Emergency Use Treatment for COVID-19

Things you should know about monoclonal antibodies

By Eugenia Jones

Many people are unaware of monoclonal antibodies, a therapy that was granted FDA Emergency Use Authorization and is effective against COVID-19.  Although it is definitely not a substitute for vaccination and not 100% successful, the drug is credited with often preventing severe disease for those who test positive for the virus and keeping patients out of the hospital.   

McCreary County’s State Senator Max Wise is hoping to bring more awareness and availability of monoclonal antibodies to the residents of Kentucky.

“We’re pushing for the monoclonal antibodies,” Wise said.  “We are looking at getting it out there, and will be working with Dr. Stack on it.”

Currently, the governors of Texas and Florida have opened state-sponsored sites where monoclonal antibody therapy is offered.  Louisiana and Utah have also expanded their use of the treatment.

Monoclonal antibodies imitate the body’s immune response to the coronavirus and spring into action while the body’s natural response is activating.  In order to be effective in preventing severe disease, the treatment needs to be administered within ten days after symptoms appear.  The treatment was recently expanded to be administered to high-risk individuals following a close contact exposure to prevent them from developing symptomatic COVID-19.

According to Tiffany McMinoway, MSN, APRN and Assistant Medical Director for Cumberland Family Medical Center, Inc., monoclonal antibodies (casirivimab/imdevimab injections) are currently being given as outpatient therapy at Whitley Family Medical Center.  Appalachian Family Care in Pine Knot is in line to begin administering the treatment in the near future and will currently refer patients for treatment.  Additional administration locations can be found at the following link:  https://protect-public.hhs.gov/pages/theraputics-distribution #distribution-locations. 

McMinoway stated the treatment has been given emergency use authorization for the treatment of mild to moderate VOCI-19 in high-risk patients ages 12 years and older weighing at least 88 pounds.  

High-risk is defined in the FDA Emergency Use fact sheet as (for adults):  older (65 and above), obese or overweight (BMI of 25 kg/m2 or above), pregnant, diabetic, or having chronic kidney disease.  High-risk also includes being immunocompromised, having cardiovascular disease/hypertension, chronic lung disease, sickle cell disease, neurodevelopmental disorders, or a medical-related technological dependency (tracheostomy, etc.).  Other medical conditions or factors may also put a patient at high-risk.  Pregnant women who receive treatment should consult their OB/GYN physicians, and children, due to limited data, should consult with infectious disease physicians.  

According to McMinoway, the only cost to the patient may be the cost of the procedure which will vary by insurance companies.  The monoclonal antibody itself is free.

“Whitley Family Medical Center is part of Cumberland Family Medical Centers (CFMC), Inc.,” McMinoway responded.  “In addition to Whitley Family Medical Center, we have other CFMC locations throughout the state that are administering COVID-19 monoclonal antibodies.  We began administering these in December 2020.  At this time, we have administered over 300 doses (throughout their clinics) and have seen success.”

Although the treatment is available at some hospitals, it is recommended for patients who do not require hospitalization due to COVID-19.

“With hospitals being so overwhelmed, offering this in clinic locations can decrease the burdens on hospitals and can prevent the need for hospitalization in high-risk COVID-19 patients,”

McMinoway stated.  “Patients who meet criteria can call the clinic to make an appointment.  If COVID-19 positive, the clinic will require a copy of their COVID-19 test results.  Additionally, they will make sure that the patient meets criteria prior to scheduling.”

In the past, monoclonal antibody treatment was only available intravenously.  At the end of July, 2021, the FDA updated the administration guidelines and now it can be administered subcutaneously in four injections (four shots.)  After receiving the antibody, the patient is monitored for one hour.

According to Susan Dunlap, Executive Director, Office of Public Affairs for Kentucky Cabinet for Health and Family Services, health care facilities order monoclonal antibodies directly from Amerisource Bergen through a program in partnership with the federal government.  According to Dunlap, the antibodies are administered by appropriately qualified health care providers to determine patient eligibility and are therefore more difficult to arrange.  

Dunlap emphasized the importance of vaccination and prevention so that treatment may be unnecessary.

“Unlike monoclonal antibodies that attempt to minimize harm once it has occurred, more than 4.9 billion doses of COVID-19 vaccine have been safely and effectively administered to approximately 1.9 billion person worldwide (WHO) 203 million Americans (CDC), and 2.5 million Kentuckians (CDC); COVID-19 vaccines prevent harm before it occurs and are the safest, most effective way for all person to reduce their risk of serious harm from COVID-19.”