Monoclonal Antibody Tx Authorized by FDA for Postexposure Prophylaxis for COVID-19

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FHEA Faculty

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Monoclonal Antibody Tx Authorized by FDA for Postexposure Prophylaxis for COVID-19

The FDA revised the emergency use authorization (EUA) for the monoclonal antibodies bamlanivimab and etesevimab, administered together, to include emergency use as postexposure 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, administered together, are authorized for use after exposure to the virus and are not authorized for preexposure prophylaxis to prevent COVID-19 before being exposed to SARS-CoV-2 virus. Healthcare providers should review the FDA’s Fact Sheet for detailed information about the use of this therapy for postexposure prophylaxis as well as information about clinical trials of this therapy and its side effects.

Bamlanivimab and etesevimab, administered together, remains authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

“Postexposure prophylaxis as authorized with bamlanivimab and etesevimab, administered together, is not a substitute for vaccination against COVID-19,” the FDA notes.

Bamlanivimab and etesevimab, administered together, can only be used as postexposure 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 (eg, people with immunocompromising conditions, including those taking immunosuppressive medications), and
  • have been exposed to an individual with SARS-CoV-2 infection consistent with close contact criteria (per the 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 (eg, nursing homes or prisons).

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Editor’s note: this post was originally published on September 29, 2021 and updated on May 20, 2024.

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