The Food and Drug Administration (FDA) authorized Evusheld on December 8 and DeSantis announced on Friday that the state secured 3,100 doses of it. With a two-dose therapy, that's enough to boost protection in about 1,600 Floridians.
"This is a positive development to especially have this, and that it really will serve a valuable purpose for those, some of those folks that are very high risk, and do need some additional help," DeSantis said on Friday.
Enough for 1600 people? There are approximately 22,000,000 people in Florida. I can’t see how this will help much.
Hopefully I’m wrong and it is a game changer.
Mark
this is only for people like us ... it is not for people who are already sick but for boosting our immune system and the prevention of covid or whatever ---- here is the quote "This includes cancer patients, transplant recipients and people who are on immune suppressant medications." james
The U.S. bought 700,000 doses, that's a 2 shot dose so 3100 ain't much.
john
Hi John , not all cancer patients are eligible .. it depends on the type of cancer that they have and what type of chemo they had and how long it has been since they had chemo .. i would imagine with CLL patients like us that we would be near the top of the list for the antibodies . and this is just the first roll out .... so we will have to wait and see how this develops ... many folks on here are very concerned about getting covid and they should be the first in line ..... then will will get a first hand report from reliable sources of how this is all working out ... james
Hi James, This is from the FDA press release, in case it's helpful:
The authorization also requires that individuals either have:
▪️ 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) or;
▪️ a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.
fda.gov/news-events/press-a...
very good . thanks
Hi John, the 3100 is just for Florida's immunocompromised folks. One dose is comprised of 2 separate shots. (tixagevimab co-packaged with cilgavimab and administered together) Here's the full info: fda.gov/news-events/press-a...
There have been a number of very good discussions on HU about this over the past week. 😀
50 states + 2
330M+ population.
What percentage is immunecompomised?
Of them, which condition(s) will be prioritized?
How much will be kept in reserve for the 'Too big to be sick' category?
It still is an excellent start!
And I guess more MABs will roll out soon.
I think the IP for MABs has been open sourced...so there is hope in the future.
This time around, if all countries can go at it in an coordinated and equitable way, these PrePs can become the same as for AIDS.
Must be the same page of the game plan.
PreP the high risk group. Hope to contain future severe mutations.
But the numbers for covid is exponentially larger...
Of that 330 million, just under 3% are immune compromised (roughly 9 million). But as we've already seen, blood cancer patients top the list of losers, where vaccine efficacy is concerned.
Hi John, the fact remains that CLL patients who have undergone or presently under going treatment most likely do not have a working immune system. They are not able to replicate and build up immunity. Case in point my husband. He was fully vaccinated, had Covid (caught it even with extreme caution) received the booster and still no anti bodies. Hopefully CLL patients who are not undergoing treatment might be helped but that is a very small amount of therapy that DiSantis is talking about. At this point our biggest hope is treatment for Covid.
Yes, I called Astra Zeneca the other day about it. The rep said it would be available soon. The problem will be who gets it. Your doctor has to order it and it is being allocated by the Federal government. Hence the small number for Florida. However, hopefully there will be more. I have reached out to my doctor at MD Anderson, as well as locally, about it. So far no idea when it may be available here.
As to the question of who is considered eligible, every thing I have read states "1% to 2%" of the population in the US. So, 1.5% of 340,000,000 is 5.1 million.. With 700,000 obtained by the US government, that's nowhere near enough. I would think this will eventually become a matter of each individual and their insurance. Just my opinion.
Reports are closer to 2.7% of Americans being immune compromised (roughly 9 million). Add to that the fact that Evusheld will also be prescribed for those with a history of allergic reactions to vaccines, the pie will be further divided into smaller slices.
I am writing to my state representative to: A) inform him re Evusheld & B) ask him to advocate for more supplies to be ordered.
When the Biden administration was informed that mAbs were in short supply, they immediately ordered 3 million more doses and began rationing doses more equitably on a per capita bases to all the states. I am confident that, as is always the case with our healthcare, knowledge is power. #FocusingOnSolutions 😍
Informed patients get appropriate healthcare.And make it easier for the moaners, groaners and terrified to also benefit.
We are all in this together.
Hopefully someday we all will pull in the same direction.
Hooroo!
PS: yes, Neil the origin for this uniquely down-under term is also nautical⚓
“Informed patients get appropriate healthcare.”
Man, if that were only true. I try. I really do. But I normally end up waiting due to inaction of the doctor(s) or just not up to speed in the information available.
Example: I reached out to my team at MDA about Evusheld. The response I got: “We are waiting for more research and data before recommending any of these treatments to our patients”.
Response from the director of the local cancer center, which is a personal acquaintance, when I sent her the emergency use approval for Evusheld: "Huh. First I have heard of it. I'll look into it". Now, this is after I shared with her about this treatment option when it was first sent to the FDA for EUA.
It's been like this my entire journey. Leaving one to believe that in most cases, we are numbers. I realize they can't get personally involved with each patient, but good grief. It's hard enough navigating the treatment environment, and now we are literally fighting for our life and it like another day to most of the doctors.
I have reached out to the state health department, which is what AZ said to do. No answer.
Merry Christmas to all.
Good job . just keep after it . it will benefit us all .. merry Christmas to you as well . james
Will do.. What other choice do we have??
🤣🤣🤣
Sometimes the lot of the informed patient is to inform their healthcare provider!
To be fair to the providers, they sometimes are too deep in the weeds to be able to look at the forest.
The good ones, will listen and discuss. And initiate the required action.
The not so good ones, go on my do not call list😇
And the likes of @neurodervish write to the White House and State reps.
Many of others on here do the same for their healthcare providers and politicos.
It too is a process!
If you remember our first DM, we were speaking the same language then too...
Must keep pushing forward..
Maximum effort (Deadpool reference) 😂
It's no wonder they refer to CLL as an orphan cancer. I too have reached out to my GP & several pharmacies. Evusheld was news to all of them.
I have sent all of them the FDA press release for healthcare providers. fda.gov/media/154701/download All the most important info for them is in the top half of the first page. Pass it around!
Yep.. I know they get aggravated and probably roll their eyes.. "It's HIM again".. LOL.. Gotta try though.. 😂
You know what they say, the squeaky wheel gets the worm! 😜
LOL... Not sure how much help that worm will be to the squeaky wheel, but hey, it's something.
That was my attempt at a metaphor for our inscrutable, and convoluted healthcare system here in the US.
It was a good one.. LOL..
Mixed metaphors, unintended consequences have (teenage Yoda)
The early worm gets eaten, and the non-squeaky wheels wear out.
😳
There is no winning some days!
Only lemonade to drink!!
🤣
hahahaha
I was kept 3 weeks in isolation in the infectious ward as they were determined to find TB. When finally they did agree to listen to what I told them at admission (I need a consult by your CLL specialist), did they stop playing "I am the doctor here and I know better".
In their defense, I am of SE origin, had returned from Turkey, and was coughing my lungs out. So Infectious Specialist is the protocol. CLL just is the underlying condition.
Specialists sometimes are worse than GPs. Tunnel vision.
I was discharged 2 days after that and put on appropriate treatment by Dr. Spaner, the best in Canada for CLL, IMBO. (in my biased opinion).
For my RT. Was pretty close to touch and go.
It wasn't a laughing matter, still isn't.
But I dare you to try and beat that story!!
Not!
What was it? And, I think I can beat that story..
I was newly diagnosed. I was in a lot of pain and ended up going to the ER. We explain what is going on. The team draws labs, etc.. ER doctor comes in and has a very confused loo on his face and he says:
ER Doctor: "Um, you have something very strange going on inside your body right now and I am nit comfortable trying to diagnose your issue."
Me: What is the problem?
ER Doctor: "You white count is really high."
Me: Yes, that is my leuk.. He interrupts me.
ER Doctor: "I mean, your white count is really, really high".
Me: How high?
ER Doctor: "71,000"..
Me: Well, I as I trying to say, it is my leukemia and.. Interrupts again..
ER Doctor: "What kind of leukemia do you have?"
Me: CLL Chronic Lymph... Interrupted again.
ER Doctor: "I am not comfortable with this and I am going to discharge you with a recommendation for you to follow up with own doctor"..
And that was it..
I have another when they tried to treat me for sepsis because my high white count trigger an automatic septicemia protocol.. LOL.. My wife had to stop them..
RT stands for Richter's Transformation.Ya. That one.
The one where days matter...
And yes - the last statement by the Internal Medicine specialist was "We really can't figure out what exactly is wrong with you. Your luekemia might be aggravating things, but the lymphoma is the concern. Ok, we will consult with the CLL specialist, and send the lymphoma biopsy for testing for matching to your CLL sample".
😑
Not a proud moment for being right.
And I owe my life to what Chris_Canada, AussieNeil and others out here helped me learn about my condition...🙏🏽
The misdiagnosis of initial CLL/SLL/PLL is par for the course, no offense meant.
It is a hard pill to swallow even by us, and W&W is fertile land for denial. Lived there blissfully for 4 years😒
Yes, do I ever know what you mean. So sorry you are dealing with RT.
Dealt.
Successful managed an U turn.
2.5 years past transplant now.
If can avoid covid and stay sane for another 2.5 years, the term would be 'medically cured'.
The donor immune cells now keep fighting the sneaky CLL ones, the ones that avoided all treatments.
Or so the theory goes...
Each day is a blessing!
She comes bearing gifts!
I have been told by my oncologist and other doctors (top hospital in Chicago, 10th in the US??) that there are basically no mAB treatments available even if I tested positive for covid.
Evusheld sounds promising. I just had the Monoclonal Antibody Infusion at a local hospital ER in Boca Raton. I had considered going to one of the 26 locations CD Maguire Corporation has set up throughout Florida, and the closest for me is a Park in West Palm Beach. My decision was to go to the local ER and get the transfusion instead if intramuscular injections at the CD Maguire location in West Palm. Now I'm wondering if I would have gotten the Evusheld if I had chosen differently. I'm also wondering what the potential harm could be if I tried now to get the Evusheld injections, having just had the other infusion.
Reading the side effects on Evusheld however, I'd suggest that our readers here be alerted to one that I picked up on. Evusheld reports that there have been cardiac arrests and other cardiac related problems resulting from the Evusheld injections. They think that the Cardiac problems might be mostly in people who had prior cardiac issues, but they clearly never studied this before the release of the product. They state in the notice online that they will be looking further into this. So be aware if you have had cardiac issues, according to Evusheld's own public notice.
Carl
We are seeing some correlations between "potency/amount of medication" and "cardiac irritation" with the Covid vaccines, I wonder if "cardiac irritation" will also be seen with the antibody infusions and long lasting injections. If there is something about part of a Covid antibody that induces irritation, and if this will turn out to be one of those meds that "more" isn't going to be "better". Which would also show up more in patients with pre existing cardiac issues.
Sofia
I was not referring to a vaccine; instead, I was commenting on the Astrozenica product Evusheld. Its is apparently a new Monoclonal Antibody Injection to compete with Regeneron. It is so new I don't know if it is available in too many places yet, but it just received an Emergency Authorization approval. I went to their own web site to read what they were saying about it, and they had a section with Side Effects. What concerned me was their own comments about some serious heart problems during testing. They went on to say that they aren't sure if those who experienced the very serious heart issues were people who already had heart problems, and if the amount of heart side effects were possibly very small in those who never had heart issues. So in essence they are admitting there were a bunch of serious heart issue side effects, but saying maybe not too bad if the person didnt already have problems.
I've never had a heart issue, but on my most recent annual exam with my Primary he remarked about something new on my EKG. I asked what it was and he said Right Bundle Block, and called it minor at this time. He said I should see a Cardiologist to get a Stress Test, and that was about a month and a half ago at this point, but I haven't done anything yet.
Anyone who understands Right Bundle Block and can enlighten me a bit about possible serious issues (or not likely to have any serious issues), your comments would be appreciated.
Carl
I know you were referring to the antibodies. I just noted that we are seeing some cardiotoxicity with high dose vaccines, and wondered if we will also see it with the antibodies. I.E., is it something about the antibody itself in higher doses that causes the cardiac irritation. As opposed to the vaccine itself caused any cardiac irritation. If so, higher single doses of either vaccine or antibody may not be optimal, it may be something that limits the optimal dose.
Truly interesting hypothesis; since, antibodies that are effective against the Covid strain we are dealing with are present in both treatments. In one treatment (the Vaccine) they are produced through reaction to proteins that simulate the virus, and in the other (the infusion) they are introduced as proteins that simulate the antibodies. In neither instance are they the actual virus or antibody.
Since both the actual virus and actual antibodies are real and not simulations, wouldn't the cardiac issues be present in equivalent amounts in patients who neither got the vaccine or the infusion (yet currently have a Covid infection). I'd think the answer is clearly yes, the same cardiac issues should be present, although we are dealing with actual virus and actual normally created antibodies. If those same cardiac issues are not present in those patients, then maybe it does have something to do with the simulations we have created for both the virus and the antibodies.
Maybe the real issue is the antibodies attacking the virus' function, which creates a stress for some reason on the heart and its vessels, and not the antibodies or the virus themselves.
Carl
Hmmm, maybe but maybe not. What is being reported is inflammatory process, not simple cardiac dysfunction. It appears there is some sort of genetic component affecting Covid severity, correct? Some people with Covid respond by massive cytokine production/overproduction. Similar to how some people have autoimmune diseases, when their body is overproducing inflammatory molecules. I wonder what or if something about the (vaccine/infection antibody response), that is causing myocarditis/pericarditis to occur in certain individuals. And if this inflammation is dose dependent. Because it is occurring in young people, not older who have a less robust immune system.
News article: nbcnews.com/health/health-n...
Just re-read your post, and to clarify, the antibodies in the Evusheld aren't proteins that "stimulate" antibody production, they ARE the antibodies. That's what Monoclonal Antibodies are, the active moieties.
I was theorizing comparisons of the vaccine and these infusions to something like Potassium, which is helpful and necessary in certain amounts, may cause havoc in the body when there is "too much". "Too much" may be responsible for this cardiac inflammation, for whatever reason/mechanism. Similar to autoimmune conditions, where the body is producing "too much" of certain molecules that are OK and even necessary in different concentrations/conditions. And of course, there will be people sensitive to amounts that don't affect others, and otherwise may be considered "normal".
3100 i would think is not enough doses. 
Covid booster shot and flu shot more or less at same time safe for CLL patients?
New Vaccine vs Evusheld
Fatigue on Venetoclax
Are UTI's more common while on Imbruvica?
Clinical Trial with BGB-11417
