Coronavirus

[bkp_duke]

Just a general comment that I think there are 2 main "lines of attack" we have that are most effective at stopping this from harming people:
#1: (obviously) the various vaccines
#2: Monoclonal antibody treatments EARLY in the course when symptoms are first detected.

If #2 were widely available, I wouldn't even be worrying so much and think of this as a more minor illness. The problem is their availability and when you get approved to get them. From what I can tell, they are highly effective at stopping symptoms. But (unless you are some high profile official), I think the only way to get them is through randomized trials, so you might end up with placebo which isn't a good place to be.

Is there any news on more widespread availability? And ability to get them prescribed without being in a randomized trial?
I assume it will always be only in a hospital settings, so no chance of some monoclonal antibody "home cure" ever coming?

All the other drugs... Remdesivir, etc, are really just about reducing the most severe symptoms. Monoclonal antibodies are more like an antidote/cure from what I can tell.

#2 is GOD AWEFUL expensive, due to the difficulty of manufacture, will never be a widespread therapy.

 

[AaronP85]

 

[AlanSubie4Life]

Maybe all those "supplements"

Maybe. You may also have been fortunate enough to not live with superspreaders. We’ll never know.

Monoclonal antibodies are more like an antidote/cure from what I can tell.

Unfortunately a lot easier to evade, for the virus, though. Unless there is a fast efficient pipeline for producing new ones and generating polyclonal cocktails we’ll just end up with ineffective ones, eventually.

I wonder whether vaccine-induced plasma will ever become a thing. Seems cheaper and maybe it will be more effective (so far plasmas have been shown to be quite ineffective, as discussed earlier). Lots of small antibody factories operating in parallel.

It seems to me these treatments have a tendency to produce variants. But they do save lives as well. For example, perhaps we are blessed with Trump’s comforting presence on our little blue orb, thanks to them.

 

[TEG]

I am fairly sure my wife got a "polyclonal" antibody treatment as a trial participant. When they showed putting her on that (or placebo) her symptoms cleared up dramatically starting the next day and she got discharged soon after.

Her doctor was now advising her to get vaccine first dose 90 days post COVID recovery, but the (poly)monoclonal antibody study people asked her to wait a little longer as they wanted one last blood sample to finish their data collection, so she will seek out a vaccine (as a booster I guess) starting in a few weeks.

By the way, she and my daughter are not complaining of any post COVID type symptoms. Both are relieved to feel some "lived through that" and are more comfortable now going out in public (still masked and distanced of course...)

 

[scottf200]

Just a general comment that I think there are 2 main "lines of attack" we have that are most effective at stopping this from harming people:
#1: (obviously) the various vaccines
#2: Monoclonal antibody treatments EARLY in the course when symptoms are first detected.

If #2 were widely available, I wouldn't even be worrying so much and think of this as a more minor illness. The problem is their availability and when you get approved to get them. From what I can tell, they are highly effective at stopping symptoms. But (unless you are some high profile official), I think the only way to get them is through randomized trials, so you might end up with placebo which isn't a good place to be.

Is there any news on more widespread availability? And ability to get them prescribed without being in a randomized trial?
I assume it will always be only in a hospital settings, so no chance of some monoclonal antibody "home cure" ever coming?

All the other drugs... Remdesivir, etc, are really just about reducing the most severe symptoms. Monoclonal antibodies are more like an antidote/cure from what I can tell.

Mar 27, I mentioned Maddow did a segment on this. I know it is a show but her show content seems to be well researched.

Coronavirus

I find this whole thing about the vaccine card to be silly. Some places across the country aren’t even giving out those cards according to friends and family. I know for a fact a few county vaccination sites and pharmacies around me that are not handing them out. Plus, one can easily just call...

teslamotorsclub.com

...
2) By chance, I was just listening to a short clip from Maddows show about monoclonal treatment and that it is available and 'free' for at risk patients. Just something to keep in the back of your mind for any friends/family/etc.

https://twitter.com/x/status/1375590724700360705

 

[AlanSubie4Life]

the Sputnik V vaccine very likely prevents severe disease, due to cell-mediated immunity, which is likely still effective

A long thread, recently updated, discussing this. The short answer is that we don't actually have enough data yet to know whether or not cases where infections occur are still reasonably well protected against severe disease (more relevant when variants are added to the mix). The data is pretty limited is the main problem.

https://twitter.com/x/status/1374241297238618112

It's tricky too, because I'm not sure we can draw a conclusion from Pfizer/Moderna or even J&J data which shows decent (wide confidence intervals though) results against severe disease relative to symptomatic disease. Particularly J&J shows this, but the Pfizer/Moderna do not. For the most part, it seems like Pfizer/Moderna results are capturing the upper limit of human immune system efficacy, on average. Some people just don't generate an immune response, or get a massive viral dose, and they get sick, even if they've been vaccinated. And a lot of those same people may get severely ill since their immune systems don't work. That's not really what we're looking to figure out, though. We want to know what happens when the neutralizing antibodies don't work because the virus has drifted (do all the other key antibodies which trigger the t-cell response still work?).

Anyway, it's not clear to me that you can extend the efficacy data we do have to variants. In some ways I'd expect variants to have a big drop-off in symptomatic cases, with a smaller drop-off in severe illness protection (since severe illness is countered by T-cells, cell-mediated immunity).

As we've said repeatedly here...no clinical data for efficacy against variants. And we also don't really have any good data showing whether protection against severe disease is better than protection against symptomatic illness, even neglecting variants.

I'm getting pretty tired of reading about neutralization studies, that's for sure.

 

[TEG]

#2 is GOD AWEFUL expensive, due to the difficulty of manufacture, will never be a widespread therapy.

Unless insurance or government pays for it... (Well not expensive to the patient...)

COVID-19 Monoclonal Antibodies | CMS

The COVID-19 public health emergency (PHE) ended at the end of the day on May 11, 2023. View Infectious diseases for a list of waivers and flexibilities that were in place during the PHE.Review this page for information about Medicare payment for administering monoclonal antibodies during and...

www.cms.gov

This would allow a broad range of providers and suppliers, including freestanding and hospital-based infusion centers, home health agencies, nursing homes, and entities with whom nursing homes contract for this, to administer these treatments in accordance with the EUA. Medicare will not pay for the COVID-19 monoclonal antibody products that providers receive for free. If providers begin to purchase COVID-19 monoclonal antibody products, Medicare anticipates setting the payment rate for the products, which will be 95% of the average wholesale price (AWP) for many health care providers, consistent with usual vaccine payment methodologies. Additionally, Medicare anticipates establishing codes and rates for the administration of the products.

Government Signs Deal For COVID-19 Treatments From Eli Lilly

The federal government plans to distribute 300,000 doses of the drug at no cost, but that doesn't mean treatment will be free. Intravenous infusion charges can run more than $1,000.

www.npr.org

Eli Lilly has struck a deal with the federal government to provide 300,000 doses of a drug that's designed to keep people infected with COVID-19 out of the hospital. The cost per dose: $1,250.
The federal government plans to distribute the 300,000 doses at no cost, but that doesn't mean treatment will be free.

 

[bkp_duke]

Unless insurance or government pays for it... (Well not expensive to the patient...)

COVID-19 Monoclonal Antibodies | CMS

The COVID-19 public health emergency (PHE) ended at the end of the day on May 11, 2023. View Infectious diseases for a list of waivers and flexibilities that were in place during the PHE.Review this page for information about Medicare payment for administering monoclonal antibodies during and...

www.cms.gov

Government Signs Deal For COVID-19 Treatments From Eli Lilly

The federal government plans to distribute 300,000 doses of the drug at no cost, but that doesn't mean treatment will be free. Intravenous infusion charges can run more than $1,000.

www.npr.org

Unfortunately . . . no.

1) the mass manufacture of antibodies is exponentially more difficult than a vaccine.
2) the cost of this would bankrupt a country, even one that prints money like the USA, if it was even possible to mass-deploy (it's not).


Here's a modern-day example:
Growth Hormone has been around for decades. I've prescribed it for kids with short stature, etc. etc. The Patent is LONG since expired. There are MANY companies that produce it (so market competition is not a problem).

It still costs $1000-5000 per month, per patient. It's a class of drug called "biologics", which simply are hard to make (requires biological organisms to build them - CANNOT be synthesized from base components), harder to scale up, and require tons of man-hours, even when mass produced.


So no, there will be no mass-distributed antibody therapy for COVID-19.

In this case, an ounce of prevention (vaccine) is worth a pound (really more like 100s of thousands of $$$) of cure.

I would bet @rxlawdude has some experience or insight on biologics and the limit of their production and exorbitant costs as well.

 

[Jeff N]

We want to know what happens when the neutralizing antibodies don't work because the virus has drifted (do all the other key antibodies which trigger the t-cell response still work?).

I don’t remember whether it’s been mentioned here, but as I understand it the mechanism that t-cells use to recognize viral antigens is different than the mechanism used to create and optimize the antibodies.

The t-cell mechanism uses more flexible pattern matching that is less prone to fail due to viral mutations. This explains why the B.1.351 (South African) variant, for example, can tend to escape from some vaccine antibodies and cause modest symptomatic disease yet not cause severe disease or death — the antibodies can fail and allow infection but the t-cells still work to clear and contain the infection.

 

[rxlawdude]

Unfortunately . . . no.

1) the mass manufacture of antibodies is exponentially more difficult than a vaccine.
2) the cost of this would bankrupt a country, even one that prints money like the USA, if it was even possible to mass-deploy (it's not).


Here's a modern-day example:
Growth Hormone has been around for decades. I've prescribed it for kids with short stature, etc. etc. The Patent is LONG since expired. There are MANY companies that produce it (so market competition is not a problem).

It still costs $1000-5000 per month, per patient. It's a class of drug called "biologics", which simply are hard to make (requires biological organisms to build them - CANNOT be synthesized from base components), harder to scale up, and require tons of man-hours, even when mass produced.


So no, there will be no mass-distributed antibody therapy for COVID-19.

In this case, an ounce of prevention (vaccine) is worth a pound (really more like 100s of thousands of $$$) of cure.

I would bet @rxlawdude has some experience or insight on biologics and the limit of their production and exorbitant costs as well.

Biologics indeed are exquisitely expensive, and as an added bonus, generic versions are impossible. Best case is "biosimilars," which approximate reference biologics. And even batches of the same company's products can vary to the point of mere "similarity."

Another fun fact: insurance companies can tell hospitals which biologics they will cover, obligating hospitals to carry multiple versions at high costs.

 

[FoverM]

Our daughter got the J&J shot today at college. Said she really didn't feel it and is now no longer afraid of shots

Note: she became afraid of shots following two rounds of the nasty Rocephin shots in her thighs back in 2008 or 2009 during the Swine Flu outbreak. She was hospitalized for one night with pneumonia - but the Rocephin had already kicked in by then so it was really unnecessary. There were complicating factors that freaked out the ER doc and he admitted her (if I had just waited for 4 more hours at home I wouldn't have taken her to the ER!).

 

[Pilar Beckner]

insurance companies can tell hospitals which biologics they will cover, obligating hospitals to carry multiple versions at high costs.

This is very true.

 

[EVNow]

Unless insurance or government pays for it... (Well not expensive to the patient...)

Still not in widespread use in countries that do have proper government (single payer) insurance - and is not a racket like its in US.

I'll check how much they cost in India ...

 

[madodel]

Drive thru vaccination by a small Pharmacy chain, with no appointments required in our county that had only a few hundred show up so they opened it up to everyone 18 or older since they had 3,000 doses of Moderna. Got my first dose even though I'm 4 months shy of 65. 2nd is scheduled for May 1st at same site. Hopefully they don't waste hundreds of doses. As much as people bitch about the appointments it serves a purpose.

 

[JRP3]

even though I'm 4 months shy of 65.

PA is officially still 65+? We're 30+ here in NY, soon to be 16+.

 

[madodel]

PA is officially still 65+? We're 30+ here in NY, soon to be 16+.

PA opens to everyone 18 and older on April 19th, so I was able get mine a couple weeks early. This week it opens to 1b and 1c which are first responders and essential workers (food store and restaurant employees). My concern was about if any doses went unused and had to be trashed. It was at our fairgrounds so no heavy duty freezer on the grounds. Maybe they kept some doses in dry ice.

 

[EVNow]

PA is officially still 65+? We're 30+ here in NY, soon to be 16+.

In WA we are still 60+, since they are prioritizing now by occupation / health risks - but will open on Apr 15. I just got in under the multi-generation clause.

 

[dhanson865]

We'll be looking at some number at the end of 2021 / beginning of 2022. The difference between those two possibilities will be decided by someone else. I'm assuming Worldometer will still be around and we can just go by the number they present. If they don't give a 2021 number we'll use the total deaths for the US minus 354,316 unless someone gives a good reason why 354,316 isn't the right number to use for 2020.

It's been about 2 months since the poll closed

rough math has it over 200,000 already in 2021 and still rising by over 800 per day. While the rate has slowed it isn't anywhere near stopping yet.

 

[dhanson865]

from

https://www.reddit.com/r/dataisbeautiful/comments/mjdmln

and the simplest rebuttal to "just like the flu" for anyone that can read a simple graph.

 

[dhanson865]

Vaccinations now tracked at informationisbeautiful. US in top 5 for doses per capita.