Monoclonal antibody as vaccine

Posted by sstillwell @sstillwell, Sep 3 12:33pm

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

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.

REPLY
@flcrakr1

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

Jump to this post

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

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

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?

REPLY
@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

REPLY
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