Information Regarding Use of Monoclonal Antibodies for Treatment or Prevention of COVID-19

As COVID-19 cases rise in North Carolina, monoclonal antibodies remain an important tool to help slow the progression of the virus in our communities and reduce the overall strain on the healthcare system. 

The Food and Drug Administration has issued an Emergency Use Authorization to allow the use of monoclonal antibody therapies for the treatment of mild to moderate COVID-19 in certain high-risk patients. Additionally, the FDA authorized this treatment for use in some patients who are exposed to COVID-19 even if they do not have symptoms. People who are not fully vaccinated or who have immunocompromising conditions, including those taking immunosuppressive medications, and have either been exposed to COVID-19 or are at high risk of exposure due to where they live or work may qualify for preventative treatment.

Monoclonal antibody therapy must be administered within 10 days of the start of COVID-19 symptoms, so early testing is crucial. 

While authorized for emergency use since last November, there have been some recent changes related to monoclonal antibodies that have significantly increased the manageability and ease of administering these products:

• The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel gives monoclonal antibodies an “AIIa” rating, strongly recommending the use of these products to treat outpatients with mild to moderate COVID-19 who are at high-risk of clinical progression.
  
• The patient eligibility criteria for monoclonal antibodies were recently expanded, giving providers more freedom to use their clinical judgement in determining who meets the emergency use authorization (EUA) definition of being at high-risk for progression to severe COVID-19.
• REGEN-COVTM (casirivimab and imdevimab) (PDF) is now authorized to be administered via subcutaneous injection and in some cases can be used as post-exposure prophylaxis in high-risk patients who have been exposed to someone with COVID-19.

Additional resources

• See Monoclonal Antibody info, including how to order direct from USDHHS
  
• Monoclonal antibodies remain available at no cost from the federal government.  Interested providers, capable of adhering to the EUA requirements, can request product directly from AmerisourceBergen.
• Providers currently offering monoclonal antibodies in NC can be found using this COVID-19 Antibody Therapy Locator from the National Infusion Center Association (NICA).
• Provider FAQs for mAbs