severely increase one's risk for developing cancer. That's an example of "informed consent" - I am informed and I won't consent.
 
PigsDad said:
Nope, just consequences for them, which sometimes involved losing their job. No one has been forced (i.e., injected w/o permission) to take this vaccine.

Kurt
Click to expand...
If you mean held down and jabed then yes. We still live in America so yes we ultimately have the freedom to choose unemployment! Not a great choice but its a choice.
 
PigsDad said:
Nope, just consequences for them, which sometimes involved losing their job. No one has been forced (i.e., injected w/o permission) to take this vaccine.

Kurt
Click to expand...

Telling someone take the vaccine or you will be fired and lose your ability to support yourself and your family is being forced. In the same way a boss saying to an employee have sex with me or I will fire you is rape.
 
jwalk03 said:
Telling someone take the vaccine or you will be fired and lose your ability to support yourself and your family is being forced. In the same way a boss saying to an employee have sex with me or I will fire you is rape.
Click to expand...

Of course some are given limited choice…but it’s still a choice. We have a history of this, so it’s difficult for me to acknowledge this is some new policy.

I suggest you review:

Vaccination policy of the United States - Wikipedia

en.wikipedia.org

With a novel virus none of us should be surprised that a vaccine would be mandatory, with few exceptions available.


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PigsDad said:
Does anyone else find it particularly ironic that many of those that were anti-covid-vaxxers due to the vaccines being "experimental drugs" and only had EUA from the FDA were also strong supporters of monoclonal antibody treatments (that are "experimental drugs" and only have EUA from the FDA)?

Things than make you go hmmm...

Kurt
Click to expand...

These Delusionals don’t even know what a monoclonal antibodies are, nor how they are produced. Nor their safety profile… nor anything about vaccines that produce anti-viral antibodies, nor the SAE between the placebo and mRNA vaccine control groups, nor anything about adjuvant immunologic response.
But, sadly they have found a platform on TUG to spew their BS.

btw - former colleagues of mine developed the Regeneron dual MAb treatment cocktail. And we’re strongly influence by yours truly on dose selection/approach. I am on related patent that awarded me $1 for what turned out to be worth many millions.
Especially for SC dosing.

Omicron has too many spike mutations for a MAb targeted against just a few. A Location Specificity issue - so not surprising it is less effective.

Turns out there is something super effective against Covid, and reduces Hospitalization by ~10x, ICU by ~17x, and death by ~20x.
It’s called a vaccine.


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