Monoclonal antibody as vaccine

Posted by sstillwell @sstillwell, Sep 3, 2021

Has anyone participated in a monoclonal vaccine trial in lieu of a viral vector or mRNA vaccine? If so how is it going? Any changes in labs?

Thank you,

Susan

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Hi Susan,
I posted this to your earlier post, but thought it bears repeating here too. Monoclonal therapy is not a vaccine and is not a replacement for getting vaccinated. It is my understanding that monoclonal antibody therapy has emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together). This monoclonal antibody therapy is for adults and children over 12 who are at high-risk of hospitalization or death after a known exposure to someone with COVID-19.

The FDA states that:
"Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible."

Here's more information:
– FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19

It doesn't look like a one vs the other situation but rather vaccination is recommended and monoclonal therapy is an option if you've have exposure to COVID-19 and are in a high-risk category. Have you been exposed to someone with COVID?

REPLY
@colleenyoung

Hi Susan,
I posted this to your earlier post, but thought it bears repeating here too. Monoclonal therapy is not a vaccine and is not a replacement for getting vaccinated. It is my understanding that monoclonal antibody therapy has emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together). This monoclonal antibody therapy is for adults and children over 12 who are at high-risk of hospitalization or death after a known exposure to someone with COVID-19.

The FDA states that:
"Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible."

Here's more information:
– FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19

It doesn't look like a one vs the other situation but rather vaccination is recommended and monoclonal therapy is an option if you've have exposure to COVID-19 and are in a high-risk category. Have you been exposed to someone with COVID?

Jump to this post

I wonder if Darstumamab Is a portion of the Covid vaccine sequencing.

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@flcrakr1

I wonder if Darstumamab Is a portion of the Covid vaccine sequencing.

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Daratumumab injection is used alone or together with other medicines to treat multiple myeloma. Do you have multiple myeloma, @flcrakr1?

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@colleenyoung

Hi Susan,
I posted this to your earlier post, but thought it bears repeating here too. Monoclonal therapy is not a vaccine and is not a replacement for getting vaccinated. It is my understanding that monoclonal antibody therapy has emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together). This monoclonal antibody therapy is for adults and children over 12 who are at high-risk of hospitalization or death after a known exposure to someone with COVID-19.

The FDA states that:
"Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible."

Here's more information:
– FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19

It doesn't look like a one vs the other situation but rather vaccination is recommended and monoclonal therapy is an option if you've have exposure to COVID-19 and are in a high-risk category. Have you been exposed to someone with COVID?

Jump to this post

If you have received both vaccines and develop COVID and receive Regeneron, how soon should be tested for Covid after receiving Regeneron. Do you have to self isolate for a period of time?

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@jam5

If you have received both vaccines and develop COVID and receive Regeneron, how soon should be tested for Covid after receiving Regeneron. Do you have to self isolate for a period of time?

Jump to this post

Back in June when the therapy was first given limited authorization, people were advised to isolate but vaccination status was not addressed, nor was the need to be tested. (https://www.reuters.com/business/healthcare-pharmaceuticals/us-authorizes-lower-dose-regenerons-covid-19-antibody-therapy-2021-06-04/)

There didn't seem to be a direct answer on the Regeneron Patient info site https://www.regencov.com/patient, but there is a phone number you can call for further help: 1-877-332-6585

Each state department of health has its own guidelines for isolation and testing by people exposed to Covid, depending on the closeness of contact and vaccination status. So if you can't get good guidance from the sources above, or your physician, I would suggest that you check your state guidelines.

I hope this helps you find the answers you need.
Sue

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I am taking Tacrolimus for MCD. I have taken the Pfizer vaccine including the booster. I did not develop antibodies. I am going on winter vacation for two months in Florida. I have read up on the Regeneron cocktail for immunosuppressed people. Has anyone taking this treatment prophylactic? What are your thoughts about prophylactic antibodies treatment?

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@codered032

I am taking Tacrolimus for MCD. I have taken the Pfizer vaccine including the booster. I did not develop antibodies. I am going on winter vacation for two months in Florida. I have read up on the Regeneron cocktail for immunosuppressed people. Has anyone taking this treatment prophylactic? What are your thoughts about prophylactic antibodies treatment?

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Hi @codered032 I just replied to another post of yours regarding being on Tacrolimus for your chronic kidney disease and having side effects.

I wondered if it’s your nephrologist or is it your PCP who has you on Tacrolimus? Do you have labs run routinely to check the amount of tacro in your blood. Checking the trough is very important as Tacro can be really rough on the kidneys, and of course, if you have a dose in your system that’s too high, your immune system will be compromised to a greater level.
Tacrolimus is a very strong anti-inflammatory drug but too much causes a host of other issues.

This is the latest regarding Regeneron and who can receive the medication:
“Regeneron monoclonal antibody therapy is for use in adult and pediatric patients (12 and older) who have either been diagnosed or exposed to someone with COVID-19 and are at high risk for progression to severe illness. The treatment is most effective when given early, and the sooner it is given the better.”

From what I’m reading the effect is short lived and should only be used if an immo compromised patient has been directly exposed to covid.

Depending on where you’re going in Florida, if you’re exposed or develop Covid here is a site where you can find Regeneron clinics in Florida.
https://cdr-healthmed.com/covidtreatment/

Just be very cautious to continue to follow all the Covid protocol for avoiding infections such as wearing a mask, washing hands, avoid exposure to people in restaurants and anywhere there are crowds. I’ll be down there for the next 2 months as well so I know it’s a concern. I’m also immuno compromised but will still be wearing my mask. Have fun!

Back to the Tacro question…do you know what your blood level is? What are your side effects?

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