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« Last edited by Joel on July 19, 2021, 01:49:19 AM »

Author Topic: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread  (Read 764853 times)

Offline yesitsme

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« Last Edit: August 29, 2021, 05:00:31 PM by TimT »

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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4762 on: August 29, 2021, 05:46:28 PM »
Anyone have any info on monoclonal antibodies being used as a prophylaxis?

(*pre-exposure, high risk)
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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4764 on: August 29, 2021, 07:20:38 PM »
Anyone have any info on monoclonal antibodies being used as a prophylaxis?

(*pre-exposure, high risk)

I believe I read this was to be studied clinically in GSK’s Sotrovimab, but I’m not sure if that’s underway.

The three current EUA-approved monoclonal antibody treatments are only approved for high risk patients with mild to moderate COVID that hasn’t progressed beyond a certain stage. AFAIK there isn’t any monoclonal antibody treatment EUA-approved for preventing a COVID-19 infection, nor study data supporting this.

ETA:

A prophylaxis study is planned in uninfected immunocompromised adults to determine whether IM-administered sotrovimab can prevent symptomatic COVID-19 infection.

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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4765 on: August 29, 2021, 07:35:46 PM »
I believe I read this was to be studied clinically in GSK’s Sotrovimab, but I’m not sure if that’s underway.

The three current EUA-approved monoclonal antibody treatments are only approved for high risk patients with mild to moderate COVID that hasn’t progressed beyond a certain stage. AFAIK there isn’t any monoclonal antibody treatment EUA-approved for preventing a COVID-19 infection, nor study data supporting this.

ETA:

It's currently FDA approved for post-exposure prophylaxis:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19

I have a relative who was given it without exposure in lieu of a booster. I'm wondering if there's any data on that or if we're back to village medicine.
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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4766 on: August 29, 2021, 07:40:40 PM »
After infection or vaccination, B cells are stimulated to make antibodies, which degrade after just a month or so.  The reason our antibody levels stay high for longer than that is because our B cells keep making more.  If monoclonal antibodies are infused, there's no virus to stimulate the B cells, so after a month, the antibody levels start to drop precipitously.   That's fine for someone getting monoclonals after an infection, since you need the antibodies only during that initial period.

Using monoclonal antibodies pre-exposure would require getting another shot every month, so wouldn't seem to be manageable on a large scale.  But AstraZeneca found a way to modify the antibodies - substituting some amino acids - so that the antibody isn't broken down in the usual way and can remain longer term.

They just reported that Provent, their  monoclonal antibody drug, shows promise.  It wouldn't be for everyone, but for people who can't get the vaccine because they're immunocompromised.

https://www.reuters.com/business/healthcare-pharmaceuticals/astrazenecas-covid-19-antibody-therapy-meets-main-goal-late-study-2021-08-20/
https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html

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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4767 on: August 29, 2021, 07:47:31 PM »
After infection or vaccination, B cells are stimulated to make antibodies, which degrade after just a month or so.  The reason our antibody levels stay high for longer than that is because our B cells keep making more.  If monoclonal antibodies are infused, there's no virus to stimulate the B cells, so after a month, the antibody levels start to drop precipitously.   That's fine for someone getting monoclonals after an infection, since you need the antibodies only during that initial period.

Using monoclonal antibodies pre-exposure would require getting another shot every month, so wouldn't seem to be manageable on a large scale.  But AstraZeneca found a way to modify the antibodies - substituting some amino acids - so that the antibody isn't broken down in the usual way and can remain longer term.

They just reported that Provent, their  monoclonal antibody drug, shows promise.  It wouldn't be for everyone, but for people who can't get the vaccine because they're immunocompromised.

https://www.reuters.com/business/healthcare-pharmaceuticals/astrazenecas-covid-19-antibody-therapy-meets-main-goal-late-study-2021-08-20/
https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html

Here's how I'm understanding it, and please correct me if I'm wrong: taking the monoclonal shot may actually be harmful, if it means you can't get a vaccine shot for 3 months and the antibodies are gone after a month. The benefits of preventing an infection post-exposure may outweigh the downside, hence the FDA EUA.
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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4768 on: August 29, 2021, 07:57:21 PM »
Here's how I'm understanding it, and please correct me if I'm wrong: taking the monoclonal shot may actually be harmful, if it means you can't get a vaccine shot for 3 months and the antibodies are gone after a month. The benefits of preventing an infection post-exposure may outweigh the downside, hence the FDA EUA.
I wrote too quickly.  The monoclonal antibodies would START to degrade after about a month, not that they suddenly drop to 0.  They gradually decline, and by about 3 months they're low enough that they chose that time point to allow the vaccine.  I think I made it sound as if you'd be protected for one month, then be unprotected for two months before the vaccine, but that's not what it means. 

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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4769 on: August 29, 2021, 07:59:25 PM »
Could it be this person got Provent, and was in the clinical trial? 

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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4770 on: August 29, 2021, 08:06:11 PM »
Actually, that Regeneron link you posted does seem to hint that their monoclonal could be used pre-exposure, repeated monthly.  I deleted stuff.... to make it readable

REGEN-COV may only be used as post-exposure prophylaxis for adults ... who are:

...not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and....

who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)
......
....For individuals who remain at high risk of exposure to another individual with SARS-CoV-2 for longer than 4 weeks, and who are not expected to mount an adequate immune response to full SARS-CoV-2 vaccination, following an initial dose ...repeat doses ....once every 4 weeks are appropriate for the duration of ongoing exposure.

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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4771 on: August 29, 2021, 08:18:24 PM »
Could it be this person got Provent, and was in the clinical trial?

No, this was one of those, "The ID doc who sits a few tables away in shul said he can give me..."

Actually, that Regeneron link you posted does seem to hint that their monoclonal could be used pre-exposure, repeated monthly.  I deleted stuff.... to make it readable

What I understood from that was that it is specifically for people who will be exposed and may not mount an adequate immune response, and only for the duration of that exposure. There has to be a downside to taking the shots without exposure, or they would be giving all high-risk or immunocompromised individuals regular shots, no?
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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4772 on: August 29, 2021, 08:33:22 PM »
No, this was one of those, "The ID doc who sits a few tables away in shul said he can give me..."
Doctors may prescribe a drug off label, so I think he is allowed to do that.  Although the FDA specifically says it's not intended for pre-exposure.

Quote
What I understood from that was that it is specifically for people who will be exposed and may not mount an adequate immune response, and only for the duration of that exposure. There has to be a downside to taking the shots without exposure, or they would be giving all high-risk or immunocompromised individuals regular shots, no?
No, I don't think there's a downside - other than whatever side effects have been found with monoclonals in general.  It doesn't make so much sense to give it that way to all high-risk people because the vaccine is cheaper and doesn't require repeated treatments, and may have a higher efficacy.  In addition, it hasn't undergone clinical trials for this purpose, so there's no proof it would remain effective over time.  The AZ antibody just completed those clinical trials so perhaps by the end of the year it will be available for those people.

ETA: And IINM the third booster dose seems to increase antibodies in those who had a low response initially, so that's better than a monthly monoclonal.
« Last Edit: August 29, 2021, 08:38:49 PM by biobook »

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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4773 on: August 29, 2021, 09:35:06 PM »
Doctors may prescribe a drug off label, so I think he is allowed to do that.  Although the FDA specifically says it's not intended for pre-exposure.

I know. I wasn't knocking it, just saying it wasn't an official trial or anything like that.

No, I don't think there's a downside - other than whatever side effects have been found with monoclonals in general.  It doesn't make so much sense to give it that way to all high-risk people because the vaccine is cheaper and doesn't require repeated treatments, and may have a higher efficacy.  In addition, it hasn't undergone clinical trials for this purpose, so there's no proof it would remain effective over time.  The AZ antibody just completed those clinical trials so perhaps by the end of the year it will be available for those people.

ETA: And IINM the third booster dose seems to increase antibodies in those who had a low response initially, so that's better than a monthly monoclonal.

I'm not really getting it. If the vaccines are not generating a good enough response in some people, why are we not putting them solely on monthly antibodies shots? Or if something in the third shot is boosting the response to adequate levels, why aren't we giving that shot earlier or increasing the dosage of the first 2 shots? And why is all of this guidance regarding prophylaxis specifically for a known exposure? Isn't a big part of Covid's problem that most exposure is presymptomatic, and therefore harder to prevent? It seems like we're missing the opportunity to prevent a significant number of hospitalizations and severe cases.
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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4774 on: August 29, 2021, 10:45:37 PM »

I'm not really getting it. If the vaccines are not generating a good enough response in some people, why are we not putting them solely on monthly antibodies shots?

In general, you wouldn't want to use a drug in a way that it hasn't been tested (monthly rather than one-time), especially when treating people who are particularly vulnerable.  This AstraZeneca announcement a couple weeks ago seems to be the first clinical trial to test monthly shots and show that this could work.  It was a smaller trial than Pfizer's vaccine - 5000 people - but they say they think it could be available by the end of the year.  It would need to get approved and manufactured.  T T T

Quote
Or if something in the third shot is boosting the response to adequate levels, why aren't we giving that shot earlier or increasing the dosage of the first 2 shots?

It has to do with the way the immune system responds to the vaccine.  This is beyond my intro bio course, so I don't know how it works, or if it's even known, but what I saw recently was something about the maturation of the immune response over time.  So it's not that you need a higher dose in the beginning, but that you need to give the body time to ramp up after the first dose, and then it becomes able to respond more effectively to the second.  Actually there was one report that people did just as well when just half a dose was used for the first shot, then a regular dose for the second.  I think that was Moderna. 

Remember early on, when Pfizer/Moderna said doses should be 3-4 weeks apart, and England (and maybe Canada) wanted to give everyone one dose first, so they separated the doses by 8 or 12 weeks instead of 3-4.  When they later looked at antibody levels in those people, they found that 8 weeks was the sweet spot - More antibodies were eventually produced in that group than in those whose doses were separated by 4 or 12 weeks. 

I just found this CDC page on immunocompromised people and it's suggesting a third dose 4 wks after the 2nd.
 
"CDC recommends that people with moderately to severely compromised immune systems receive an additional dose of mRNA COVID-19 vaccine at least 28 days after a second dose of Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine."

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html



Quote
And why is all of this guidance regarding prophylaxis specifically for a known exposure? 
It could be it's just a matter of supply.  Monoclonals were first reserved to treat the infected elderly, obese, and those who seemed particularly vulnerable.  It seems it's more widely available now, but perhaps they want to maintain the supply for those with the highest medical need.

Quote
Isn't a big part of Covid's problem that most exposure is presymptomatic, and therefore harder to prevent? It seems like we're missing the opportunity to prevent a significant number of hospitalizations and severe cases.
That's why we have the vaccine.

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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4778 on: September 10, 2021, 05:32:29 AM »
Count me in. I’m not recommending that my older teens get the vaccine. And that would be true even if they didn’t have covid antibodies. The risk/ reward of an experimental vaccine with an EUA and a slight known risk of complications just isn’t compelling at their age.
https://www.google.com/amp/s/www.telegraph.co.uk/news/2021/09/09/teenage-boys-risk-vaccines-covid/amp/

“Young males are six times more likely to suffer from heart problems after being jabbed than be hospitalised from coronavirus, study finds“

For younger teenage males it ranges from 4 times more likely (periods of high hospitalization rates) to 23 times more likely (periods of low hospitalization).

Here’s the study (preprint):

https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1.full.pdf+html




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Re: COVID-19 (Wuhan Novel Coronavirus) Pandemic Master Thread
« Reply #4779 on: September 10, 2021, 07:11:44 AM »
Any info on the study they are talking about?
https://www.msn.com/en-us/health/watch/36-percent-of-americans-didnt-develop-covid-19-antibodies-after-contracting-it/vp-AAO9x2N?ocid=msedgdhp

Sounds too high to be accurate, likely science being quoted out of context for a hyperbolic headline.
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