monoclonal antibody use revoked?

[ktgrok]

https://www.floridahealth.gov/newsroom/2022/01/20220124-fda-removes-treatment-authorization.pr.html?_ga=2.17000569.1543171488.1643375441-89456238.1628358413

[Faith-manor]

From what I am reading, the previous MAB had no effect on omicron so it no longer has emergency use authorization for covid cases unless their sample is sequenced and found to be Delta or at least that was how my EKG/Lab Tech niece explained it to me. 

[Drama Llama]

4 minutes ago, ktgrok said:

https://www.floridahealth.gov/newsroom/2022/01/20220124-fda-removes-treatment-authorization.pr.html?_ga=2.17000569.1543171488.1643375441-89456238.1628358413

They just removed the ones that don't work on omicron.  I'm pretty sure there is evidence that they don't work.  The FDA didn't make up that fact. 

[ktgrok]

Just now, Baseballandhockey said:

They just removed the ones that don't work on omicron.  I'm pretty sure there is evidence that they don't work.  The FDA didn't make up that fact. 

Oh I'm not accusing the FDA of anything, was just surprised I hadn't heard about this already. Or at least, I guess surprised that none of the ones my state was using were doing anything. 

[Drama Llama]

Just now, ktgrok said:

Oh I'm not accusing the FDA of anything, was just surprised I hadn't heard about this already. Or at least, I guess surprised that none of the ones my state was using were doing anything. 

Oh, sorry, I didn't mean to sound like I was arguing with you. Just your state government.  

[ktgrok]

3 minutes ago, Baseballandhockey said:

Oh, sorry, I didn't mean to sound like I was arguing with you. Just your state government.  

Yeah, that's why I came here immediately after seeing it, I trust them as far as I can throw them, lol. 

[TechWife]

Yes, the EUA for widespread use has been rescinded because it is not effective against the omicron variant, which is the predominant strain. There is no need for an expensive, ineffective treatment. The manufacturers themselves have stated that it doesn’t work and are not disputing the decision. There are treatments available that do help omicron and there are also vaccines that lessen the effects of the illness and prevent it. Frankly, the Florida government is the only voice I’ve heard opposing this. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron

Data the FL DHS site says doesn’t exist (don’t ask me to interpret it - not a data scientist here):

https://opendata.ncats.nih.gov/variant/activity

News story (there are others): 

https://www.npr.org/2022/01/26/1075772530/the-fda-limits-the-use-of-some-monoclonal-antibodies-treatments

[Fritz]

My understanding is the FDA has made the assumption that all cases are Omicron when in fact Delta is still circulating as well. 

[KSera]

2 minutes ago, Fritz said:

My understanding is the FDA has made the assumption that all cases are Omicron when in fact Delta is still circulating as well. 

As of January 22, it was estimated 99.5% of infections were omicron. It would be nice if we had the resources to sequence every case, because .5% of a big number is still a chunk of people, though of course it would only be a smaller number of that 0.5% who needed the MAB. With so many cases right now though, I don’t see how we possibly sequence all. At least Paxlovid works for both strains, though there are some contraindications for certain people.

[Pam in CT]

re ineffective against Omicron

37 minutes ago, TechWife said:

...The manufacturers themselves have stated that it doesn’t work and are not disputing the decision. ...

... Frankly, the Florida government is the only voice I’ve heard opposing this.

This.

 

The Pfizer antiviral pill *does* look to be showing promise as a treatment against Omicron and they are all-hands-on-deck ramping up manufacturing; and other manufacturers are racing to get other antivirals up & EUA'd & out the door.

And *one* of the MCAB that does look to have some effectiveness will continue to be EUA'd (from the NPR link above):

Quote

The FDA reports the monoclonal antibody treatment sotrovimab is still authorized because it is expected to remain effective at lessening the risk of severe disease even against the omicron variant; although it is in short supply across the country. Other therapies are also available including Paxlovid and molnupiravir, two pills patients can take at home to reduce the risk of hospitalization from severe COVID-19, and the antiviral drug remdesivir, for which the FDA recently broadened approval.

The Department of Health and Human Services will no longer distribute the monoclonal antibody treatments for which the FDA has reduced its authorization. The department says that in the future, if people are likely to be infected with a variant that is susceptible to these treatments, use of the drugs may be authorized again.

There really is no justification for EUA of a much-more-expensive treatment that *has been shown not to work against this variant* under any circumstances.  Even less so when the federal government is still underwriting substantial treatment costs and overburdened hospitals are piling up unrecoverable accounts receivables for remaining surrounding costs.  Even less so when our nation, and this state, continue to organize the health sector around for-profit imperatives.  Well, we organize health care around profit measures, we decry inefficient federal expenditures, that adds up to: we can't have it all, all the time, when interventions don't work.

But yeah, go ahead, make political hay. We are where we are.

[BeachGal]

The mAb sotrovimab (Xevudy) is effective against omicron but is in short supply. GlaxoSmithKline and Vir Biotechnology are in the process of setting up a second manufacturing facility which should be up and running in a few months.

https://www.precisionvaccinations.com/2022/01/23/sotrovimab-slow-production-delays-omicron-effective-treatments

GSK and Vir expect to manufacture about 2 million mAbs doses globally in the first half of 2022.

However, during the week of January 17, 2022, only 52,064 sotrovimab doses were distributed in the U.S.

Edited January 28, 2022 by BeachGal
spelling

[BeachGal]

You can see the distribution table for sotrovimab, evusheld, paxlovid, etc. here:

https://www.phe.gov/emergency/events/COVID19/therapeutics/distribution/Pages/data-tables.aspx

A table showing what US states and territories have received:

https://www.phe.gov/emergency/events/COVID19/therapeutics/distribution/Documents/mabs-distribution-24Jan2022.pdf

 

Edited January 28, 2022 by BeachGal
added second table

[SKL]

Wonder if they'll also change anything about the vaxes / boosters that are essentially useless against Omicron.  And the tests that don't detect a lot of Omicron.

Edited January 28, 2022 by SKL

[Drama Llama]

3 minutes ago, SKL said:

Wonder if they'll also change anything about the vaxes / boosters that are essentially useless against Omicron.  And the tests that don't detect a lot of Omicron.

Which vaxes and boosters are useless against omicron?  

There are already vaccines in clinical trials that will hopefully work better against omicron, so obviously they are hoping to change things, but the vaccines and boosters work well.  

 

[sbgrace]

24 minutes ago, SKL said:

Wonder if they'll also change anything about the vaxes / boosters that are essentially useless against Omicron.  And the tests that don't detect a lot of Omicron.

I think there was miscomunication early on and a general misunderstanding of what makes a vaccine effective. These vaccines, like previous infection, don't completely prevent infection. There is a lot of difference between Omicron and the vaccine and antibodies are going to wane with time regardless. The antibodies, if matched well, are the ones that are protective for infection. FWIW, I don't know that a recent booster is entirely ineffective. We had a ton of close exposure to someone contagious without infection recently. My sister also avoided infection after everyone else in her family got it. She had a recent booster. Several friend's family had the same experience. But, if there is any booster protection, it's waning and not entirely effective.

However, the vaccines and boosters, like natural infection, do give you T and B cell (and memory...not sure what else exactly) protection from severe disease and long covid. Not 100%, but a significant reduction. I'd rather get that protection from a vaccine than an infection, though both appear to work well. 

Anyway, they work. I wish they provided long term, sterilizing immunity. But almost no vaccines for any disease do that--even the more stable viruses. We're fortunate these are so effective. Think about flu vaccine effectiveness--I'm so glad COVID vaxes do better than that. 

Edited January 28, 2022 by sbgrace

[Matryoshka]

1 hour ago, BeachGal said:

The mAb sotrovimab (Xevudy) is effective against omicron but is in short supply. GlaxoSmithKline and Vir Biotechnology are in the process of setting up a second manufacturing facility which should be up and running in a few months.

https://www.precisionvaccinations.com/2022/01/23/sotrovimab-slow-production-delays-omicron-effective-treatments

GSK and Vir expect to manufacture about 2 million mAbs doses globally in the first half of 2022.

However, during the week of January 17, 2022, only 52,064 sotrovimab doses were distributed in the U.S.

Yeah, they only revoked the two kinds that didn't work with Omicron,  because although this was already known (I read about it weeks ago, and most states had voluntarily stopped using the ineffective ones because ... science).

My parents are mid 80s, and my dad was just in the hospital for non-covid pulmonary embolism a few weeks ago. Dad got covid at one of the follow up Dr appointments since apparently the days of having you wait in the car are over even though this is the biggest surge ever. 🙄 Anyway, he then passed it to my mom. 

Took me a ton of calling around,  but I was able to get them both monoclonal antibodies (the kind with S that still works).  The whole thing in FL is just DeSantis having a hissy because he's somehow financially in bed with the regeneron folks.  So he's like, now no one can have anything. It's because of a few states/clinics that were happily still taking money for a treatment that no longer works that the FDA had to step in.

My parents are vaxxed and boosted, and thank heavens for that. The vaxxes are still very effective against hospitalization and death. Omicron just seems to get around the first line of defense with a vaccine that was made for what is now a very different virus from Omicron. With their ages and health issues,  I also wanted to make sure they weren't among the small number of people that got seriously ill even though vaxxed, as it does seem to be mostly the elderly.  Happy there's still one mAb that's working 

Edited January 28, 2022 by Matryoshka

[KSera]

19 minutes ago, SKL said:

Wonder if they'll also change anything about the vaxes / boosters that are essentially useless against Omicron.  And the tests that don't detect a lot of Omicron.

I’m not sure how one can look at hospitalization and death rates of vaccinated vs unvaccinated with omicron and conclude the vaccines are useless. The vaccines are remarkably effective at preventing serious disease. I wish they were still as effective at preventing infection as they were with previous variants (they still show a significant effect, but it’s MUCH smaller and not nearly what we’d want). Pfizer and Moderna are both testing omicron tweaked vaccines currently. 
 

I don’t know whether there’s anything to be done to make the tests pick up omicron earlier. I get the idea there may be some function of this variant that makes it virulent before there’s enough of it for the tests to pick up. If there is someway to change the test so they pick it up earlier, that would be super helpful. Currently, we don’t feel confident enough to use a rapid test as a screening to allow getting together with relatives.

[BeachGal]

22 minutes ago, SKL said:

Wonder if they'll also change anything about the vaxes / boosters that are essentially useless against Omicron.  And the tests that don't detect a lot of Omicron.

Pfizer’s omicron vaccine will be ready in March.
 

A number of second generation vaccines look promising. Some of them are multivariant and require a much smaller dose that can be administered through a skin patch. One dose should do the trick. A few nasal spray vaccines are being developed but the problem with them has been durability. They don’t remain effective for very long. Researchers might be able to solve that, though. There are even oral vaccines in the works. The link below lists where these vaccines are in trials.

https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker

[Fritz]

36 minutes ago, KSera said:

I’m not sure how one can look at hospitalization and death rates of vaccinated vs unvaccinated with omicron and conclude the vaccines are useless. The vaccines are remarkably effective at preventing serious disease. I wish they were still as effective at preventing infection as they were with previous variants (they still show a significant effect, but it’s MUCH smaller and not nearly what we’d want). Pfizer and Moderna are both testing omicron tweaked vaccines currently. 
 

 

Here it is an almost even split of unvaccinated and vaccinated being hospitalized. May be different in your area.

[Drama Llama]

4 minutes ago, Fritz said:

Here it is an almost even split of unvaccinated and vaccinated being hospitalized. May be different in your area.

Are people in the most vulnerable categories evenly split though?

I live in an area where vaccinations rates for adults, and particularly the elderly, are over 90%.  So, if the population of people hospitalized was split evenly that would mean that vaccines are working really well.  

[KSera]

1 hour ago, BeachGal said:

Pfizer’s omicron vaccine will be ready in March.
 

A number of second generation vaccines look promising. Some of them are multivariant and require a much smaller dose that can be administered through a skin patch. One dose should do the trick. A few nasal spray vaccines are being developed but the problem with them has been durability. They don’t remain effective for very long. Researchers might be able to solve that, though. There are even oral vaccines in the works. The link below lists where these vaccines are in trials.

https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker

There’s a super interesting vaccine preparing for human trials that uses a priming dose via a standard IM shot, and then after the immune system has been primed by that, an un-adjuvated nasal spray that induces mucosal immunity. 

36 minutes ago, Fritz said:

Here it is an almost even split of unvaccinated and vaccinated being hospitalized. May be different in your area.

That may be true when looking at raw percentages of how many people are in the hospital, depending on how much of the population is vaccinated. Most places, by the time you get into the elderly age group that is most likely to be hospitalized, the vaccination rate is super high, even in areas that have low vaccination rates overall. If you have a 50-50 split in an area where 95% of the elderly people are vaccinated, that indicates the vaccine is doing a pretty good job.  I have yet to see anywhere where they are publishing hospitalization and death rates on a per population basis where the risk reduction isn’t stunning and stark. If someone wants to look at that and decide they still want to take the risk, that’s one thing, but there’s no basis for anyone to deny the difference.

 

 

 

 

Edited January 28, 2022 by KSera

[KSera]

This chart is really interesting as well, and I’ve seen the pattern repeated across many locations. In this chart from Utah, it’s babies, who obviously have no vaccine available who have the highest hospitalization rate right now. This was not the case earlier in the pandemic.

Edited January 28, 2022 by KSera

[Matryoshka]

52 minutes ago, KSera said:

This chart is really interesting as well, and I’ve seen the pattern repeated across many locations. In this chart from Utah, it’s babies, who obviously have no vaccine available who have the highest hospitalization rate right now. This was not the case earlier in the pandemic.

This definitely shows vaccination is protective, even for younger kids.  Although I'm not sure babies would be highest in hospitalizations overall if this chart included the two most vulnerable age ranges.... I notice the lines for 65+ are absent here (they're in the key but the lines are missing - I can't imagine it's because they're at 0).  From what I've seen locally, those are still the bulk of the hospitalizations overall - which I wouldn't at all put down to the vax not being protective, but just that generally a lot of older people don't mount as an effective immune response to the vaccine as younger folk.  It's still hugely protective.

[kokotg]

3 hours ago, KSera said:

As of January 22, it was estimated 99.5% of infections were omicron. It would be nice if we had the resources to sequence every case, because .5% of a big number is still a chunk of people, though of course it would only be a smaller number of that 0.5% who needed the MAB. With so many cases right now though, I don’t see how we possibly sequence all. At least Paxlovid works for both strains, though there are some contraindications for certain people.

The estimate is 99.9% omicron now. 

[KSera]

24 minutes ago, Matryoshka said:

This definitely shows vaccination is protective, even for younger kids.  Although I'm not sure babies would be highest in hospitalizations overall if this chart included the two most vulnerable age ranges.... I notice the lines for 65+ are absent here (they're in the key but the lines are missing - I can't imagine it's because they're at 0).  From what I've seen locally, those are still the bulk of the hospitalizations overall - which I wouldn't at all put down to the vax not being protective, but just that generally a lot of older people don't mount as an effective immune response to the vaccine as younger folk.  It's still hugely protective.

Yeah, I went and found the original source and viewed it with all lines present. I will paste below, except I could only get part of the chart screen shorted because it doesn’t display well on the phone. It looks like they removed the oldest age groups so that the scale for the younger age groups could be expanded to show more clearly the differences between them.

[Matryoshka]

Just now, KSera said:

Yeah, I went and found the original source and viewed it with all lines present. I will paste below, except I could only get part of the chart screen shorted because it doesn’t display well on the phone. It looks like they removed the oldest age groups so that the scale for the younger age groups could be expanded to show more clearly the differences between them.

Yeah, that's exactly why I thought they did that. It more clearly shows the huge leap in the infant group without the noise from the still vulnerable old folks.

[KSera]

1 minute ago, Matryoshka said:

Yeah, that's exactly why I thought they did that. It more clearly shows the huge leap in the infant group without the noise from the still vulnerable old folks.

It would be useful to know how many of those babies were born positive and how many were admitted for Covid. Either way is very meaningful, as omicron is affecting small children and babies upper airways particularly, which is very risky for a newborn baby.

[BeachGal]

@KSera My phone won’t let me quote but that is going to be an interesting vaccine to watch! Is it being developed in Japan? I can’t remember. It will be very exciting if it works. 🤞🏼

[scholastica]

4 hours ago, Fritz said:

Here it is an almost even split of unvaccinated and vaccinated being hospitalized. May be different in your area.

I would love to see the data for your area on that. Your area would definitely be an outlier if that is the case. They would probably need to figure out why that happened? Bad batch of vaccines, vaccines not handled or administered properly. Would be an interesting study.

[whitestavern]

CT is running about 50/50 as well. 

[melmichigan]

10 hours ago, Fritz said:

My understanding is the FDA has made the assumption that all cases are Omicron when in fact Delta is still circulating as well. 

Based on sequencing, what some are assuming is omicron, based on the PCR test alone, is actually BA.2, which shows the same as delta and previous strains.  Only running genetic sequencing can determine the difference anymore and that is happening in very few places.

[KSera]

4 hours ago, BeachGal said:

@KSera My phone won’t let me quote but that is going to be an interesting vaccine to watch! Is it being developed in Japan? I can’t remember. It will be very exciting if it works. 🤞🏼

It's out of Yale. One of the lead researchers is Prof. Akiko Iwasaki:

https://twitter.com/VirusesImmunity/status/1486510697332842498?s=20&t=ScGNO2eMUS8p8reMcicc_A

1 hour ago, whitestavern said:

CT is running about 50/50 as well. 

In Connecticut, hospitalization rates is 8 times higher in unvaccinated currently (death rate is 13 times higher in unvaccinated):

 

Connecticut has a super high vaccination rate (92% of the population has one dose and 76% is fully vaccinated), so you can't extrapolate how effective the vaccine is just from raw numbers of who is in the hospital, you have to calculate the relative risk according to vaccination rate. If there was no difference from the vaccine, 92% of the people hospitalized would be vaccinated.

[Lady Florida.]

7 hours ago, scholastica said:

I would love to see the data for your area on that. Your area would definitely be an outlier if that is the case. They would probably need to figure out why that happened? Bad batch of vaccines, vaccines not handled or administered properly. Would be an interesting study.

Yes. Every day my local hospital system makes posts like this one. And every day it's 95% or higher unvaccinated. The past few days it's been around 99%. 

 

 

[KSera]

37 minutes ago, Lady Florida. said:

Yes. Every day my local hospital system makes posts like this one. And every day it's 95% or higher unvaccinated. The past few days it's been around 99%. 

 

 

Wow. Is your vaccination rate super low in your area (I know Florida is not known for high vaccination rates, but I don’t know exactly where you are and how it differs by area)?

[kokotg]

4 hours ago, whitestavern said:

CT is running about 50/50 as well. 

Here are the relative risks in CT (https://portal.ct.gov/-/media/Coronavirus/CTDPHCOVID19summary01272022.pdf😞

Compared to being vaccinated, being unvaccinated currently has the following relative risk:

• 3 Times higher risk of being infected with COVID-19

• 13 Times higher risk of dying from COVID-19

• 8 Times higher risk of being hospitalized with COVID-19

ETA: oops...I see this has already been posted!

Edited January 29, 2022 by kokotg

[kokotg]

Here's a major hospital system in my area. I notice they've just started breaking down by whether people have been boosted or not, which makes the difference even more stark: 

 

[KSera]

10 minutes ago, kokotg said:

Here's a major hospital system in my area. I notice they've just started breaking down by whether people have been boosted or not, which makes the difference even more stark: 

 

Yes, booster makes a HUGE difference with omicron. A study I saw today put it at 99% reduction in hospitalization. The above charts are still misleading to people who don’t understand relative risk reduction according to how much of the population is vaccinated—the effect is even bigger than it appears there. Presumably, like everywhere else, the percentage vaccinated in the area is much higher than the percent they represent of those hospitalized.