FDA Clears Covid Treatment for the Immunocompromised

An injectable monoclonal antibody cocktail with an 83% effective at preventing symptomatic disease in immunocompromised patients.

https://www.cnbc.com/amp/2021/12/09/fda-clears-astrazeneca-covid-antibody-treatment-for-immunocompromised.html

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The Food and Drug Administration authorized the first injectable monoclonal antibody cocktail for long-term prevention of Covid-19 among people with weakened immune systems before they have been exposed to the coronavirus.

The FDA issued an emergency use authorization Wednesday for AstraZeneca's antibody cocktail, Evusheld, for what is known as pre-exposure prophylaxis, or PrEP, against Covid-19.


To date, such laboratory-produced antibodies have been authorized only as early treatment of Covid-19 or as preventive therapy for high-risk people immediately after close contact with someone who has tested positive.

Evusheld can be used as PrEP by people ages 12 and older who are moderately to severely immunocompromised and may not get adequate immune responses from a Covid vaccine. The therapy is also an option for the rare people who have histories of severe adverse reactions to a Covid vaccine or its components.

The AstraZeneca therapy involves getting preventive injections as often as every six months. According to a large placebo-controlled clinical trial, the cocktail is about 83 percent effective at preventing symptomatic disease during such an interval.

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clo2014 said...
Thanks for posting this Keith.

I wonder if people on anti-tnf meds can take this,?

Clo

The article didn’t list exclusions for patients. I’d assume that any immunocompromised patient could take this medication if their doctor approves it.

The medication should be available in a few weeks.

We are at a higher risk of a break through infection if we are exposed to the virus.

“ Immunosuppression is associated with a much higher risk of breakthrough coronavirus infections and severe Covid. Even after vaccination, many people — including transplant recipients and those treated for cancer or autoimmune conditions”

Colie09 said...
Did anyone else catch this part: "Seventy-five percent of the participants had health conditions that put them at risk of severe Covid, such as diabetes or obesity. Although only 3 percent were immunocompromised,..."

Glad they're working to diversify covid therapy options, but the mention of only 3% left me crestfallen and feeling misled by the article's title.

I’m not sure how the title was misleading, this treatment is for immunocompromised patients who are more at risk and they are finding that we “immunocompromised” are not producing as many antibodies to protect us as the general population.

3% of Americans are estimated to be immunocompromised — they mentioned it a few times in the article.

“
Still, for many of the estimated 3 percent of U.S. adults who are immunocompromised, the long-awaited news that antibody PrEP has finally been cleared should bring profound relief. “

I thought that it was different.

I just want to get on the waiting list. I called my PCP and GI--neither had any information about this.

I wonder what doctor we would call to get this?

Keith, Thanks again for posting this. You gave me a glimmer of hope.

Clo

This is a new drug and it will be released "very soon" according to AstraZeneca. The FDA has approved it under emergency use authorization.

According to the FDA's website this is who it approved for:

"moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for health care providers)"

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure

Has anyone tried to get this yet or was successful in getting it?

ks1905 said...
Has anyone tried to get this yet or was successful in getting it?

Good question. I understand they ordered 700,000 doses=14,000 per state.

Sounds scarce. Things have gone quite on this. No one I’ve personally spoken to has ever even heard of it.

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Currently on Humira

CCinPA said...

There was a case here that made national news because the wife of a man on a vent insisted that the hospital give him Ivermectin. The hospital refused and she got some unaffiliated doctor from New York to give it to him. That doc swore that all his patients recovered. The man died.

I wish they would charge doctors who behave that way with homicide. They went through medical school and swore an oath which they have betrayed. The doctor should at least lose their medical license.

Keith,

I tried to call my GI, Infectious Disease, PCP, Rheumatologist, and nephrologist. No one has even heard of this and none of them knew where to get it. Still researching. I will let you know if I find out anything at all.

If I were in a hospital, they thought I was not going to make it, they'd tried other medications on me and they wanted to try ivermectin as a last ditch medication... I would hope that the doctor would try it if my family signed a waiver. I am not saying it works--but I am not saying it doesn't. There have been people... salt of the earth, no nonsense, sceptical, honest to the core neighbors that I know, that have been in pretty bad shape and when they took it it helped them... Alot. They are old with additional comorbidities. So I am not ruling anything out. I am open minded to the possibilities.

I listened to my sister in law, nephew and 2 inlaw parents die, begging for doctor's to try anything, begging for more oxygen. They were dying, they had nothing left to lose, and to not even try something..anything ... breaks my heart. What if even one of them had been like the neighbor couple down the street that recovered? If it's your loved one or yourself staring death in the face you sometimes find yourself willing to try anything. And if your argument is what if it does harm... I would hope that someone's else's beliefs--which may be right for them--do not prohibit me from trying something. I am willing to accept the possibility of harm. If a doctor doesn't want to try it... Fine.. move over and allow someone else to give me a final chance... And the doctor that tries it should be immune to censor or discipline/lawsuits. He is trying a last "hail Mary" to save a patient. I've been there personally and my doctor's have had to pull rabbits out of the hat for me... I have coded after surgery. I also know the 4 other doctors we had for my family members were unwilling to try anything and that haunts me every single day. (They were located in different states) So I have a completely different take on trying different medications as a last resort. I guess facing death -- thru a family member or your own experience -- can make you see things differently..cause it did for me, my husband, my kids and my other family members. Maybe it won't for others and they don't want to have that "Hail Mary" option. I'm fine with that to. I don't want to force anyone to try something but I don't want to lose an opportunity for me either.

Hopefully this new medication will make it so that immune compromised individuals and their families don't have to even think of that scenario. So if anyone finds out anything please let us know.

Mask up and stay safe you all!
Clo

@Clo, the reason your drs are probably not aware of the new stuff is they receive letters/emails from the FDA & CDC with full content, including access & administering a new drug. Unfortunately, the media jumps on an approval & broadcasts things without full content. With the media it's a race of who can be first to get something out there. I do not rely on the media for my information as their accuracy record is not the best by a long shot. I subscribe to the FDA & get emails, I suggest you consider doing the same. Their information is very easy to read.

It's the same here at HW many times with the vaccines, you have to do your own research. I take everything I read here with a grain of salt & do not rely on it being the gospel. Please remember, the shots will not prevent us from getting the virus, it's purpose is to help prevent us from getting severely ill & on a vent.

Take care.

Interesting article on paxlovid

https://www.theguardian.com/commentisfree/2021/dec/21/paxlovid-anti-covid-pill-why-not-available?

CCinPA said...
Thanks, poopydoop. That's the Pfizer pill and it sounds like it could be a game changer with Covid. Hopefully they can get production ramped up. Until that happens it should be available to people like Clo once it gets approved. Clo -- keep your eyes on this treatment.

To bad it takes 6 months to create.

Hey all,

I spoke to one of my doctor's today. He said that he has heard and read multiple things. The end point was the state/people/establishments will receive a small amount at first, around 1400 to 1800 doses??. Then the state will divy it up. It will take awhile to ramp up so they are not expecting to receive additional doses until after March of next year --and that's only if the government doesn't decide to send doses to states suffering from a higher load of Covid cases (which he thinks will happen) But I don't know if that's just for his office or what. He was in a hurry and it's air head time for me. (Methotrexate) He has heard and read that this works.

To obtain you will have to have proof of a positive Covid test ... No at home testing results will be accepted, they must have official positives from a reliable source. He has heard that there is some nausea and diarrhea for some individuals. It can start at any time after starting the pills and last up to a week to 10 days after you are finished?? But he heard there aren't very many side effects and they do not last that long once you stop taking the medication. This is all guessing since he has absolutely no experience with this medication. He said we will know more when people start to report to him directly. He does not know if it will cause me to flare..but he can not say for sure. He's big on follow the science but he is also very analytical and follows what happens with his patients.

He believes this will be a game changer. He recommended that I stock up on Covid tests and if I have a positive result I have to call in and get in that day so they can meet the timeframe for the best results. (I am shaking my head here cause I have a very hard time getting an appointment a week away let alone that day...) His office will not be calling these in to be filled until they see you and confirm you have Covid. (Apparently there are hoarders out there that are already trying to get them and they aren't even Covid positive...nor are they immune compromised...🙀) He has spoken to many other doctors in north Texas and they are planning to screen people to those who really needs this medication. (Made me chuckle... I hope that there's some real accountability for these pills and they don't go out to family and friends at first.) So good news but there's gonna a time delay and some confusion at first.

So people, don't toss your mask, do not forget to get your shots, continue to do the social distancing thing, and wash your hands alot. The new virus variant is out there waiting to meet your acquaintance.... Let's outsmart and outmanuver it for just alittle while longer.

Clo

Post Edited (clo2014) : 12/23/2021 8:05:53 PM (GMT-7)