On July 30, 2021, the US Food and Drug Administration (FDA) authorized an additional use for the COVID-19 monoclonal antibody therapy REGEN-COV (casirivimab and imdevimab). The REGENCOV Emergency Use Authorization (EUA) has been expanded to include post-exposure prophylaxis. This new authorization is in addition to the prior authorization of REGEN-COV to treat non-hospitalized patients with mild to moderate COVID-19 in adult and pediatric patients, age 12 and older, with positive results of a direct SARS-CoV-2 viral test, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
REGEN-COV is expected to be effective against circulating variants, including the Delta variant. It should be noted that post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19 and REGEN-COV is not authorized for pre-exposure prophylaxis. For both non-hospitalized treatment and post-exposure prophylaxis use, the authorized dose is 600 mg of casirivimab and 600 mg of imdevimab. For treatment of mild to moderate COVID-19, a single intravenous infusion is strongly recommended; however, subcutaneous injection may be an alternative if infusion is not feasible or would significantly delay treatment. For post-exposure prophylaxis, REGEN-COV may be administered as either subcutaneous injection or a single IV infusion. Please refer to the following links for full details about dosing and administration.
The new authorization is for post-exposure prophylaxis use:
- In adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
- Not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and
- Have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per CDC, or
- Who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of COVID-19 infection in other individuals in the same institutional setting (for example, nursing homes, home health, or prisons).
- Fact Sheet for Healthcare Providers: https://www.fda.gov/media/145611/download
- Clinical Management COVID-19 Treatment Guidelines: https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/
- Contact the West Virginia Poison Control Center at (800) 222-1222
For questions about this advisory, contact the Office of Epidemiology and Prevention Services (OEPS) at 1-800-423-1271, ext. 1; 304-558-5358, ext. 2; or the 24/7 answering service at 304-342-5151.
Wheeling-Ohio County Health Department
1500 Chapline Street, Room 106
Wheeling, WV 26003
Howard Gamble, MPH
Elizabeth Fowler, RN
Lock Johnson, RS
Threat Preparedness Director
WHEELING-OHIO COUNTY HEALTH DEPARTMENT PRESS RELEASE November 28, 2021 (1:00pm) Wheeling-Ohio County Health Department is announcing One Hundred and Twenty-Two (122) new cases of COVID-19 in Ohio County since November 21, 2021. This includes 16 cases under the age of 18 years of age. Case surveillance, contact tracing, and monitoring continue for many of the reported cases. Wheeling-Ohio County Health Department COVID-19 Testi...Full Article