On 7/30/2021, The FDA authorized an additional use for the COVID-19 monoclonal antibody therapeutic REGEN-COV (casirivimab and imdevimab). The REGEN-COV Emergency Use Authorization (EUA) has been expanded to include post-exposure prophylaxis for individuals who are at high risk for progression to severe COVID-19. Additional information regarding this announcement can be found here.
Nationwide distribution of bamlanivimab + etesivimab remains paused as it is not effective against the Gamma and Beta variants. MDHHS recommends immediately transitioning to REGEN-COV and/or sotrovimab. Additional information regarding this announcement can be found here.
What are monoclonal antibody therapies?
Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system's attack on cells. Monoclonal antibodies are designed to block viral attachment and entry into human cells, thus neutralizing the virus. It is designed to limit viral replication and may be effective for the treatment of COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
When administered to non-hospitalized patients as soon as possible after positive viral testing for SARS-CoV-2 and within 10 days of symptom onset, monoclonal antibodies may reduce viral load, symptoms, and risk of hospitalizations and emergency room visits associated with COVID-19. Information reported by the manufacturers to the food and drug administration indicates that among high-risk symptomatic individuals, there is a 70% reduction in hospitalizations and deaths. In a published article, REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load.
Monoclonal antibody treatment is for people who have tested positive for COVID-19 and have mild to moderate symptoms. These treatments are allowed by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) while clinical studies continue to look at their usefulness and safety. Casirivimab + imdevimab has recently been granted expanded authorization for post-exposure prophylaxis in select high-risk adult and pediatric populations.