OMICRON VARIANT UPDATE:
Two of the three monoclonal antibodies FDA-authorized for COVID-19 in the United States, REGEN-COV and bam/ete, are ineffective against the Omicron variant. As such, new shipments of REGEN-COV and bam/ete to Kentucky have ended as of January 3, 2022. The third FDA-authorized monoclonal antibody, sotrovimab, is available nationwide in only very limited quantities. Unless sotrovimab supplies increase and/or new monoclonal antibodies effective against the Omicron variant are released, supplies in Kentucky will be extremely limited and many treatment locations will not have monoclonal antibodies to offer at their sites. We urge all eligible persons 5 and older to get vaccinated and/or boosted with a Moderna or Pfizer mRNA COVID-19 vaccine to prevent serious and/or life-threatening COVID-19 disease.
Kentucky is receiving limited quantities of EVUSHELD from the U.S. Department of Health and Human Services and is distributing them to the medical facilities identified below.
A referral letter from the patient’s treating physician documenting their immunocompromising condition and proof of prior COVID-19 vaccination will assist in efficiently determining patient eligibility for EVUSHELD in Kentucky.
What is a monoclonal antibody?
A monoclonal antibody is a laboratory-made protein that mimics your immune system’s ability to fight off harmful viruses that can cause disease. It is a treatment that may make your COVID-19 disease less severe and hasten your recovery. Monoclonal antibody treatment is not a substitute for a COVID-19 vaccine.
Who can receive a monoclonal antibody treatment?
If you test positive for COVID-19 and meet the following criteria, you may be eligible to receive a monoclonal antibody treatment:
- Not hospitalized
- 12 years of age or older and weigh at least 88 lbs.
- Have mild to moderate symptoms of COVID-19 that started less than 10 days ago
- At higher risk for severe COVID-19 infection due to any of the below:
- Age 65 years or older
- Overweight or obese (may include a Body Mass Index (BMI) of > 25 for adults or > 85th percentile for children)
- Diabetes (Type I or Type II)
- Chronic kidney disease
- Immunosuppressive disease or taking medication that suppresses the immune system
- Cardiovascular disease (including congenital heart disease) or hypertension (high blood pressure)
- Chronic lung disease such as chronic obstructive pulmonary disease (COPD), moderate to severe asthma, cystic fibrosis, or pulmonary hypertension
- Sickle cell disease
- Neurodevelopmental disorders such as cerebral palsy
- Medical-related technological dependence (tracheostomy, gastrostomy, or ventilation not related to COVID)
A physician referral or clinician evaluation is necessary to receive monoclonal antibody treatment. If you believe you meet the criteria above, reach out to your healthcare provider to discuss this option or seek evaluation at a monoclonal antibody center that provides eligibility screenings.
Monoclonal Antibody Treatment
- Fights Coronavirus with manufactured antibodies
- Administered through IV infusion or multiple injections within 10 days of a positive COVID-19 test
- May be out of pocket cost
- Limited availability, short treatment window, & protections for less than 90 days
- Under FDA Emergency Use Authorization (EUA)
- 70-85% effective in reducing severe disease, hospitalization, or death
- Defends against Coronavirus with your own immune system and antibodies
- Administered in one or two injections before infection
- No out of pocket cost
- Readily available, nearly all persons 12 and older eligible, & protection for more than 8 months
- FDA approved and/or Under EUA
- Greater than 99% effective in reducing severe disease, hospitalization, or death