FDA authorizes Bamlanivimab and Etesevimab for Post-exposure prophylaxis (Prevention) for COVID-19

The U.S. Food and Drug Administration authorizes bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

Bamlanivimab and etesevimab are monoclonal antibodies.

In this EUA, bamlanivimab and etesevimab, administered together, are authorized for use after exposure to the virus and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus.

Post-exposure prophylaxis with Bamlanivimab and Etesevimab, administered together, is not a substitute for vaccination against COVID-19

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Who to Treat?

Bamlanivimab and etesevimab, administered together, may only be used as post-exposure prophylaxis for adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are:

at high risk for progression to severe COVID-19, including hospitalization or death, and

not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people 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 Centers for Disease Control and Prevention (CDC), or
who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)