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12.15.20

Monoclonal Antibodies FAQs

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Keri Barclay

Manager of Clinical Preparedness/Coalition Administrative Liaison

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COVID-19 guide

Updated: March 2, 2021

What are monoclonal antibodies?

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.1  “Monoclonal antibodies are basically antibodies that will attach to the spike protein of the SARS-CoV-2 virus (the virus that causes COVID-19). What it does is once it attaches to that spike protein, the virus cannot attach itself to the cells, thereby limiting the spread of the infection and preventing it from progressing further.”2

What monoclonal antibody therapies are available?

There currently are two therapies — bamlanivimab, and casirivimab and imdevimab — that have an emergency use authorization from the U.S. Food and Drug Administration for treatment of COVID-19. Additional details are below.

Monoclonal Antibody Therapies

What’s the difference between convalescent plasma and monoclonal antibodies?

Basically, monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Convalescent plasma is from patients who already have recovered from COVID-19 and may contain antibodies against the virus.

How do I request allocation of mAB for my facility?

Every two weeks on Tuesday from 10 a.m. to 4 p.m., there is a query in EMResource for this information. This query has been initiated to collect information related to a facility’s preference in receiving these treatment options and the quantity they are able to administer within the next two weeks. Failure to respond to the query will affect the amount of treatment allocated to the facility.

This query has been set up as “private,” which means that users only will be able to view data from their own associated facilities. We ask that each response be coordinated with the appropriate facility personnel, including pharmacy leadership, to ensure the most accurate data is collected.

Allotment — Are you requesting an allotment of bamlanivimab treatment this week? Bamlanivimab — How many doses of bamlanivimab are you requesting for administration in the next two weeks? Allotment — Are you requesting an allotment of casirivimab and imdevimab treatment this week? Casirivimab and imdevimab — How many doses of casirivimab and imdevimab are you requesting for administration in the next two weeks?

Accept — You would accept an allocation this week.

Decline — Short Term. You are declining allocation this week.

Decline — Long Term. You are declining allocation long term and will be removed from the query. You may reengage in the survey at any time by reaching out to MHA directly.

This is a number. How many doses would you like to have on hand to administer in the next two weeks?

Accept — You would accept an allocation this week.

Decline — Short Term. You are declining allocation this week.

Decline — Long Term. You are declining allocation long term and will be removed from the query. You may reengage in the survey at any time by reaching out to MHA directly.

This is a number. How many doses would you like to have on hand to administer in the next two weeks?

 

There is no shortage in supply of these drugs, and there is enough on hand to meet the needs of all treatment facilities. For this reason, both therapeutics (bamlanivimab and casirivimab/imdevimab) now are being made available through direct ordering only. All treatment sites meeting EUA requirements now must order bamlanivimab and casirivimab/imdevimab (when available for shipping) directly from AmerisourceBergen Corporation (ABC), the drugs’ sole distributor. The products remain free of charge to requesting sites. Treatment sites should review the direct ordering process guide and place orders directly with ABC.

 

What additional information is available to assist with decision-making and operational Implementation of this treatment for COVID-19?

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